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Last updated: 19 Apr 2016

Interferon beta-1b

Summary
Trade name: 
Betaseron (in the US)
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Betaferon (in Europe)
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
Extavia
(35)
Multiple sclerosis: pathogenesis and treatment.
Loma I, Heyman R
Curr Neuropharmacol. 2011 Sep; 9(3):409-16. PMID: 22379455. Abstract
ZIFERON
(36)
Zist Daru, ZIFERON
Zist Daru, 2010
Accessed on 28 Mar 2012 from http://www.zistdaru.ir/01.html..
Class: 
Immunomodulator
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Target: 
T lymphocytes
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
Blood-brain barrier (?)
(6)
Long-term experience with interferon beta-1b (Betaferon)in multiple sclerosis.
Arnason BGW
J Neurol. 2005 Sep; 252 Suppl 3:iii28-iii33. PMID: 16170497. Abstract
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
(21)
Interferon-beta-1b protects against multiple sclerosis-induced endothelial cells apoptosis.
Haghjooy Javanmard S, Saadatnia M M, Homayouni V V, Nikoogoftar M M, Maghzi AH, Etemadifar M, Chaitanya VG, McGee JC, Minagar A, Alexander SJ
Front Biosci (Elite Ed). 2012; 4:1368-74. PMID: 22201961. Abstract
T cell trafficking (?)
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
(43)
Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis.
Leppert D, Waubant E, Bürk MR, Oksenberg JR, Hauser SL
Ann Neurol. 1996 Dec; 40(6):846-52. PMID: 9007089. Abstract
Matrix metalloproteinases
(43)
Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis.
Leppert D, Waubant E, Bürk MR, Oksenberg JR, Hauser SL
Ann Neurol. 1996 Dec; 40(6):846-52. PMID: 9007089. Abstract
(44)
Chemokine-enhanced migration of human peripheral blood mononuclear cells is antagonized by interferon beta-1b through an effect on matrix metalloproteinase-9.
Stuve O, Chabot S, Jung SS, Williams G, Yong VW
J Neuroimmunol. 1997 Dec; 80(1-2):38-46. PMID: 9413258. Abstract
(45)
Changes of serum sICAM-1 and MMP-9 induced by rIFNbeta-1b treatment in relapsing-remitting MS.
Trojano M, Avolio C, Liuzzi GM, Ruggieri M, Defazio G, Liguori M, Santacroce MP, Paolicelli D, Giuliani F, Riccio P, et al.
Neurology. 1999 Oct 22; 53(7):1402-8. PMID: 10534242. Abstract
(46)
IFNbeta lowers MMP-9/TIMP-1 ratio, which predicts new enhancing lesions in patients with SPMS.
Waubant E, Goodkin D, Bostrom A, Bacchetti P, Hietpas J, Lindberg R, Leppert D
Neurology. 2003 Jan 14; 60(1):52-7. PMID: 12525717. Abstract
Inflammatory cytokines
(47)
Alterations in serum MMP-8, MMP-9, IL-12p40 and IL-23 in multiple sclerosis patients treated with interferon-beta1b.
Alexander JS, Harris MK, Wells SR, Mills G, Chalamidas K, Ganta VC, McGee J, Jennings MH, Gonzalez-Toledo E, Minagar A
Mult Scler. 2010 Jul; 16(7):801-9. PMID: 20621951. Abstract
Inflammasome
(66)
Interferon-β therapy against EAE is effective only when development of the disease depends on the NLRP3 inflammasome.
Inoue M, Williams KL, Oliver T, Vandenabeele P, Rajan JV, Miao EA, Shinohara ML
Sci Signal. 2012 May 22; 5(225):ra38. PMID: 22623753. Abstract
Status for MS: 
Approved in US, EU, and other countries for relapsing forms of MS
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
(38)
Berlex continues legal challenge to FDA over MS drug.
Glaser V
Nat Biotechnol. 1996 Jul; 14(7):811-2. PMID: 9630997. Abstract
Approved in EU for CIS, RRMS, and SPMS with active disease
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
First disease-modifying therapy approved by the US Food and Drug Administration for use in MS (July, 1993)
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
(38)
Berlex continues legal challenge to FDA over MS drug.
Glaser V
Nat Biotechnol. 1996 Jul; 14(7):811-2. PMID: 9630997. Abstract
Administration: 
For Betaseron, the recommended dose is 0.25 mg by subcutaneous injection every other day, according to information from the manufacturer
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
For Extavia, the recommended dose is 0.25 mg by subcutaneous injection every other day, according to information from the manufacturer
(40)
Extavia Prescribing Information
Novartis, Aug 2009
Accessed on 28 Mar 2012 from http://www.pharma.us.novartis.com/product/pi/pdf/extavia.pdf.
The Betaconnect autoinjector was associated with a high level of patient satisfaction in an industry-funded study involving 118 individuals with MS
(195)
Patient Satisfaction with the New Interferon Beta-1b Autoinjector (BETACONNECT™).
Ziemssen T, Sylvester L, Rametta M, Ross A P
Neurol Ther. 2015 Dec; 4(2):125-36. Epub 2015 Oct 27. PMID: 26662362. Abstract
Commercial: 
Betaferon/Betaseron was developed by Schering AG (which operated as Berlex Laboratory in North America), a company that was taken over by Bayer HealthCare
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
Betaferon/Betaseron is marketed by Bayer HealthCare
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
Novartis introduced Extavia in 2009; Extavia is manufactured by Bayer HealthCare and distributed by Novartis
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
(40)
Extavia Prescribing Information
Novartis, Aug 2009
Accessed on 28 Mar 2012 from http://www.pharma.us.novartis.com/product/pi/pdf/extavia.pdf.
Zist Daru Danesh Ltd (Iran) began producing ZIFERON in 2010
(36)
Zist Daru, ZIFERON
Zist Daru, 2010
Accessed on 28 Mar 2012 from http://www.zistdaru.ir/01.html..
(37)
Iran mass produces MS drug Ziferon
PRESSTV, 18 Sep 2010
Accessed on 28 Mar 2012 from http://www.presstv.ir/detail/143010.html.
Mountain View Pharmaceuticals received a European patent for polyethylene glycol conjugates of interferon beta-1b with enhanced biological potency (press release, June 2012)
(51)
Mountain View Pharmaceuticals receives European patent on potential long-acting drug for multiple sclerosis
Mountain View Pharmaceuticals, 11 Jun 2012
Accessed on 12 Jun 2012 from http://www.mvpharm.com/Documents/MVP%20Receives%20European%20Patent%20on%20Long-Acting%20MS%20Drug%20June%2011,%202012.pdf.
Filing of a supplemental Biologics License Application by Bayer for Betaconnect, a new means of delivering Betaseron, has been accepted by the US Food and Drug Administration (22 April 2015)
(169)
FDA Accepts Filing of BETACONNECT™* for Relapsing-Remitting Multiple Sclerosis Patients Taking BETASERON® (interferon beta-1b)
PR Newswire, 22 Apr 2015
Accessed on 28 Apr 2015 from http://www.prnewswire.com/news-releases/fda-accepts-filing-of-betaconnect-for-relapsing-remitting-multiple-sclerosis-patients-taking-betaseron-interferon-beta-1b-300070199.html.
Betaconnect, the first electronic autoinjector for use in treating RRMS, has been approved by the US Food and Drug Administration; this device is used for delivering Betaseron (September 25, 2015)
(187)
Bayer Receives FDA Approval for BETACONNECT - First and Only Electronic Autoinjector in Relapsing-Remitting Multiple Sclerosis (RRMS) Treatment
PR Newswire, 25 Sep 2015
Accessed on 29 Sep 2015 from http://www.prnewswire.com/news-releases/bayer-receives-fda-approval-for-betaconnect---first-and-only-electronic-autoinjector-in-relapsing-remitting-multiple-sclerosis-rrms-treatment-300149438.html.
