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Last updated: 19 Apr 2016

Glatiramer acetate

Summary
Trade name: 
Copaxone
(25)
Our Products (page shows "Copaxone" as a trade name for glatiramer acetate)
Teva
Accessed on 4 Jan 2012 from http://www.tevapharm.com/en-US/Products/Pages/default.aspx.
Glatopa (generic)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Polimunol (Synthon; marketed in Argentina as a generic version as of May 2014)
(242)
Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition.
Hasson T, Kolitz S, Towfic F, Laifenfeld D, Bakshi S, Beriozkin O, Shacham-Abramson M, Timan B, Fowler KD, Birnberg T, et al.
J Neuroimmunol. 2016 Jan 15; 290:84-95. Epub 2015 Nov 24. PMID: 26711576. Abstract
Class: 
Immunomodulator
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Neuroprotector
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Target: 
Immune cells
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
26S proteasome-mediated degradation of myelin basic protein
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Status for MS: 
Approved in US (1996), EU, and other countries for RRMS
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
(7)
Drugs@FDA (Enter "glatiramer acetate" in search box.)
FDA
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Approved in US (2009) and other countries for treating CIS patients in cases suggestive of MS
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
(7)
Drugs@FDA (Enter "glatiramer acetate" in search box.)
FDA
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Generic version has been approved in US (2015)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Generic version has been approved in Europe (2016)
(253)
Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon, 12 Apr 2016
Accessed on 19 Apr 2016 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-obtains-approval-for-glatiramer-acetate-20-mg-mL-in-Europe.aspx.
Administration: 
Involves daily subcutaneous injection, according to information from the US Food and Drug Administration
(29)
Full Prescribing Information, Copaxone (glatiramer acetate)
FDA, Feb 2009
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf.
Prefilled syringes contain 20 mg glatiramer acetate in solution
(23)
Copaxone
Drugs.com, Sep 2011
Accessed on 4 Jan 2012 from http://www.drugs.com/pro/copaxone.html.
(29)
Full Prescribing Information, Copaxone (glatiramer acetate)
FDA, Feb 2009
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf.
Three-times-weekly (40 mg/1 ml) subcutaneous injection has been approved by the US Food and Drug Administration
(126)
Teva announces U.S. FDA approval of three-times-a-week COPAXONE® (glatiramer acetate injection) 40mg/mL
Market Watch, The Wall Street Journal, 28 Jan 2014
Accessed on 30 Jan 2014 from http://www.marketwatch.com/story/teva-announces-us-fda-approval-of-three-times-a-week-copaxone-glatiramer-acetate-injection-40mgml-2014-01-28?reflink=MW_news_stmp.
Intramuscular version (GA Depot, which consists of microspheres containing glatiramer acetate) given once every 4 weeks is being tested in a Phase IIa study that began December, 2014
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Nasal administration appears effective in experimental autoimmune encephalomyelitis mice
(76)
Nasal administration of drugs as a new non-invasive strategy for efficient treatment of multiple sclerosis.
Duchi S, Ovadia H, Touitou E
J Neuroimmunol. 2013 Mar 18. PMID: 23517929. Abstract
Commercial: 
In North America, marketed by Teva Neuroscience, a subsidiary of Teva Pharmaceutical Industries
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
In Europe, marketed by Teva Pharmaceutical Industries and Sanofi-aventis
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
Sales and marketing rights in the EU have been taken back from Sanofi by Teva (May 2012)
(34)
Teva Pharmaceutical Industries Limited's CEO Discusses Q1 2012 Results - Earnings Call Transcript
SeekingAlpha.com, 9 May 2012
Accessed on 15 May 2012 from http://seekingalpha.com/article/575201-teva-pharmaceutical-industries-limited-s-ceo-discusses-q1-2012-results-earnings-call-transcript.
Teva has attempted to delay marketing approval of generic versions of Copaxone through legal measures against other companies and regulatory channels; Teva's fourth petition to US Food and Drug Administration, asking that marketing for a generic version would not be approved without clinical trials, was denied, as the previous three had been (5 December 2012)
(60)
FDA denies Teva Copaxone generic trials petition
Globes, Israel Business News, 5 Dec 2012
Accessed on 10 Dec 2012 from http://www.globes.co.il/serveen/globes/docview.asp?did=1000804017&fid=1725.
Application for a US patent for a Copaxone-Laquinimod mixed treatment (which would be administered via an injection) for MS has been filed by Teva (13 February 2013)
(69)
BRIEF: Teva files for Copaxone-Laquinimod patent
Middle East North Africa Financial Network, 13 Feb 2013
Accessed on 18 Feb 2013 from http://www.menafn.com/menafn/46d9c3c8-74ec-4f41-a64f-6aa0560bdea7/BRIEF-Teva-files-for-CopaxoneLaquinimod-patent?src=main.
Application for US Food and Drug Administration (FDA) approval for a 40 mg/1 ml three-times weekly dose of Copaxone has been filed by Teva (March, 2013)
(87)
UPDATE 1-Teva Pharmaceutical banks on thrice-weekly Copaxone
Cohen T, Reuters, 2 May 2013
Accessed on 5 May 2013 from http://www.reuters.com/article/2013/05/02/tevapharm-results-idUSL6N0DJ35O20130502.
and accepted for review by the FDA (30 May 2013)
(92)
Teva announces FDA acceptance of sNDA for a higher concentration dose of COPAXONE® given three times a week
Business Wire, 30 May 2013
Accessed on 31 May 2013 from http://www.businesswire.com/news/home/20130530005718/en/Teva-Announces-FDA-Acceptance-sNDA-Higher-Concentration.
Patent covering the use of a combination of estriol and glatiramer acetate for treating MS has been issued to the Regents of the University of California by the US Patent & Trademark Office (4 April 2013)
(78)
Synthetic Biologics announces issuance of U.S. patent covering combination of estriol and Copaxone® for multiple sclerosis
Synthetic Biologics, 4 Apr 2013
Accessed on 8 Apr 2013 from http://www.syntheticbiologics.com/2013-04-04-Synthetic-Biologics-Announces-Issuance-of-U-S-Patent-Covering-Combination-of-Estriol-and-Copaxone-for-Multiple-Sclerosis.
US patent for a long-acting formulation (a prolonged-release version now under development that would be injected once a month rather than daily) has been granted to Mapi Pharma Ltd (6 May 2013)
(88)
Mapi Pharma granted United States patent covering glatiramer depot for multiple sclerosis
Mapi Pharma, 6 May 2013
Accessed on 21 May 2013 from http://www.mapi-pharma.com/news/?pid=30.
Will lose patent protection in 2014 instead of 2015 on the basis of a US appeals court ruling; Novartis and Momenta Pharmaceuticals are developing a generic version together, as are Mylan Inc and Natco Pharma (26 July 2013)
(101)
US court permits generic version of Teva MS drug a year sooner
Bartz D, Pierson R, Reuters, 26 Jul 2013
Accessed on 29 Jul 2013 from http://www.reuters.com/article/2013/07/26/teva-copaxone-patent-idUSL1N0FW17H20130726.
Validity of Teva's patent protection is upheld until May 2015 by the Court of Appeal for England and Wales (29 July 2013)
(103)
English Court of Appeal finds in favor of Teva on Copaxone(R) patent litigation and upholds validity of Copaxone patent until May 2015
Market Watch, The Wall Street Journal, 29 Jul 2013
Accessed on 8 Aug 2013 from http://www.marketwatch.com/story/english-court-of-appeal-finds-in-favor-of-teva-on-copaxoner-patent-litigation-and-upholds-validity-of-copaxone-patent-until-may-2015-2013-07-29?reflink=MW_news_stmp.
Commercialization rights in Japan have been granted to Takeda Pharmaceutical Company by Teva Pharmaceutical Industries; a New Drug Application to register the drug in Japan will be submitted by Takeda (announced 4 December 2013)
(119)
Teva and Takeda announce agreement for glatiramer acetate for multiple sclerosis treatment in Japan
The Wall Street Journal, 4 Dec 2013
Accessed on 4 Dec 2013 from http://online.wsj.com/article/PR-CO-20131204-902576.html?dsk=y.
New Drug Application for use of glatiramer acetate in Japan to prevent relapses in MS has been submitted by Takeda Pharmaceutical Company to the Japanese Ministry of Health, Labour and Welfare (25 December 2014)
(190)
Takeda Submits a New Drug Application for Glatiramer Acetate in Japan for the Relapse Prevention of Multiple Sclerosis
Takeda, 25 Dec 2015
Accessed on 6 Jan 2015 from https://www.takeda.com/news/2014/20141225_6846.html.
Three-times-weekly (40 mg/1 ml) Copaxone dose has been approved by the US Food and Drug Administration (28 January 2014)
(126)
Teva announces U.S. FDA approval of three-times-a-week COPAXONE® (glatiramer acetate injection) 40mg/mL
Market Watch, The Wall Street Journal, 28 Jan 2014
Accessed on 30 Jan 2014 from http://www.marketwatch.com/story/teva-announces-us-fda-approval-of-three-times-a-week-copaxone-glatiramer-acetate-injection-40mgml-2014-01-28?reflink=MW_news_stmp.
Generic version is being developed by Synthon; Phase III clinical trial is underway (March, 2014)
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
US Supreme Court will hear Teva's appeal of the decision of a lower court that invalidated the claim of a US patent that covers the manufacture of the active ingredient in Copaxone and that expires in September 2015 (31 March 2014)
(137)
Teva Announces U.S. Supreme Court Will Hear Its Appeal on COPAXONE(R) Patent
The Wall Street Journal, 31 Mar 2014
Accessed on 2 Apr 2014 from http://online.wsj.com/article/PR-CO-20140331-910272.html.
US Supreme Court will not prevent a lower-court ruling (favoring generic versions of glatiramer acetate) from going into effect while the Supreme Court considers appeal (18 April 2014)
(141)
US top court denies Israel's Teva Pharmaceuticals stay in Copaxone patent fight
The Jerusalem Post, 18 Apr 2014
Accessed on 5 May 2014 from http://www.jpost.com/Business/Business-News/US-top-court-denies-Israels-Teva-Pharmaceuticals-stay-in-Copaxone-patent-fight-349886.
US Patent to Mapi Pharma Ltd., covering "glatiramer acetate depot" (a prolonged release formulation), has been extended to December 2030 and an earlier patent has been awarded additional claims (27 May 2014)
(150)
Mapi Pharma Receives Additional Claims for Its U.S. Patent for Glatiramer Acetate Depot for the Treatment of Multiple Sclerosis
Market Watch, The Wall Street Journal, 27 May 2014
Accessed on 29 May 2014 from http://www.marketwatch.com/story/mapi-pharma-receives-additional-claims-for-its-us-patent-for-glatiramer-acetate-depot-for-the-treatment-of-multiple-sclerosis-2014-05-27.
Abbreviated new drug application from Mylan for generic three times per week glatiramer acetate 40 mg/ml has been accepted for filing by the US Food and Drug Administration (28 August 2014)
(165)
Mylan's ANDA for Three Times Per Week Generic Copaxone® 40 mg/mL Accepted for Filing by FDA
Mylan, 28 Aug 2014
Accessed on 2 Sep 2014 from http://www.mylan.com/news/press-releases/item?id=123246.
Three-times-weekly (40 mg/1 ml) Copaxone dose has received a positive outcome in Europe after a Positive Assessment Report from the Reference Member State’s Medicines and Healthcare Products Regulatory Agency and other EU member states (4 December 2014)
(181)
Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)
Teva Pharmaceutical Industries Ltd., 4 Dec 2014
Accessed on 9 Dec 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1995004.
Phase IIa study of GA Depot for treating RRMS has begun; study is being conducted by Mapi Pharma (December, 2014)
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
US Supreme Court reverses a decision by the Federal Circuit Court that invalidated one of Teva's patents for Copaxone; the case has been remanded to the Federal Circuit for further review (20 January 2015)
(191)
Teva Announces U.S. Supreme Court Decision to Reverse Federal Circuit Court’s Judgment on COPAXONE® 20 mg/mL Case and Remand for Further Review
Teva Pharmaceutical Industries, 20 Jan 2015
Accessed on 27 Jan 2015 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2008891.
; the US Court of Appeals for the Federal Circuit again invalidated the patent (18 June 2015)
(211)
Momenta Pharmaceuticals Announces CAFC Decision to Invalidate Remanded Teva Pharmaceuticals Patent in Daily COPAXONE(R) 20 mg Suit
Momenta, 18 Jun 2015
Accessed on 23 Jun 2015 from http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=918548.
Glatopa (a substitutable generic for Copaxone 20 mg), which was developed in a collaboration between Momenta Pharmaceuticals and Sandoz, has been approved by the US Food and Drug Administration for treating RRMS (16 April 2015)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Glatopa, a generic equivalent of Copaxone 20 mg, has been launched in the US by Sandoz, as announced by Momenta Pharmaceuticals (18 Jun 2015)
(212)
Momenta Pharmaceuticals Announces Launch of Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 18 Jun 2015
Accessed on 23 Jun 2015 from http://ir.momentapharma.com/releasedetail.cfm?releaseid=918623.
Exclusive commercialization rights in the US for the potential generic version being developed by Synthon have been acquired by Pfizer (3 August 2015)
(219)
Pfizer and Synthon Enter Into U.S. Commercialization Agreement for Potential Generic Treatment of Multiple Sclerosis
Synthon, 3 Aug 2015
Accessed on 5 Aug 2015 from http://www.synthon.com/Corporate/News/PressReleases/Pfizer-and-Synthon-Enter-Into-US-Commercialization-Agreement-for-Potential-Generic-Treatment-of-MS.aspx.
Copaxone (20 mg subcutaneous injection) has been approved in Japan for treating MS; the approval was obtained by Takeda Pharmaceutical Company (September 28, 2015)
(226)
Takeda Pharmaceutical: New Drug Application Approval in Japan for Copaxone® Subcutaneous Injection 20 mg Syringe, a Drug for the Treatment of Multiple Sclerosis
Business Wire, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.businesswire.com/news/home/20150928005506/en/Takeda-Pharmaceutical-Drug-Application-Approval-Japan-Copaxone®#.Vgr0Ps4buXs.
Three-times-weekly (40 mg/1 ml) Copaxone dose has been approved in Russia for treating RRMS (8 October 2015)
(230)
Teva Announces Approval of Three-Times-A-Week COPAXONE® 40 mg/mL in Russia for the Treatment of Relapsing-Remitting Multiple Sclerosis
Teva, 8 Oct 2015
Accessed on 13 Oct 2015 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2095367.
Synthon's generic version (20 mg/ml) has been approved in Europe on the basis of results from the GATE trial (12 April 2016)
(253)
Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon, 12 Apr 2016
Accessed on 19 Apr 2016 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-obtains-approval-for-glatiramer-acetate-20-mg-mL-in-Europe.aspx.
Names
Name: 
Glatiramer acetate
Trade name: 
Copaxone
(25)
Our Products (page shows "Copaxone" as a trade name for glatiramer acetate)
Teva
Accessed on 4 Jan 2012 from http://www.tevapharm.com/en-US/Products/Pages/default.aspx.
Glatopa (generic)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Polimunol (Synthon; marketed in Argentina as a generic version as of May 2014)
(242)
Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition.
Hasson T, Kolitz S, Towfic F, Laifenfeld D, Bakshi S, Beriozkin O, Shacham-Abramson M, Timan B, Fowler KD, Birnberg T, et al.
J Neuroimmunol. 2016 Jan 15; 290:84-95. Epub 2015 Nov 24. PMID: 26711576. Abstract
Synonyms: 
COP-1
(5)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Copaxone
(25)
Our Products (page shows "Copaxone" as a trade name for glatiramer acetate)
Teva
Accessed on 4 Jan 2012 from http://www.tevapharm.com/en-US/Products/Pages/default.aspx.
Copolymer-1
(5)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
GA
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
GA Depot
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
Glatopa
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
L-Glutamic acid peptide with L-alanine, L-lysine and L-tyrosine, acetate (salt)
(5)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
GTR
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
M356
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
UNII-5M691HL4BO
(5)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Systematic name: 
L-Glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt)
(5)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class: 
Immunomodulator
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Neuroprotector
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Target: 
Immune cells
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
26S proteasome-mediated degradation of myelin basic protein
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Properties: 
Designed to mimic myelin basic protein
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Random polymer of four residues found in myelin basic protein (L-glutamic acid, L-alanine, L-lysine, L-tyrosine)
(26)
Multiple sclerosis: clinical presentation, diagnosis and treatment.
Brod SA, Lindsey JW, Wolinsky JS
Am Fam Physician. 1996 Sep 15; 54(4):1301-6, 1309-11. PMID: 8816574. Abstract
Average molecular weight, 6.4 kDa
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Polar
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Not likely to cross the blood-brain barrier
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Binds to class II major histocompatibility complex molecules on antigen-presenting cells
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract

Mechanisms/Effects

Human: 
Exact mechanism unknown
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Is an immunomodulator that appears to normalize dysregulated immune system circuits in MS
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
May act as a universal antigen (induces in vitro proliferation of naive T cell populations from both healthy controls and MS patients)
(24)
Glatiramer acetate (Copaxone) induces degenerate, Th2-polarized immune responses in patients with multiple sclerosis.
Duda PW, Schmied MC, Cook SL, Krieger JI, Hafler DA
J Clin Invest. 2000 Apr; 105(7):967-76. PMID: 10749576. Abstract
Affects the function of many types of immune cells, including several types of T cells, dendritic cells, and natural killer cells
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Shifts CD4+ T cell response from Th1 (pro-inflammatory cytokine secreting T helper type 1) to Th2 (anti-inflammatory cytokine secreting T helper type 2)
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Upregulates cytotoxic CD8+ T cells to healthy levels
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Increases the capability of T regulatory cells (which suppress autoimmunity)
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Induces CD8+ T cell proliferative responses that are lower in individuals with untreated MS than in healthy individuals; over months, glatiramer acetate therapy upregulates the CD8+ T cell responses to levels seen in healthy people
(240)
Glatiramer acetate (Copaxone) therapy induces CD8(+) T cell responses in patients with multiple sclerosis.
Karandikar NJ, Crawford MP, Yan X, Ratts RB, Brenchley JM, Ambrozak DR, Lovett-Racke AE, Frohman EM, Stastny P, Douek DC, et al.
J Clin Invest. 2002 Mar; 109(5):641-9. PMID: 11877472. Abstract
Induces CD4+ T cell proliferative responses that are similar in healthy individuals and individuals with untreated MS
(240)
Glatiramer acetate (Copaxone) therapy induces CD8(+) T cell responses in patients with multiple sclerosis.
Karandikar NJ, Crawford MP, Yan X, Ratts RB, Brenchley JM, Ambrozak DR, Lovett-Racke AE, Frohman EM, Stastny P, Douek DC, et al.
J Clin Invest. 2002 Mar; 109(5):641-9. PMID: 11877472. Abstract
Induces cytotoxic CD8+ T cells that can kill CD4+ T cells
(241)
Therapeutic induction of regulatory, cytotoxic CD8+ T cells in multiple sclerosis.
Tennakoon DK, Mehta RS, Ortega SB, Bhoj V, Racke MK, Karandikar NJ
J Immunol. 2006 Jun 1; 176(11):7119-29. PMID: 16709875. Abstract
Increases the frequency of naïve T cells, decreases the frequency of central memory T cells (which is increased in MS patients), and increases the frequency of T-suppressor cells in RRMS patients
(40)
Immunoregulatory T cells in multiple sclerosis and the effect of interferon beta and glatiramer acetate treatment on T cell subpopulations.
Praksova P, Stourac P, Bednarik J, Vlckova E, Mikulkova Z, Michalek J
J Neurol Sci. 2012 Aug 15; 319(1-2):18-23. Epub 2012 Jun 05. PMID: 22676847. Abstract
Induces expression of interferon gamma and interleukin 4 mRNAs ex vivo in mononuclear cells from MS patients; expression above a certain threshold predicts a better response to glatiramer acetate in patients (a better chance of being relapse free and a better relapse-free survival rate)
(35)
Classification of individuals based on ex-vivo glatiramer acetate-induced interferon-γ and interleukin-4 response.
Gilli F, Navone ND, Valentino P, Granieri L, Perga S, Malucchi S, Bertolotto A
Mult Scler. 2012 Oct; 18(10):1484-92. Epub 2012 May 04. PMID: 22562951. Abstract
Increases the killing ability of natural killer cells from humans against dendritic cells
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Often increases the cytotoxic activity of natural killer (NK) cells (isolated from RRMS patients treated with glatiramer acetate) toward immortalized leukemia cells (an increased activity that correlates with increased expression of NK cell activating cytotoxicity receptors and reduced expression of CD158, an inhibitor molecule, on the NK cell surface); these NK cells can also lyse both autologous immature and mature dendritic cells
(85)
A One Year Follow-Up Study of Natural Killer and Dendritic Cells Activities in Multiple Sclerosis Patients Receiving Glatiramer Acetate (GA).
Høglund RA, Holmøy T, Harbo HF, Maghazachi AA
PLoS One. 2013; 8(4):e62237. Epub 2013 Apr 22. PMID: 23614042. Abstract
Reduces the percentage of dendritic cells expressing CD40 in MS patients; a higher percentage of such cells is associated with an increased risk of relapse
(39)
Dendritic cell, monocyte and T cell activation and response to glatiramer acetate in multiple sclerosis.
Sellebjerg F, Hesse D, Limborg S, Lund H, Søndergaard HB, Krakauer M, Sørensen PS
Mult Scler. 2012 May 31. PMID: 22653658. Abstract
Downregulates the expression of the P2X7 purinergic receptor in peripheral blood monocytes from MS patients, as shown by PCR analysis
(41)
Monocytes P2X7 purinergic receptor is modulated by glatiramer acetate in multiple sclerosis.
Caragnano M, Tortorella P, Bergami A, Ruggieri M, Livrea P, Specchio L M, Martino G, Trojano M, Furlan R, Avolio C
J Neuroimmunol. 2012 Apr; 245(1-2):93-7. Epub 2012 Feb 26. PMID: 22370183. Abstract
Increases the phagocytic activity of monocytes, based on a comparison of cells from treated versus non-treated MS patients or healthy controls and on in vitro experiments, an activity that appears to come from a CD14++CD16+ subset of monocytes
(63)
Glatiramer acetate increases phagocytic activity of human monocytes in vitro and in multiple sclerosis patients.
Pul R, Morbiducci F, Skuljec J, Skripuletz T, Singh V, Diederichs U, Garde N, Voss E V, Trebst C, Stangel M
PLoS One. 2012; 7(12):e51867. Epub 2012 Dec 20. PMID: 23284793. Abstract
Decreases microglial activation, as determined by measuring uptake of [(11)C]-R-PK11195, a radiopharmaceutical for positron emission tomography, in MS patients before and after 1 year of treatment
(79)
Decreased microglial activation in MS patients treated with glatiramer acetate.
Ratchford JN, Endres CJ, Hammoud DA, Pomper MG, Shiee N, McGready J, Pham DL, Calabresi PA
J Neurol. 2012 Jun; 259(6):1199-205. Epub 2011 Dec 09. PMID: 22160466. Abstract
Rapidly (within 4 to 12 hours after the first exposure) changes immune cell levels and function, such that the CD4/CD8 T cell ratio decreases, CD8+ T cell homeostasis alters, suppression by CD8+ T cells increases, and interleukin 10 and tumor necrosis factor-α production increases
(81)
Modulation of immune function occurs within hours of therapy initiation for multiple sclerosis.
Ayers CL, Mendoza JP, Sinha S, Cunnusamy K, Greenberg BM, Frohman EM, Karandikar NJ
Clin Immunol. 2013 May; 147(2):105-19. Epub 2013 Mar 06. PMID: 23578552. Abstract
Restores the production of interleukin-10 (IL-10) and decreases the production of IL-6 by peripheral B cells, as shown by a comparison of B cells isolated from healthy individuals and individuals with MS with or without treatment with glatiramer acetate
(171)
The Effect of Glatiramer Acetate Therapy on Functional Properties of B Cells From Patients With Relapsing-Remitting Multiple Sclerosis.
Ireland SJ, Guzman AA, O'Brien DE, Hughes S, Greenberg B, Flores A, Graves D, Remington G, Frohman EM, Davis LS, et al.
JAMA Neurol. 2014 Sep 29. PMID: 25264704. Abstract
Treatment alters the proliferation of and increases immunoglobulin production by in vitro-activated B cells, as shown by a comparison of B cells isolated from healthy individuals and individuals with MS with or without treatment with glatiramer acetate
(171)
The Effect of Glatiramer Acetate Therapy on Functional Properties of B Cells From Patients With Relapsing-Remitting Multiple Sclerosis.
Ireland SJ, Guzman AA, O'Brien DE, Hughes S, Greenberg B, Flores A, Graves D, Remington G, Frohman EM, Davis LS, et al.
JAMA Neurol. 2014 Sep 29. PMID: 25264704. Abstract
Attenuates the pro-migratory pattern of immune cell adhesion molecules [which includes upregulated LFA-1 (on certain T cells and B cells), VLA-4 (on certain T cells and natural killer cells), ICAM-1 (on B cells), and ICAM-3 (on natural killer cells)] in RRMS patients, but the effects are relatively slow and unselective
(86)
Glatiramer acetate attenuates the pro-migratory profile of adhesion molecules on various immune cell subsets in multiple sclerosis.