Names
Name: 
Interferon beta-1b
Trade name: 
Betaseron (in the US)
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Betaferon (in Europe)
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
Extavia
(35)
Multiple sclerosis: pathogenesis and treatment.
Loma I, Heyman R
Curr Neuropharmacol. 2011 Sep; 9(3):409-16. PMID: 22379455. Abstract
ZIFERON
(36)
Zist Daru, ZIFERON
Zist Daru, 2010
Accessed on 28 Mar 2012 from http://www.zistdaru.ir/01.html..
Synonyms: 
17-L-Serine-2-166-interferon beta1 (human fibroblast reduced)
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
BAY 86-5046
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
BAY86-5046
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Betaferon
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Betaseron
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
DRG-0054
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Extavia
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
IFN-beta (sub ser)
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
IFNB-1b
(25)
Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials.
Kappos L, Weinshenker B, Pozzilli C, Thompson AJ, Dahlke F, Beckmann K, Polman C, McFarland H, European(EU-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent Advis, North American(NA-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent
Neurology. 2004 Nov 23; 63(10):1779-87. PMID: 15557490. Abstract
IFNbeta-1b
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Interferon beta-1b
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Interferon-1b
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-TTD90R31WZ
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
ZIFERON
(36)
Zist Daru, ZIFERON
Zist Daru, 2010
Accessed on 28 Mar 2012 from http://www.zistdaru.ir/01.html..
Systematic name: 
2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine-
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Interferon beta1, 17-L-serine-, (2S-(2R*,5R*))-
(1)
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
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Target: 
T lymphocytes
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
Blood-brain barrier (?)
(6)
Long-term experience with interferon beta-1b (Betaferon)in multiple sclerosis.
Arnason BGW
J Neurol. 2005 Sep; 252 Suppl 3:iii28-iii33. PMID: 16170497. Abstract
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
(21)
Interferon-beta-1b protects against multiple sclerosis-induced endothelial cells apoptosis.
Haghjooy Javanmard S, Saadatnia M M, Homayouni V V, Nikoogoftar M M, Maghzi AH, Etemadifar M, Chaitanya VG, McGee JC, Minagar A, Alexander SJ
Front Biosci (Elite Ed). 2012; 4:1368-74. PMID: 22201961. Abstract
T cell trafficking (?)
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
(43)
Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis.
Leppert D, Waubant E, Bürk MR, Oksenberg JR, Hauser SL
Ann Neurol. 1996 Dec; 40(6):846-52. PMID: 9007089. Abstract
Matrix metalloproteinases
(43)
Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis.
Leppert D, Waubant E, Bürk MR, Oksenberg JR, Hauser SL
Ann Neurol. 1996 Dec; 40(6):846-52. PMID: 9007089. Abstract
(44)
Chemokine-enhanced migration of human peripheral blood mononuclear cells is antagonized by interferon beta-1b through an effect on matrix metalloproteinase-9.
Stuve O, Chabot S, Jung SS, Williams G, Yong VW
J Neuroimmunol. 1997 Dec; 80(1-2):38-46. PMID: 9413258. Abstract
(45)
Changes of serum sICAM-1 and MMP-9 induced by rIFNbeta-1b treatment in relapsing-remitting MS.
Trojano M, Avolio C, Liuzzi GM, Ruggieri M, Defazio G, Liguori M, Santacroce MP, Paolicelli D, Giuliani F, Riccio P, et al.
Neurology. 1999 Oct 22; 53(7):1402-8. PMID: 10534242. Abstract
(46)
IFNbeta lowers MMP-9/TIMP-1 ratio, which predicts new enhancing lesions in patients with SPMS.
Waubant E, Goodkin D, Bostrom A, Bacchetti P, Hietpas J, Lindberg R, Leppert D
Neurology. 2003 Jan 14; 60(1):52-7. PMID: 12525717. Abstract
Inflammatory cytokines
(47)
Alterations in serum MMP-8, MMP-9, IL-12p40 and IL-23 in multiple sclerosis patients treated with interferon-beta1b.
Alexander JS, Harris MK, Wells SR, Mills G, Chalamidas K, Ganta VC, McGee J, Jennings MH, Gonzalez-Toledo E, Minagar A
Mult Scler. 2010 Jul; 16(7):801-9. PMID: 20621951. Abstract
Inflammasome
(66)
Interferon-β therapy against EAE is effective only when development of the disease depends on the NLRP3 inflammasome.
Inoue M, Williams KL, Oliver T, Vandenabeele P, Rajan JV, Miao EA, Shinohara ML
Sci Signal. 2012 May 22; 5(225):ra38. PMID: 22623753. Abstract
Properties: 
Interferons are naturally-occurring cytokines that are secreted in response to pathogens
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Betaseron is a recombinant protein that is produced by fermentation of a strain of Escherichia coli containing a plasmid for expression of human interferon beta(ser17) (in which serine is substituted for cysteine at position 17)
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Extavia is identical to Betaseron
(35)
Multiple sclerosis: pathogenesis and treatment.
Loma I, Heyman R
Curr Neuropharmacol. 2011 Sep; 9(3):409-16. PMID: 22379455. Abstract
Unlike the natural protein, is not glycosylated
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Lyophilized, 165-residue protein
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Molecular weight, 18,500 daltons
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Serum concentrations are very low or undetectable after subcutaneous administration at the recommended dose
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Pharmacokinetic properties have been determined in healthy volunteers
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Controlled release, PEGylated version has been studied in mice
(56)
Enzon presents pre-clinical data on controlled release of PEGylated interferon-beta-1b and PEGylated anti-TNF-a antibody fragment at the Controlled Release Society annual meeting
Market Watch, The Wall Street Journal, 16 Jul 2012
Accessed on 16 Jul 2012 from http://www.marketwatch.com/story/enzon-presents-pre-clinical-data-on-controlled-release-of-pegylated-interferon-beta-1b-and-pegylated-anti-tnf-a-antibody-fragment-at-the-controlled-release-society-annual-meeting-2012-07-16.
Analysis has been performed to determine residues where covalent modification with polyethylene glycol does not inhibit (or improves) bioactivities in vitro (in contrast, random modification decreases the bioactivity)
(101)
Site-Specific PEGylation Enhances the Pharmacokinetic Properties and Antitumor Activity of Interferon Beta-1b.
Lee JI, Eisenberg SP, Rosendahl MS, Chlipala EA, Brown JD, Doherty DH, Cox GN
J Interferon Cytokine Res. 2013 Aug 20. PMID: 23962003. Abstract
Betaseron (interferon beta-1b) and Rebif (interferon beta-1a), which are formulated with human serum albumin, contain more aggregated protein and particles than does Avonex (interferon beta-1a), and the high levels of aggregates correlate with higher reported rates of neutralizing-antibody formation for Betaseron and Rebif
(72)
Characterization and quantitation of aggregates and particles in interferon-β products: Potential links between product quality attributes and immunogenicity.
Barnard JG, Babcock K, Carpenter JF
J Pharm Sci. 2012 Dec 11. PMID: 23233295. Abstract
A single injection can induce anti-drug antibodies in immune tolerant transgenic mice, and the titer increases with increasing frequency of treatment and dose
(76)
Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice.
Kijanka G, Jiskoot W, Schellekens H, Brinks V
Pharm Res. 2013 Jan 30. Epub 2013 Jan 30. PMID: 23361590. Abstract
Induces anti-drug antibodies in immune tolerant transgenic mice, such that intravenous delivery is the most immunogenic route; intramuscular, subcutaneous, and intraperitoneal delivery are similar to each other in their immunogenic effects
(76)
Effect of Treatment Regimen on the Immunogenicity of Human Interferon Beta in Immune Tolerant Mice.
Kijanka G, Jiskoot W, Schellekens H, Brinks V
Pharm Res. 2013 Jan 30. Epub 2013 Jan 30. PMID: 23361590. Abstract

Mechanisms/Effects

Human: 
Mechanism in MS is unknown
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Suppresses the development of inflammatory brain lesions in MS patients
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Decreases the expected number of contrast enhancing lesions (CELs) seen in MRI, such that new CEL formation is inhibited, but the resolution of previously-formed CELs is not enhanced, as shown by a population analysis using datasets from two different studies involving 24 individuals
(181)
A Population Approach to Characterize Interferon Beta-1b Effect on Contrast Enhancing Lesions in Patients With Relapsing Remitting Multiple Sclerosis.
Gulati A, Bagnato F, Villoslada P, Velez de Mendizabal N
CPT Pharmacometrics Syst Pharmacol. 2015 May; 4(5):295-304. Epub 2015 Apr 24. PMID: 26225255. Abstract
Stabilizes the blood-brain barrier (BBB), based on experiments in which serum from RRMS patients treated with interferon beta-1b reduced the permeability of an in vitro BBB model (human endothelial cells co-cultured with rat astrocytes) as compared with serum from untreated patients
(3)
Serum from interferon-β-1b-treated patients with early multiple sclerosis stabilizes the blood-brain barrier in vitro.
Müller M, Frese A, Nassenstein I, Hoppen M, Marziniak M, Ringelstein E B, Kim K S, Schäbitz W-R, Kraus J
Mult Scler. 2012 Feb; 18(2):236-9. Epub 2011 Aug 15. PMID: 21844066. Abstract
Downregulates expression of the integrin VLA-4/CD49d (which is implicated in MS pathology) on CD8+ T cells and on primed but not naïve CD4+ cells in MS patients, in agreement with the idea that the drug influences the interaction of immune cells and the blood-brain barrier
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
Increases the plasma concentration of soluble vascular cell adhesion molecule-1 (the soluble form of the VLA-4 integrin ligand) in MS patients
(20)
Cytokines and adhesion molecules in multiple sclerosis patients treated with interferon-beta1b.
Jensen J, Krakauer M, Sellebjerg F
Cytokine. 2005 Jan 7; 29(1):24-30. PMID: 15579375. Abstract
Inhibits MS-induced apoptosis of endothelial cells (potentially indicating a role in preserving the blood-brain barrier), as shown by experiments in which apoptosis of human umbilical endothelial cells was induced by sera from exacerbating MS patients and blocked by interferon beta-1b
(21)
Interferon-beta-1b protects against multiple sclerosis-induced endothelial cells apoptosis.
Haghjooy Javanmard S, Saadatnia M M, Homayouni V V, Nikoogoftar M M, Maghzi AH, Etemadifar M, Chaitanya VG, McGee JC, Minagar A, Alexander SJ
Front Biosci (Elite Ed). 2012; 4:1368-74. PMID: 22201961. Abstract
Inhibits interleukin-2–induced secretion of gelatinases (matrix metalloproteinases that digest subendothelial basement membrane components) and migration across an artificial basement membrane by human T cells, suggesting that the drug might interfere with the migration of activated T cells to the central nervous system
(43)
Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis.
Leppert D, Waubant E, Bürk MR, Oksenberg JR, Hauser SL
Ann Neurol. 1996 Dec; 40(6):846-52. PMID: 9007089. Abstract
Inhibits chemokine-induced expression of matrix metalloproteinase-9 and migration of human peripheral blood mononuclear cells across a fibronectin matrix
(44)
Chemokine-enhanced migration of human peripheral blood mononuclear cells is antagonized by interferon beta-1b through an effect on matrix metalloproteinase-9.
Stuve O, Chabot S, Jung SS, Williams G, Yong VW
J Neuroimmunol. 1997 Dec; 80(1-2):38-46. PMID: 9413258. Abstract
Decreases serum matrix metalloproteinase-9 activity in MS patients
(45)
Changes of serum sICAM-1 and MMP-9 induced by rIFNbeta-1b treatment in relapsing-remitting MS.
Trojano M, Avolio C, Liuzzi GM, Ruggieri M, Defazio G, Liguori M, Santacroce MP, Paolicelli D, Giuliani F, Riccio P, et al.
Neurology. 1999 Oct 22; 53(7):1402-8. PMID: 10534242. Abstract
Increases serum levels of intercellular adhesion molecule-1 in MS patients
(45)
Changes of serum sICAM-1 and MMP-9 induced by rIFNbeta-1b treatment in relapsing-remitting MS.
Trojano M, Avolio C, Liuzzi GM, Ruggieri M, Defazio G, Liguori M, Santacroce MP, Paolicelli D, Giuliani F, Riccio P, et al.
Neurology. 1999 Oct 22; 53(7):1402-8. PMID: 10534242. Abstract
Reduces the ratio of matrix metalloproteinase-9 to tissue inhibitor of metalloproteinase-1 (a ratio that is a predictor of new gadolinium-enhancing lesions) in SPMS patients
(46)
IFNbeta lowers MMP-9/TIMP-1 ratio, which predicts new enhancing lesions in patients with SPMS.
Waubant E, Goodkin D, Bostrom A, Bacchetti P, Hietpas J, Lindberg R, Leppert D
Neurology. 2003 Jan 14; 60(1):52-7. PMID: 12525717. Abstract
Reduces serum levels of inflammatory cytokines that are associated with MS pathogenesis (interleukin-12 p40 and interleukin-23) in RRMS patients
(47)
Alterations in serum MMP-8, MMP-9, IL-12p40 and IL-23 in multiple sclerosis patients treated with interferon-beta1b.
Alexander JS, Harris MK, Wells SR, Mills G, Chalamidas K, Ganta VC, McGee J, Jennings MH, Gonzalez-Toledo E, Minagar A
Mult Scler. 2010 Jul; 16(7):801-9. PMID: 20621951. Abstract
Affects cytokine release differently in cultured CD4+ and CD8+ T cells from RRMS and PPMS patients, such that the drug inhibits interferon-gamma and induces interleukin (IL)-4 selectively in CD4+ T cells from RRMS patients; induces IL-10 in all RRMS cell populations but only slightly in PPMS cells; always inhibits IL-5; and does not affect IL-17A
(62)
Differential effects of interferon-β1b on cytokine patterns of CD4+ and CD8+ T cells derived from RRMS and PPMS patients.
Skrzipek S, Vogelgesang A, Bröker BM, Dressel A
Mult Scler. 2012 May; 18(5):674-8. Epub 2011 Oct 24. PMID: 22025329. Abstract
Reduces serum levels of interferon-gamma (a sign of the intensity of an immune reaction) during relapses, based on a study of 35 women with RRMS
(141)
Cytokines and Disability in Interferon-β-1b Treated and Untreated Women with Multiple Sclerosis.
Trenova AG, Slavov GS, Manova MG, Kostadinova II
Arch Med Res. 2014 Aug 14. PMID: 25130430. Abstract
Interferon beta increases serum levels of interleukin-7, a cytokine that has been associated with MS, but decreases IL-7 receptor alpha chain expression and IL-7 consumption in peripheral blood leukocytes, indicating that interferon beta impairs IL-7 responsiveness
(130)
Interferon beta treatment of multiple sclerosis increases serum interleukin-7.
Lundström W, Hermanrud C, Sjöstrand M, Brauner S, Wahren-Herlenius M, Olsson T, Karrenbauer V, Hillert J, Fogdell-Hahn A
Mult Scler. 2014 May 12. PMID: 24821684. Abstract
Natalizumab or interferon beta treatment is associated with significantly reduced serum levels of a "cytokine signature" [a summed value of levels of tumor necrosis factor-alpha, interferon gamma, S100B, interleukin-1beta (IL-1beta), IL-6, IL-8, IL-17, and IL-23] in individuals with MS as compared with levels in drug naïve individuals with MS
(135)
The use of cytokine signature patterns: separating drug naïve, interferon and natalizumab-treated multiple sclerosis patients.