Sellner J, Koczi W, Harrer A, Oppermann K, Obregon-Castrillo E, Pilz G, Wipfler P, Afazel S, Haschke-Becher E, Trinka E, et al.
Clin Exp Immunol. 2013 Apr 24. PMID: 23611040. Abstract
Does not affect the frequency of CD27+CD43+ B1 cells, which is reduced in RRMS
(149)
B1 cells are unaffected by immune modulatory treatment in remitting-relapsing multiple sclerosis patients.
Rovituso D, Heller S, Schroeter M, Kleinschnitz C, Kuerten S
J Neuroimmunol. 2014 Apr 24. PMID: 24814390. Abstract
Reduces the absolute number of circulating CD19+ B cells (which is reduced in naïve-to-treatment individuals with RRMS relative to healthy controls), as shown in a longitudinal study
(209)
Longitudinal assessment of immuno-metabolic parameters in multiple sclerosis patients during treatment with glatiramer acetate.
Carrieri PB, Carbone F, Perna F, Bruzzese D, La Rocca C, Galgani M, Montella S, Petracca M, Florio C, Maniscalco GT, et al.
Metabolism. 2015 May 8. PMID: 25986733. Abstract
Does not affect the absolute number of peripheral CD4+CD45RO+ cells (CD4+ T cells with a memory phenotype), which is increased in naïve-to-treatment individuals with RRMS, as shown in a longitudinal study
(209)
Longitudinal assessment of immuno-metabolic parameters in multiple sclerosis patients during treatment with glatiramer acetate.
Carrieri PB, Carbone F, Perna F, Bruzzese D, La Rocca C, Galgani M, Montella S, Petracca M, Florio C, Maniscalco GT, et al.
Metabolism. 2015 May 8. PMID: 25986733. Abstract
Reduces circulating concentrations of soluble CD40 ligand and soluble tumor necrosis factor-receptor, as shown in a longitudinal study of individuals with RRMS
(209)
Longitudinal assessment of immuno-metabolic parameters in multiple sclerosis patients during treatment with glatiramer acetate.
Carrieri PB, Carbone F, Perna F, Bruzzese D, La Rocca C, Galgani M, Montella S, Petracca M, Florio C, Maniscalco GT, et al.
Metabolism. 2015 May 8. PMID: 25986733. Abstract
Benefits a subset of individuals with RRMS (such that the time since last relapse and the duration of treatment is positively correlated), and only these responders exhibit brain antigen-specific B cells in their blood, based on a study of 34 individuals; the correlation between B cells and treatment response was not seen in 23 individuals treated with interferon beta
(224)
The brain antigen-specific B cell response correlates with glatiramer acetate responsiveness in relapsing-remitting multiple sclerosis patients.
Rovituso DM, Duffy CE, Schroeter M, Kaiser CC, Kleinschnitz C, Bayas A, Elsner R, Kuerten S
Sci Rep. 2015; 5:14265. PMID: 26387426. Abstract
In contrast to interferon beta, does not increase blood levels of B-cell activating factor (BAFF, the primary survival factor for B cells); BAFF levels are higher in individuals with MS than in healthy controls, but those with MS who do not relapse have higher BAFF levels than those who do, as shown in a prospective longitudinal study of 170 individuals with MS over 2.3 years
(236)
Changes in Blood B Cell-Activating Factor (BAFF) Levels in Multiple Sclerosis: A Sign of Treatment Outcome.
Kannel K, Alnek K, Vahter L, Gross-Paju K, Uibo R, Kisand KV
PLoS One. 2015; 10(11):e0143393. Epub 2015 Nov 23. PMID: 26600308. Abstract
Displays neuroprotective functions
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
(82)
Neuroprotection with glatiramer acetate: evidence from the PreCISe trial.
Arnold DL, Narayanan S, Antel S
J Neurol. 2013 Apr 16. PMID: 23589190. Abstract
Associated with increased levels of soluble thrombomodulin, which is released from the cell surface of cerebrovascular endothelial cells when they are damaged and promotes a protective response, in RRMS patients
(83)
Soluble thrombomodulin levels in plasma of multiple sclerosis patients and their implication.
Festoff BW, Li C, Woodhams B, Lynch S
J Neurol Sci. 2012 Dec 15; 323(1-2):61-5. Epub 2012 Sep 08. PMID: 22967748. Abstract
Promotes production of brain-derived neurotrophic factor by T cells, which promotes nerve regeneration and remyelination
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Response induced in patients appears to be influenced by allelic combinations of immune-response genes
(43)
Allelic combinations of immune-response genes associated with glatiramer acetate treatment response in Russian multiple sclerosis patients.
Tsareva EY, Kulakova OG, Boyko AN, Shchur SG, Lvovs D, Favorov AV, Gusev EI, Vandenbroeck K, Favorova OO
Pharmacogenomics. 2012 Jan; 13(1):43-53. Epub 2011 Nov 23. PMID: 22111603. Abstract
Affects the expression of certain genes in monocytes, as shown in an mRNA microarray study involving 8 individuals with RRMS
(114)
Glatiramer acetate treatment effects on gene expression in monocytes of multiple sclerosis patients.
Thamilarasan M, Hecker M, Goertsches R H, Paap B K, Schröder I, Koczan D, Thiesen H-J, Zettl U K
J Neuroinflammation. 2013 Oct 17; 10(1):126. Epub 2013 Oct 17. PMID: 24134771. Abstract
Upregulates expression of genes encoding anti-inflammatory markers, and affects expression of genes involved in multiple pathways related to the immune system, in a manner different than that of Probioglat, a different glatiramoid, as shown by genome-wide expression studies in a human monocyte cell line
(210)
Gene expression studies of a human monocyte cell line identify dissimilarities between differently manufactured glatiramoids.
Kolitz S, Hasson T, Towfic F, Funt JM, Bakshi S, Fowler KD, Laifenfeld D, Grinspan A, Artyomov MN, Birnberg T, et al.
Sci Rep. 2015; 5:10191. PMID: 25998228. Abstract
Affects the expression of hundreds of genes, and many of these are differentially affected by Copaxone (Teva) and a generic version, Polimunol (Synthon), as shown by studies in a human monocyte cell line
(242)
Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition.
Hasson T, Kolitz S, Towfic F, Laifenfeld D, Bakshi S, Beriozkin O, Shacham-Abramson M, Timan B, Fowler KD, Birnberg T, et al.
J Neuroimmunol. 2016 Jan 15; 290:84-95. Epub 2015 Nov 24. PMID: 26711576. Abstract
Probably does not play a large role in regulating Fcγ receptors on immune cells in RRMS patients
(64)
Fcγ receptors in Norwegian multiple sclerosis patients and healthy controls.
Gavasso S, Torkildsen Ø, Marøy TH, Ulvestad E, Myhr K-M, Vedeler CA
Acta Neurol Scand Suppl. 2012(195):84-9. PMID: 23278662. Abstract
Does not affect the fraction of CD8+ T cells that produce interleukin-17 (IL-17) or IL-10, cell subsets that are elevated in RRMS patients in remission as compared with healthy people
(96)
Fraction of IL-10+ and IL-17+ CD8 T cells is increased in MS patients in remission and during a relapse, but is not influenced by immune modulators.
Peelen E, Thewissen M, Knippenberg S, Smolders J, Muris A-H, Menheere P, Tervaert CJW, Hupperts R, Damoiseaux J
J Neuroimmunol. 2013 May 15; 258(1-2):77-84. Epub 2013 Mar 19. PMID: 23517930. Abstract
Appears to have a stabilizing effect on erythrocyte membranes in individuals with RRMS
(100)
[The membrane stabilizing effect of glatiramer acetate in multiple sclerosis].
Kravtsov II, Kicherova OA
Zh Nevrol Psikhiatr Im S S Korsakova. 2013; 113(3):69-71. PMID: 23612414. Abstract
Reduces increased levels of phospholipase A2 in erythrocyte membranes in individuals with RRMS
(100)
[The membrane stabilizing effect of glatiramer acetate in multiple sclerosis].
Kravtsov II, Kicherova OA
Zh Nevrol Psikhiatr Im S S Korsakova. 2013; 113(3):69-71. PMID: 23612414. Abstract
Reduces levels of lipid peroxidation products in erythrocyte membranes in individuals with RRMS
(100)
[The membrane stabilizing effect of glatiramer acetate in multiple sclerosis].
Kravtsov II, Kicherova OA
Zh Nevrol Psikhiatr Im S S Korsakova. 2013; 113(3):69-71. PMID: 23612414. Abstract
Associated with increased levels of advanced glycation end products in blood serum proteins relative to levels in untreated individuals with RRMS, which are in turn higher than in healthy individuals
(109)
Oxidative modification of serum proteins in multiple sclerosis.
Sadowska-Bartosz I, Adamczyk-Sowa M, Galiniak S, Mucha S, Pierzchala K, Bartosz G
Neurochem Int. 2013 Sep 12. PMID: 24036284. Abstract
Reduces plasma levels of osteopontin (a protein with roles in inflammation and immunity), which are increased in RRMS and SPMS
(107)
Evaluation of circulating osteopontin levels in an unselected cohort of patients with multiple sclerosis: relevance for biomarker development.
Kivisäkk P, Healy BC, Francois K, Gandhi R, Gholipour T, Egorova S, Sevdalinova V, Quintana F, Chitnis T, Weiner HL, et al.
Mult Scler. 2013 Sep 4. PMID: 24005026. Abstract
Reduces expression of the transcription factor interferon regulatory factor-1 (IRF-1) in chondrocytes from individuals with osteoarthritis, in which IRF-1 levels are increased, and this role involves inhibition of transcription factor STAT1 activation
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
Reduces the tumor necrosis factor-α–induced upregulation of interferon regulatory factor-1 expression at both the RNA and protein level in human chondrocytes
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
Suppresses the tumor necrosis factor-α–induced upregulation of matrix metalloproteinase 13 (an enzyme that degrades collagen and that is encoded by a gene that is a target of the transcription factor interferon regulatory factor-1) at both the RNA and protein level in human chondrocytes
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
Suppresses the tumor necrosis factor-α–induced degradation of collagen II in human chondrocytes
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
Suppresses the tumor necrosis factor-α–induced production of nitric oxide and expression of inducible nitric oxide synthase in human chondrocytes
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
Inhibits binding (induced by tumor necrosis factor-α) of monocytes (from a human monocytic cell line) to primary human umbilical vein endothelial cells
(187)
Glatiramer acetate (GA) prevents TNF-α-induced monocyte adhesion to primary endothelial cells through interfering with the NF-κB pathway.
Wei G, Zhang X, Su Z, Li X
Biochem Biophys Res Commun. 2014 Dec 19. PMID: 25529444. Abstract
Inhibits the expression of the the proinflammatory chemokine monocyte chemotactic protein-1 and the adnesion molecules vascular adhesion molecule-1 and E-selectin induced by tumor necrosis factor-α in human umbilical vein endothelial cells
(187)
Glatiramer acetate (GA) prevents TNF-α-induced monocyte adhesion to primary endothelial cells through interfering with the NF-κB pathway.
Wei G, Zhang X, Su Z, Li X
Biochem Biophys Res Commun. 2014 Dec 19. PMID: 25529444. Abstract
Inhibits the nuclear translocation of NF-κB p65 induced by tumor necrosis factor-α in human umbilical vein endothelial cells
(187)
Glatiramer acetate (GA) prevents TNF-α-induced monocyte adhesion to primary endothelial cells through interfering with the NF-κB pathway.
Wei G, Zhang X, Su Z, Li X
Biochem Biophys Res Commun. 2014 Dec 19. PMID: 25529444. Abstract
Inhibits the phosphorylation and subsequent degradation of IκBα (which inhibits NF-κB nuclear translocation) induced by tumor necrosis factor-α in human umbilical vein endothelial cells
(187)
Glatiramer acetate (GA) prevents TNF-α-induced monocyte adhesion to primary endothelial cells through interfering with the NF-κB pathway.
Wei G, Zhang X, Su Z, Li X
Biochem Biophys Res Commun. 2014 Dec 19. PMID: 25529444. Abstract
Increases serum levels of endogenous secretory receptor for advanced glycation end-products (esRAGE); serum esRAGE levels are reduced during clinical relapse
(179)
Disease modifying drugs modulate endogenous secretory receptor for advanced glycation end-products, a new biomarker of clinical relapse in multiple sclerosis.
Sternberg Z, Sternberg D, Drake A, Chichelli T, Yu J, Hojnacki D
J Neuroimmunol. 2014 Sep 15; 274(1-2):197-201. Epub 2014 Jul 15. PMID: 25064498. Abstract
Inhibits production of proinflammatory cytokines by human monocytes by inhibiting signaling mediated by Toll-IL-1 receptor domain-containing adaptor inducing interferon-β (TRIF), as shown by experiments involving specific Toll-like receptor agonists
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits the proteasome-mediated degradation of human myelin basic protein expressed in human embryonic kidney 293 cells
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Might influence the intracellular processing of myelin basic protein by antigen-presenting cells in regions outside of the central nervous system
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Inhibits human platelet activation in vitro
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
Reduces thrombin-induced calcium influx into human platelets, as well as thrombin-induced expression of activation markers and platelet aggregation
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
During treatment, new inflammatory events are more likely in individuals with MS who display a distinct RNA profile, with increased expression of RNAs involved in lymphocyte signaling pathways
(104)
An RNA profile identifies two subsets of multiple sclerosis patients differing in disease activity.
Ottoboni L, Keenan BT, Tamayo P, Kuchroo M, Mesirov JP, Buckle GJ, Khoury SJ, Hafler DA, Weiner HL, De Jager PL
Sci Transl Med. 2012 Sep 26; 4(153):153ra131. PMID: 23019656. Abstract
Effectiveness (measured in terms of a lack of relapses and disease progression) correlates with a decrease in the titer of IgG antibodies against human herpes virus 6A/B, whereas an increase predicts relapse, as shown in a 2-year longitudinal study
(162)
Anti-Human Herpesvirus 6A/B IgG Correlates with Relapses and Progression in Multiple Sclerosis.
Ortega-Madueño I, Garcia-Montojo M, Dominguez-Mozo M I, Garcia-Martinez A, Arias-Leal A M, Casanova I, Arroyo R, Alvarez-Lafuente R
PLoS One. 2014; 9(8):e104836. Epub 2014 Aug 11. PMID: 25110949. Abstract
Associated with reduced expression of microRNA-146a (miR-146a) and miR-142-3p, which is increased in peripheral blood mononuclear cells from individuals with RRMS versus healthy controls, indicating that glatiramer acetate may normalize abnormal miRNA expression
(152)
Glatiramer acetate treatment normalizes deregulated microRNA expression in relapsing remitting multiple sclerosis.
Waschbisch A, Atiya M, Linker RA, Potapov S, Schwab S, Derfuss T
PLoS One. 2011; 6(9):e24604. Epub 2011 Sep 16. PMID: 21949733. Abstract
Associated with decreased macular volume in individuals with RRMS
(115)
Assessment of structural and functıonal vısual outcomes ın relapsıng remıttıng multıple sclerosıs wıth vısual evoked potentıals and optıcal coherence tomography.
Tugcu B, Soysal A, Kılıc M, Yuksel B, Kale N, Yıgıt U, Arpaci B
J Neurol Sci. 2013 Oct 1. PMID: 24148562. Abstract
Mean adherence rates have been determined (through the analysis of 24 studies reporting on this topic) for intramuscular interferon beta-1a, given once a week (69.4%); subcutaneous interferon beta-1b, given every other day (63.8%); subcutaneous interferon beta-1a, given 3 times a week (58.4%); and glatiramer acetate, given daily (56.8%), with better outcomes in adherent versus nonadherent individuals shown in a smaller number of studies
(142)
Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis.
Menzin J, Caon C, Nichols C, White L A, Friedman M, Pill MW
J Manag Care Pharm. 2013 Jan-Feb; 19(1 Suppl A):S24-40. PMID: 23383731. Abstract
Associated with a relative reduction of 21.6% in the risk of ≥1 relapses during 2 years of treatment and is less cost effective than natalizumab, according to a pharmacoeconomic analysis that used pre-existing data
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
 and costs of treatment in the Russian healthcare system
(156)
[Pharmacoeconomic analysis of the efficacy of natalizumab in relapsing-remitting multiple sclerosis].
Zh Nevrol Psikhiatr Im S S Korsakova. 2014; 114(5):65-9. PMID: 24988963. Abstract
Treatment is associated with a distinct gut microbiome (with genus-level differences) in individuals with MS
(174)
The MS Microbiome Consortium (MSMC): an academic multi-disciplinary collaborative effort to elucidate the role of the gut microbiota in MS
Baranzini SE, Katz-Sand I, Mazmanian SK, Becosme Y, London J, Farber R, Kanner R, Gomez R, Cree BA, Knight R, et al.
Accessed on 14 Oct 2014 from http://www.professionalabstracts.com/msboston2014/planner/index.php?go=abstract&action=abstract_show&absno=754&.
Use is associated with differences in the composition of the gut microbiome; differences between treated and untreated individuals with MS were found for Bacteroidaceae, Faecalibacterium, Ruminococcus, Lactobacillaceae, and Clostridium in an exploratory study
(196)
Gut Microbiota in Multiple Sclerosis: Possible Influence of Immunomodulators.
Cantarel BL, Waubant E, Chehoud C, Kuczynski J, DeSantis TZ, Warrington J, Venkatesan A, Fraser CM, Mowry EM
J Investig Med. 2015 Mar 14. PMID: 25775034. Abstract
Responders to glatiramer acetate (who are clinically stable) exhibit higher expression of response gene to complement 32 and Fas ligand and lower expression of interleukin 21 as compared with nonresponders (who experience acute relapses), as shown in a study that monitored a cohort of 15 individuals with RRMS for 2 years
(227)
RGC-32 as a potential biomarker of relapse and response to treatment with glatiramer acetate in multiple sclerosis.
Kruszewski AM, Rao G, Tatomir A, Hewes D, Tegla CA, Cudrici CD, Nguyen V, Royal W, Bever CT, Rus V, et al.
Exp Mol Pathol. 2015 Sep 25; 99(3):498-505. PMID: 26407760. Abstract
Because specific disease-modifying therapies (DMTs) are effective in some individuals and not others, genetic biomarkers of treatment sensitivity could be useful in DMT selection; discriminative genetic markers (variants of CCR5, IFNAR1, TGFB1, DRB1 or CTLA4 genes) have been identified, with the CCR5*d+ IFNAR1*G combination indicating interferon beta rather than glatiramer acetate treatment, based on a study of responders and nonresponders among >500 individuals treated with interferon beta or glatiramer acetate
(147)
Comparative pharmacogenetics of multiple sclerosis: IFN-β versus glatiramer acetate.
Kulakova OG, Tsareva E Y, Lvovs D, Favorov AV, Boyko AN, Favorova OO
Pharmacogenomics. 2014 Apr; 15(5):679-85. PMID: 24798724. Abstract
Unlike natalizumab, was not observed to decrease the extent and severity of damage to white matter, as shown in a diffusion tensor imaging study
(250)
White Matter Diffusion Changes during the First Year of Natalizumab Treatment in Relapsing-Remitting Multiple Sclerosis.
Wiebenga OT, Schoonheim MM, Hulst HE, Nagtegaal GJA, Strijbis EMM, Steenwijk MD, Polman CH, Pouwels PJW, Barkhof F, Geurts JJG
AJNR Am J Neuroradiol. 2016 Mar 10. PMID: 26965463. Abstract
Not an immunosuppressor
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Does not affect the percentage of circulating 6-sulfo LacNAc(+) dendritic cells, proinflammatory cells that are present in demyelinated brain lesions and are often present in cerebrospinal fluid in individuals with MS
(177)
Accumulation and therapeutic modulation of 6-sulfo LacNAc(+) dendritic cells in multiple sclerosis.
Thomas K, Dietze K, Wehner R, Metz I, Tumani H, Schultheiß T, Günther C, Schäkel K, Reichmann H, Brück W, et al.
Neurol Neuroimmunol Neuroinflamm. 2014 Oct; 1(3):e33. Epub 2014 Sep 18. PMID: 25340085. Abstract
Does not increase plasma levels of brain-derived neurotrophic factor (BDNF) in individuals with RRMS; BDNF levels are reduced in these individuals
(153)
Effect of Glatiramer Acetate on Peripheral Blood Brain-Derived Neurotrophic Factor and Phosphorylated TrkB Levels in Relapsing-Remitting Multiple Sclerosis.
Văcăraş V, Major ZZ, Mureşanu DF, Krausz TL, Mărginean I, Buzoianu DA
CNS Neurol Disord Drug Targets. 2014 Jun 18. PMID: 24938775. Abstract
Does not affect levels of phosphorylated receptor tyrosine kinase B in blood cells from individuals with RRMS
(153)
Effect of Glatiramer Acetate on Peripheral Blood Brain-Derived Neurotrophic Factor and Phosphorylated TrkB Levels in Relapsing-Remitting Multiple Sclerosis.
Văcăraş V, Major ZZ, Mureşanu DF, Krausz TL, Mărginean I, Buzoianu DA
CNS Neurol Disord Drug Targets. 2014 Jun 18. PMID: 24938775. Abstract
Does not affect markers of neuroprotection that include serum levels of brain-derived neurotrophic factor (BDNF), BDNF expression in peripheral immune cells, nerve conduction, and neuropsychological parameters, as shown in a 24-month observational study of 21 individuals with RRMS
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Does not affect an MS-associated pattern of peripheral oxidative stress markers (reduced blood levels of Coenzyme Q10 and increased blood levels of anti-oxidized-low-density lipoprotein antibodies)
(184)
Oxidative stress is differentially present in multiple sclerosis courses, early evident, and unrelated to treatment.
Gironi M, Borgiani B, Mariani E, Cursano C, Mendozzi L, Cavarretta R, Saresella M, Clerici M, Comi G, Rovaris M, et al.
J Immunol Res. 2014; 2014:961863. Epub 2014 Mar 26. PMID: 24741637. Abstract
Resumption of treatment within two weeks after delivery (versus later in the postpartum year) does not decrease the risk of relapse in the first six months postpartum, but might decrease the risk later in the first year postpartum
(180)
Immunomodulatory agents and risk of postpartum multiple sclerosis relapses.
Beaber B E, Chi MD, Brara S M, Zhang J L, Langer-Gould AM
Perm J. 2014 Winter; 18(1):9-13. PMID: 24626066. Abstract
Animal: 
Augments B cell activity in mice, suppressing experimental autoimmune encephalomyelitis (EAE), as shown by the finding that B cells from glatiramer acetate-treated mice suppress EAE in recipient mice
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Induces production of antibodies against glatiramer acetate that might enhance remyelination in experimental autoimmune encephalomyelitis mice
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Developed to induce experimental autoimmune encephalomyelitis, but surprisingly inhibited it
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
Induces the secretion of CXCL13 (a chemoattractant for B cells) after administration to mice
(51)
Macrophage-specific chemokines induced via innate immunity by amino acid copolymers and their role in EAE.
Kovalchin J, Krieger J, Genova M, Kawamoto N, Augustyniak M, Collins K, Bloom T, Masci A, Hittinger T, Dufour I, et al.
PLoS One. 2011; 6(12):e26274. Epub 2011 Dec 15. PMID: 22194778. Abstract
Induces the secretion of CCL22 (a chemoattractant for Th2 cells) after administration to mice, and this effect is independent of the class II major histocompatibility complex, indicating involvement of an innate immune receptor
(51)
Macrophage-specific chemokines induced via innate immunity by amino acid copolymers and their role in EAE.
Kovalchin J, Krieger J, Genova M, Kawamoto N, Augustyniak M, Collins K, Bloom T, Masci A, Hittinger T, Dufour I, et al.
PLoS One. 2011; 6(12):e26274. Epub 2011 Dec 15. PMID: 22194778. Abstract
Induces the secretion of CCL22 (a chemoattractant for Th2 cells) in bone marrow-derived macrophages from mice
(51)
Macrophage-specific chemokines induced via innate immunity by amino acid copolymers and their role in EAE.
Kovalchin J, Krieger J, Genova M, Kawamoto N, Augustyniak M, Collins K, Bloom T, Masci A, Hittinger T, Dufour I, et al.
PLoS One. 2011; 6(12):e26274. Epub 2011 Dec 15. PMID: 22194778. Abstract
Reduces the expression of Toll-like receptor (TLR) 9, which plays a role in the activation of innate immunity and subsequent adaptive immunity, and Myd88, a universal adapter protein for TLRs, in experimental autoimmune encephalomyelitis mice
(59)
Glatiramer acetate biases dendritic cells towards an anti-inflammatory phenotype by modulating OPN, IL-17, and RORγt responses and by increasing IL-10 production in experimental allergic encephalomyelitis.
Begum-Haque S, Christy M, Wang Y, Kasper E, Ochoa-Reparaz J, Smith JY, Haque A, Kasper LH
J Neuroimmunol. 2012 Nov 6. PMID: 23141166. Abstract
Shifts dendritic cells toward an anti-inflammatory phenotype, reducing expression of the cytokine osteopontin, interleukin 17, and its mediator the nuclear receptor RORgamma, in dendritic cells of experimental autoimmune encephalomyelitis mice
(59)
Glatiramer acetate biases dendritic cells towards an anti-inflammatory phenotype by modulating OPN, IL-17, and RORγt responses and by increasing IL-10 production in experimental allergic encephalomyelitis.