O'Connell KE, Mok T, Sweeney B, Ryan AM, Dev KK
Autoimmunity. 2014 Jun 30:1-7. PMID: 24974887. Abstract
Interferon beta treatment is associated with higher serum levels of pro-inflammatory cytokines as compared with natalizumab treatment in individuals with MS
(135)
The use of cytokine signature patterns: separating drug naïve, interferon and natalizumab-treated multiple sclerosis patients.
O'Connell KE, Mok T, Sweeney B, Ryan AM, Dev KK
Autoimmunity. 2014 Jun 30:1-7. PMID: 24974887. Abstract
Associated with increased serum levels of brain-derived neurotrophic factor, which are inversely correlated with the degree of disability (measured by the Expanded Disability Status Scale score), as shown in a study of 82 individuals with MS
(190)
Increased Serum Brain-derived Neurotrophic Factor in Multiple Sclerosis Patients on Interferon-β and Its Impact on Functional Abilities.
Mehrpour M, Akhoundi FH, Delgosha M, Keyvani H, Motamed MR, Sheibani B, Meysamie A
Neurologist. 2015 Oct; 20(4):57-60. PMID: 26468869. Abstract
In vitro treatment decreases CXCR4-dependent chemotaxis of T cells from individuals with RRMS or healthy individuals
(178)
Effect of IFN β-1b on CXCR4-dependent chemotaxis in T cells from multiple sclerosis patients.
Wostradowski T, Gudi V, Pul R, Gingele S, Lindquist JA, Stangel M, Lindquist S
Clin Exp Immunol. 2015 Jul 25. PMID: 26212126. Abstract
Reduces expression of CXCR4 mRNA, as well as surface expression of CXCR4, by primary human T cells
(178)
Effect of IFN β-1b on CXCR4-dependent chemotaxis in T cells from multiple sclerosis patients.
Wostradowski T, Gudi V, Pul R, Gingele S, Lindquist JA, Stangel M, Lindquist S
Clin Exp Immunol. 2015 Jul 25. PMID: 26212126. Abstract
Three major forms of interferon beta therapy (Avonex, Betaseron, and Rebif) are associated with a robust gene expression signature from blood that involves 25 upregulated genes; all of the drugs induce a similar maximum interferon beta activation state, although the average effect of Avonex is less than that of the other drugs
(164)
A robust type I interferon gene signature from blood RNA defines quantitative but not qualitative differences between three major IFNβ drugs in the treatment of multiple sclerosis.
Harari D, Orr I, Rotkopf R, Baranzini SE, Schreiber G
Hum Mol Genet. 2015 Feb 26. PMID: 25721402. Abstract
Interferon beta does not affect the frequency of CD27+CD43+ B1 cells, which is reduced in RRMS
(131)
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
Decreases plasma concentrations of nitrogen dioxide + nitrate radical, 3-nitrotyrosine, and S-nitrosothiol, increases plasma concentrations of asymmetric and symmetric dimethyl-L-arginine, and increases plasma arginase activity in patients with RRMS
(85)
INF-β1b therapy modulates L-arginine and nitric oxide metabolism in patients with relapse remittent multiple sclerosis.
Stojanovic I, Vojinovic S, Ljubisavljevic S, Pavlovic R, Basic J, Pavlovic D, Ilic A, Cvetkovic T, Stukalov M
J Neurol Sci. 2012 Dec 15; 323(1-2):187-92. Epub 2012 Sep 28. PMID: 23026532. Abstract
Reduces serum nitrite levels (by 71%) and the annual relapse rate (by 71%), but does not affect cytokine levels or ratios in a manner that reflects effects on disease course, based on a 3-year longitudinal study of 18 RRMS patients receiving subcutaneous interferon beta-1b as monotherapy
(89)
Effects of Interferon β-1a and Interferon β-1b Monotherapies on Selected Serum Cytokines and Nitrite Levels in Patients with Relapsing-Remitting Multiple Sclerosis: A 3-Year Longitudinal Study.
Stępień A, Chalimoniuk M, Lubina-Dąbrowska N, Chrapusta SJ, Galbo H, Langfort J
Neuroimmunomodulation. 2013 May 24; 20(4):213-222. Epub 2013 May 24. PMID: 23711618. Abstract
Affects the expression of multiple genes (including CD20, a target of B cell depletion therapy), as shown by DNA microarray experiments to examine genome-wide RNA expression profiles of peripheral mononuclear blood cells from RRMS patients
(48)
Long-term genome-wide blood RNA expression profiles yield novel molecular response candidates for IFN-beta-1b treatment in relapsing remitting MS.
Goertsches RH, Hecker M, Koczan D, Serrano-Fernandez P, Moeller S, Thiesen H-J, Zettl UK
Pharmacogenomics. 2010 Feb; 11(2):147-61. PMID: 20136355. Abstract
Affects the expression of a variety of genes, including genes with roles in antioxidant activity, mitochondrial fatty acid metabolism, and immune regulation, as shown by analysis of patient gene expression profiles; greater changes were seen in long-term versus acute dosing
(53)
Interferon-beta-1b-induced short- and long-term signatures of treatment activity in multiple sclerosis.
Croze E, Yamaguchi KD, Knappertz V, Reder AT, Salamon H
Pharmacogenomics J. 2012 Jun 19. PMID: 22711062. Abstract
Increases the expression of mRNAs encoding Toll-like receptors TLR3 and TLR7 and MyD88 (a TLR adaptor molecule) in vitro in peripheral blood mononuclear cells from healthy volunteers and in vivo in individuals with RRMS
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Increases the expression of Toll-like receptor 7 (TLR7) and MyD88 (a TLR adaptor molecule) proteins in plasmacytoid dendritic cells (DCs), but not in monocytes, myeloid DCs, B cells, CD4+ T cells, or CD8+ T cells
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Treatment is associated with an increase in the expression of Toll-like receptor 7 in plasmacytoid dendritic cells of individuals with CIS or RRMS
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Increases the expression Toll-like receptor 7 (TLR7) in plasmacytoid dendritic cells from healthy volunteers; subsequent stimulation of these cells with a TLR7-specific ligand then strongly increases production of interferon-alpha as compared to production in cells not pretreated with interferon beta-1b
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Decreases the expression of mRNAs encoding Toll-like receptors TLR6 and TLR9 in vitro in peripheral blood mononuclear cells from healthy volunteers and decreases TLR9 (but not TLR6) mRNA expression in vivo in individuals with RRMS
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Does not significantly affect the expression of mRNAs encoding Toll-like receptors TLR1, TLR2, TLR4, TLR8, and TLR10 in peripheral blood mononuclear cells from healthy volunteers
(100)
Multiple Sclerosis: Modulation of Toll-Like Receptor (TLR) Expression by Interferon-β Includes Upregulation of TLR7 in Plasmacytoid Dendritic Cells.
Derkow K, Bauer JMJ, Hecker M, Paap BK, Thamilarasan M, Koczan D, Schott E, Deuschle K, Bellmann-Strobl J, Paul F, et al.
PLoS One. 2013; 8(8):e70626. Epub 2013 Aug 12. PMID: 23950974. Abstract
Increases intracellular levels of Cu Zn superoxide dismutase (SOD1) in peripheral blood mononuclear cells (PBMCs); levels of SOD1 are reduced in cerebrospinal fluid and PBMCs in individuals with RRMS versus healthy controls
(183)
The IFN-β 1b effect on Cu Zn superoxide dismutase (SOD1) in peripheral mononuclear blood cells of relapsing-remitting multiple sclerosis patients and in neuroblastoma SK-N-BE cells.
Damiano S, Sasso A, De Felice B, Terrazzano G, Brescia Morra V, Carotenuto A, Orefice NS, Orefice G, Vacca G, Belfiore A, et al.
Brain Res Bull. 2015 Sep 3; 118:1-6. PMID: 26327496. Abstract
Increases intracellular and extracellular levels of Cu Zn superoxide dismutase (SOD1) in SK-N-BE neuroblastoma cell culture; levels of SOD1 are reduced in cerebrospinal fluid and PBMCs in individuals with RRMS versus healthy controls
(183)
The IFN-β 1b effect on Cu Zn superoxide dismutase (SOD1) in peripheral mononuclear blood cells of relapsing-remitting multiple sclerosis patients and in neuroblastoma SK-N-BE cells.
Damiano S, Sasso A, De Felice B, Terrazzano G, Brescia Morra V, Carotenuto A, Orefice NS, Orefice G, Vacca G, Belfiore A, et al.
Brain Res Bull. 2015 Sep 3; 118:1-6. PMID: 26327496. Abstract
Induces the transcription of an alternate form of nuclear receptor coactivator 7 (NCOA7), termed NCOA7-AS (alternate start), in peripheral blood mononuclear cells from both healthy individuals and individuals with MS, as well as fetal brain cells and tumor cells; this transcript contains a unique first exon and the last 5 exons of full-length NCOA7
(149)
Induction of a Unique Isoform of the NCOA7 Oxidation Resistance Gene by Interferon β-1b.
Yu L, Croze E, Yamaguchi KD, Tran T, Reder AT, Litvak V, Volkert MR
J Interferon Cytokine Res. 2014 Oct 20. PMID: 25330068. Abstract
Induces the transcription of an alternate form of nuclear receptor coactivator 7 (NCOA7), termed NCOA7-AS (alternate start); the encoded protein displays oxidation resistance activity
(149)
Induction of a Unique Isoform of the NCOA7 Oxidation Resistance Gene by Interferon β-1b.
Yu L, Croze E, Yamaguchi KD, Tran T, Reder AT, Litvak V, Volkert MR
J Interferon Cytokine Res. 2014 Oct 20. PMID: 25330068. Abstract
Induces the transcription of an alternate form of nuclear receptor coactivator 7 (NCOA7), termed NCOA7-AS (alternate start); this induction requires activation of the interferon receptor as well as the JAK-STAT pathway
(149)
Induction of a Unique Isoform of the NCOA7 Oxidation Resistance Gene by Interferon β-1b.
Yu L, Croze E, Yamaguchi KD, Tran T, Reder AT, Litvak V, Volkert MR
J Interferon Cytokine Res. 2014 Oct 20. PMID: 25330068. Abstract
Increases the relative proportion of CD4+ T cells and decreases the proportion of CD8+ T cells in MS patients
(19)
VLA-4/CD49d downregulated on primed T lymphocytes during interferon-beta therapy in multiple sclerosis.
Muraro PA, Leist T, Bielekova B, McFarland HF
J Neuroimmunol. 2000 Nov 1; 111(1-2):186-94. PMID: 11063837. Abstract
Increases CD8+ regulatory T cell function in MS patients to levels similar to those in patients without MS
(6)
Long-term experience with interferon beta-1b (Betaferon)in multiple sclerosis.
Arnason BGW
J Neurol. 2005 Sep; 252 Suppl 3:iii28-iii33. PMID: 16170497. Abstract
Increases the proportion of CD56(bright) (immature) natural killer cells and decreases the proportion of cytotoxic CD56(dim) (mature) natural killer cells in the periphery
(83)
The role of natural killer cells in multiple sclerosis and their therapeutic implications.
Chanvillard C, Jacolik RF, Infante-Duarte C, Nayak RC
Front Immunol. 2013; 4:63. Epub 2013 Mar 13. PMID: 23493880. Abstract
Interferon beta reduces expression of natural killer cell receptor 1 in peripheral blood mononuclear cells; such expression is increased in individuals with MS relative to healthy controls
(142)
Are natural killer cells involved in multiple sclerosis etiology? Evidences from NKp46/NCR1 receptor modulation in an observational study.
Galuppo M, Giacoppo S, Sessa E, Bramanti P, Mazzon E
J Neurol Sci. 2014 Jul 30. PMID: 25115502. Abstract
Interferon beta (either -1a or -1b) treatment increases the frequncy of naïve T cells and decreases the frequency of central memory T cells (which is increased in MS) in RRMS patients
(79)
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
Interferon beta increases serum levels of endogenous secretory receptor for advanced glycation end-products (esRAGE); serum esRAGE levels are reduced during clinical relapse
(153)
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
Interferon beta expands the number of peripheral regulatory CD19+CD24++CD38++ transitional B cells in individuals with RRMS as compared with the number in treatment-naïve individuals or those treated with glatiramer acetate
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
Interferon beta expands the number of peripheral regulatory CD19+CD24++CD38++ transitional B cells in individuals with RRMS; such cells are a significant source of interleukin-10 in these individuals and in healthy controls
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
Interferon beta does not induce the secretion of interleukin-10 from unstimulated peripheral blood mononuclear cells from healthy individuals, but does enhance secretion when the cells are stimulated
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
Interferon beta increases 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
(194)
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
Induces the proliferation and differentiation of human neural stem/progenitor cells in vitro
(18)
Interferon β-1b directly modulates human neural stem/progenitor cell fate.
Arscott TW, Soltys J, Knight J, Mao-Draayer Y
Brain Res. 2011 Sep 21; 1413:1-8. Epub 2011 Jul 23. PMID: 21855056. Abstract
Induces the development of anti-interferon antibodies in about one-third of MS patients, which usually disappear over time, but the effect of these antibodies on the response to treatment is unclear
(6)
Long-term experience with interferon beta-1b (Betaferon)in multiple sclerosis.
Arnason BGW
J Neurol. 2005 Sep; 252 Suppl 3:iii28-iii33. PMID: 16170497. Abstract
Interferon beta treatment can cause the production of antibodies that bind the drug, and their prevalence varies depending on the drug preparation; in one study of 124 individuals, 38.1% of those receiving Betaferon, 21.9% receiving Rebif, and 26.8% receiving CinnoVex produced binding antibodies
(114)
Antibodies to Interferon beta in Patients with Multiple Sclerosis Receiving CinnoVex, Rebif, and Betaferon.
Zare N, Zarkesh-Esfahani S H, Gharagozloo M, Shaygannejad V
J Korean Med Sci. 2013 Dec; 28(12):1801-6. Epub 2013 Nov 26. PMID: 24339712. Abstract
Interferon beta is associated with the formation of neutralizing antibodies; in a cross-sectional study in which serum samples from 2711 individuals with MS were submitted to the same independent laboratory, such antibodies occurred at a frequency of 35% for Rebif 44 microg (subcutaneous interferon beta-1a), 22% for Betaseron (interferon beta-1b) and Rebif 22 microg, and 7.5% for Avonex (intramuscular interferon beta-1a)
(176)
Frequency and magnitude of interferon β neutralizing antibodies in the evaluation of interferon β immunogenicity in patients with multiple sclerosis.
Grossberg SE, Oger J, Grossberg LD, Gehchan A, Klein JP
J Interferon Cytokine Res. 2011 Mar; 31(3):337-44. Epub 2011 Jan 12. PMID: 21226608. Abstract
Interferon beta is associated with the formation of neutralizing antibodies; in one study of 2711 individuals with MS, in those with detectable neutralizing antibodies, the titer was very high in 42% to 47% of individuals treated with interferon beta-1a but in only 22% of those treated with beta interferon-1b
(176)
Frequency and magnitude of interferon β neutralizing antibodies in the evaluation of interferon β immunogenicity in patients with multiple sclerosis.