Begum-Haque S, Christy M, Wang Y, Kasper E, Ochoa-Reparaz J, Smith JY, Haque A, Kasper LH
J Neuroimmunol. 2012 Nov 6. PMID: 23141166. Abstract
Enhances production of interleukin 10 by dendritic cells in experimental autoimmune encephalomyelitis mice
(59)
Glatiramer acetate biases dendritic cells towards an anti-inflammatory phenotype by modulating OPN, IL-17, and RORγt responses and by increasing IL-10 production in experimental allergic encephalomyelitis.
Begum-Haque S, Christy M, Wang Y, Kasper E, Ochoa-Reparaz J, Smith JY, Haque A, Kasper LH
J Neuroimmunol. 2012 Nov 6. PMID: 23141166. Abstract
Reduces the expression of pro-inflammatory, brain-specific chemokines that might attract antigen promoting cells to the central nervous system in experimental autoimmune encephalomyelitis mice
(59)
Glatiramer acetate biases dendritic cells towards an anti-inflammatory phenotype by modulating OPN, IL-17, and RORγt responses and by increasing IL-10 production in experimental allergic encephalomyelitis.
Begum-Haque S, Christy M, Wang Y, Kasper E, Ochoa-Reparaz J, Smith JY, Haque A, Kasper LH
J Neuroimmunol. 2012 Nov 6. PMID: 23141166. Abstract
Induces a strong neuroprotective response in mice who received a crush injury to the optic nerve after glatiramer acetate treatment, but this response is absent if the mice are exposed to chronic mild stress before receiving glatiramer acetate (and the response is regained if glatiramer acetate is combined with Prozac)
(65)
Chronic mild stress eliminates the neuroprotective effect of Copaxone after CNS injury.
Smirnov I, Walsh JT, Kipnis J
Brain Behav Immun. 2013 Jan 4. PMID: 23295266. Abstract
Has a neuroprotective role against glutamate toxicity in experimental autoimmune encephalomyelitis mice
(66)
Glatiramer Acetate Protects Against Inflammatory Synaptopathy in Experimental Autoimmune Encephalomyelitis.
Gentile A, Rossi S, Studer V, Motta C, De Chiara V, Musella A, Sepman H, Fresegna D, Musumeci G, Grasselli G, et al.
J Neuroimmune Pharmacol. 2013 Jan 31. Epub 2013 Jan 31. PMID: 23370991. Abstract
Reverses the changes in striatal glutamate-mediated excitatory postsynaptic currents (which are induced by tumor necrosis factor-α) that occur in experimental autoimmune encephalomyelitis mice
(66)
Glatiramer Acetate Protects Against Inflammatory Synaptopathy in Experimental Autoimmune Encephalomyelitis.
Gentile A, Rossi S, Studer V, Motta C, De Chiara V, Musella A, Sepman H, Fresegna D, Musumeci G, Grasselli G, et al.
J Neuroimmune Pharmacol. 2013 Jan 31. Epub 2013 Jan 31. PMID: 23370991. Abstract
Reduces microglial activation and expression of tumor necrosis factor-α in experimental autoimmune encephalomyelitis mice
(66)
Glatiramer Acetate Protects Against Inflammatory Synaptopathy in Experimental Autoimmune Encephalomyelitis.
Gentile A, Rossi S, Studer V, Motta C, De Chiara V, Musella A, Sepman H, Fresegna D, Musumeci G, Grasselli G, et al.
J Neuroimmune Pharmacol. 2013 Jan 31. Epub 2013 Jan 31. PMID: 23370991. Abstract
Partially prevents the rapid decline in memory that occurs in relapsing-remitting experimental autoimmune encephalomyelitis mice
(182)
Glatiramer Acetate Guards Against Rapid Memory Decline During Relapsing-Remitting Experimental Autoimmune Encephalomyelitis.
Lopresti P
Neurochem Res. 2014 Dec 7. Epub 2014 Dec 07. PMID: 25481047. Abstract
Does not decrease damage when administered after cerebral ischemia in mice, despite an increase in neurogenesis (with induced permanent middle cerebral artery occlusion) and a decrease in microglial proinflammatory cytokines (with induced transient occlusion)
(72)
Glatiramer Acetate administration does not reduce damage after cerebral ischemia in mice.
Poittevin M, Deroide N, Azibani F, Delcayre C, Giannesini C, Levy BI, Pocard M, Kubis N
J Neuroimmunol. 2013 Jan 15; 254(1-2):55-62. Epub 2012 Sep 29. PMID: 23026222. Abstract
Significantly upregulates or downregulates 1,474 genes in mouse splenocytes [which were harvested after mice were treated with glatiramer acetate (GA), and then reactivated ex vivo with GA], as shown by gene expression profiling
(73)
Gene expression analysis reveals functional pathways of glatiramer acetate activation.
Bakshi S, Chalifa-Caspi V, Plaschkes I, Perevozkin I, Gurevich M, Schwartz R
Expert Opin Ther Targets. 2013 Apr; 17(4):351-362. Epub 2013 Mar 08. PMID: 23469939. Abstract
Induces pathways involved with T and B lymphocyte proliferation and activation, antigen presenting cell stimulation, and effector T lymphocyte differentiation in mouse splenocytes, as shown by gene expression profiling and functional pathway analysis
(73)
Gene expression analysis reveals functional pathways of glatiramer acetate activation.
Bakshi S, Chalifa-Caspi V, Plaschkes I, Perevozkin I, Gurevich M, Schwartz R
Expert Opin Ther Targets. 2013 Apr; 17(4):351-362. Epub 2013 Mar 08. PMID: 23469939. Abstract
Affects the expression of hundreds of genes, and many of these are differentially affected by Copaxone (Teva) and a generic version, Polimunol (Synthon), as shown by studies in mouse splenocytes
(242)
Functional effects of the antigen glatiramer acetate are complex and tightly associated with its composition.
Hasson T, Kolitz S, Towfic F, Laifenfeld D, Bakshi S, Beriozkin O, Shacham-Abramson M, Timan B, Fowler KD, Birnberg T, et al.
J Neuroimmunol. 2016 Jan 15; 290:84-95. Epub 2015 Nov 24. PMID: 26711576. Abstract
Modulates the expression of several microRNAs (miR-155-5p, miR-27a-3p, miR-9-5p, and miR-350-5p, as detected in urine), indicating that they are potential biomarkers of glatiramer acetate response, at the peak of disease in a mouse model of experimental autoimmune encephalomyelitis
(221)
Targeted Stage-Specific Inflammatory microRNA Profiling in Urine During Disease Progression in Experimental Autoimmune Encephalomyelitis: Markers of Disease Progression and Drug Response.
Singh J, Deshpande M, Suhail H, Rattan R, Giri S
J Neuroimmune Pharmacol. 2015 Aug 16. Epub 2015 Aug 16. PMID: 26277791. Abstract
Promotes maturation of oligodendrocytes in an animal model (involving cuprizone-induced demyelination)
(84)
Glatiramer promotes oligodendroglial cell maturation in a cuprizone-induced demyelination model.
Rosato Siri MV, Badaracco ME, Pasquini JM
Neurochem Int. 2013 Apr 22. PMID: 23619394. Abstract
Reduces expression of brain-derived neurotrophic factor and neuregulin (a soluble gliotrophic factor) in experimental autoimmune encephalomyelitis (EAE) mice (both factors that are increased in EAE), but does not affect either in the absence of EAE
(97)
Complexity of trophic factor signaling in experimental autoimmune encephalomyelitis: Differential expression of neurotrophic and gliotrophic factors.
Song F, Bandara M, Deol H, Loeb JA, Benjamins J, Lisak RP
J Neuroimmunol. 2013 Jun 10. PMID: 23763772. Abstract
Inhibits experimental autoimmune encephalomyelitis (EAE), and this therapeutic effect requires CD8+ T cells; furthermore, adoptive transfer of glatiramer acetate-induced CD8+ T cells suppresses signs of EAE, a process that requires non-classical MHC I, interferon gamma, and perforin, but not interleukin 10
(99)
CD8(+) T Cells Are Required For Glatiramer Acetate Therapy in Autoimmune Demyelinating Disease.
Tyler AF, Mendoza JP, Firan M, Karandikar NJ
PLoS One. 2013; 8(6):e66772. Epub 2013 Jun 21. PMID: 23805274. Abstract
Attenuates demyelination, sciatic nerve axonal injury, and neurological deficits in experimental autoimmune neuritis rats, which serve as a model for Guillain-Barré syndrome, a demyelinating disease of the peripheral nervous system
(118)
Glatiramer acetate ameliorates experimental autoimmune neuritis.
Zhang C-J, Zhai H, Yan Y, Hao J, Li M-S, Jin W-N, Su N, Vollmer TL, Shi F-D
Immunol Cell Biol. 2013 Nov 26. PMID: 24275856. Abstract
Inhibits autoreactive T-cell proliferation stimulated by the peripheral nervous system antigen P0 or by the central nervous system antigen myelin basic protein, as shown with lymphocytes isolated from experimental autoimmune neuritis rats
(118)
Glatiramer acetate ameliorates experimental autoimmune neuritis.
Zhang C-J, Zhai H, Yan Y, Hao J, Li M-S, Jin W-N, Su N, Vollmer TL, Shi F-D
Immunol Cell Biol. 2013 Nov 26. PMID: 24275856. Abstract
Suppresses behavioral changes that occur at an early phase of a model of MS in mice, concomitant with an increase in circulating T cells in the blood, but before T cell infiltration into the central nervous system
(120)
Emotional Change-Associated T Cell Mobilization at the Early Stage of a Mouse Model of Multiple Sclerosis.
Piras G, Rattazzi L, McDermott A, Deacon R, D'Acquisto F
Front Immunol. 2013; 4:400. Epub 2013 Nov 21. PMID: 24312102. Abstract
Protects the myelin sheath from demyelination in rats treated with pentylenetetrazol to induce epilepsy, reducing epileptiform discharges (seen on an electroencephalogram) and the frequency of seizures
(121)
Glatiramer acetate, an anti-demyelination drug, reduced rats' epileptic seizures induced by pentylenetetrazol via protection of myelin sheath.
You Y, Zhao Y, Bai H, Liu Z, Meng F, Zhang H, Xu R
Eur J Pharm Sci. 2013 Jun 14; 49(3):366-70. Epub 2013 Apr 21. PMID: 23611724. Abstract
Reduces myelin damage in the spinal cord of mice with relapsing-remitting or chronic experimental autoimmune encephalomyelitis; this reduction occurs even when treatment is given late in the disease course, indicating that glatiramer acetate may mediate myelin repair
(192)
Enhanced myelination in autoimmunity and in normal development induced by glatiramer acetate.
Aharoni R, Arnon R
Isr Med Assoc J. 2014 Oct; 16(10):611-3. PMID: 25438444. Abstract
Increases the number of myelinated axons, and the thickness of the myelin sheath, in the spinal cords of mice treated on postnatal days 7 to 21
(128)
Oligodendrogenesis and myelinogenesis during postnatal development effect of glatiramer acetate.
From R, Eilam R, Bar-Lev DD, Levin-Zaidman S, Tsoory M, Lopresti P, Sela M, Arnon R, Aharoni R
Glia. 2014 Apr; 62(4):649-65. Epub 2014 Jan 30. PMID: 24481644. Abstract
Increases axon diameter in mice treated on postnatal days 7 to 21
(128)
Oligodendrogenesis and myelinogenesis during postnatal development effect of glatiramer acetate.
From R, Eilam R, Bar-Lev DD, Levin-Zaidman S, Tsoory M, Lopresti P, Sela M, Arnon R, Aharoni R
Glia. 2014 Apr; 62(4):649-65. Epub 2014 Jan 30. PMID: 24481644. Abstract
Increases the number of proliferating progenitor and mature oligodendrocytes in mice treated on postnatal days 7 to 21
(128)
Oligodendrogenesis and myelinogenesis during postnatal development effect of glatiramer acetate.
From R, Eilam R, Bar-Lev DD, Levin-Zaidman S, Tsoory M, Lopresti P, Sela M, Arnon R, Aharoni R
Glia. 2014 Apr; 62(4):649-65. Epub 2014 Jan 30. PMID: 24481644. Abstract
Therapeutic treatment has beneficial effects on both myelinated and non-myelinated axons in a chronic experimental autoimmune encephalomyelitis mouse model
(157)
Restoration of axon conduction and motor deficits by therapeutic treatment with glatiramer acetate.
Moore S, Khalaj AJ, Patel R, Yoon J, Ichwan D, Hayardeny L, Tiwari-Woodruff SK
J Neurosci Res. 2014 Jul 3. PMID: 24989965. Abstract
Therapeutic treatment restores axon conduction and improves motor performance in a chronic experimental autoimmune encephalomyelitis mouse model
(157)
Restoration of axon conduction and motor deficits by therapeutic treatment with glatiramer acetate.
Moore S, Khalaj AJ, Patel R, Yoon J, Ichwan D, Hayardeny L, Tiwari-Woodruff SK
J Neurosci Res. 2014 Jul 3. PMID: 24989965. Abstract
Therapeutic treatment reduces infiltrataion of microglia/macrophages and T cells in the spinal cord and corpus callosum in a chronic experimental autoimmune encephalomyelitis mouse model
(157)
Restoration of axon conduction and motor deficits by therapeutic treatment with glatiramer acetate.
Moore S, Khalaj AJ, Patel R, Yoon J, Ichwan D, Hayardeny L, Tiwari-Woodruff SK
J Neurosci Res. 2014 Jul 3. PMID: 24989965. Abstract
Therapeutic treatment increases the number of oligodendrocytes in the spinal cord and corpus callosum in a chronic experimental autoimmune encephalomyelitis mouse model
(157)
Restoration of axon conduction and motor deficits by therapeutic treatment with glatiramer acetate.
Moore S, Khalaj AJ, Patel R, Yoon J, Ichwan D, Hayardeny L, Tiwari-Woodruff SK
J Neurosci Res. 2014 Jul 3. PMID: 24989965. Abstract
Therapeutic treatment improves nodal protein organization in a chronic experimental autoimmune encephalomyelitis mouse model
(157)
Restoration of axon conduction and motor deficits by therapeutic treatment with glatiramer acetate.
Moore S, Khalaj AJ, Patel R, Yoon J, Ichwan D, Hayardeny L, Tiwari-Woodruff SK
J Neurosci Res. 2014 Jul 3. PMID: 24989965. Abstract
Prophylactic treatment normalizes the expression of experimental autoimmune encephalomyelitis-induced genetic markers in the spinal cord in mice
(138)
Altered Expression of Oligodendrocyte and Neuronal Marker Genes Predicts the Clinical Onset of Autoimmune Encephalomyelitis and Indicates the Effectiveness of Multiple Sclerosis-Directed Therapeutics.
Evangelidou M, Karamita M, Vamvakas S-S, Szymkowski DE, Probert L
J Immunol. 2014 Mar 28. PMID: 24683189. Abstract
Increases levels of insulin-like growth factor and brain-derived neurotrophic factor in white matter in mice treated on postnatal days 7 to 21
(128)
Oligodendrogenesis and myelinogenesis during postnatal development effect of glatiramer acetate.
From R, Eilam R, Bar-Lev DD, Levin-Zaidman S, Tsoory M, Lopresti P, Sela M, Arnon R, Aharoni R
Glia. 2014 Apr; 62(4):649-65. Epub 2014 Jan 30. PMID: 24481644. Abstract
Improves function in a performance test (given on postnatal day 21) in mice treated on postnatal days 7 to 21
(128)
Oligodendrogenesis and myelinogenesis during postnatal development effect of glatiramer acetate.
From R, Eilam R, Bar-Lev DD, Levin-Zaidman S, Tsoory M, Lopresti P, Sela M, Arnon R, Aharoni R
Glia. 2014 Apr; 62(4):649-65. Epub 2014 Jan 30. PMID: 24481644. Abstract
Increases levels of brain-derived neurotrophic factor (deficiencies in which may play a role in Huntington's disease) in both wild-type and Huntington's disease model striatal cells, as well as in striatal tissue from a transgenic mouse model of Huntington's disease
(175)
Disease Modifying Potential of Glatiramer Acetate in Huntington's Disease.
Corey-Bloom J, Jia H, Aikin AM, Thomas EA
J Huntingtons Dis. 2014; 3(3):311-6. PMID: 25300334. Abstract
Reduces an early hyperactivity phenotype that is displayed by a transgenic mouse model of Huntington's disease
(175)
Disease Modifying Potential of Glatiramer Acetate in Huntington's Disease.
Corey-Bloom J, Jia H, Aikin AM, Thomas EA
J Huntingtons Dis. 2014; 3(3):311-6. PMID: 25300334. Abstract
Inhibits the degradation of myelin basic protein (purified from bovine brain) by the 26S proteasome (purified from mouse brain) in a ubiquitin-free in vitro system
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Binds the 26S proteasome (purified from mouse brain) but does not bind myelin basic protein (purified from bovine brain)
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Does not undergo 26S proteasome-mediated hydrolysis in an in vitro system, despite binding to the proteasome (purified from mouse brain)
(173)
Glatiramer Acetate and Nanny Proteins Restrict Access of the Multiple Sclerosis Autoantigen Myelin Basic Protein to the 26S Proteasome.
Kuzina E, Kudriaeva A, Smirnov I, Dubina MV, Gabibov A, Belogurov A
Biomed Res Int. 2014; 2014:926394. Epub 2014 Sep 08. PMID: 25276831. Abstract
Inhibits type I interferon signaling, as shown in experiments involving mice lacking various proteins involved in innate immune signaling pathways
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Induces phosphorylation of Akt on serine 473, a marker of phosphoinositide 3-kinase activation, but does not increase intracellular concentrations of cAMP, in mouse monocytes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits production of proinflammatory cytokines by monocytes in response to Toll-like receptor ligands in a manner that does not require myeloid differentiation primary response gene 88 (MyD88) but does require Toll-IL-1 receptor domain-containing adaptor inducing interferon-β (TRIF), as shown in experiments involving cells derived from mice deficient for these genes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits production of proinflammatory cytokines in a manner that does not appear to require nuclear factor-κB signaling, as shown in lipopolysaccharide-stimulated mouse monocytes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits production of proinflammatory cytokines by lipopolysaccharide-stimulated monocytes in a manner that requires interferon-α/β receptor subunit 1 (IFNAR1), as shown in experiments involving cells derived from IFNAR1-deficient mice
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits production of interferon-beta, a cytokine induced by the Toll-IL-1 receptor domain-containing adaptor inducing interferon-β (TRIF) pathway, by lipopolysaccharide-stimulated mouse monocytes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits activation of p38 mitogen-activated protein kinase, which regulates activating transcription factor-2, an interferon-beta enhanceosome component, by lipopolysaccharide-stimulated mouse monocytes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits nuclear translocation of components of the interferon-beta enhanceosome in lipopolysaccharide-stimulated mouse monocytes
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Does not provide clinical benefit in mice deficient for Toll-IL-1 receptor domain-containing adaptor inducing interferon-β (TRIF) upon induction of experimental autoimmune encephalomyelitis
(235)
Glatiramer acetate treatment negatively regulates type I interferon signaling.
Molnarfi N, Prod'homme T, Schulze-Topphoff U, Spencer CM, Weber MS, Patarroyo JC, Lalive PH, Zamvil SS
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e179. Epub 2015 Nov 09. PMID: 26601118. Abstract
Inhibits mouse platelet activation in vitro
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
Reduces thrombin-induced calcium influx into mouse platelets, as well as thrombin-induced expression of activation markers and platelet aggregation
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
Inhibits platelet-mediated macrophage activation, in an experiment involving co-culture of mouse cells
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
Prolongs bleeding time (which occurs if platelet activation is reduced) by 2.7-fold in a tail bleeding test in mice
(214)
Glatiramer acetate (copaxone) modulates platelet activation and inhibits thrombin-induced calcium influx: possible role of copaxone in targeting platelets during autoimmune neuroinflammation.
Starossom SC, Veremeyko T, Dukhinova M, Yung AWY, Ponomarev ED
PLoS One. 2014; 9(5):e96256. Epub 2014 May 02. PMID: 24788965. Abstract
In mouse splenocytes, the biological effect of the branded version is more constant across batches than that of a generic version, as assessed by transcriptional profiling and computational methods, according to a study from Teva
(127)
Comparing the biological impact of glatiramer acetate with the biological impact of a generic.
Towfic F, Funt JM, Fowler KD, Bakshi S, Blaugrund E, Artyomov MN, Hayden MR, Ladkani D, Schwartz R, Zeskind B
PLoS One. 2014; 9(1):e83757. Epub 2014 Jan 08. PMID: 24421904. Abstract
In mouse splenocytes, the branded version induces distinct changes in regulatory T cells and cells of myeloid lineage as compared to a generic version, as assessed by transcriptional profiling and computational methods, according to a study from Teva
(127)
Comparing the biological impact of glatiramer acetate with the biological impact of a generic.
Towfic F, Funt JM, Fowler KD, Bakshi S, Blaugrund E, Artyomov MN, Hayden MR, Ladkani D, Schwartz R, Zeskind B
PLoS One. 2014; 9(1):e83757. Epub 2014 Jan 08. PMID: 24421904. Abstract
In mouse Th2-polarized T cells, which are responsive to glatiramer acetate, Glatopa and Copaxone induced equivalent changes in gene expression in a microarray analysis involving 39,429 probes across the entire genome, according to a study from Momenta
(232)
Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®.
D'Alessandro JS, Duffner J, Pradines J, Capila I, Garofalo K, Kaundinya G, Greenberg BM, Kantor D, Ganguly TC
PLoS One. 2015; 10(10):e0140299. Epub 2015 Oct 16. PMID: 26473741. Abstract
Does not affect survival of mice infected with the neuroinvasive parasite Toxoplasma gondii, but does affect leukocyte numbers and parasite load in the brain
(167)
Testing effects of glatiramer acetate and fingolimod in an infectious model of CNS immune surveillance.
Castro-Rojas C, Deason K, Hussain RZ, Hayardeny L, Cravens PC, Yarovinsky F, Eagar TN, Arellano B, Stüve O
J Neuroimmunol. 2014 Sep 2. PMID: 25227585. Abstract
Reduces neurological deficit in a rat model of acute ischemic stroke
(199)
Copolymer-1 promotes neurogenesis and improves functional recovery after acute ischemic stroke in rats.
Cruz Y, Lorea J, Mestre H, Kim-Lee J H, Herrera J, Mellado R, Gálvez V, Cuellar L, Musri C, Ibarra A
PLoS One. 2015; 10(3):e0121854. Epub 2015 Mar 30. PMID: 25821957. Abstract
Increases production of neurotrophin-3 and thus neurogenesis in the subventricular zone, subgranular zone, and cerebral cortex in a rat model of acute ischemic stroke
(199)
Copolymer-1 promotes neurogenesis and improves functional recovery after acute ischemic stroke in rats.
Cruz Y, Lorea J, Mestre H, Kim-Lee J H, Herrera J, Mellado R, Gálvez V, Cuellar L, Musri C, Ibarra A
PLoS One. 2015; 10(3):e0121854. Epub 2015 Mar 30. PMID: 25821957. Abstract
Reduces infarct volume in a rat model of transient middle cerebral artery occlusion, even when given during the chronic phase
(199)
Copolymer-1 promotes neurogenesis and improves functional recovery after acute ischemic stroke in rats.
Cruz Y, Lorea J, Mestre H, Kim-Lee J H, Herrera J, Mellado R, Gálvez V, Cuellar L, Musri C, Ibarra A
PLoS One. 2015; 10(3):e0121854. Epub 2015 Mar 30. PMID: 25821957. Abstract
Does not protect mice against acute ischemic stroke
(131)
Glatiramer acetate does not protect from acute ischemic stroke in mice.
Kraft P, Göbel K, Meuth SG, Kleinschnitz C
Exp Transl Stroke Med. 2014; 6(1):4. Epub 2014 Feb 27. PMID: 24576335. Abstract
Regulatory and Commercial Status
Status for MS: 
Approved in US (1996), EU, and other countries for RRMS
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
(7)
Drugs@FDA (Enter "glatiramer acetate" in search box.)
FDA
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Approved in US (2009) and other countries for treating CIS patients in cases suggestive of MS
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
(7)
Drugs@FDA (Enter "glatiramer acetate" in search box.)
FDA
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Generic version has been approved in US (2015)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Generic version has been approved in Europe (2016)
(253)
Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon, 12 Apr 2016
Accessed on 19 Apr 2016 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-obtains-approval-for-glatiramer-acetate-20-mg-mL-in-Europe.aspx.
Highest status achieved (for any condition): 
Approved
(7)
Drugs@FDA (Enter "glatiramer acetate" in search box.)
FDA
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
Other uses: 
Has positive effects in a mouse model of Alzheimer disease
(18)
Glatiramer acetate fights against Alzheimer's disease by inducing dendritic-like microglia expressing insulin-like growth factor 1.
Butovsky O, Koronyo-Hamaoui M, Kunis G, Ophir E, Landa G, Cohen H, Schwartz M
Proc Natl Acad Sci U S A. 2006 Aug 1; 103(31):11784-9. Epub 2006 Jul 24. PMID: 16864778. Abstract
Safety and tolerability in individuals with Alzheimer's disease will be examined in a Phase I trial launched by Cedars-Sinai (13 August 2013)
(105)
Patient trial of immunization to treat Alzheimer’s disease begins at Cedars-Sinai
Cedars-Sinai, 13 Aug 2013
Accessed on 18 Aug 2013 from http://www.cedars-sinai.edu/About-Us/News/News-Releases-2013/Patient-trial-of-immunization-to-treat-Alzheimer’s-disease-begins-at-Cedars-Sinai.aspx.
Did not affect progression of amyotrophic lateral sclerosis (ALS) in a human trial, although it has positive effects in a mouse model of ALS
(15)
Glatiramer acetate has no impact on disease progression in ALS at 40 mg/day: a double- blind, randomized, multicentre, placebo-controlled trial.
Meininger V, Drory VE, Leigh NP, Ludolph A, Robberecht W, Silani V
Amyotroph Lateral Scler. 2009 Oct-Dec; 10(5-6):378-83. PMID: 19922128. Abstract
(16)
Therapeutic vaccine for acute and chronic motor neuron diseases: implications for amyotrophic lateral sclerosis.
Angelov DN, Waibel S, Guntinas-Lichius O, Lenzen M, Neiss WF, Tomov TL, Yoles E, Kipnis J, Schori H, Reuter A, et al.
Proc Natl Acad Sci U S A. 2003 Apr 15; 100(8):4790-5. Epub 2003 Mar 31. PMID: 12668759. Abstract
Reduces risk of developing cerebral malaria, a condition that appears to involve host immune responses, in an experimental mouse model
(14)
Glatiramer acetate reduces the risk for experimental cerebral malaria: a pilot study.
Lackner P, Part A, Burger C, Dietmann A, Broessner G, Helbok R, Reindl M, Schmutzhard E, Beer R
Malar J. 2009; 8:36. Epub 2009 Feb 27. PMID: 19250545. Abstract
Might be useful in treating diseases with endothelial dysfunction, based on studies in human umbilical vein endothelial cells
(187)
Glatiramer acetate (GA) prevents TNF-α-induced monocyte adhesion to primary endothelial cells through interfering with the NF-κB pathway.
Wei G, Zhang X, Su Z, Li X
Biochem Biophys Res Commun. 2014 Dec 19. PMID: 25529444. Abstract
Might be useful for controlling epileptic seizures, based on experiments in rats
(121)
Glatiramer acetate, an anti-demyelination drug, reduced rats' epileptic seizures induced by pentylenetetrazol via protection of myelin sheath.
You Y, Zhao Y, Bai H, Liu Z, Meng F, Zhang H, Xu R
Eur J Pharm Sci. 2013 Jun 14; 49(3):366-70. Epub 2013 Apr 21. PMID: 23611724. Abstract
Inhibits graft rejection in mice
(20)
Copolymer 1 inhibits manifestations of graft rejection.
Aharoni R, Teitelbaum D, Arnon R, Sela M
Transplantation. 2001 Aug 27; 72(4):598-605. PMID: 11544417. Abstract
May be useful in Guillain-Barré syndrome, a demyelinating disease of the peripheral nervous system, on the basis of experiments in experimental autoimmune neuritis rats, which serve as a model of that disease
(118)
Glatiramer acetate ameliorates experimental autoimmune neuritis.
Zhang C-J, Zhai H, Yan Y, Hao J, Li M-S, Jin W-N, Su N, Vollmer TL, Shi F-D
Immunol Cell Biol. 2013 Nov 26. PMID: 24275856. Abstract
Reduces inflammation and neurodegeneration in a mouse model of HIV1 encephalomyelitis
(21)
Copolymer-1 induces adaptive immune anti-inflammatory glial and neuroprotective responses in a murine model of HIV-1 encephalitis.
Gorantla S, Liu J, Sneller H, Dou H, Holguin A, Smith L, Ikezu T, Volsky DJ, Poluektova L, Gendelman HE
J Immunol. 2007 Oct 1; 179(7):4345-56. PMID: 17878329. Abstract
Might be useful for treating Huntington's disease, based on experiments in mice and cultured cells
(175)
Disease Modifying Potential of Glatiramer Acetate in Huntington's Disease.
Corey-Bloom J, Jia H, Aikin AM, Thomas EA
J Huntingtons Dis. 2014; 3(3):311-6. PMID: 25300334. Abstract
Has positive effects in mouse models of inflammatory bowel disease
(19)
Immunomodulatory therapeutic effect of glatiramer acetate on several murine models of inflammatory bowel disease.
Aharoni R, Kayhan B, Brenner O, Domev H, Labunskay G, Arnon R
J Pharmacol Exp Ther. 2006 Jul; 318(1):68-78. Epub 2006 Apr 19. PMID: 16624971. Abstract
(80)
Glatiramer acetate ameliorates inflammatory bowel disease in mice through the induction of Qa-1-restricted CD8⁺ regulatory cells.
Yao Y, Han W, Liang J, Ji J, Wang J, Cantor H, Lu L
Eur J Immunol. 2013 Jan; 43(1):125-36. Epub 2012 Nov 07. PMID: 23002042. Abstract
Weekly vaccination decreased symptoms of dry age-related macular degeneration in a small human trial
(17)
Weekly vaccination with Copaxone (glatiramer acetate) as a potential therapy for dry age-related macular degeneration.
Landa G, Butovsky O, Shoshani J, Schwartz M, Pollack A
Curr Eye Res. 2008 Nov; 33(11):1011-3. PMID: 19085384. Abstract
Might have therapeutic use in osteoarthritis, based on studies of isolated human chondrocytes
(136)
Glatiramer acetate inhibits degradation of collagen II by suppressing the activity of interferon regulatory factor-1.
Lu H, Zeng C, Zhao H, Lian L, Dai Y
Biochem Biophys Res Commun. 2014 Mar 18. PMID: 24657155. Abstract
May be useful in treating acute ischemic stroke, based on studies in rat
(199)
Copolymer-1 promotes neurogenesis and improves functional recovery after acute ischemic stroke in rats.
Cruz Y, Lorea J, Mestre H, Kim-Lee J H, Herrera J, Mellado R, Gálvez V, Cuellar L, Musri C, Ibarra A
PLoS One. 2015; 10(3):e0121854. Epub 2015 Mar 30. PMID: 25821957. Abstract
Did not show potential as a therapy against acute ischemic stroke in a mouse study
(131)
Glatiramer acetate does not protect from acute ischemic stroke in mice.
Kraft P, Göbel K, Meuth SG, Kleinschnitz C
Exp Transl Stroke Med. 2014; 6(1):4. Epub 2014 Feb 27. PMID: 24576335. Abstract
Administration: 
Involves daily subcutaneous injection, according to information from the US Food and Drug Administration
(29)
Full Prescribing Information, Copaxone (glatiramer acetate)
FDA, Feb 2009
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf.
Prefilled syringes contain 20 mg glatiramer acetate in solution
(23)
Copaxone
Drugs.com, Sep 2011
Accessed on 4 Jan 2012 from http://www.drugs.com/pro/copaxone.html.
(29)
Full Prescribing Information, Copaxone (glatiramer acetate)
FDA, Feb 2009
Accessed on 4 Jan 2012 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf.
Three-times-weekly (40 mg/1 ml) subcutaneous injection has been approved by the US Food and Drug Administration
(126)
Teva announces U.S. FDA approval of three-times-a-week COPAXONE® (glatiramer acetate injection) 40mg/mL
Market Watch, The Wall Street Journal, 28 Jan 2014
Accessed on 30 Jan 2014 from http://www.marketwatch.com/story/teva-announces-us-fda-approval-of-three-times-a-week-copaxone-glatiramer-acetate-injection-40mgml-2014-01-28?reflink=MW_news_stmp.
Intramuscular version (GA Depot, which consists of microspheres containing glatiramer acetate) given once every 4 weeks is being tested in a Phase IIa study that began December, 2014
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Nasal administration appears effective in experimental autoimmune encephalomyelitis mice
(76)
Nasal administration of drugs as a new non-invasive strategy for efficient treatment of multiple sclerosis.
Duchi S, Ovadia H, Touitou E
J Neuroimmunol. 2013 Mar 18. PMID: 23517929. Abstract
Negative effects: 
IgE-mediated allergic reactions to glatiramer acetate after the initial dose have been described in 3 individuals with MS
(193)
IgE-Mediated Allergic Reactions after the First Administration of Glatiramer Acetate in Patients with Multiple Sclerosis.
Corominas M, Postigo I, Cardona V, Lleonart R, Romero-Pinel L, Martinez J
Int Arch Allergy Immunol. 2014; 165(4):244-6. Epub 2015 Jan 29. PMID: 25634237. Abstract
Dyspnea (shortness of breath)
(9)
Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis.
Johnson KP
Ther Clin Risk Manag. 2010; 6:153-72. Epub 2010 Apr 15. PMID: 20421914. Abstract
Associated with a case of eosinophilia that resulted in shock, respiratory distress, and eosinophilic myocarditis
(163)
Diagnosis of exclusion: a case report of probable glatiramer acetate-induced eosinophilic myocarditis.
Michaud CJ, Bockheim HM, Nabeel M, Daum TE
Case Rep Neurol Med. 2014; 2014:786342. Epub 2014 Jul 03. PMID: 25105037. Abstract
May have contributed to the development of Guillain-Barré syndrome in one patient
(38)
Development of Guillain-Barré syndrome in a patient with multiple sclerosis during treatment with glatiramer acetate.
Motta E, Gołba A, Huć M, Kazibutowska Z
Neurol Neurochir Pol. 2012; 46(2):189-191. PMID: 22581602. Abstract
Associated with severe acute hepatitis in one patient
(48)
Glatiramer acetate induced hepatotoxicity.
Subramaniam K, Pavli P, Llewellyn H, Chitturi S
Curr Drug Saf. 2012 Apr 1; 7(2):186-8. PMID: 22873505. Abstract
Induced acute hepatitis in one case; markers of infection or autoimmunity were not observed
(205)
Glatiramer acetate-induced hepatitis in a young female patient with multiple sclerosis.
La Gioia S, Bacis G, Sonzogni A, Frigeni B, Conti M Z, Vedovello M, Rottoli M R
Mult Scler Relat Disord. 2014 Nov; 3(6):732-4. Epub 2014 Aug 15. PMID: 25891553. Abstract
Can potentially unmask hepatitis, based on the observation of (possible and definite) autoimmune hepatitis in two individuals during treatment with glatiramer acetate, who had previously exhibited hepatitis exacerbations during treatment with interferon beta-1a
(204)
Does glatiramer acetate provoke hepatitis in multiple sclerosis?
Sinagra E, Raimondo D, Cottone S, Guddo F, Gabriele Rizzo A, Amvrosiadis G, Perricone G, Cottone M, Madonia S
Mult Scler Relat Disord. 2014 Mar; 3(2):266-8. Epub 2013 Oct 08. PMID: 25878015. Abstract
Hepatotoxicity (in the absence of positive autoimmune markers) has been reported in a pediatric patient
(102)
Glatiramer acetate-induced acute hepatotoxicity in an adolescent with MS.
Makhani N, Ngan B-Y, Kamath BM, Yeh AE
Neurology. 2013 Jul 24. PMID: 23884038. Abstract
Hypersensitivity
(9)
Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis.
Johnson KP
Ther Clin Risk Manag. 2010; 6:153-72. Epub 2010 Apr 15. PMID: 20421914. Abstract
Rarely induces delayed-type hypersensitivity reactions, and this response involves T(H)1 cells that express skin-homing receptors, as shown by analysis of the responses of two patients
(52)
Immunological mechanisms underlying delayed-type hypersensitivity reactions to glatiramer acetate.
Mayorga C, Blazquez AB, Doña I, Gomez F, Chaves P, Sanchez-Quintero MJ, Blanca-López N, Melendez L, Blanca M, Torres M J
Ann Allergy Asthma Immunol. 2012 Jul; 109(1):47-51. Epub 2012 May 23. PMID: 22727157. Abstract
Injection-site reactions
(9)
Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis.
Johnson KP
Ther Clin Risk Manag. 2010; 6:153-72. Epub 2010 Apr 15. PMID: 20421914. Abstract
Long-term use (≥2 years) is associated with a high prevalence (75%) of individuals exhibiting ≥1 cutaneous adverse event at a given point in time, based on a cross-sectional study
(170)
Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality of life in patients with multiple sclerosis: a cross-sectional study.
Balak D M, Hengstman G J, Hajdarbegovic E, van den Brule R J, Hupperts RMM, Thio H B
BMC Neurol. 2013 Oct 16; 13(1):146. Epub 2013 Oct 16. PMID: 24131589. Abstract
Meralgia paresthetica has been reported after subcutaneous injection
(195)
Meralgia paresthetica after subcutaneous injection of glatiramer acetate.
Lagueny A, Ouallet J C
Muscle Nerve. 2015 Feb 20. PMID: 25703091. Abstract
Administration was associated with Nicolau syndrome in an individual with RRMS
(155)
[Nicolau syndrome after administration of glatiramer acetate].
Pulido Pérez A, Parra Blanco V, Suárez Fernández R
Neurologia. 2013 Sep; 28(7):448-9. Epub 2012 Jun 13. PMID: 22698594. Abstract
Subcutaneous injections were associated with recurrent Nicolau syndrome in an individual with MS
(238)
Recurrent Nicolau syndrome associated with subcutaneous glatiramer acetate injection-a case report.
Zecca C, Mainetti C, Blum R, Gobbi C
BMC Neurol. 2015; 15:249. Epub 2015 Dec 02. PMID: 26630967. Abstract
Lipoatrophy
(154)
Lipoatrophy in patients with multiple sclerosis on glatiramer acetate.
Edgar CM, Brunet DG, Fenton P, McBride VE, Green P
Can J Neurol Sci. 2004 Feb; 31(1):58-63. PMID: 15038472. Abstract
Long-term treatment is associated with injection-site indurations and panniculitis/lipoatrophy, which can be reduced through endermology, as shown by a 6-week study, involving endermology twice per week for 70 individuals with RRMS
(160)
Benefit of Endermology on Indurations and Panniculitis/Lipoatrophy During Relapsing-Remitting Multiple Sclerosis Long-Term Treatment with Glatiramer Acetate.
Márquez-Rebollo C, Vergara-Carrasco L, Díaz-Navarro R, Rubio-Fernández D, Francoli-Martínez P, Sánchez-de la Rosa R
Adv Ther. 2014 Jul 22. Epub 2014 Jul 22. PMID: 25047757. Abstract
Associated with the development of injection-site cutaneous necrosis and radial nerve palsy in an MS patient with psoriasis
(98)
Necrotizing skin lesion and radial nerve palsy in a patient treated with glatiramer acetate.
Carotenuto A, Iodice R, Barbato F, Orefice N S, Orefice G
J Neurol Sci. 2013 Jun 15. PMID: 23778027. Abstract
Urticaria (hives)
(9)
Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis.
Johnson KP
Ther Clin Risk Manag. 2010; 6:153-72. Epub 2010 Apr 15. PMID: 20421914. Abstract
Reduced the efficacy of vaccination against pandemic H1N1 (swine flu, in 2009) and seasonal influenza (in 2010)
(122)
Immunotherapies influence the influenza vaccination response in multiple sclerosis patients: an explorative study.
Olberg HK, Cox RJ, Nostbakken JK, Aarseth JH, Vedeler CA, Myhr K-M
Mult Scler. 2014 Jan 16. PMID: 24436455. Abstract
Vasodilatation
(9)
Risks vs benefits of glatiramer acetate: a changing perspective as new therapies emerge for multiple sclerosis.
Johnson KP
Ther Clin Risk Manag. 2010; 6:153-72. Epub 2010 Apr 15. PMID: 20421914. Abstract
Is associated with a lower risk of adverse events as compared with dimethyl fumarate and teriflunomide, based on meta-analysis of 3 randomized controlled trials involving 3737 individuals with RRMS
(178)
Meta-analysis of adverse events in recent randomized clinical trials for dimethil fumarate, glatiramer acetate and teriflunomide for the treatment of relapsing forms of multiple sclerosis.
Zagmutt FJ, Carroll CA
Int J Neurosci. 2014 Nov 24. PMID: 25387069. Abstract
Exposure during pregnancy does not seem to be a major teratogenic risk, based on an analysis of 41 pregnancies
(54)
Multiple sclerosis and pregnancy: experience from a nationwide database in Germany.
Hellwig K, Haghikia A, Rockhoff M, Gold R
Ther Adv Neurol Disord. 2012 Sep; 5(5):247-53. PMID: 22973421. Abstract
Exposure during pregnancy is not associated with an increased risk of spontaneous abortion or other negative pregnancy or fetal outcomes, based on a prospective observational study of 423 pregnancies, 17 of which involved glatiramer acetate exposure
(58)
Pregnancy and fetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study.
Giannini M, Portaccio E, Ghezzi A, Hakiki B, Pastò L, Razzolini L, Piscolla E, De Giglio L, Pozzilli C, Paolicelli D, et al.
BMC Neurol. 2012; 12:124. Epub 2012 Oct 22. PMID: 23088447. Abstract
Was not associated with an increased incidence of thyroid dysfunction or autoimmunity in an Italian multicenter study
(130)
Thyroid autoimmunity and dysfunction in multiple sclerosis patients during long-term treatment with interferon beta or glatiramer acetate: an Italian multicenter study.
Frisullo G, Calabrese M, Tortorella C, Paolicelli D, Ragonese P, Annovazzi P, Radaelli M, Malucchi S, Gallo A, Tomassini V, et al.
Mult Scler. 2014 Feb 10. PMID: 24515732. Abstract
Exposure in would-be fathers just before (within 64 days, the duration of spermatogenesis) or at the time of conception does not appear to be associated with lower birth weight or a change in gestational age of newborns, based on an analysis of 16 cases
(133)
Birth Outcomes in Newborns Fathered by Men with Multiple Sclerosis Exposed to Disease-Modifying Drugs.
Lu E, Zhu F, Zhao Y, van der Kop M, Synnes A, Dahlgren L, Sadovnick DA, Traboulsee A, Tremlett H
CNS Drugs. 2014 Mar 19. PMID: 24643915. Abstract
Paternal exposure was not associated with increased risk of spontaneous abortion, congenital malformations, or adverse fetal outcomes, based on a study of 6 pregnancies fathered by men with MS exposed to glatiramer acetate at time of conception as compared with 33 pregnancies fathered by men with MS without disease-modifying therapy exposure at that time
(151)
Paternal therapy with disease modifying drugs in multiple sclerosis and pregnancy outcomes: a prospective observational multicentric study.
Pecori C, Giannini M, Portaccio E, Ghezzi A, Hakiki B, Pastò L, Razzolini L, Sturchio A, De Giglio L, Pozzilli C, et al.
BMC Neurol. 2014 May 26; 14(1):114. Epub 2014 May 26. PMID: 24884599. Abstract
Commercial: 
In North America, marketed by Teva Neuroscience, a subsidiary of Teva Pharmaceutical Industries
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
In Europe, marketed by Teva Pharmaceutical Industries and Sanofi-aventis
(6)
Significant Reduced Loss of Brain Volume in Multiple Sclerosis Patients Treated with COPAXONE(R)
MarketWatch, The Wall Street Journal, 11 Oct 2011
Accessed on 4 Jan 2012 from http://www.marketwatch.com/story/significant-reduced-loss-of-brain-volume-in-multiple-sclerosis-patients-treated-with-copaxoner-2011-10-11.
Sales and marketing rights in the EU have been taken back from Sanofi by Teva (May 2012)
(34)
Teva Pharmaceutical Industries Limited's CEO Discusses Q1 2012 Results - Earnings Call Transcript
SeekingAlpha.com, 9 May 2012
Accessed on 15 May 2012 from http://seekingalpha.com/article/575201-teva-pharmaceutical-industries-limited-s-ceo-discusses-q1-2012-results-earnings-call-transcript.
Teva has attempted to delay marketing approval of generic versions of Copaxone through legal measures against other companies and regulatory channels; Teva's fourth petition to US Food and Drug Administration, asking that marketing for a generic version would not be approved without clinical trials, was denied, as the previous three had been (5 December 2012)
(60)
FDA denies Teva Copaxone generic trials petition
Globes, Israel Business News, 5 Dec 2012
Accessed on 10 Dec 2012 from http://www.globes.co.il/serveen/globes/docview.asp?did=1000804017&fid=1725.
Application for a US patent for a Copaxone-Laquinimod mixed treatment (which would be administered via an injection) for MS has been filed by Teva (13 February 2013)
(69)
BRIEF: Teva files for Copaxone-Laquinimod patent
Middle East North Africa Financial Network, 13 Feb 2013
Accessed on 18 Feb 2013 from http://www.menafn.com/menafn/46d9c3c8-74ec-4f41-a64f-6aa0560bdea7/BRIEF-Teva-files-for-CopaxoneLaquinimod-patent?src=main.
Application for US Food and Drug Administration (FDA) approval for a 40 mg/1 ml three-times weekly dose of Copaxone has been filed by Teva (March, 2013)
(87)
UPDATE 1-Teva Pharmaceutical banks on thrice-weekly Copaxone
Cohen T, Reuters, 2 May 2013
Accessed on 5 May 2013 from http://www.reuters.com/article/2013/05/02/tevapharm-results-idUSL6N0DJ35O20130502.
and accepted for review by the FDA (30 May 2013)
(92)
Teva announces FDA acceptance of sNDA for a higher concentration dose of COPAXONE® given three times a week
Business Wire, 30 May 2013
Accessed on 31 May 2013 from http://www.businesswire.com/news/home/20130530005718/en/Teva-Announces-FDA-Acceptance-sNDA-Higher-Concentration.
Patent covering the use of a combination of estriol and glatiramer acetate for treating MS has been issued to the Regents of the University of California by the US Patent & Trademark Office (4 April 2013)
(78)
Synthetic Biologics announces issuance of U.S. patent covering combination of estriol and Copaxone® for multiple sclerosis
Synthetic Biologics, 4 Apr 2013
Accessed on 8 Apr 2013 from http://www.syntheticbiologics.com/2013-04-04-Synthetic-Biologics-Announces-Issuance-of-U-S-Patent-Covering-Combination-of-Estriol-and-Copaxone-for-Multiple-Sclerosis.
US patent for a long-acting formulation (a prolonged-release version now under development that would be injected once a month rather than daily) has been granted to Mapi Pharma Ltd (6 May 2013)
(88)
Mapi Pharma granted United States patent covering glatiramer depot for multiple sclerosis
Mapi Pharma, 6 May 2013
Accessed on 21 May 2013 from http://www.mapi-pharma.com/news/?pid=30.
Will lose patent protection in 2014 instead of 2015 on the basis of a US appeals court ruling; Novartis and Momenta Pharmaceuticals are developing a generic version together, as are Mylan Inc and Natco Pharma (26 July 2013)
(101)
US court permits generic version of Teva MS drug a year sooner
Bartz D, Pierson R, Reuters, 26 Jul 2013
Accessed on 29 Jul 2013 from http://www.reuters.com/article/2013/07/26/teva-copaxone-patent-idUSL1N0FW17H20130726.
Validity of Teva's patent protection is upheld until May 2015 by the Court of Appeal for England and Wales (29 July 2013)
(103)
English Court of Appeal finds in favor of Teva on Copaxone(R) patent litigation and upholds validity of Copaxone patent until May 2015
Market Watch, The Wall Street Journal, 29 Jul 2013
Accessed on 8 Aug 2013 from http://www.marketwatch.com/story/english-court-of-appeal-finds-in-favor-of-teva-on-copaxoner-patent-litigation-and-upholds-validity-of-copaxone-patent-until-may-2015-2013-07-29?reflink=MW_news_stmp.
Commercialization rights in Japan have been granted to Takeda Pharmaceutical Company by Teva Pharmaceutical Industries; a New Drug Application to register the drug in Japan will be submitted by Takeda (announced 4 December 2013)
(119)
Teva and Takeda announce agreement for glatiramer acetate for multiple sclerosis treatment in Japan
The Wall Street Journal, 4 Dec 2013
Accessed on 4 Dec 2013 from http://online.wsj.com/article/PR-CO-20131204-902576.html?dsk=y.
New Drug Application for use of glatiramer acetate in Japan to prevent relapses in MS has been submitted by Takeda Pharmaceutical Company to the Japanese Ministry of Health, Labour and Welfare (25 December 2014)
(190)
Takeda Submits a New Drug Application for Glatiramer Acetate in Japan for the Relapse Prevention of Multiple Sclerosis
Takeda, 25 Dec 2015
Accessed on 6 Jan 2015 from https://www.takeda.com/news/2014/20141225_6846.html.
Three-times-weekly (40 mg/1 ml) Copaxone dose has been approved by the US Food and Drug Administration (28 January 2014)
(126)
Teva announces U.S. FDA approval of three-times-a-week COPAXONE® (glatiramer acetate injection) 40mg/mL
Market Watch, The Wall Street Journal, 28 Jan 2014
Accessed on 30 Jan 2014 from http://www.marketwatch.com/story/teva-announces-us-fda-approval-of-three-times-a-week-copaxone-glatiramer-acetate-injection-40mgml-2014-01-28?reflink=MW_news_stmp.
Generic version is being developed by Synthon; Phase III clinical trial is underway (March, 2014)
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
US Supreme Court will hear Teva's appeal of the decision of a lower court that invalidated the claim of a US patent that covers the manufacture of the active ingredient in Copaxone and that expires in September 2015 (31 March 2014)
(137)
Teva Announces U.S. Supreme Court Will Hear Its Appeal on COPAXONE(R) Patent
The Wall Street Journal, 31 Mar 2014
Accessed on 2 Apr 2014 from http://online.wsj.com/article/PR-CO-20140331-910272.html.