Grossberg SE, Oger J, Grossberg LD, Gehchan A, Klein JP
J Interferon Cytokine Res. 2011 Mar; 31(3):337-44. Epub 2011 Jan 12. PMID: 21226608. Abstract
Interferon beta is associated with the formation of neutralizing antibodies; a systematic review and meta-analysis of randomized and non-randomized controlled trial data indicated that interferon beta-1a (Avonex) is least likely to lead to the formation of such antibodies (2.0 to 18.9% of individuals, as compared with 16.5 to 35.4% of individuals for interferon beta-1a (Rebif) and 27.3% to 53.3% for interferon beta-1b (Betaferon/Betaseron)
(182)
Development of interferon beta-neutralising antibodies in multiple sclerosis-a systematic review and meta-analysis.
Govindappa K, Sathish J, Park K, Kirkham J, Pirmohamed M
Eur J Clin Pharmacol. 2015 Aug 14. Epub 2015 Aug 14. PMID: 26268445. Abstract
Inhibits the activity of the ubiquitin/proteasome system (which is elevated in MS patients), as shown by analysis of plasma from MS patients; the level of inhibition correlates with the reduction in the number of T1-weighted enhancing lesions
(54)
Plasma ubiquitin?proteasome system profile in patients with multiple sclerosis: correlation with clinical features, neuroimaging, and treatment with interferon-beta-1b.
Minagar A, Ma W, Zhang X, Wang X, Zhang K, Alexander SJ, Gonzalez-Toledo E, Albitar M
Neurol Res. 2012 Jun 16. PMID: 22709658. Abstract
During interferon beta 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
(98)
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
Additively enhances the effects of 25-hydroxyvitamin D [25(OH)D] on MS activity, as shown in a study that measured serum levels of 25(OH)D and global gene expression profiles in individuals who began interferon beta-1b treatment after a CIS, who were monitored for ≤2 years
(148)
Molecular mechanism underlying the impact of vitamin D on disease activity of MS.
Munger KL, Köchert K, Simon KC, Kappos L, Polman CH, Freedman MS, Hartung HP, Miller DH, Montalbán X, Edan G, et al.
Ann Clin Transl Neurol. 2014 Aug; 1(8):605-17. Epub 2014 Aug 22. PMID: 25285313. Abstract
Effectiveness of interferon beta (measured in terms of a lack of relapses and disease progression), in individuals lacking neutralizing antibodies against the drug, 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
(140)
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
Response to interferon beta treatment correlates with levels of IgM antibodies against Epstein-Barr viral capsid antigen, as shown in a study of 87 individuals with MS
(192)
Antibodies to Epstein-Barr virus and MRI disease activity in multiple sclerosis.
Kvistad S, Myhr K-M, Holmøy T, Bakke S, Beiske AG, Bjerve KS, Hovdal H, Løken-Amsrud KI, Lilleås F, Midgard R, et al.
Mult Scler. 2014 May 19. PMID: 24842958. Abstract
Together with the anticoagulant agent warfarin, was used successfully to treat an individual with Baló's concentric sclerosis (a rare form of MS) and antiphospholipid syndrome
(161)
Combination Treatment of Interferon β-1b and Warfarin for a Patient With Baló's Concentric Sclerosis and Antiphospholipid Syndrome.
Tso A-C, Tsao W-L, Chen C-Y, Yang C-F, Peng G-S
Neurologist. 2015 Jan; 19(2):46-8. PMID: 25607332. 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
(128)
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 10.5% (Betaferon) 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
(91)
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
(136)
[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
Unlike natalizumab, interferon beta was not observed to decrease the extent and severity of damage to white matter, as shown in a diffusion tensor imaging study
(200)
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
Interferon beta probably does not play a large role in regulating Fcγ receptors on immune cells in RRMS patients
(73)
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
Lack of response to interferon beta-1b treatment for 2 years is not correlated with an increase in serum levels of interleukin 17F (IL-17F), although levels of IL-17F above 200 pg/ml might forecast nonresponsiveness, based on analysis of samples from 239 RRMS patients
(90)
Interleukin 17F Level and Interferon Beta Response in Patients With Multiple Sclerosis.
Hartung H-P, Steinman L, Goodin DS, Comi G, Cook S, Filippi M, O'Connor P, Jeffery DR, Kappos L, Axtell R, et al.
JAMA Neurol. 2013 Jun 3:1-5. PMID: 23732754. Abstract
Interferon beta 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
(94)
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
Interferon beta 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)
(156)
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
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
(129)
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
Resumption of interferon beta 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
(154)
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
Potential interferon beta treatment response genetic markers have been identified in a genome-wide association study involving 151 individuals with MS and validated in an independent group of 479 individuals
(203)
Response to interferon-beta treatment in multiple sclerosis patients: a genome-wide association study.
Mahurkar S, Moldovan M, Suppiah V, Sorosina M, Clarelli F, Liberatore G, Malhotra S, Montalban X, Antigüedad A, Krupa M, et al.
Pharmacogenomics J. 2016 Mar 22. PMID: 27001119. Abstract
Nonresponse to interferon beta therapy is associated with an intronic variant in the gene SLC9A9, which encodes an Na+ -H+ exchanger, as shown in a genome-wide association study and validated in 3 independent cohorts
(174)
A pharmacogenetic study implicates SLC9a9 in multiple sclerosis disease activity.
Esposito F, Sorosina M, Ottoboni L, Lim ET, Replogle JM, Raj T, Brambilla P, Liberatore G, Guaschino C, Romeo M, et al.
Ann Neurol. 2015 Apr 25. PMID: 25914168. Abstract
Animal: 
Interferon beta (used experimentally rather than interferon beta-1b) affects myeloid antigen-presenting cells, which may be responsible for immune modulation mediated by interferon beta, as shown by experiments in mice
(12)
Bench to bedside: tempering antigen-presenting cells in multiple sclerosis.
Prod'homme T, Zamvil SS
Nat Med. 2008 Jun; 14(6):614-5. PMID: 18535577. Abstract
Appears to suppress the Nod-like receptor, pyrin domain-containing 3 inflammasome and thereby ameliorate experimental autoimmune encephalomyelitis in a mouse model
(66)
Interferon-β therapy against EAE is effective only when development of the disease depends on the NLRP3 inflammasome.
Inoue M, Williams KL, Oliver T, Vandenabeele P, Rajan JV, Miao EA, Shinohara ML
Sci Signal. 2012 May 22; 5(225):ra38. PMID: 22623753. Abstract
Supresses Nod-like receptor, pyrin domain-containing 3 inflammasome activity in a mechanism that is mediated by suppressor of cytokine signaling 1, Vav1, Rac1-GTP, and mitochondrial reactive oxygen species generation
(66)
Interferon-β therapy against EAE is effective only when development of the disease depends on the NLRP3 inflammasome.
Inoue M, Williams KL, Oliver T, Vandenabeele P, Rajan JV, Miao EA, Shinohara ML
Sci Signal. 2012 May 22; 5(225):ra38. PMID: 22623753. Abstract
Attenuates experimental autoimmune encephalomyelitis (EAE) pathogenicity, but only in Nod-like receptor, pyrin domain-containing 3 (NLRP3) inflammasome-dependent, and not in NLRP3 inflammasome-independent, EAE
(66)
Interferon-β therapy against EAE is effective only when development of the disease depends on the NLRP3 inflammasome.
Inoue M, Williams KL, Oliver T, Vandenabeele P, Rajan JV, Miao EA, Shinohara ML
Sci Signal. 2012 May 22; 5(225):ra38. PMID: 22623753. Abstract
Combination therapy consisting of murine interferon beta (which is immunomodulatory) and dimethyl fumarate (which is neuroprotective) is more effective in treating experimental autoimmune encephalomyelitis (providing better axon protection) than either therapy alone
(126)
Neuroprotective dimethyl fumarate synergizes with immunomodulatory interferon beta to provide enhanced axon protection in autoimmune neuroinflammation.