US Supreme Court will not prevent a lower-court ruling (favoring generic versions of glatiramer acetate) from going into effect while the Supreme Court considers appeal (18 April 2014)
(141)
US top court denies Israel's Teva Pharmaceuticals stay in Copaxone patent fight
The Jerusalem Post, 18 Apr 2014
Accessed on 5 May 2014 from http://www.jpost.com/Business/Business-News/US-top-court-denies-Israels-Teva-Pharmaceuticals-stay-in-Copaxone-patent-fight-349886.
US Patent to Mapi Pharma Ltd., covering "glatiramer acetate depot" (a prolonged release formulation), has been extended to December 2030 and an earlier patent has been awarded additional claims (27 May 2014)
(150)
Mapi Pharma Receives Additional Claims for Its U.S. Patent for Glatiramer Acetate Depot for the Treatment of Multiple Sclerosis
Market Watch, The Wall Street Journal, 27 May 2014
Accessed on 29 May 2014 from http://www.marketwatch.com/story/mapi-pharma-receives-additional-claims-for-its-us-patent-for-glatiramer-acetate-depot-for-the-treatment-of-multiple-sclerosis-2014-05-27.
Abbreviated new drug application from Mylan for generic three times per week glatiramer acetate 40 mg/ml has been accepted for filing by the US Food and Drug Administration (28 August 2014)
(165)
Mylan's ANDA for Three Times Per Week Generic Copaxone® 40 mg/mL Accepted for Filing by FDA
Mylan, 28 Aug 2014
Accessed on 2 Sep 2014 from http://www.mylan.com/news/press-releases/item?id=123246.
Three-times-weekly (40 mg/1 ml) Copaxone dose has received a positive outcome in Europe after a Positive Assessment Report from the Reference Member State’s Medicines and Healthcare Products Regulatory Agency and other EU member states (4 December 2014)
(181)
Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)
Teva Pharmaceutical Industries Ltd., 4 Dec 2014
Accessed on 9 Dec 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1995004.
Phase IIa study of GA Depot for treating RRMS has begun; study is being conducted by Mapi Pharma (December, 2014)
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
US Supreme Court reverses a decision by the Federal Circuit Court that invalidated one of Teva's patents for Copaxone; the case has been remanded to the Federal Circuit for further review (20 January 2015)
(191)
Teva Announces U.S. Supreme Court Decision to Reverse Federal Circuit Court’s Judgment on COPAXONE® 20 mg/mL Case and Remand for Further Review
Teva Pharmaceutical Industries, 20 Jan 2015
Accessed on 27 Jan 2015 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2008891.
; the US Court of Appeals for the Federal Circuit again invalidated the patent (18 June 2015)
(211)
Momenta Pharmaceuticals Announces CAFC Decision to Invalidate Remanded Teva Pharmaceuticals Patent in Daily COPAXONE(R) 20 mg Suit
Momenta, 18 Jun 2015
Accessed on 23 Jun 2015 from http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=918548.
Glatopa (a substitutable generic for Copaxone 20 mg), which was developed in a collaboration between Momenta Pharmaceuticals and Sandoz, has been approved by the US Food and Drug Administration for treating RRMS (16 April 2015)
(203)
Momenta Pharmaceuticals Announces FDA Approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 16 Apr 2015
Accessed on 21 Apr 2015 from http://files.shareholder.com/downloads/MNTA/70100481x0x821673/F5FCB506-E766-4DEC-876E-BD7A8982D9F5/MNTA_News_2015_4_16_General_Releases.pdf.
Glatopa, a generic equivalent of Copaxone 20 mg, has been launched in the US by Sandoz, as announced by Momenta Pharmaceuticals (18 Jun 2015)
(212)
Momenta Pharmaceuticals Announces Launch of Glatopa(TM) (glatiramer acetate injection), the First Substitutable Generic for COPAXONE(R) (glatiramer acetate injection) 20mg
Momenta, 18 Jun 2015
Accessed on 23 Jun 2015 from http://ir.momentapharma.com/releasedetail.cfm?releaseid=918623.
Exclusive commercialization rights in the US for the potential generic version being developed by Synthon have been acquired by Pfizer (3 August 2015)
(219)
Pfizer and Synthon Enter Into U.S. Commercialization Agreement for Potential Generic Treatment of Multiple Sclerosis
Synthon, 3 Aug 2015
Accessed on 5 Aug 2015 from http://www.synthon.com/Corporate/News/PressReleases/Pfizer-and-Synthon-Enter-Into-US-Commercialization-Agreement-for-Potential-Generic-Treatment-of-MS.aspx.
Copaxone (20 mg subcutaneous injection) has been approved in Japan for treating MS; the approval was obtained by Takeda Pharmaceutical Company (September 28, 2015)
(226)
Takeda Pharmaceutical: New Drug Application Approval in Japan for Copaxone® Subcutaneous Injection 20 mg Syringe, a Drug for the Treatment of Multiple Sclerosis
Business Wire, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.businesswire.com/news/home/20150928005506/en/Takeda-Pharmaceutical-Drug-Application-Approval-Japan-Copaxone®#.Vgr0Ps4buXs.
Three-times-weekly (40 mg/1 ml) Copaxone dose has been approved in Russia for treating RRMS (8 October 2015)
(230)
Teva Announces Approval of Three-Times-A-Week COPAXONE® 40 mg/mL in Russia for the Treatment of Relapsing-Remitting Multiple Sclerosis
Teva, 8 Oct 2015
Accessed on 13 Oct 2015 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2095367.
Synthon's generic version (20 mg/ml) has been approved in Europe on the basis of results from the GATE trial (12 April 2016)
(253)
Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon, 12 Apr 2016
Accessed on 19 Apr 2016 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-obtains-approval-for-glatiramer-acetate-20-mg-mL-in-Europe.aspx.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis (meeting report, April 2014; publ December 2015)
(143)
Adeona Announces Completion of Planned Enrollment in Phase II Multiple Sclerosis Clinical Trial
Adeona Pharmaceuticals, 9 Sep 2011
Accessed on 3 Jan 2012 from http://www.syntheticbiologics.com/index.php?s=43&item=90.
(144)
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 23 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00451204.
(145)
Synthetic Biologics Reports UCLA Announcement of Preliminary Positive Topline Efficacy and Safety Results from Investigator-Led Phase II Study of Trimesta™ for RRMS
Synthetic Biologics, 29 Apr 2014
Accessed on 5 May 2014 from http://www.syntheticbiologics.com/2014-04-29-Synthetic-Biologics-Reports-UCLA-Announcement-of-Preliminary-Positive-Topline-Efficacy-and-Safety-Results-from-Investigator-Led-Phase-II-Study-of-Trimesta-for-Relapsing-Remitting-Multiple-Sclerosis.
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Phase: 
Phase II trial
(144)
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 23 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00451204.
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Study Design: 
Investigator-initiated, institute-funded, randomized, double-blind, placebo-controlled, multicenter, US-based trial to compare the efficacy of oral estriol (8 mg per day) and injectable glatiramer acetate (20 mg per day) versus placebo and glatiramer acetate, with the annualised relapse rate (ARR) after 24 months as the primary endpoint
(144)
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 23 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00451204.
(145)
Synthetic Biologics Reports UCLA Announcement of Preliminary Positive Topline Efficacy and Safety Results from Investigator-Led Phase II Study of Trimesta™ for RRMS
Synthetic Biologics, 29 Apr 2014
Accessed on 5 May 2014 from http://www.syntheticbiologics.com/2014-04-29-Synthetic-Biologics-Reports-UCLA-Announcement-of-Preliminary-Positive-Topline-Efficacy-and-Safety-Results-from-Investigator-Led-Phase-II-Study-of-Trimesta-for-Relapsing-Remitting-Multiple-Sclerosis.
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Disease Stage: 
RRMS
(144)
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 23 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00451204.
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Enrollment/Number of Patients: 
164 women
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Duration: 
2 years
(144)
A Combination Trial of Copaxone plus Estriol in Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 23 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00451204.
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
Status/Outcome: 
Estriol plus glatiramer acetate was associated with a 47% decrease (statistically significant) in the ARR at 12 months as compared with placebo plus glatiramer acetate, and a 32% decrease at 24 months
(145)
Synthetic Biologics Reports UCLA Announcement of Preliminary Positive Topline Efficacy and Safety Results from Investigator-Led Phase II Study of Trimesta™ for RRMS
Synthetic Biologics, 29 Apr 2014
Accessed on 5 May 2014 from http://www.syntheticbiologics.com/2014-04-29-Synthetic-Biologics-Reports-UCLA-Announcement-of-Preliminary-Positive-Topline-Efficacy-and-Safety-Results-from-Investigator-Led-Phase-II-Study-of-Trimesta-for-Relapsing-Remitting-Multiple-Sclerosis.
; estriol plus glatiramer acetate was associated with an ARR of 0.25 relapses per year versus 0.37 for the glatiramer acetate alone group; similar proportions in the two groups exhibited serious adverse events; irregular menses occurred more frequently, but vaginal infections less frequently, in the estriol and glatiramer acetate group versus the glatiramer acetate alone group
(237)
Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial.
Voskuhl RR, Wang HJ, Wu JTC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, et al.
Lancet Neurol. 2015 Nov 24. PMID: 26621682. Abstract
; independent analyses of trial results by two different organizations did not show differences that were statistically significant between estriol and glatiramer acetate versus glatiramer acetate alone for either clinical or MRI results at either 12 or 24 months; the ARR at 12 months was 0.13 versus 0.19 for the estriol plus glatiramer acetate group versus the glatiramer acetate alone group, and at 24 months was 0.17 versus 0.25 (February 2016)
(247)
Synthetic Biologics Reports Results of Independent Third Party Evaluations of Trimesta™ Data from Investigator-Sponsored Phase 2 Clinical Trial for Relapsing-Remitting Multiple Sclerosis
Synthetic Biologics, 2 Feb 2016
Accessed on 9 Feb 2016 from http://www.syntheticbiologics.com/news-media/press-releases/detail/198/synthetic-biologics-reports-results-of-independent-third.
Trial name: 
Fox et al., Neurology, April 2014 study (RESTORE)
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
(239)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09. PMID: 25381458. Abstract
Phase: 
Exploratory study
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
Study Design: 
Industry-funded, randomized, partially placebo-controlled exploratory study to examine disease activity in individuals who had been treated with natalizumab (with no relapse activity during the previous year and no gadolinium-enhancing lesions at the time of screening) during an interruption of natalizumab treatment; participants received either natalizumab, interferon beta-1a, glatiramer acetate, methylprednisolone, or placebo during the interruption
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
(239)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09. PMID: 25381458. Abstract
Disease Stage: 
RRMS
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
Enrollment/Number of Patients: 
175
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
Duration: 
24 weeks (length of interruption)
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
Status/Outcome: 
Interruption in natalizumab treatment was associated with an increased risk of MRI and relapse activity even when other therapies were used; relapses occurred in 4% of participants receiving natalizumab versus 15% to 29% of participants in other arms of the study
(139)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology. 2014 Apr 9. Epub 2014 Mar 28. PMID: 24682966. Abstract
; during the randomized treatment period, gadolinium-enhancing lesions were observed in 0% of individuals receiving natalizumab, 48% of those receiving other treatments, and 61% of those on placebo; such lesions were primarily observed at week 16 or later
(239)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09. PMID: 25381458. Abstract
Trial name: 
Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) (press release, March 2014; publ October 2015)
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Phase: 
Phase III trial
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Study Design: 
Company-sponsored, multinational, randomized, double-blind, active- and placebo-controlled trial to compare the efficacy and safety of GTR [a generic version of glatiramer acetate produced by Synthon (daily injected dose, 20 mg)] to that of Copaxone [(glatiramer acetate produced by Teva (daily injected dose, 20 mg)] or placebo; the primary outcome is the number of gadolinium-enhancing lesions detected by MRI during months 7, 8, and 9
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Disease Stage: 
RRMS
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Enrollment/Number of Patients: 
794
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Duration: 
9 months (followed by a 15-month open-label extension)
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Status/Outcome: 
GTR and Copaxone reduced the number of gadolinium-enhancing lesions during months 7, 8, and 9 to an equivalent degree and were associated with a comparable incidence, severity, and range of adverse reactions (including injection site reactions)
(134)
Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate
Synthon, 27 Mar 2014
Accessed on 1 Apr 2014 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-announces-successful-outcome-of-the-PhaseIII-GATE-study-with-its-generic-glatiramer-acetate?sc_lang=en.
(231)
Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial.
Cohen J, Belova A, Selmaj K, Wolf C, Sormani M P, Oberyé J, van den Tweel E, Mulder R, Koper N, Voortman G, et al.
JAMA Neurol. 2015 Oct 12:1-9. Epub 1969 Dec 31. PMID: 26458034. Abstract
Trial name: 
Glatiramer Acetate Low-Frequency Administration (GALA) (press releases, June 2012 and October 2012, publ May 2013, December 2014)
(42)
Teva announces top-line results from GALA Phase III trial evaluating a new dosage for glatiramer acetate given three times weekly for relapsing-remitting multiple sclerosis
Market Watch, The Wall Street Journal, 14 Jun 2012
Accessed on 18 Jun 2012 from http://www.marketwatch.com/story/teva-announces-top-line-results-from-gala-phase-iii-trial-evaluating-a-new-dosage-for-glatiramer-acetate-given-three-times-weekly-for-relapsing-remitting-multiple-sclerosis-2012-06-14.
(57)
Teva to present positive data for glatiramer acetate 40 mg/1 ml given three times weekly for relapsing-remitting MS
Teva Pharmaceutical Industries, 10 Oct 2012
Accessed on 16 Oct 2012 from http://www.tevapharm.com/Media/News/Pages/2012/1743500.aspx.
(90)
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, for the GALA Study Group
Ann Neurol. 2013 May 20. PMID: 23686821. Abstract
(189)
Effect of glatiramer acetate three-times weekly on the evolution of new, active multiple sclerosis lesions into T1-hypointense "black holes": a post hoc magnetic resonance imaging analysis.
Zivadinov R, Dwyer M, Barkay H, Steinerman JR, Knappertz V, Khan O
J Neurol. 2014 Dec 27. Epub 2014 Dec 27. PMID: 25542295. Abstract
(225)
The Effect of Three Times a Week Glatiramer Acetate on Cerebral T1 Hypointense Lesions in Relapsing-Remitting Multiple Sclerosis.
Zivadinov R, Dwyer MG, Ramasamy DP, Davis MD, Steinerman JR, Khan O
J Neuroimaging. 2015 Sep 22. PMID: 26394270. Abstract
Phase: 
Phase III trial
(42)
Teva announces top-line results from GALA Phase III trial evaluating a new dosage for glatiramer acetate given three times weekly for relapsing-remitting multiple sclerosis
Market Watch, The Wall Street Journal, 14 Jun 2012
Accessed on 18 Jun 2012 from http://www.marketwatch.com/story/teva-announces-top-line-results-from-gala-phase-iii-trial-evaluating-a-new-dosage-for-glatiramer-acetate-given-three-times-weekly-for-relapsing-remitting-multiple-sclerosis-2012-06-14.
Study Design: 
Company-sponsored, multinational, randomized, double-blind, placebo-controlled trial to study the safety and effect of glatiramer acetate injection (40 mg/1 ml, administered 3 times weekly) on reducing the number of confirmed relapses (primary endpoint) [the dose in this study is higher but less frequent than the marketed dose (20 mg/1 ml daily) at the time of this press release]
(42)
Teva announces top-line results from GALA Phase III trial evaluating a new dosage for glatiramer acetate given three times weekly for relapsing-remitting multiple sclerosis
Market Watch, The Wall Street Journal, 14 Jun 2012
Accessed on 18 Jun 2012 from http://www.marketwatch.com/story/teva-announces-top-line-results-from-gala-phase-iii-trial-evaluating-a-new-dosage-for-glatiramer-acetate-given-three-times-weekly-for-relapsing-remitting-multiple-sclerosis-2012-06-14.
Disease Stage: 
RRMS
(42)
Teva announces top-line results from GALA Phase III trial evaluating a new dosage for glatiramer acetate given three times weekly for relapsing-remitting multiple sclerosis
Market Watch, The Wall Street Journal, 14 Jun 2012
Accessed on 18 Jun 2012 from http://www.marketwatch.com/story/teva-announces-top-line-results-from-gala-phase-iii-trial-evaluating-a-new-dosage-for-glatiramer-acetate-given-three-times-weekly-for-relapsing-remitting-multiple-sclerosis-2012-06-14.
Enrollment/Number of Patients: 
1404
(90)
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, for the GALA Study Group
Ann Neurol. 2013 May 20. PMID: 23686821. Abstract
Duration: 
12 months
(42)
Teva announces top-line results from GALA Phase III trial evaluating a new dosage for glatiramer acetate given three times weekly for relapsing-remitting multiple sclerosis
Market Watch, The Wall Street Journal, 14 Jun 2012
Accessed on 18 Jun 2012 from http://www.marketwatch.com/story/teva-announces-top-line-results-from-gala-phase-iii-trial-evaluating-a-new-dosage-for-glatiramer-acetate-given-three-times-weekly-for-relapsing-remitting-multiple-sclerosis-2012-06-14.
Status/Outcome: 
Drug at the 40 mg, 3 times a week dose reduced the annualized relapse rate by 34.0% as compared with placebo (mean annualized relapse rate for patients receiving the drug was 0.331 versus 0.505 for those on placebo)
(90)
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, for the GALA Study Group
Ann Neurol. 2013 May 20. PMID: 23686821. Abstract
; additionally, the drug reduced the cumulative number of new and enlarging T2 lesions by 34.7% and the cumulative number of gadolinium-enhancing lesions by 44.8% as compared with placebo
(90)
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, for the GALA Study Group
Ann Neurol. 2013 May 20. PMID: 23686821. Abstract
, but the drug did not affect the percent change of brain volume at 12 months
(57)
Teva to present positive data for glatiramer acetate 40 mg/1 ml given three times weekly for relapsing-remitting MS
Teva Pharmaceutical Industries, 10 Oct 2012
Accessed on 16 Oct 2012 from http://www.tevapharm.com/Media/News/Pages/2012/1743500.aspx.
; posthoc analysis of MRI data showed that glatiramer acetate reduced the conversion of new active lesions (identified 6 months after the trial began) to "black holes" (at month 12), such that both the mean number (0.31 for glatiramer acetate versus 0.45 for placebo) and proportion (15.8% versus 19.6%) of new lesions converting decreased
(189)
Effect of glatiramer acetate three-times weekly on the evolution of new, active multiple sclerosis lesions into T1-hypointense "black holes": a post hoc magnetic resonance imaging analysis.
Zivadinov R, Dwyer M, Barkay H, Steinerman JR, Knappertz V, Khan O
J Neurol. 2014 Dec 27. Epub 2014 Dec 27. PMID: 25542295. Abstract
; glatiramer acetate was found to reduce the number of both new or enlarging T1H total lesions and T1H non-enhancing lesions
(225)
The Effect of Three Times a Week Glatiramer Acetate on Cerebral T1 Hypointense Lesions in Relapsing-Remitting Multiple Sclerosis.
Zivadinov R, Dwyer MG, Ramasamy DP, Davis MD, Steinerman JR, Khan O
J Neuroimaging. 2015 Sep 22. PMID: 26394270. Abstract
Trial name: 
Comparator and aN oral Fumarate In RRMS (CONFIRM) (publ September 2012 and June 2013, press release April 2012)
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
(95)
Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study.
Hutchinson M, Fox RJ, Miller DH, Phillips TJ, Kita M, Havrdova E, O'Gorman J, Zhang R, Novas M, Viglietta V, et al.
J Neurol. 2013 Jun 8. PMID: 23749293. Abstract
Phase: 
Phase III trial
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
Study Design: 
Company-sponsored, global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the safety and efficacy of oral BG-12 (dimethyl fumarate) (240 mg given either twice a day or three times a day) or glatiramer acetate (20 mg subcutaneous injection each day) in reducing the annualized relapse rate (ARR) (primary endpoint) and the proportion of patients who relapse at two years and the number of T2-hyperintense lesions (secondary endpoints); study was not designed to test whether dimethyl fumarate is superior or noninferior to glatiramer acetate
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
Disease Stage: 
RRMS
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
Enrollment/Number of Patients: 
1430
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
Duration: 
2 years
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
Status/Outcome: 
Dimethyl fumarate reduced the ARR by 44% (twice a day dose; ARR=0.22) or 51% (three times a day dose; ARR=0.20) and glatiramer acetate reduced this rate by 29% (ARR=0.29) as compared to placebo (ARR=0.40); dimethyl fumarate reduced the proportion of patients who relapsed at two years by 34% (twice a day dose) or 45% (three times a day dose) and glatiramer acetate reduced this rate by 29% as compared to placebo; dimethyl fumarate also had a significant effect on brain lesions
(36)
Positive results from Phase 3 CONFIRM clinical trial show efficacy and safety of oral BG-12 in multiple sclerosis
Biogen Idec, 24 Apr 2012
Accessed on 16 May 2012 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377.
(55)
Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.
Fox RJ, Miller DH, Phillips TJ, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, et al.
N Engl J Med. 2012 Sep 20; 367(12):1087-97. Epub 1969 Dec 31. PMID: 22992072. Abstract
; additional analyses of patient subgroups (based on demographics and disease characteristics) showed that the ARR was reduced across subgroups by dimethyl fumarate, with reductions ranging from 34% to 53% (twice a day dose) and from 13% to 67% (three times a day dose)
(95)
Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study.
Hutchinson M, Fox RJ, Miller DH, Phillips TJ, Kita M, Havrdova E, O'Gorman J, Zhang R, Novas M, Viglietta V, et al.
J Neurol. 2013 Jun 8. PMID: 23749293. Abstract
; glatiramer acetate also reduced the ARR in most subgroups
(95)
Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study.
Hutchinson M, Fox RJ, Miller DH, Phillips TJ, Kita M, Havrdova E, O'Gorman J, Zhang R, Novas M, Viglietta V, et al.
J Neurol. 2013 Jun 8. PMID: 23749293. Abstract
; posthoc analysis of the MRI group indicated that dimethyl fumarate reduced inflammatory disease activity (measured by the presence of relapses and MRI lesions) relative to glatiramer acetate, such that 36% of individuals on dimethyl fumarate were free of such activity during weeks 0-24 versus 29% of those on glatiramer acetate
(229)
New Data Show Strong, Sustained Effects of TECFIDERA® (Dimethyl Fumarate) in Newly-Diagnosed and Early Disease Course Multiple Sclerosis Patients
Biogen, 7 Oct 2015
Accessed on 13 Oct 2015 from http://media.biogen.com/press-release/neurology/new-data-show-strong-sustained-effects-tecfidera-dimethyl-fumarate-newly-dia.
Trial name: 
Early GA Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis in Subjects Presenting With a Clinically Isolated Syndrome (CIS) (PreCISe) (publ 2009; further analyses publ 2013)
(1)
Recent insights into the mechanism of action of glatiramer acetate.
Kala M, Miravalle A, Vollmer T
J Neuroimmunol. 2011 Jun; 235(1-2):9-17. Epub 2011 Mar 13. PMID: 21402415. Abstract
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
(82)
Neuroprotection with glatiramer acetate: evidence from the PreCISe trial.
Arnold DL, Narayanan S, Antel S
J Neurol. 2013 Apr 16. PMID: 23589190. Abstract
Phase: 
Phase III trial
(27)
Study to evaluate early glatiramer acetate treatment in delaying conversion to CDMS of subjects presenting with CIS (PreCISe)
ClinicalTrials.gov, 4 Apr 2011
Accessed on 16 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT00666224.
Study Design: 
Randomized, double-blind, multicenter trial to study the effect of early glatiramer acetate (20 mg per day) on the time to clinically definite MS from clinically isolated syndrome (primary outcome measure)
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
Disease Stage: 
CIS
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
Enrollment/Number of Patients: 
481
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
Duration: 
Up to 36 months
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
Status/Outcome: 
Drug reduced the risk of CIS converting to clinically definite MS by 45% as compared to placebo
(13)
Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial.
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, Hartung HP, Hillert J, et al.
Lancet. 2009 Oct 31; 374(9700):1503-11. Epub 2009 Oct 06. PMID: 19815268. Abstract
; in a substudy (involving 34 patients, 20 of whom did not relapse and were in the study through 12 months of followup), the drug (versus placebo) appeared to exert a neuroprotective effect in a large central brain volume, based on measurements of the ratio of a marker of neuronal integrity (N-acetylaspartate) relative to creatine
(82)
Neuroprotection with glatiramer acetate: evidence from the PreCISe trial.
Arnold DL, Narayanan S, Antel S
J Neurol. 2013 Apr 16. PMID: 23589190. Abstract
Trial name: 
Metz et al., Mult. Scler., Oct 2009 trial
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Phase: 
Phase II trial
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Study Design: 
Double-blind, placebo-controlled study to compare the effects of glatiramer acetate plus minocycline (100 mg twice daily) versus glatiramer acetate plus placebo on the total number of T1 gadolinium-enhanced lesions
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Disease Stage: 
RRMS
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Enrollment/Number of Patients: 
44, with 40 completing study
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Duration: 
9 months
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Status/Outcome: 
Glatiramer acetate plus minocycline reduced the number of T1 gadolinium-enhanced lesions by 63% as compared to glatiramer acetate alone
(28)
Glatiramer acetate in combination with minocycline in patients with relapsing--remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial.
Metz LM, Li D, Traboulsee A, Myles ML, Duquette P, Godin J, Constantin M, Yong VW, GA/minocycline study investigators
Mult Scler. 2009 Oct; 15(10):1183-94. Epub 2009 Sep 23. PMID: 19776092. Abstract
Trial name: 
PROMiSe Trial
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Phase: 
Phase III trial
(30)
Glatiramer acetate in the treatment of multiple sclerosis
Tselis A, Khan O, Lisak RP, Apr 2007
Accessed on 21 Mar 2012 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2654627/.
Study Design: 
Multinational, multicenter, double-blind, placebo-controlled trial to test whether glatiramer acetate (20 mg per day) results in a delay in time to sustained progression of accumulated disability in PPMS (primary outcome)
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Disease Stage: 
PPMS
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Enrollment/Number of Patients: 
943
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Duration: 
3 years
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Status/Outcome: 
Study was stopped prematurely when an interim analysis (at which time 757 patients had completed 2 or more years of the study or had ended participation prematurely) showed that there was no discernible effect of glatiramer acetate on the primary outcome
(22)
Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial.
Wolinsky JS, Narayana PA, O'Connor P, Coyle PK, Ford C, Johnson K, Miller A, Pardo L, Kadosh S, Ladkani D, et al.
Ann Neurol. 2007 Jan; 61(1):14-24. PMID: 17262850. Abstract
Trial name: 
Comi et al., Ann. Neurol., Mar 2001 trial
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Phase: 
Phase of trial not stated in article
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Study Design: 
Multicenter, double-blind, randomized, placebo-controlled European/Canadian trial to study the effects of glatiramer acetate (20 mg per day) on disease activity (primary outcome, the number of enhancing lesions on T1-weighted images), as measured with monthly MRI scans and clinical assessments
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Disease Stage: 
RRMS
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Enrollment/Number of Patients: 
239
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Duration: 
9 months
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Status/Outcome: 
Drug was associated with a reduction in the total number of enhancing lesions (-10.8) as compared to placebo (primary outcome), as well as a reduction in the relapse rate (33%) in the treatment versus placebo group
(4)
European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging--measured disease activity and burden in patients with relapsing multiple sclerosis.
Comi G, Filippi M, Wolinsky JS
Ann Neurol. 2001 Mar; 49(3):290-7. PMID: 11261502. Abstract
Trial name: 
Johnson et al., Neurology, July 1995 trial
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Phase: 
Phase III trial
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Study Design: 
Multicenter, double-blind, randomized, placebo-controlled trial to determine whether glatiramer acetate (20 mg per day) caused a difference in the relapse rate (primary end point)
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Disease Stage: 
RRMS
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Enrollment/Number of Patients: 
251
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Duration: 
2 years
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Status/Outcome: 
Drug was associated with a reduction in the relapse rate (primary outcome measure) (1.19 versus 1.68 over 2 years in the treatment versus placebo group)
(3)
Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group.
Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, Myers LW, Panitch HS, Rose JW, Schiffer RB
Neurology. 1995 Jul; 45(7):1268-76. PMID: 7617181. Abstract
Trial name: 
Bornstein et al., N. Engl. J. Med., Aug 1987 trial
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Phase: 
Pilot trial; phase II trial
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Study Design: 
Single-center, double-blind, randomized, placebo-controlled trial to test the effects of glatiramer acetate (20 mg per day) on the number of exacerbations
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Disease Stage: 
Exacerbating-remitting MS
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Enrollment/Number of Patients: 
50
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Duration: 
2 years (2)
Status/Outcome: 
Drug was associated with a reduction in the number of exacerbations (0.6 versus 2.7 average per patient in treatment versus placebo group over 2 years)
(2)
A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis.
Bornstein MB, Miller A, Slagle S, Weitzman M, Crystal H, Drexler E, Keilson M, Merriam A, Wassertheil-Smoller S, Spada V
N Engl J Med. 1987 Aug 13; 317(7):408-14. PMID: 3302705. Abstract
Head-to-Head Trials: 
Trial name: 
Oreja-Guevara et al., BMC Neurol., September 2012 study
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Phase: 
Observational study
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Study Design: 
Cross-sectional, observational study to compare the Th2/Th1 cytokine profile after treatment with glatiramer acetate versus natalizumab; serum levels of Th1 and Th2 cytokines were determined by flow cytometry
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Disease Stage: 
RRMS
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Enrollment/Number of Patients: 
23 (12 patients treated with glatiramer acetate and 11 with natalizumab)
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Duration: 
1 year
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Status/Outcome: 
Patients treated with natalizumab exhibited higher levels of interleukin 6 (IL-6), monocyte chemotactic protein, and granulocyte macrophage colony stimulating factor, and a trend for higher IL-12p70, IL-1b, tumor necrosis factor-α, and interferon-gamma as compared with those treated with glatiramer acetate, whereas treatment with natalizumab reduced cytokine ratios that serve as markers of the Th2/Th1 ratio as compared with glatiramer acetate; the results suggest that glatiramer acetate supports a better Th2-biased anti-inflammatory response than does natalizumab
(89)
TH1/TH2 Cytokine profile in relapsing-remitting multiple sclerosis patients treated with Glatiramer acetate or Natalizumab.
Oreja-Guevara C, Ramos-Cejudo J, Stark Aroeira L, Chamorro B, Diez-Tejedor E
BMC Neurol. 2012; 12:95. Epub 2012 Sep 18. PMID: 22989378. Abstract
Trial name: 
Calabrese et al., Mult. Scler., April 2012 trial
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Phase: 
Postmarketing
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Study Design: 
Randomized study to compare the effects of subcutaneous (sc) interferon beta-1a (44 mcg three times weekly), intramuscular (im) interferon beta-1a (30 mcg weekly), and glatiramer acetate (20 mg daily) on the development of cortical lesions and cortical atrophy
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Disease Stage: 
RRMS
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Enrollment/Number of Patients: 
165 treated patients and 50 untreated patients, with 141 treated patients completing the study
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Duration: 
24 months
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Status/Outcome: 
Interferon beta-1a and glatiramer acetate significantly decreased the development of new cortical lesions and the progression of cortical atrophy, with the most pronounced effects seen with sc interferon beta-1a, such that at 12 months, one or more new cortical lesions were seen in 26% of patients receiving sc interferon beta-1a, 64% of patients receiving im interferon beta-1a, 50% of patients receiving glatiramer acetate, and 74% of untreated patient
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
Trial name: 
Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) (results described at meeting, July 2012, publ February 2013)
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
Phase: 
Phase III trial
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
Study Design: 
NIH-funded, randomized, double-blind, controlled study to examine whether a combination of interferon beta-1a (30 microg, intramuscularly, per week) and glatiramer acetate (20 mg per day) is more effective than either treatment alone plus placebo, with a reduction in the annualized relapse rate (ARR) the primary endpoint; time to confirmed disability, the Multiple Sclerosis Functional Composite (MSFC) score, and MRI measures were among the secondary endpoints
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Disease Stage: 
RRMS
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
Enrollment/Number of Patients: 
1008
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
Duration: 
3 years
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
Status/Outcome: 
Combination therapy did not reduce the risk of relapse as compared to glatiramer acetate alone, but both of those treatments were superior to interferon beta-1a in this regard; combination therapy did not reduce confirmed progression of the Extended Disability Status Scale or MSFC score as compared to either therapy alone, but combination therapy was better than either therapy alone in reducing the accumulation of lesions and new lesion activity
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
; the combination therapy resulted in a half-point benefit on the 22-point scale measuring bladder control
(46)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov, 18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(47)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News, 16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
; a Markov model using efficacy data from the CombiRx study indicated that, from the perspective of the Spanish National Health Service, glatiramer acetate was associated with a lower annual cost as well as greater effectiveness than interferon beta-1a or the combination therapy
(176)
Cost-effectiveness of glatiramer acetate and interferon beta-1a for relapsing-remitting multiple sclerosis, based on the CombiRx study.
Darbà J, Kaskens L, Sánchez-de la Rosa R
J Med Econ. 2014 Mar; 17(3):215-22. PMID: 24494728. Abstract
Trial name: 
Rinaldi et al., Mult. Scler., May 2012 trial
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Phase: 
Postmarketing
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Study Design: 
Prospective study to determine the efficacy of natalizumab versus interferon beta-1a or glatiramer acetate in reducing the accumulation of new cortical lesions
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Disease Stage: 
RRMS
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Enrollment/Number of Patients: 
120
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Duration: 
2 years
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Status/Outcome: 
Natalizumab reduced the accumulation of new cortical lesions and the progression of cortical atrophy as compared to interferon beta-1a, glatiramer acetate, or no treatment
(37)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler. 2012 May 8. PMID: 22570359. Abstract
Trial name: 
BECOME (BEtaseron vs COpaxone in Multiple Sclerosis with Triple-Dose Gadolinium and 3-Tesla MRI Endpoints) (publ 2009)
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Phase: 
Phase IV
(31)
Phase IV, Rater-blinded, Randomized Study, Comparing the Effects of 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting or Clinically Isolated Forms of Multiple Sclerosis Using 3 Tesla MRI With Triple-dose Gadolinium
ClinicalTrials.gov, 6 May 2010
Accessed on 21 Mar 2012 from http://clinicaltrials.gov/show/NCT00176592.
Study Design: 
Trial to compare the ability of interferon beta-1b and glatiramer acetate to suppress signs of disease activity (primary outcome, number of combined active lesions per patient per scan in first year) as measured by monthly brain MRI
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Disease Stage: 
CIS or RRMS
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Enrollment/Number of Patients: 
75
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Duration: 
Up to 2 years
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Status/Outcome: 
Patients taking either interferon beta-1b and glatiramer acetate showed similar numbers of combined active lesions per patient for first year (primary outcome) and similar numbers of relapses for 2 years
(12)
Efficacy of treatment of MS with IFNbeta-1b or glatiramer acetate by monthly brain MRI in the BECOME study.
Cadavid D, Wolansky LJ, Skurnick J, Lincoln J, Cheriyan J, Szczepanowski K, Kamin SS, Pachner AR, Halper J, Cook SD
Neurology. 2009 Jun 9; 72(23):1976-83. Epub 2009 Mar 11. PMID: 19279320. Abstract
Trial name: 
BEYOND (Betaferon Efficiency Yielding Outcomes of a New Dose) (publ 2009)
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Phase: 
Phase III trial
(32)
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
ClinicalTrials.gov, 18 Dec 2008
Accessed on 21 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00099502.
Study Design: 
Multicenter, randomised, prospective study to compare the efficacy, safety, and tolerability of interferon beta-1b (250 or 500 microg every other day) and glatiramer acetate (20 mg per day) (primary outcome, relapse risk)
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Disease Stage: 
RRMS
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Enrollment/Number of Patients: 
2447
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Duration: 
2.0 to 3.5 years
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Status/Outcome: 
Relapse risk, expanded disability status scale progression, and T1-hypointense lesion volume were similar among all treatment groups
(11)
250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study.
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung H-P, Jeffery D, Kappos L, Boateng F, et al.
Lancet Neurol. 2009 Oct; 8(10):889-97. Epub 2009 Sep 02. PMID: 19729344. Abstract
Trial name: 
REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease) (publ 2008)
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Phase: 
Phase IV trial
(33)
Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
ClinicalTrials.gov, 19 Apr 2011
Accessed on 21 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00078338?term=NCT00078338.
Study Design: 
Multicenter, randomised, comparative, parallel-group, open-label study to compare effect of interferon beta-1a (44 microg 3 times a week) and glatiramer acetate (20 mg per day) on time to first relapse (primary outcome) or brain lesions (secondary outcomes)
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Disease Stage: 
RRMS
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Enrollment/Number of Patients: 
764
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Duration: 
96 weeks
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Status/Outcome: 
Study showed no significant difference between interferon beta-1a and glatiramer acetate on the primary outcome or secondary outcomes, except that interferon beta-1a was associated with fewer gadolinium-enhanding lesions per patient per scan
(10)
Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, Stubinski B, Uitdehaag B M, REGARD study group
Lancet Neurol. 2008 Oct; 7(10):903-14. Epub 2008 Sep 11. PMID: 18789766. Abstract
Other Trials: 
Trial name: 
Signori et al., Mult. Scler. Relat. Disord., March 2016 study
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Phase: 
Observational study
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Study Design: 
Meta-analysis of all published observational studies (14) that examined the long-term effect of glatiramer acetate or interferon beta; the primary outcome was the effect on disease progression to secondary phase (SP) or to a sustained Extended Disability Status Scale (EDSS) score of 6
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Disease Stage: 
RRMS
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Enrollment/Number of Patients: 
13,238
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Duration: 
N/A
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Status/Outcome: 
All except two of the studies examined described a consistent effect on long-term disease progression and nonparametric tests showed a pooled effect on EDSS score progression or progression to SP that was significant, indicating that the drugs appear to reduce the long-term risk of disability progression
(252)
Long-term impact of interferon or Glatiramer acetate in multiple sclerosis: A systematic review and meta-analysis.
Signori A, Gallo F, Bovis F, Di Tullio N, Maietta I, Sormani M P
Mult Scler Relat Disord. 2016 Mar; 6:57-63. Epub 2016 Feb 02. PMID: 27063624. Abstract
Trial name: 
Chevalier et al., PLoS One, March 2016 study
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Phase: 
Economic analysis
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Study Design: 
Industry-funded study using a Markov model to estimate the cost-effectiveness of dimethyl fumarate versus interferon beta-1a (44 microg or 30 microg), interferon beta-1b (250 microg), teriflunomide, glatiramer acetate, and fingolimod from a French societal perspective; event probabilities were taken from pivotal dimethyl fumarate clinical trials and the London Ontario Dataset
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Disease Stage: 
RRMS
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Enrollment/Number of Patients: 
Theoretical cohort, 1000 people
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Duration: 
30-year time horizon in simulation
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Status/Outcome: 
Dimethyl fumarate and interferon beta-1a (44 microg) were found to be the best options, dominating the other therapies with respect to quality-adjusted life years and cost; from a societal perspective, the incremental cost-effectiveness ratio of dimethyl fumarate versus interferon beta-1a (44 microg) was €13,110 per quality-adjusted life year
(251)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One. 2016; 11(3):e0150703. Epub 2016 Mar 17. PMID: 26987055. Abstract
Trial name: 
Hernandez et al., J. Med. Econ., March 2016 study
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Phase: 
Economic analysis
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Study Design: 
Company-sponsored study to compare the cost-effectiveness, from the viewpoint of a US payer, of peginterferon beta-1a (125 microg, once every 2 weeks), interferon beta-1a (44 microg, three times a week), and glatiramer acetate (20 mg, once a day) using a Markov cohort economic model that predicts relapse occurrence, disability progression, and adverse events and converts them to quality-adjusted life years (QALYs) and costs; data from the ADVANCE trial (peginterferon beta-1a) placebo arm, the London Ontario database, and a population-based MS survey were used; costs in 2014 US dollars were obtained from literature and public databases; and network meta-analysis was used to obtain the comparative efficacy of each therapy versus placebo
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Disease Stage: 
RRMS
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Enrollment/Number of Patients: 
N/A
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Duration: 
10 year time horizon
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Status/Outcome: 
Peginterferon beta-1a was found to be less costly and more effective compared to the other two drugs, with an estimated cost-savings of $22,070 and $19,163 and an additional 0.06 and 0.07 QALYs relative to interferon beta-1a (44 microg) and glatiramer acetate, respectively
(249)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ. 2016 Mar 7:1-12. PMID: 26947984. Abstract
Trial name: 
Ziemssen et al., J. Neurol., February 2016 study (QualiCOP)
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Phase: 
Observational/open-label study
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Study Design: 
Industry-sponsored, open-label, multicenter study to examine the real-world effectiveness and tolerability of subcutaneous glatiramer acetate (20 mg/ml given once daily) as well as its effect on quality of life
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Disease Stage: 
RRMS (96% of participants)
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Enrollment/Number of Patients: 
754
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Duration: 
24 months
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Status/Outcome: 
Over 24 months, glatiramer acetate was associated with a decrease in the annual relapse rate (from 0.81 to 0.48 relapses for disease-modifying therapy naïve participants and from 0.98 to 0.54 relapses for previously-treated participants); during treatment, depressive symptoms were reduced and cognition was improved, whereas quality of life, fatigue, and disease severity were stable
(248)
QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.
Ziemssen T, Calabrese P, Penner I-K, Apfel R
J Neurol. 2016 Feb 25. Epub 2016 Feb 25. PMID: 26914926. Abstract
Trial name: 
Ayzenberg et al., J. Neurol., January 2016 study
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Phase: 
Retrospective analysis
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Study Design: 
Multicenter, retrospective analysis to examine the effect of glatiramer acetate on annualized relapse rate (ARR) and expanded disability status scale (EDSS) score progression
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Disease Stage: 
Neuromyelitis optica spectrum disorder
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Enrollment/Number of Patients: 
23, 16 of whom were aquaporin-4 antibody-positive
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Duration: 
<6 months for 7 individuals; ≥6 months for 16 individuals
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Status/Outcome: 
Glatiramer acetate therapy did not decrease the mean ARR in the whole group or in the individuals who were were aquaporin-4 antibody-positive; during therapy, the median EDSS increased from 2.5 to 3.5
(246)
Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.
Ayzenberg I, Schöllhammer J, Hoepner R, Hellwig K, Ringelstein M, Aktas O, Kümpfel T, Krumbholz M, Trebst C, Paul F, et al.
J Neurol. 2016 Jan 25. PMID: 26810718. Abstract
Trial name: 
Spelman et al., Eur. J. Neurol., January 2016 study
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Phase: 
Observational study
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Study Design: 
Study to compare the risk of early relapse and disease progression in individuals with stable disease on injectable therapy (glatiramer acetate, interferon beta-1a, or interferon beta-1b) who switch to oral therapy (dimethyl fumarate, fingolimod, or teriflunomide) versus individuals who remain on injectable therapy, using data from the MSBase Registry, an international, longitudinal, observational registry that prospectively collects MS-related information
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Disease Stage: 
RRMS
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Enrollment/Number of Patients: 
792 (396 individuals who switched to oral therapy propensity-matched 1:1 with 396 individuals who stayed on injectable therapy)
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Duration: 
≥12 months stability on injectable treatment pre-baseline and ≥6 months post-baseline
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Status/Outcome: 
Switching to oral therapy was not associated with a change in the rate of disability progression or in the proportion of individuals experiencing ≥1 relapse in the 6 month period post-baseline
(245)
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis.
Spelman T, Mekhael L, Burke T, Butzkueven H, Hodgkinson S, Havrdova E, Horakova D, Duquette P, Izquierdo G, Grand'maison F, et al.
Eur J Neurol. 2016 Jan 19. PMID: 26782663. Abstract
Trial name: 
Herbstritt et al., Mult. Scler., January 2016 study
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Phase: 
Observational/open-label study
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Study Design: 
Observational, prospective, cohort study to examine the effect of exposure to glatiramer acetate during pregnancy on the outcomes of such pregnancies, using data from women enrolled in the German Multiple Sclerosis and Pregnancy registry
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Disease Stage: 
MS
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Enrollment/Number of Patients: 
246 pregnancies (151 with exposure to glatiramer acetate and 95 without exposure to disease-modifying therapy)
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Duration: 
N/A
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Status/Outcome: 
Exposure to glatiramer acetate during the first trimester was not associated with adverse outcomes with respect to the pregnancy or delivery; the frequency of congenital abnormalities was 2.2% for the exposed group and 6.7% for the control group, and the frequencies of spontaneous abortions, Cesarean sections, preterm births, and reduced birth weight were not higher for the exposed group
(244)
Glatiramer acetate during early pregnancy: A prospective cohort study.
Herbstritt S, Langer-Gould A, Rockhoff M, Haghikia A, Queisser-Wahrendorf A, Gold R, Hellwig K
Mult Scler. 2016 Jan 11. PMID: 26754804. Abstract
Trial name: 
Mauskopf et al., J. Med. Econ., December 2015 study
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Phase: 
Economic analysis
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Study Design: 
Industry-sponsored study that used a Markov model to compare the cost-effectiveness of delayed-release dimethyl fumarate to that of glatiramer acetate and fingolimod over a 20-year time horizon from a US payer perspective; clinical trial data were used to estimate efficacy and safety
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Disease Stage: 
Relapsing forms of MS
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Enrollment/Number of Patients: 
N/A
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Duration: 
N/A
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Status/Outcome: 
According to this model, relative to once-daily glatiramer acetate and fingolimod, dimethyl fumarate increases quality-adjusted life-years (by +0.450 and +0.359, respectively) and decreases 20-year costs (by -$70,644 and -$32,958, respectively)
(243)
Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States.
Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T
J Med Econ. 2015 Dec 26:1-36. PMID: 26707273. Abstract
Trial name: 
Rotstein et al., Neurol. Neuroimmunol. Neuroinflamm., October 2015 study
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Phase: 
Observational/open-label study
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Study Design: 
Observational study to examine the relationship between vitamin D status, measured as serum 25-hydroxyvitamin D (25[OH]D) concentration adjusted for season, and disease activity (time to relapse or the development of a new gadolinium-enhancing lesion) in individuals treated with interferon beta-1a, interferon beta-1b, glatiramer acetate, or fingolimod
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Disease Stage: 
RRMS
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Enrollment/Number of Patients: 
324 from the Comprehensive Longitudinal Investigation of MS at Brigham and Women's Hospital (CLIMB) Study
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Duration: 
One blood draw within 18 months of beginning treatment, and a second 3 to 18 months after the first
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Status/Outcome: 
Generally, higher 25(OH)D levels were associated with reduced disease activity, but some differences were seen between treatment groups
(234)
Effect of vitamin D on MS activity by disease-modifying therapy class.
Rotstein DL, Healy BC, Malik MT, Carruthers RL, Musallam AJ, Kivisakk P, Weiner HL, Glanz B, Chitnis T
Neurol Neuroimmunol Neuroinflamm. 2015 Dec; 2(6):e167. Epub 2015 Oct 29. PMID: 26568968. Abstract
Trial name: 
Ehling et al., J. Neuroimmunol., October 2015 study
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Phase: 
Observational/open-label study
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Study Design: 
Industry-supported, prospective, observational study to examine the effect of glatiramer acetate (20 mg given subcutaneously once daily) on markers of neuroprotection, with the primary outcome the effect on serum levels of brain-derived neurotrophic factor (BDNF)
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Disease Stage: 
RRMS
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Enrollment/Number of Patients: 
21 initially therapy-naive individuals, with 14 initiating glatiramer acetate and 7 remaining therapy-naive
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Duration: 
24 months
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Status/Outcome: 
Glatiramer acetate did not affect serum BDNF levels or BDNF expression in peripheral immune cells, nerve conduction, neuropsychological parameters, or cerebral MRI parameters, but did transiently increase serum IgG antibodies against myelin basic peptide
(228)
Impact of glatiramer acetate on paraclinical markers of neuroprotection in multiple sclerosis: A prospective observational clinical trial.
Ehling R, Di Pauli F, Lackner P, Rainer C, Kraus V, Hegen H, Lutterotti A, Kuenz B, De Zordo T, Schocke M, et al.
J Neuroimmunol. 2015 Oct 15; 287:98-105. Epub 2015 Aug 10. PMID: 26439969. Abstract
Trial name: 
Tramacere et al., Cochrane Database Syst. Rev., September 2015 study
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Phase: 
Retrospective clinical trial analysis
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Study Design: 
Retrospective network meta-analysis to compare the benefits of alemtuzumab, azathioprine, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, immunoglobulins, interferon beta-1a (Avonex, Rebif), pegylated interferon beta-1a, interferon beta-1b, laquinimod, mitoxantrone, natalizumab, and teriflunomide; data were extracted from 39 randomized controlled trials that compared one or more of the 15 drugs used as monotherapy to placebo or another drug
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Disease Stage: 
Adults with RRMS
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Enrollment/Number of Patients: 
25,113 individuals were randomized in the studies included in the analyses
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Duration: 
Median duration of studies, 24 months
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Status/Outcome: 
Alemtuzumab was found to be the most protective against relapses during the first 24 months of therapy (moderate quality evidence); the next most protective were found to be mitoxantrone (very low quality evidence), natalizumab (high quality evidence), and fingolimod (moderate quality evidence); mitoxantrone (low quality evidence) was found to be the most effective at delaying disability worsening, followed by alemtuzumab (low quality evidence) and natalizumab (moderate quality evidence); these results must be interpreted conservatively because few trials have been performed for most of the drugs
(223)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev. 2015 Sep 18; 9:CD011381. PMID: 26384035. Abstract
Trial name: 
Iaffaldano et al., Brain, September 2015 study
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Phase: 
Observational/open-label study
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Study Design: 
Observational, multicenter, prospectively acquired cohort study to examine the effects of fingolimod versus interferon beta or glatiramer acetate in individuals (in the Italian iMedWeb registry) who had discontinued natalizumab; the risk of relapse was first estimated during the washout and new therapy periods using Poisson regression analyses in separated models; individuals who switched to fingolimod or interferon beta/glatiramer acetate were also propensity score-matched before further modeling
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Disease Stage: 
Relapsing MS
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Enrollment/Number of Patients: 
613
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Duration: 
12-month followup
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Status/Outcome: 
The risk of relapse after switching drugs was greater in those with a washout period >3 months, with more relapses before and during natalizumab therapy, and with comorbidities; the risk of an initial relapse after switching treatments was lower in individuals treated with fingolimod versus interferon beta/glatiramer acetate, although the time to 3-month confirmed disability was similar between groups
(222)
Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis.