Reick C, Ellrichmann G, Thöne J, Scannevin RH, Saft C, Linker RA, Gold R
Exp Neurol. 2014 Apr 13. PMID: 24731948. Abstract
Treatment with a combination of interferon beta-secreting mesenchymal stem cells and minocycline reduces the severity of experimental autoimmune encephalomyelitis, primarily by promoting blood-spinal cord barrier integrity
(137)
Interferon β-secreting mesenchymal stem cells combined with minocycline attenuate experimental autoimmune encephalomyelitis.
Hou Y, Ryu C H, Jun J A, Kim S M, Jeong C H, Jeun S-S
J Neuroimmunol. 2014 Jun 20. PMID: 25005115. Abstract
(Recombinant mouse) interferon beta expands the population of transitional and regulatory B cells, and increases secretion of interleukin-10 in the spleen, in experimental autoimmune encephalomyelitis mice
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
(Recombinant mouse) interferon beta reduces the severity of experimental autoimmune encephalomyelitis in mice
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
(Recombinant mouse) interferon beta increases the production of anti-myelin oligodendrocyte glycoprotein IgG, but not IgM, in experimental autoimmune encephalomyelitis mice; disease severity does not correlate with the increased IgG levels
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
(Recombinant mouse) interferon beta does not provide a clinical or histopathological benefit in experimental autoimmune encephalomyelitis (EAE) mice that are deficient for B cells (muMT mice), although it does in wild-type EAE mice
(162)
IFN-β Treatment Requires B Cells for Efficacy in Neuroautoimmunity.
Schubert RD, Hu Y, Kumar G, Szeto S, Abraham P, Winderl J, Guthridge JM, Pardo G, Dunn J, Steinman L, et al.
J Immunol. 2015 Mar 1; 194(5):2110-2116. Epub 2015 Feb 02. PMID: 25646307. Abstract
Regulatory and Commercial Status
Status for MS: 
Approved in US, EU, and other countries for relapsing forms of MS
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(5)
10 years of interferon beta-1b (Beta feron therapy.
Kappos L, Hartung H-P
J Neurol. 2005 Sep; 252 Suppl 3:iii1-iii2. PMID: 16170493. Abstract
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
(38)
Berlex continues legal challenge to FDA over MS drug.
Glaser V
Nat Biotechnol. 1996 Jul; 14(7):811-2. PMID: 9630997. Abstract
Approved in EU for CIS, RRMS, and SPMS with active disease
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
First disease-modifying therapy approved by the US Food and Drug Administration for use in MS (July, 1993)
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
(38)
Berlex continues legal challenge to FDA over MS drug.
Glaser V
Nat Biotechnol. 1996 Jul; 14(7):811-2. PMID: 9630997. Abstract
Highest status achieved (for any condition): 
Approved
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Other uses: 
Has been tested in pilot studies for use in chronic viral dilated cardiomyopathy
(41)
Interferon beta-1b therapy in chronic viral dilated cardiomyopathy--is there a role for specific therapy?
Zimmermann O, Rodewald C, Radermacher M, Vetter M, Wiehe JM, Bienek-Ziolkowski M, Hombach V, Torzewski J
J Card Fail. 2010 Apr; 16(4):348-56. Epub 2010 Feb 07. PMID: 20350703. Abstract
Has been tested but not found to be effective for use in neuromyelitis optica
(42)
Interferon-beta(1b) treatment in neuromyelitis optica.
Tanaka M, Tanaka K, Komori M
Eur Neurol. 2009; 62(3):167-70. Epub 2009 Jul 07. PMID: 19590215. Abstract
Administration: 
For Betaseron, the recommended dose is 0.25 mg by subcutaneous injection every other day, according to information from the manufacturer
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
For Extavia, the recommended dose is 0.25 mg by subcutaneous injection every other day, according to information from the manufacturer
(40)
Extavia Prescribing Information
Novartis, Aug 2009
Accessed on 28 Mar 2012 from http://www.pharma.us.novartis.com/product/pi/pdf/extavia.pdf.
The Betaconnect autoinjector was associated with a high level of patient satisfaction in an industry-funded study involving 118 individuals with MS
(195)
Patient Satisfaction with the New Interferon Beta-1b Autoinjector (BETACONNECT™).
Ziemssen T, Sylvester L, Rametta M, Ross A P
Neurol Ther. 2015 Dec; 4(2):125-36. Epub 2015 Oct 27. PMID: 26662362. Abstract
Negative effects: 
Anaphylaxis
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Decreased neutrophil count
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Decreased white blood cell count
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Depression
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Elevated liver enzymes
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
One case of severe liver dysfunction has been reported in a patient who received interferon beta-1b and who had taken a melilot (sweet clover) supplement containing coumarin for three years
(50)
Severe liver dysfunction possibly caused by the combination of interferon beta-1b therapy and melilot (sweet clover) supplement.
Tamura S, Warabi Y, Matsubara S
J Clin Pharm Ther. 2012 May 30. PMID: 22642738. Abstract
Flu-like symptoms (which generally decrease after the first year)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Injection site necrosis
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Injection site reactions (such as redness, swelling, pain, and hypersensitivity) (generally decrease after the first year)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Associated with multiple cutaneous necrotic lesions after 3 months of treatment in an individual with RRMS
(172)
Multiple cutaneous necrotic lesions associated with Interferon beta-1b injection for multiple sclerosis treatment: A case report and literature review.
Faghihi G, Basiri A, Pourazizi M, Abtahi-Naeini B, Saffaei A
J Res Pharm Pract. 2015 Apr-Jun; 4(2):99-103. PMID: 25984549. Abstract
Associated with severe septal panniculitis at the injection site in an individual with MS
(160)
Severe septal panniculitis in a multiple sclerosis patient treated with interferon-beta.
Mazzon E, Guarneri C, Giacoppo S, Rifici C, Tchernev G, Polimeni G, Wollina U
Int J Immunopathol Pharmacol. 2014 Oct-Dec; 27(4):669-74. PMID: 25572749. 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
(147)
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
Lymphopenia
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Lymphadenopathy
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
Nephrotic syndrome, with membraneous nephropathy revealed by histology, has occurred in two MS patients after long-term therapy
(74)
Nephrotic syndrome in multiple sclerosis patients who had undergone long-term interferon β-1b therapy.
Ikeda K, Okamoto T, Yamamura T, Ohsawa I, Furutera R, Murata M
Rinsho Shinkeigaku. 2013; 53(1):19-23. PMID: 23328061. Abstract
Nephrotic syndrome (suggestive of lupus nephritis) has been observed in one patient (with no evidence of systemic lupus erythematosus) after long-term treatment, which partially subsided after the patient switched to glatiramer acetate
(78)
Nephrotic Syndrome in a Multiple Sclerosis Patient Receiving Long-term Interferon Beta Therapy.
Wallbach M, Gröne HJ, Kitze B, Müller GA, Koziolek MJ
Am J Kidney Dis. 2013 Jan 31. PMID: 23375818. Abstract
Associated with pulmonary and cutaneous sarcoidosis in one individual with MS
(113)
Cutaneous and pulmonary sarcoidosis following treatment of multiple sclerosis with interferon-beta-1b: a case report.
Sahraian M A, Naser Moghadasi A, Owji M, Maboudi M, Kosari F, McGee JC, Minagar A
J Med Case Rep. 2013 Dec 13; 7(1):270. Epub 2013 Dec 13. PMID: 24330713. Abstract
Seizures
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Interferon beta treatment has been associated with the development of severe systemic side effects in MS patients with rare variants in MEFV (Mediterranean fever gene) in a Belgian population
(75)
Rare MEFV variants are not associated with risk to develop multiple sclerosis and severity of disease.