Iaffaldano P, Lucisano G, Pozzilli C, Brescia Morra V, Ghezzi A, Millefiorini E, Patti F, Lugaresi A, Zimatore G B, Marrosu M G, et al.
Brain. 2015 Sep 11. PMID: 26362907. Abstract
Trial name: 
Fernández-Fournier et al., BMC Neurol., August 2015 study
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Phase: 
Retrospective medical record review
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Study Design: 
Retrospective study to examine the effect of previous treatment with interferon beta versus no treatment on persistence of glatiramer acetate treatment
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Disease Stage: 
RRMS
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Enrollment/Number of Patients: 
155 (treatment-naive, 100; previously treated with interferon, 55)
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Duration: 
34 months (median followup)
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Status/Outcome: 
Previous treatment with interferon beta was associated with a reduced probability of glatiramer acetate discontinuation, such that there was a 2.8 times greater risk of discontinuing glatiramer acetate for treatment-naive individuals
(220)
Differential glatiramer acetate treatment persistence in treatment-naive patients compared to patients previously treated with interferon.
Fernández-Fournier M, Tallón-Barranco A, Chamorro B, Martínez-Sánchez P, Puertas I
BMC Neurol. 2015; 15:141. Epub 2015 Aug 19. PMID: 26286576. Abstract
Trial name: 
Lus et al., Eur. J. Neurol., July 2015 study
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Phase: 
Retrospective, observational study
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Study Design: 
Observational, retrospective cohort study to examine the effects of discontinuation of interferon beta-1a, interferon beta-1b, or glatiramer acetate on time to relapse
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Disease Stage: 
RRMS
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Enrollment/Number of Patients: 
128, with 60 discontinuing treatment
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Duration: 
Median followup, 108 months
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Status/Outcome: 
The median time to relapse among individuals who discontinued treatment was 31.1 months, versus 85.8 months for those who did not
(218)
Treatment withdrawal in relapsing-remitting multiple sclerosis: a retrospective cohort study.
Lus G, Signoriello E, Maniscalco GT, Bonavita S, Signoriello S, Gallo C
Eur J Neurol. 2015 Jul 26. PMID: 26212486. Abstract
Trial name: 
Hansen et al., PLoS One, July 2015 study
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Phase: 
Retrospective claims data review
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Study Design: 
Retrospective cohort study to examine adherence to intramuscular and subcutaneous interferon beta-1a (Avonex and Rebif), interferon beta-1b (Betaferon), and glatiramer acetate (Copaxone) among insured individuals, using pharmacy claims data from the German Institute for Drug Use Evaluation from 2001 through 2009; the medication possession ratio served as a measure of compliance
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Disease Stage: 
MS
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Enrollment/Number of Patients: 
52,516 medication profiles from 50,057 individuals
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Duration: 
24 months
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Status/Outcome: 
Overall compliance was 39.9%, with small differences between the drugs [Avonex (42.8%), Betaferon (40.6%), Rebif (39.2%), Copaxone (37%)]; overall persistence, after 24 months, was 32.3% (such that in 32.3% of the therapy cycles discontinuations or interruptions did not occur)
(217)
Adherence to Disease Modifying Drugs among Patients with Multiple Sclerosis in Germany: A Retrospective Cohort Study.
Hansen K, Schüssel K, Kieble M, Werning J, Schulz M, Friis R, Pöhlau D, Schmitz N, Kugler J
PLoS One. 2015; 10(7):e0133279. Epub 2015 Jul 27. PMID: 26214805. Abstract
Trial name: 
Johnson et al., CNS Drugs, June 2015 study
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Phase: 
Retrospective claims data analysis
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Study Design: 
Comparison of relapse rates and time to relapse, using US administrative claims data from the Truven Health MarketScan Research Databases and propensity score matching, in individuals treated with platform therapy (interferon beta or glatiramer acetate) or natalizumab
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Disease Stage: 
MS
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Enrollment/Number of Patients: 
882
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Duration: 
12 months of claims data, as well as continuous enrollment for 12 months both before and after the first claim
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Status/Outcome: 
Natalizumab was associated with a reduced rate of relapse (which occurred in 26.5% of individuals in the natalizumab group and 35.5% in the platform group) and greater time to relapse (308 days for the natalizumab group and 283 days for the platform group)
(215)
Platform Therapy Compared with Natalizumab for Multiple Sclerosis: Relapse Rates and Time to Relapse Among Propensity Score-Matched US Patients.
Johnson BH, Bonafede MM, Watson C
CNS Drugs. 2015 Jun 26. PMID: 26113055. Abstract
Trial name: 
Izquierdo et al., Brain Behav., June 2015 study
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Phase: 
Retrospective observational study
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Study Design: 
Industry-funded observational cohort study, using data from an MS patient database, to examine the effectiveness of glatiramer acetate versus other therapies in clinical practice by comparing individuals on glatiramer acetate (GA cohort) to those who switched from glatiramer acetate to another therapy because of ineffectiveness or adverse events (non-GA cohort), with the primary endpoint the Expanded Disability Status Scale (EDSS) score at the last check-up or the end of treatment
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Disease Stage: 
MS
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Enrollment/Number of Patients: 
180 (with 120 in the GA cohort and 60 in the non-GA cohort)
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Duration: 
Mean duration of study treatments, 81.1 months (GA cohort) and 92.4 months (non-GA cohort)
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Status/Outcome: 
EDSS scores were similar between the two cohorts at the beginning of the study treatments, but better (lower) in the GA cohort at the last check-up or end of treatment (with a mean EDSS score of 2.8 in the GA cohort versus 3.9 in the non-GA cohort)
(213)
Effectiveness of glatiramer acetate compared to other multiple sclerosis therapies.
Izquierdo G, García-Agua Soler N, Rus M, García-Ruiz A J
Brain Behav. 2015 Jun; 5(6):e00337. Epub 2015 May 01. PMID: 26085963. Abstract
Trial name: 
Extension of Efficacy and Safety of GTR in Comparison to Copaxone® (GATE) trial (press release, April 2015)
(135)
Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)
ClinicalTrials.gov, 31 Mar 2014
Accessed on 1 Apr 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01489254.
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Phase: 
Open-label extension of a Phase III trial
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Study Design: 
Company-sponsored, open-label extension study to examine the efficacy and safety of GTR [a generic version of glatiramer acetate produced by Synthon (daily injected dose, 20 mg)]; individuals given GTR in the original trial continued on this treatment and those given placebo or Copaxone in the original trial switched to GTR
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Disease Stage: 
RRMS
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Enrollment/Number of Patients: 
796 in the original trial
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Duration: 
15 months (following 9 months in the original trial for a total of 2 years)
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Status/Outcome: 
Results supported the safety of a switch from Copaxone to GTR, as well as equivalent safety and efficacy of Copaxone and GTR (press release, April 2015)
(208)
Synthon Announces Successful Outcomes from the Open-label extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate
Synthon, 28 Apr 2015
Accessed on 12 May 2015 from http://www.synthon.com/Corporate/News/PressReleases/Synthon-Announces-Successful-Outcomes-from-the-Open-label-extension-of-the-GATE-Study?sc_lang=en.
Trial name: 
Spelman et al., Ann. Clin. Transl. Neurol., April 2015 study
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Phase: 
Retrospective data analysis
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Study Design: 
Analysis of data from the MSBase registry and the TYSABRI Observational Program to compare the effects of switching to natalizumab versus switching between interferon beta and glatiramer acetate in individuals who experienced a relapse while on interferon beta or glatiramer acetate; datasets were propensity matched
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Disease Stage: 
Active MS
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Enrollment/Number of Patients: 
869
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Duration: 
Mean followup, 1.7 to 2.2 years
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Status/Outcome: 
Switching to natalizumab was associated with a reduction in annualized relapse rate in the first year by 65 to 75% and a reduction in the risk of confirmed disability progression over the first 24 months by 26% as compared with switching between interferon beta and glatiramer acetate
(207)
Comparative efficacy of switching to natalizumab in active multiple sclerosis.
Spelman T, Kalincik T, Zhang A, Pellegrini F, Wiendl H, Kappos L, Tsvetkova L, Belachew S, Hyde R, Verheul F, et al.
Ann Clin Transl Neurol. 2015 Apr; 2(4):373-87. Epub 2015 Feb 27. PMID: 25909083. Abstract
Trial name: 
Extension of Glatiramer Acetate Low-Frequency Administration (GALA) trial (meeting report, April 2015)
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Phase: 
Extension of a Phase III trial
(90)
Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis.
Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R, for the GALA Study Group
Ann Neurol. 2013 May 20. PMID: 23686821. Abstract
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Study Design: 
Industry-sponsored, open-label extension of the GALA trial to compare results for individuals who began the 40 mg per ml, 3 times weekly dose early (at the beginning of the placebo-controlled trial) versus late (after the 12-month placebo-controlled phase)
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Disease Stage: 
Relapsing forms of MS
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Enrollment/Number of Patients: 
1253 (834, early start and 419, late start)
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Duration: 
36 months (trial plus extension)
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Status/Outcome: 
Beginning the 40 mg per ml, 3 times a week glatiramer acetate treatment early versus late was associated with a lower adjusted mean annualized relapse rate over 36 months (0.23 versus 0.30)
(206)
Teva Presents Data Comparing Early Treatment with COPAXONE® 40 mg/mL to Delayed Start Treatment at 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.
Business Wire, 23 Apr 2015
Accessed on 28 Apr 2015 from http://www.businesswire.com/news/home/20150423005324/en/Teva-Presents-Data-Comparing-Early-Treatment-COPAXONE®#.VT-C_ijOZiY.
Trial name: 
Zhornitsky et al., PLoS One, April 2015 study
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Phase: 
Observational/open-label study
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Study Design: 
Observational cohort study to examine long-term persistence with injectable disease-modifying therapy (DMT) (interferon beta or glatiramer acetate)
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Disease Stage: 
RRMS
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Enrollment/Number of Patients: 
1471 (906 initially on glatiramer acetate and 565 initially on interferon beta), with followup information for 87%
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Duration: 
18 years
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Status/Outcome: 
High persistence with injectable DMTs was observed; the median time-to-discontinuation was 11.1 years for all injectable DMTs and 8.6 years for the first DMT (with individuals originally prescribed glatiramer acetate staying on treatment longer)
(202)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One. 2015; 10(4):e0123824. Epub 2015 Apr 13. PMID: 25867095. Abstract
Trial name: 
Rinaldi et al., Mult. Scler. Int., February 2015 study
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Phase: 
Extension of a postmarketing study
(49)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12. PMID: 21228025. Abstract
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Study Design: 
Extension study to compare the effects of subcutaneous (sc) interferon beta-1a (44 mcg three times weekly), intramuscular (im) interferon beta-1a (30 mcg weekly), and glatiramer acetate (20 mg daily) on the development of cortical lesions and cortical atrophy; 50 individuals in a reference population were untreated for the first 24 months, after which time 43 of them switched to one of the three disease-modifying drugs (DMDs)
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Disease Stage: 
RRMS
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Enrollment/Number of Patients: 
165, plus 50 initially untreated individuals
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Duration: 
24 months in the original study, plus 24 months in the extension
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Status/Outcome: 
At 48 months, sc interferon beta-1a use was associated with a lower mean standard deviation number of new cortical lesions (1.4 ± 1) than either im interferon beta-1a (2.3 ± 1.3) or glatiramer acetate (2.2 ± 1.5); cortical lesion accumulation and development was reduced in those individuals who began using DMDs after month 24, as compared with the previous 24 month period
(197)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int. 2015; 2015:369348. Epub 2015 Feb 23. PMID: 25802758. Abstract
Trial name: 
Cohen et al., Mult. Scler. Relat. Disord., January 2015 study [Therapy Optimization in MS (TOP MS)]
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Phase: 
Observational/open-label study
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Study Design: 
Observational, prospective, cohort study to examine the connection between adherence to MS disease-modifying therapies (DMTs, which included interferon beta and glatiramer acetate) and the risk of relapse; participants were recruited by specific pharmacies and the medication possession ratio (MPR, derived from pharmacy shipment records) was used as a measure of adherence; electronic data capture was also used and involved monthly entries by participants
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Disease Stage: 
MS
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Enrollment/Number of Patients: 
3151, with 2410 completing the 2-year study
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Duration: 
2 years
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Status/Outcome: 
Higher DMT adherence was associated with better clinical results, such that the odds of relapse for an individual in a higher adherence group (MPR >0.9) were 64% that of an individual in a lower adherence group (MPR <0.5)
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07. PMID: 25787057. Abstract
Trial name: 
He et al., JAMA Neurol., February 2015 study
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Phase: 
Retrospective data analysis
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Study Design: 
Analysis of data from the MSBase registry to compare the effects of switching to fingolimod versus an injectable therapy (interferon beta or glatiramer acetate) on the annualized relapse rate (ARR), disability progression, and therapy persistence in individuals who were originally treated with an injectable disease-modifying therapy and who had had on-treatment disease activity ≤12 months before the switch; the new treatment was given for ≥3 months after the switch
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Disease Stage: 
RRMS
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Enrollment/Number of Patients: 
527 (379 in the interferon beta/glatiramer acetate group matched to 148 in the fingolimod group)
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Duration: 
13.1 months (median followup duration)
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Status/Outcome: 
Fingolimod was associated with a lower mean ARR (0.31 versus 0.42), a lower hazard of disability progression (hazard ratio, 0.53), and a lower hazard of treatment discontinuation (hazard ratio, 0.55) than were the injectable therapies
(194)
Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis.
He A, Spelman T, Jokubaitis V, Havrdova E, Horakova D, Trojano M, Lugaresi A, Izquierdo G, Grammond P, Duquette P, et al.
JAMA Neurol. 2015 Feb 9:1-10. PMID: 25665031. Abstract
Trial name: 
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS (began December, 2014)
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Phase: 
Phase IIa study
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Study Design: 
Industry-sponsored, prospective, open-label, multicenter, single-arm study to test the safety, tolerability, and efficacy of GA Depot (80 mg, given intramuscularly once every 4 weeks) in individuals previously treated with Copaxone for ≥12 months, with the primary outcome the number of participants who experience adverse events and a secondary outcome the relapse rate as compared to the rate during the previous 12 months
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Disease Stage: 
RRMS
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Enrollment/Number of Patients: 
20 (estimated)
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Duration: 
1 year
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Status/Outcome: 
First individual treated in December, 2014
(185)
First patient treated in Mapi Pharma's Phase IIa clinical trial of GA Depot for relapsing remitting multiple sclerosis (RRMS)
Mapi Pharma, 17 Dec 2014
Accessed on 23 Dec 2014 from http://www.mapi-pharma.com/first-patient-treated-in-mapi-pharmas-phase-iia-clinical-trial-of-ga-depot-for-relapsing-remitting-multiple-sclerosis-rrms/.
; estimated study completion date, April 2016
(186)
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 mg GA Depot in Subjects With RRMS
ClinicalTrials.gov, 12 Dec 2014
Accessed on 23 Dec 2014 from https://clinicaltrials.gov/ct2/show/NCT02212886.
Trial name: 
Kalincik et al., Mult. Scler., December 2014 study
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Phase: 
Retrospective registry data analysis
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Study Design: 
Pairwise analysis of data from the international MSBase registry to compare the real-world effectiveness of glatiramer acetate, subcutaneous interferon beta-1a, intramuscular interferon beta-1a, and interferon beta-1b, as measured by relapse and disability outcomes
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Disease Stage: 
RRMS
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Enrollment/Number of Patients: 
3326
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Duration: 
Median followup, 3.7 years
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Status/Outcome: 
Glatiramer acetate and subcutaneous interferon beta-1a were associated with a slightly lower incidence of relapses as compared with intramuscular interferon beta-1a and interferon beta-1b, but the 12-month confirmed progression of disability did not differ between drugs
(183)
Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, Lugaresi A, Oreja-Guevara C, Bergamaschi R, Hupperts R, et al.
Mult Scler. 2014 Dec 5. PMID: 25480857. Abstract
Trial name: 
Arnal-Garcia et al., J. Clin. Neurosci., September 2014 study (XPERIENCIA-5 study)
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Phase: 
Retrospective cohort study
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Study Design: 
Industry-sponsored, retrospective, multicenter study to evaluate the long-term effectiveness of glatiramer acetate in clinical practice
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Disease Stage: 
RRMS
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Enrollment/Number of Patients: 
149
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Duration: 
Mean treatment period, 6.9 years, with 21 individuals treated for 9 years
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Status/Outcome: 
Glatiramer acetate treatment over the long-term was associated with freedom from disability progression (with 75.2% showing no disability progression for ≥5 consecutive years) and stable or improved Expanded Disability Status Scale scores; furthermore, treatment was associated with decreased annual relapse rates, which were maintained during the entire treatment period
(172)
Long-term effectiveness of glatiramer acetate in clinical practice conditions.
Arnal-García C, Amigo-Jorrin M D C, López-Real A M, Lema-Devesa C, Llopis N, Sánchez-de la Rosa R, XPERIENCIA-5 Study Group
J Clin Neurosci. 2014 Sep 22. Epub 1969 Dec 31. PMID: 25257663. Abstract
Trial name: 
Ziemssen et al., J. Neurol, August 2014 study (COPTIMIZE study)
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Phase: 
Observational/open-label study
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Study Design: 
Industry-supported, multinational, observational study to examine the disease course of individuals who switched to glatiramer acetate (20 mg per day) from a different disease-modifying treatment (given for 3 to 6 months) because of lack of efficacy or adverse events
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Disease Stage: 
RRMS
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Enrollment/Number of Patients: 
672
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Duration: 
24 months
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Status/Outcome: 
Glatiramer acetate was associated with a decrease in the mean annual relapse rate [from 0.86 (before changing drugs) to 0.32 (at 24 months)] and a halt in the progression of disability; 72.7% of participants were relapse-free over the 24-month period
(164)
A 2-year observational study of patients with relapsing-remitting multiple sclerosis converting to glatiramer acetate from other disease-modifying therapies: the COPTIMIZE trial.
Ziemssen T, Bajenaru OA, Carrá A, De Klippel N, de Sá JC, Edland A, Frederiksen JL, Heinzlef O, Karageorgiou KE, Lander Delgado RH, et al.
J Neurol. 2014 Aug 14. Epub 2014 Aug 14. PMID: 25119836. Abstract
Trial name: 
Rossi et al., CNS Neurosci. Ther., August 2014 study
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Phase: 
Observational/open-label study
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Study Design: 
Observational study to examine whether glatiramer acetate, glatiramer acetate plus corticosteroids, or interferon beta-1b is better at reducing disease activity in individuals who have discontinued natalizumab treatment
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Disease Stage: 
MS
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Enrollment/Number of Patients: 
105
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Duration: 
6 month period after natalizumab discontinuation
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Status/Outcome: 
Glatiramer acetate alone was associated with a higher proportion of relapse-free individuals as compared with glatiramer acetate plus corticosteroids or interferon beta-1b (65% versus 40% and 24%, respectively)
(200)
Treatment Options to Reduce Disease Activity After Natalizumab: Paradoxical Effects of Corticosteroids.
Rossi S, Motta C, Studer V, Boffa L, De Chiara V, Castelli M, Barbieri F, Buttari F, Monteleone F, Germani G, et al.
CNS Neurosci Ther. 2014 May 19. PMID: 24837039. Abstract
Trial name: 
La Mantia et al., Cochrane Database Syst. Rev., July 2014 study
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
; similar paper published December 2014
(188)
Comparative efficacy of interferon β versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
J Neurol Neurosurg Psychiatry. 2014 Dec 30. PMID: 25550414. Abstract
Phase: 
Retrospective clinical trials review
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Study Design: 
Retrospective, systematic review of 5 randomized controlled trials that compared the effects of interferon beta (interferon beta-1a, 44 microg, interferon beta-1a, 30 microg, or interferon beta-1b, 250 microg) and glatiramer acetate head-to-head to evaluate whether the two types of drugs differ in their safety and efficacy
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Disease Stage: 
RRMS
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Enrollment/Number of Patients: 
2858 (1679 assigned to interferon beta and 1179 to glatiramer acetate)
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Duration: 
3 years (1 study) and 2 years (each of the other 4 studies)
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Status/Outcome: 
Both types of drugs were similarly effective clinically at 24 months, but 1 study indicated that relapse rates were lower in the glatiramer acetate group at 36 months; the increase in MRI lesion burden was lower in the interferon beta versus glatiramer acetate groups
(161)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev. 2014; 7:CD009333. Epub 1969 Dec 31. PMID: 25062935. Abstract
Trial name: 
Glanz et al., Int. J. MS Care, Summer 2014 study
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Phase: 
Observational/open-label study
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Study Design: 
Study to compare patient satisfaction with intramuscular interferon beta-1a, subcutaneous interferon beta-1a, glatiramer acetate, and natalizumab and to compare links between therapy adherence and satisfaction; the Treatment Satisfaction Questionnaire for Medicine and multivariable models were used
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Disease Stage: 
MS
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Enrollment/Number of Patients: 
226
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Duration: 
N/A
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Status/Outcome: 
Overall, the drugs were associated with similar levels of satisfaction; compared to intramuscular interferon beta-1a, natalizumab was associated with more satisfaction with the ability of the drug to treat or prevent MS and was considered more convenient; natalizumab was considered easier to use than either form of interferon beta or glatiramer acetate; intramuscular interferon beta-1a was associated with less satisfaction with ease of planning than the other drugs; and for subcutaneous interferon beta-1a and glatiramer acetate, lower convenience scores were linked with reduced adherence
(159)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care. 2014 Summer; 16(2):68-75. PMID: 25061430. Abstract
Trial name: 
Bergvall et al., J. Med. Econ., July 2014 study
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Phase: 
Retrospective claims data review
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Study Design: 
Company-sponsored, retrospective study to compare persistence with and adherence to fingolimod versus glatiramer acetate, interferon, and natalizumab using administrative claims data from the US PharMetrics Plus database
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Disease Stage: 
MS
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Enrollment/Number of Patients: 
3750 [fingolimod (889), glatiramer acetate (1233), any interferon (1341), natalizumab (287)]
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Duration: 
Study included individuals with at least one prescription for or administration of a relevant drug between 1 October 2010 and 30 September 2011
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Status/Outcome: 
Drug discontinuation rates were lower for fingolimod (27.9%) versus other therapies [glatiramer acetate (39.5%), interferons (43.7%), natalizumab (39.5%)]; fingolimod was also associated with a lower risk of non-adherence compared to the other therapies
(158)
Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Petrilla AA, Karkare SU, Lahoz R, Agashivala N, Pradhan A, Capkun G, Makin C, Balderston McGuiness C, Korn JR
J Med Econ. 2014 Jul 23:1-12. PMID: 25019581. Abstract
Trial name: 
GLatiramer Acetate low frequenCy safety and patIent ExpeRience (GLACIER) study (press release, 2014; publ 2015)
(146)
Safety and Tolerability of Glatiramer Acetate (GLACIER)
ClinicalTrials.gov, 14 Apr 2014
Accessed on 15 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01874145.
(166)
Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg
Teva, 11 Sep 2014
Accessed on 15 Sep 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1966166.
(216)
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis.
Wolinsky JS, Borresen ET, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S, GLACIER Study Group
Mult Scler Relat Disord. 2015 Jul; 4(4):370-6. PMID: 26195058. Abstract
Phase: 
Phase IIIb study
(146)
Safety and Tolerability of Glatiramer Acetate (GLACIER)
ClinicalTrials.gov, 14 Apr 2014
Accessed on 15 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01874145.
(166)
Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg
Teva, 11 Sep 2014
Accessed on 15 Sep 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1966166.
Study Design: 
Company-sponsored, open-label, randomized, multicenter, parallel-arm study to compare the safety and tolerability of two different doses of subcutaneous glatiramer acetate (40 mg three times weekly versus 20 mg daily), with the primary outcome measure the rate of injection-related adverse events (reactions at the injection site as well as other events happening immediately after the injection, such as flushing)
(146)
Safety and Tolerability of Glatiramer Acetate (GLACIER)
ClinicalTrials.gov, 14 Apr 2014
Accessed on 15 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01874145.
(216)
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis.
Wolinsky JS, Borresen ET, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S, GLACIER Study Group
Mult Scler Relat Disord. 2015 Jul; 4(4):370-6. PMID: 26195058. Abstract
Disease Stage: 
RRMS
(146)
Safety and Tolerability of Glatiramer Acetate (GLACIER)
ClinicalTrials.gov, 14 Apr 2014
Accessed on 15 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01874145.
(216)
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis.
Wolinsky JS, Borresen ET, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S, GLACIER Study Group
Mult Scler Relat Disord. 2015 Jul; 4(4):370-6. PMID: 26195058. Abstract
Enrollment/Number of Patients: 
209 (who had previously used the 20 mg dosing regime for an average of 6.7 years); 101 continued on the 20 mg dose and 108 converted to the 40 mg dose
(166)
Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg
Teva, 11 Sep 2014
Accessed on 15 Sep 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1966166.
(216)
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis.
Wolinsky JS, Borresen ET, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S, GLACIER Study Group
Mult Scler Relat Disord. 2015 Jul; 4(4):370-6. PMID: 26195058. Abstract
Duration: 
4 months (core study, with evaluations at months 1, 2, and 4), followed by an extension phase, with evaluations every 4 months
(146)
Safety and Tolerability of Glatiramer Acetate (GLACIER)
ClinicalTrials.gov, 14 Apr 2014
Accessed on 15 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01874145.
(166)
Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg
Teva, 11 Sep 2014
Accessed on 15 Sep 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1966166.
Status/Outcome: 
The 40 mg dosing regimen was associated with a 50% reduction in the adjusted mean annualized rate of injection-related adverse events (35.3 events per year) as compared with the 20 mg dosing regimen (70.4 events per year)
(166)
Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg
Teva, 11 Sep 2014
Accessed on 15 Sep 2014 from http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1966166.
(216)
GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40mg three-times weekly versus 20mg daily in patients with relapsing-remitting multiple sclerosis.
Wolinsky JS, Borresen ET, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S, GLACIER Study Group
Mult Scler Relat Disord. 2015 Jul; 4(4):370-6. PMID: 26195058. Abstract
Trial name: 
Rio et al., Mult. Scler., March 2014 study
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Phase: 
Observational/open-label study
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Study Design: 
Prospective, longitudinal study to examine whether a scoring system based on new active lesions detected by MRI, relapses, and sustained disability progression after treatment with glatiramer acetate for 1 year can predict disability progression
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Disease Stage: 
RRMS
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Enrollment/Number of Patients: 
151
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Duration: 
3 years
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Status/Outcome: 
A score based on a combination of clinical measures during year 1 of treatment may be useful for identifying individuals who will exhibit disease activity in the following 2 years
(132)
Evaluating the response to glatiramer acetate in relapsing-remitting multiple sclerosis (RRMS) patients.
Río J, Rovira A, Tintoré M, Sastre-Garriga J, Castilló J, Auger C, Nos C, Comabella M, Tur C, Vidal A, et al.
Mult Scler. 2014 Mar 12. PMID: 24622350. Abstract
Trial name: 
Bergvall et al., PLoS One, February 2014 study
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Phase: 
Retrospective claims data review
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Study Design: 
Company-sponsored, retrospective cohort analysis to assess effects in a real-world setting on relapse rates in individuals who switched from interferon beta to glatiramer acetate versus fingolimod between 1 Oct 2010 and 31 Mar 2012; relapses were identified using a claims-based algorithm and administrative claims data from the US PharMetrics Plus database; individuals receiving fingolimod versus glatiramer acetate were matched 1:1 on disease and demographic characteristics
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Disease Stage: 
MS
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Enrollment/Number of Patients: 
264 (132 in each cohort)
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Duration: 
360 days of persistent therapy after switching treatments
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Status/Outcome: 
After switching from interferon beta (on which 33.3% of individuals in each cohort experienced at least one relapse), a lower proportion of patients in the fingolimod cohort had at least one relapse (12.9% versus 25.0% for the glatiramer acetate cohort); the annual relapse rate was 0.19 for the fingolimod cohort and 0.51 for the glatiramer acetate cohort
(129)
Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla AA, Karkare SU, Balderston McGuiness C, Korn JR
PLoS One. 2014; 9(2):e88472. Epub 2014 Feb 06. PMID: 24516663. Abstract
Trial name: 
Palace et al., BMJ Open, January 2014 study
(168)
UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model.
Palace J, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, Duddy M, Dobson C
BMJ Open. 2014; 4(1):e004073. PMID: 24441054. Abstract
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
Phase: 
Observational/open-label study
(168)
UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model.
Palace J, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, Duddy M, Dobson C
BMJ Open. 2014; 4(1):e004073. PMID: 24441054. Abstract
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
Study Design: 
Health-department- and industry-funded, prospective, observational study to examine the effects of long-term therapy with interferon beta or glatiramer acetate on disability and quality of life, in which data from a cohort of individuals being treated with these drugs in clinical practice in the UK were compared with data from a matched, untreated cohort in British Columbia (for which data had been collected before the introduction of these drugs); furthermore, modeling approaches were used to calculate the expected progression of disease with and without treatment; the aim is to examine whether treatment is cost-effective (i.e., if worsening quality of life, which is related to disability progression, is reduced to a particular target set by the UK government) over the long-term
(168)
UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model.
Palace J, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, Duddy M, Dobson C
BMJ Open. 2014; 4(1):e004073. PMID: 24441054. Abstract
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
Disease Stage: 
RRMS
(168)
UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model.
Palace J, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, Duddy M, Dobson C
BMJ Open. 2014; 4(1):e004073. PMID: 24441054. Abstract
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
Enrollment/Number of Patients: 
4137 (UK cohort) and 898 (British Columbia cohort)
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
Duration: 
6-year data have been reported (2014, 2015)
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
; final analysis will cover a 10-year period
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
Status/Outcome: 
Over a 6-year followup period, with data modelled over a trajectory of 20 years, individuals in the UK cohort taking glatiramer acetate or interferon beta fared better (exhibited 24 to 40% less disability progression) than those in the untreated cohort, indicating that the shorter-term effects on disability observed in clinical trials are maintained; furthermore, the drugs were found to be cost-effective based on specific criteria in the UK
(169)
Beta-Interferon, Glatiramer Acetate Cost-Effective in MS
Hughes S, Medscape Medical News, 18 Sep 2014
Accessed on 23 Sep 2014 from http://www.medscape.com/viewarticle/831921.
(201)
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, et al.
Lancet Neurol. 2015 Apr 1. PMID: 25841667. Abstract
Trial name: 
Oleen-Burkey et al., BMC Neurol., January 2014 study
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Phase: 
Retrospective database review
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Study Design: 
Industry-sponsored database review to examine persistence to glatiramer acetate treatment (that is, continuous use for the duration of followup) relative to other available disease-modifying therapies (DMTs)
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Disease Stage: 
MS
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Enrollment/Number of Patients: 
For glatiramer acetate, 12,144 (12 months of followup), 7387 (24 months), and 4693 (36 months); for other DMTs, 35,312 (12 months), 21,927 (24 months), and 14,343 (36 months)
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Duration: 
12, 24, or 36 months of followup
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Status/Outcome: 
Glatiramer acetate was associated with higher persistence rates (80% for all time periods examined) than other DMTs (68.3%, 12 months; 53.9%, 24 months; and 70.1% (36 months)
(123)
Retrospective US database analysis of persistence with glatiramer acetate vs. available disease-modifying therapies for multiple sclerosis: 2001-2010.
Oleen-Burkey M, Cyhaniuk A, Swallow E
BMC Neurol. 2014; 14(1):11. Epub 2014 Jan 14. PMID: 24423119. Abstract
Trial name: 
Fox et al., Int. J. MS Care, Winter 2013 study
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Phase: 
Retrospective database analysis
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Study Design: 
Cross-sectional analysis of data from the North American Research Committee on Multiple Sclerosis database (which contains patient-reported information that is updated semiannually) to examine (i) participants' reasons for discontinuation of injectable disease-modifying therapies (intramuscular or subcutaneous interferon beta-1a, subcutaneous interferon beta-1b, or subcutaneous glatiramer acetate) and (ii) disease progression
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Disease Stage: 
MS
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Enrollment/Number of Patients: 
1956 (number of individuals who discontinued treatment, identified the treatment, and identified why)
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Duration: 
Study examined data from the Spring 2005 update
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Status/Outcome: 
Relative to the other therapies, intramuscular interferon beta-1a and glatiramer acetate were associated with fewer discontinuations because of safety concerns (however, glatiramer acetate was associated with lower patient-reported efficacy and higher burden) and subcutaneous interferon beta-1a was associated with more difficulties in tolerability; among individuals who remained on therapy, intramuscular interferon beta-1a was associated with less self-reported disability progression
(124)
Treatment discontinuation and disease progression with injectable disease-modifying therapies: findings from the north american research committee on multiple sclerosis database.
Fox RJ, Salter AR, Tyry T, Sun J, You X, Laforet G, Campagnolo D
Int J MS Care. 2013 Winter; 15(4):194-201. PMID: 24453783. Abstract
Trial name: 
Kirzinger et al., Int. J. MS Care, Fall 2013 study
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Phase: 
Retrospective medical record review
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Study Design: 
Retrospective study to examine whether interferon beta-1a or -1b is associated with a higher level of depression than glatiramer acetate; participants completed a depression inventory when treatment began and every 6 months afterwards
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Disease Stage: 
RRMS
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Enrollment/Number of Patients: 
112
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Duration: 
48 months
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Status/Outcome: 
Neither interferon beta nor glatiramer acetate was associated with increased depression
(125)
Relationship between disease-modifying therapy and depression in multiple sclerosis.
Kirzinger SS, Jones J, Siegwald A, Crush A B
Int J MS Care. 2013 Fall; 15(3):107-12. PMID: 24453772. Abstract
Trial name: 
Hutchinson et al., Curr. Med. Res. Opin., November 2013 study
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Phase: 
Retrospective clinical trial review
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Study Design: 
Systematic review of published randomized, controlled clinical trials to compare the effects of dimethyl fumarate to those of existing disease-modifying treatments; relative effect sizes were derived from mixed treatment comparisons
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Disease Stage: 
RRMS
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Enrollment/Number of Patients: 
N/A
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Duration: 
N/A
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Status/Outcome: 
Dimethyl fumarate (240 mg twice a day) was associated with a greater reduction in the annualized relapse rate (ARR) than placebo, interferon beta-1a, interferon beta-1b, glatiramer acetate, and teriflunomide (7 mg and 14 mg doses); dimethyl fumarate and fingolimod showed similar effects on the ARR; natalizumab was associated with a greater reduction in the ARR than dimethyl fumarate; dimethyl fumarate was associated with favorable safety outcomes; variability in how outcomes were defined and in the heterogeneity of enrolled individuals in the included trials were limitations of this review
(117)
Efficacy and safety of BG-12 (dimethyl fumarate) and other disease modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison.
Hutchinson M, Fox RJ, Havrdova E, Kurukulasuriya NC, Sarda SP, Agarwal S, Siddiqui M K, Taneja A, Deniz B
Curr Med Res Opin. 2013 Nov 7. Epub 1969 Dec 31. PMID: 24195574. Abstract
Trial name: 
Bonafede et al., Clin. Ther., October 2013 study
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Phase: 
Retrospective observational cohort study
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Study Design: 
Retrospective study to assess patterns of treatment among individuals who began disease-modifying therapy (DMT; interferon beta, glatiramer acetate, or natalizumab) between Jan 2007 and Sep 2009
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Disease Stage: 
MS
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Enrollment/Number of Patients: 
6181
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Duration: 
Individuals were followed for 2 years after beginning a DMT
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Status/Outcome: 
Most individuals (92.8%) began treatment with either interferon beta or glatiramer acetate, but individuals who began treatment with natalizumab were more likely to continue with that treatment (32.3% versus 16.9%) and were less likely to have a treatment gap or switch treatments
(116)
Treatment patterns in disease-modifying therapy for patients with multiple sclerosis in the United States.
Bonafede MM, Johnson BH, Wenten M, Watson C
Clin Ther. 2013 Oct; 35(10):1501-12. PMID: 24139422. Abstract
Trial name: 
Sternberg et al., Cardiovasc. Ther., October 2013 study
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Phase: 
Retrospective medical record review
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Study Design: 
Retrospective study to examine associations between (i) disease modifying therapies (DMTs; interferon beta-1b, glatiramer acetate, and natalizumab) and cardiovascular risk factors and (ii) cardiovascular drugs and MS severity
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Disease Stage: 
MS
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Enrollment/Number of Patients: 
298 (188 who were receiving DMTs and 110 who were DMT naïve)
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Duration: 
N/A
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Status/Outcome: 
DMTs were associated with increased cardiovascular risk factors, such as increased diastolic blood pressure; as compared with a lack of DMT, interferon beta-1b and glatiramer acetate were associated with higher risk and natalizumab with lower risk; additionally, cardiovascular drugs in DMT-naïve individuals were associated with increased MS severity
(113)
Disease Modifying Therapies Modulate Cardiovascular Risk Factors in Multiple Sclerosis Patients.
Sternberg Z, Leung C, Sternberg D, Yu J, Hojnacki D
Cardiovasc Ther. 2013 Oct 1. PMID: 24119301. Abstract
Trial name: 
Fragoso et al., CNS Drugs, October 2013 study
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Phase: 
Retrospective medical record review
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Study Design: 
Retrospective study to examine the potential long-term effects of disease modifying drugs (DMDs, primarily interferon beta or glatiramer acetate) during pregnancy on the resulting offspring, using medical data from the children (aged 1 to 39 years at the time of the study) of women with MS who (i) were not exposed to disease-modifying therapies 3 months before pregnancy or during pregnancy or (ii) had 2 or more weeks exposure to DMDs during this period
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Disease Stage: 
MS
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Enrollment/Number of Patients: 
Not stated in abstract
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Duration: 
Up to 39 years
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Status/Outcome: 
No long-term deleterious effects were detected specifically in the children of women exposed to DMDs during pregnancy
(112)
Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review.
Fragoso YD, Adoni T, Alves-Leon SV, Azambuja ND, Barreira AA, Brooks JBB, Carneiro DSD, Carvalho MJ, Claudino R, Comini-Frota ER, et al.
CNS Drugs. 2013 Oct 10. PMID: 24114585. Abstract
Trial name: 
Agashivala et al., BMC Neurol., October 2013 study
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Phase: 
Retrospective claims data review
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Study Design: 
Retrospective cohort study that examined compliance to oral fingolimod and injectable disease-modifying therapies (interferon beta-1b, intramuscular and subcutaneous interferon beta-1a, and glatiramer acetate) among individuals who initiated treatment between Oct 2010 and Feb 2011, as measured by examination of pharmacy claims data
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Disease Stage: 
MS
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Enrollment/Number of Patients: 
1891
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Duration: 
12 months
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Status/Outcome: 
Fingolimod was associated with more compliance, less discontinuation of treatment, and later discontinuation of treatment over 12 months than the injectable disease-modifying therapies
(111)
Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.
Agashivala N, Wu N, Abouzaid S, Wu Y, Kim E, Boulanger L, Brandes DW
BMC Neurol. 2013 Oct 4; 13(1):138. Epub 2013 Oct 04. PMID: 24093542. Abstract
Trial name: 
Tsai and Lee, Clin. Drug Investig., September 2013 study
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Phase: 
Observational/open-label study
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Study Design: 
Study to examine the effect of disease-modifying therapies (DMTs; specifically, interferon beta-1a, interferon beta-1b, or glatiramer acetate) on survival in Taiwan
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Disease Stage: 
MS
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Enrollment/Number of Patients: 
1240
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Duration: 
Mean followup time, 54.3 months
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Status/Outcome: 
Lower adherence to DMT use was an independent risk factor for mortality, supporting the idea that DMTs can improve survival
(140)
Impact of Disease-Modifying Therapies on the Survival of Patients with Multiple Sclerosis in Taiwan, 1997-2008.
Tsai C-P, Lee C T-C
Clin Drug Investig. 2013 Jul 17. PMID: 23861171. Abstract
Trial name: 
Bergvall et al., Curr. Med. Res. Opin., September 2013 study
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Phase: 
Retrospective claims data review
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Study Design: 
Company-sponsored, retrospective study to assess real-world differences in relapse rates in individuals with MS who began fingolimod, interferon beta, or glatiramer acetate treatment between 1 Oct 2010 and 31 Mar 2011 (and who had experienced a relapse in the previous year); relapses were identified using a claims-based algorithm and administrative claims data from the US PharMetrics Plus database (rather than clinical assessment)
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Disease Stage: 
MS
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Enrollment/Number of Patients: 
525 (fingolimod cohort, 128; interferon beta or glatiramer acetate combined cohort, 397)
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Duration: 
540 days of post-index continuous enrollment
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Status/Outcome: 
Compared with interferon beta/glatiramer acetate treatment, fingolimod treatment was associated with a 50% reduction in the annualized relapse rate (after adjustments to account for baseline differences)
(108)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin. 2013 Oct 1. Epub 1969 Dec 31. PMID: 24059944. Abstract
Trial name: 
Hadjigeorgiou et al., J. Clin. Pharm. Ther., August 2013 study
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Phase: 
Retrospective trial review
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Study Design: 
Study to examine the relative effectiveness and safety of marketed treatments for MS [interferon beta-1b (250 microg), interferon beta-1a (30 microg, 44 microg, or 22 microg), teriflunomide (7 mg or 14 mg), glatiramer acetate (20 mg), natalizumab (300 mg), fingolimod (0.5 mg), and mitoxantrone (12 mg per m[2])]; a network analysis that performed pairwise comparisons of these treatments, based on results from randomized controlled trials, was undertaken to examine 4 clinical outcomes: (i) patients free of relapse, (ii) patients without disease progression, (iii) patients without MRI progression, and (iv) patients with adverse events
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Disease Stage: 
Relapsing MS
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Enrollment/Number of Patients: 
20,455
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Duration: 
N/A
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Status/Outcome: 
Fingolimod was associated with a better response for 2 outcomes (patients free of relapse, patients without MRI progression) as compared with interferon beta-1a (Avonex); interferon beta-1b (Betaferon) was associated with a better response for 2 outcomes (patients without disease progression, patients without MRI progression) as compared with interferon beta-1a (Avonex); and natalizumab might be more effective than other treatments for 2 outcomes (patients free of relapse, patients without MRI progression); conclusions about patients with adverse events could not be reached because of a lack of data
(106)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther. 2013 Aug 20. PMID: 23957759. Abstract
Trial name: 
Filippini et al., Cochrane Database Syst. Rev., June 2013 study
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Phase: 
Retrospective trial review
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Study Design: 
Study that examined 44 randomized controlled trials of drugs used in MS to estimate the relative efficacy of interferon beta-1b (Betaseron), interferon beta-1a (Rebif and Avonex), glatiramer acetate, natalizumab, mitoxantrone, cyclophosphamide, and other treatments, using pairwise meta-analysis and network meta-analysis
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Disease Stage: 
RRMS and progressive MS
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Enrollment/Number of Patients: 
17401
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Duration: 
24 months (median duration of trials)
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Status/Outcome: 
Natalizumab and interferon beta-1a (Rebif) were determined to be better than other treatments for preventing relapses in RRMS over the short term (24 months), and these two drugs probably inhibited disability progression in RRMS in this time period, although they are linked with long-term adverse events; in RRMS, interferon beta-1b and mitoxantrone probably decreased the probability of relapses, whereas interferon beta-1a (Avonex) and cyclophosphamide lacked convincing efficacy data; none of the treatments effectively decreased disability progression in progressive MS
(93)
Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.
Filippini G, Giovane C D, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, Salanti G
Cochrane Database Syst Rev. 2013 Jun 6; 6:CD008933. PMID: 23744561. Abstract
Trial name: 
Gobbi et al., Eur. Neurol., May 2013 study
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Phase: 
Retrospective cohort study
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Study Design: 
Multicenter, non-interventional, retrospective cohort study to compare the effects of intramuscular and subcutaneous interferon beta-1a, subcutaneous interferon beta-1b, and subcutaneous glatiramer acetate on the annualized relapse rate (ARR) and the Expanded Disability Status Scale (EDSS) score in a real-world setting
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Disease Stage: 
CIS or RRMS
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Enrollment/Number of Patients: 
546
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Duration: 
2 years of constant treatment with one drug for each patient
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Status/Outcome: 
All drugs had comparable effects on ARRs and EDSS scores, but injection site reactions and flu-like symptoms were reduced with intramuscular interferon beta-1a and glatiramer acetate, respectively
(91)
Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies.
Gobbi C, Zecca C, Linnebank M, Müller S, You X, Meier R, Borter E, Traber M
Eur Neurol. 2013 May 14; 70(1):35-41. Epub 2013 May 14. PMID: 23689307. Abstract
Trial name: 
Campbell et al., Am. J. Manag. Care, April 2013 study
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Phase: 
Simulation model
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Study Design: 
Study to estimate the relative long-term effectiveness of glatiramer acetate, fingolimod, and natalizumab based on inputs that included effects from randomized controlled trials, natural history progressions, and risk of progressive multifocal leukoencephalopathy; the average risks and benefits over 20 years were estimated with a simulation model
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Disease Stage: 
RRMS, negative for anti-JC virus antibodies initially
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Enrollment/Number of Patients: 
N/A
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Duration: 
20 years (simulation)
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Status/Outcome: 
Natalizumab was associated with a gain in quality-adjusted life years (an aggregate measure of risks and benefits) as compared with fingolimod or glatiramer acetate
(94)
Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis.
Campbell JD, McQueen BR, Miravalle A, Corboy JR, Ackermann RT, Vollmer TL, Nair K
Am J Manag Care. 2013; 19(4):278-85. PMID: 23725360. Abstract
Trial name: 
Jokubaitis et al., PLoS One, March 2013 study
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Phase: 
Prospective cohort study
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Study Design: 
Multicenter Australian cohort study using the MSBase platform to characterize use of disease-modifying therapies (DMTs, which included interferon beta, glatiramer acetate, and natalizumab); specifically, treatment persistence, factors that predict treatment discontinuation, and rates of switching between DMTs were studied
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Disease Stage: 
RRMS
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Enrollment/Number of Patients: 
1113
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Duration: 
4.2 years (median time patients were followed)
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Status/Outcome: 
Treatment persistence in this study was short, such that patients remained on their first DMT for 2.5 years (median) and on their next DMT for 2.3 years; annualized switch or cessation rates were 9.5 to 12.5% (interferon beta), 11.6% (glatiramer acetate), and 4.4% (natalizumab); younger age and higher disability scores predicted DMT discontinuation
(77)
The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform.
Jokubaitis VG, Spelman T, Lechner-Scott J, Barnett M, Shaw C, Vucic S, Liew D, Butzkueven H, Slee M, Slee M
PLoS One. 2013; 8(3):e59694. Epub 2013 Mar 19. PMID: 23527252. Abstract
Trial name: 
CombiRx extension study (conference report, March 2013)
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Phase: 
Extension phase of Phase III trial
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Study Design: 
Extension of the CombiRx trial, comparing effectiveness of combination therapy (interferon beta-1a and glatiramer acetate) with either therapy alone in reducing the annualized relapse rate (primary endpoint)
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Disease Stage: 
RRMS (in original study)
(71)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol. 2013 Feb 19. Epub 1969 Dec 31. PMID: 23424159. Abstract
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Enrollment/Number of Patients: 
687
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Duration: 
90 months
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Status/Outcome: 
Combination therapy did not reduce the risk of relapsing or confirmed disability progression as compared to glatiramer acetate, and glatiramer acetate reduced the risk of relapse more than interferon beta-1a, over 90 months; combination therapy was associated with a higher proportion of patients who were free of disease activity (driven by results from MRI) as compared with either therapy alone, but this effect is reduced over time
(75)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News, 21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Trial name: 
Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (press release, 18 March 2013)
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Phase: 
Retrospective medical record review
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Study Design: 
Data from two MS patient registries [TYSABRI Observational Program (TOP) and MSCOMET] were used in a propensity-matched analysis to compare the effects of natalizumab, interferon beta, and glatiramer acetate on relapses
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Disease Stage: 
MS
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Enrollment/Number of Patients: 
N/A
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Duration: 
N/A
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Status/Outcome: 
Natalizumab was associated with a lower rate of first relapse as compared to interferon beta and glatiramer acetate; relapses in patients treated with natalizumab also occurred more slowly than in those treated with the other drugs
(74)
New Tysabri data reaffirm substantial efficacy in treatment of people with MS and demonstrate stability of anti-JCV antibody status
Biogen Idec, 18 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1797077.
Trial name: 
Romeo et al., Eur. J. Neurol., February 2013 study
(70)
Clinical and MRI predictors of response to interferon-beta and glatiramer acetate in relapsing-remitting multiple sclerosis patients.
Romeo M, Martinelli-Boneschi F, Rodegher M, Esposito F, Martinelli V, Comi G, San Raffaele Multiple Sclerosis Clinical Group
Eur J Neurol. 2013 Feb 20. PMID: 23425504. Abstract
Phase: 
Observational/open-label study
(70)
Clinical and MRI predictors of response to interferon-beta and glatiramer acetate in relapsing-remitting multiple sclerosis patients.
Romeo M, Martinelli-Boneschi F, Rodegher M, Esposito F, Martinelli V, Comi G, San Raffaele Multiple Sclerosis Clinical Group
Eur J Neurol. 2013 Feb 20. PMID: 23425504. Abstract
Study Design: 
Observational study to determine clinical- and MRI-based predictors of response to glatiramer acetate and interferon beta; patients were considered "responders" if clinical and MRI activity were absent during treatment and "non-responders" in the presence of MRI activity or if the reduction in annualized relapse rate (ARR) was <50% of the ARR in the 2 previous years
(70)
Clinical and MRI predictors of response to interferon-beta and glatiramer acetate in relapsing-remitting multiple sclerosis patients.
Romeo M, Martinelli-Boneschi F, Rodegher M, Esposito F, Martinelli V, Comi G, San Raffaele Multiple Sclerosis Clinical Group
Eur J Neurol. 2013 Feb 20. PMID: 23425504. Abstract
Disease Stage: 
RRMS
(70)
Clinical and MRI predictors of response to interferon-beta and glatiramer acetate in relapsing-remitting multiple sclerosis patients.
Romeo M, Marti