Pauwels I, Cosemans L, Boonen S, Dubois B, Goris A
Mult Scler. 2013 Jan 16. PMID: 23325590. Abstract
Suicide
(15)
Betaseron (Interferon Beta-1b) for SC Injection
Bayer HealthCare Pharmaceuticals Inc. , May 2010
Accessed on 27 Mar 2012 from http://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf..
Induced Sweet's syndrome in one MS patient
(95)
Interferon beta-1b-induced Sweet's syndrome in a patient with multiple sclerosis.
Kim Y J, Lee H Y, Lee J Y, Yoon T Y
Int J Dermatol. 2013 Jun 20. PMID: 23786157. Abstract
Interferon beta has been associated with thrombotic microangiopathy caused by acquired ADAMTS13 deficiency, which was in turn the result of anti-ADAMTS13 IgG antibodies that developed after interferon beta therapy in one MS patient
(81)
Thrombotic microangiopathy due to acquired ADAMTS13 deficiency in a patient receiving interferon-beta treatment for multiple sclerosis.
Orvain C, Augusto J-F, Besson V, Marc G, Coppo P, Subra J-F, Sayegh J
Int Urol Nephrol. 2013 Feb 24. Epub 2013 Feb 24. PMID: 23435773. Abstract
Association of interferon beta drugs with thrombotic microangiopathy and nephrotic syndrome has led the European Medicines Agency to require stronger label warnings for Betaferon and Extavia (August 2014)
(143)
EU regulator warns on possible MS drugs side effects
Reuters, 20 Aug 2014
Accessed on 25 Aug 2014 from http://www.reuters.com/article/2014/08/20/ms-drugs-sideeffects-idUSL5N0QQ3T620140820.
Warning about a risk of thrombotic microangiopathy has been added to the patient package insert of Betaseron and Extavia by the US Food and Drug Administration (December 2015)
(198)
Drug Safety Labeling Changes
US Food and Drug Administration, 13 Jan 2016
Accessed on 29 Jan 2016 from http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm480758.htm.
Interferon beta has been associated with an increased incidence of thyroid dysfunction and thyroid autoimmunity during the initial year of treatment in an Italian multicenter study
(122)
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
Has been associated with the development of tumefactive brain lesions in neuromyelitis optica
(157)
Interferon-ß-related tumefactive brain lesion in a Caucasian patient with neuromyelitis optica and clinical stabilization with tocilizumab.
Harmel J, Ringelstein M, Ingwersen J, Mathys C, Goebels N, Hartung H-P, Jarius S, Aktas O
BMC Neurol. 2014 Dec 17; 14(1):247. Epub 2014 Dec 17. PMID: 25516429. Abstract
Associated with livedo reticularis and secondary Raynaud phenomenon in one individual with MS, which, along with complications seen in other individuals, suggest that the drug can have vasoconstrictive and procoagulant effects
(115)
Interferons beta have vasoconstrictive and procoagulant effects: A woman who developed livedo reticularis and Raynaud phenomenon in association with interferon beta treatment for multiple sclerosis.
Rot U, Ledinek A H
Clin Neurol Neurosurg. 2013 Dec; 115 Suppl 1:S79-81. PMID: 24321162. Abstract
Exposure to interferon beta during pregnancy does not seem to be a major teratogenic risk, based on an analysis of 78 pregnancies
(65)
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
Not associated with increased rates of pregnancy-related adverse events or birth defects in a prospective observational study involving a registry of 99 pregnant women with MS
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Exposure to Betaferon/Betaseron during pregnancy is not associated with an increased rate of birth defects or spontaneous abortion, according to data on 423 prospective pregnancies (pregnant at time of reporting) with known outcomes in a pharmacovigilance database
(144)
Pregnancy outcomes in patients exposed to interferon beta-1b.
Romero RS, Lünzmann C, Bugge J-P
J Neurol Neurosurg Psychiatry. 2014 Sep 2. PMID: 25185209. 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 37 cases of exposure to interferon beta
(125)
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 39 pregnancies fathered by men with MS exposed to interferon beta at time of conception as compared with 33 pregnancies fathered by men with MS without disease-modifying therapy exposure at that time
(134)
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
Does not cause teratogenic effects at the macroscopic level in cultured rat embryos, but does retard embryonic growth
(196)
The potential teratogenic effects of interferon beta-1a (IFNβ-1a) and interferon beta-1b (IFNβ-1b) on in vitro embryonic development.
Uçar İ, Ertekin T, Nisari M, Ceylan D, Al Ö, Ülger H
Folia Morphol (Warsz). 2015 Dec 29. PMID: 26711647. Abstract
Interferon beta did not reduce the efficacy of vaccination against pandemic H1N1 (swine flu, in 2009) or seasonal influenza (in 2010)
(116)
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
Interferon beta was not found to be associated with an increased risk of cancer (overall or specifically breast, colorectal, lung, or prostate) over 12 years in a case-control study involving 5146 individuals with RRMS, but a non-significant trend toward an association with breast cancer was detected
(151)
Assessment of cancer risk with β-interferon treatment for multiple sclerosis.
Kingwell E, Evans C, Zhu F, Oger J, Hashimoto S, Tremlett H
J Neurol Neurosurg Psychiatry. 2014 Mar 4. PMID: 24594506. Abstract
Commercial: 
Betaferon/Betaseron was developed by Schering AG (which operated as Berlex Laboratory in North America), a company that was taken over by Bayer HealthCare
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
Betaferon/Betaseron is marketed by Bayer HealthCare
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
Novartis introduced Extavia in 2009; Extavia is manufactured by Bayer HealthCare and distributed by Novartis
(39)
Interferon beta-1b
PrescriptionDrug-Info.com, 26 Jan 2012
Accessed on 28 Mar 2012 from http://www.prescriptiondrug-info.com/drug_details.asp?title=Extavia&page=1008148&ad=true.
(40)
Extavia Prescribing Information
Novartis, Aug 2009
Accessed on 28 Mar 2012 from http://www.pharma.us.novartis.com/product/pi/pdf/extavia.pdf.
Zist Daru Danesh Ltd (Iran) began producing ZIFERON in 2010
(36)
Zist Daru, ZIFERON
Zist Daru, 2010
Accessed on 28 Mar 2012 from http://www.zistdaru.ir/01.html..
(37)
Iran mass produces MS drug Ziferon
PRESSTV, 18 Sep 2010
Accessed on 28 Mar 2012 from http://www.presstv.ir/detail/143010.html.
Mountain View Pharmaceuticals received a European patent for polyethylene glycol conjugates of interferon beta-1b with enhanced biological potency (press release, June 2012)
(51)
Mountain View Pharmaceuticals receives European patent on potential long-acting drug for multiple sclerosis
Mountain View Pharmaceuticals, 11 Jun 2012
Accessed on 12 Jun 2012 from http://www.mvpharm.com/Documents/MVP%20Receives%20European%20Patent%20on%20Long-Acting%20MS%20Drug%20June%2011,%202012.pdf.
Filing of a supplemental Biologics License Application by Bayer for Betaconnect, a new means of delivering Betaseron, has been accepted by the US Food and Drug Administration (22 April 2015)
(169)
FDA Accepts Filing of BETACONNECT™* for Relapsing-Remitting Multiple Sclerosis Patients Taking BETASERON® (interferon beta-1b)
PR Newswire, 22 Apr 2015
Accessed on 28 Apr 2015 from http://www.prnewswire.com/news-releases/fda-accepts-filing-of-betaconnect-for-relapsing-remitting-multiple-sclerosis-patients-taking-betaseron-interferon-beta-1b-300070199.html.
Betaconnect, the first electronic autoinjector for use in treating RRMS, has been approved by the US Food and Drug Administration; this device is used for delivering Betaseron (September 25, 2015)
(187)
Bayer Receives FDA Approval for BETACONNECT - First and Only Electronic Autoinjector in Relapsing-Remitting Multiple Sclerosis (RRMS) Treatment
PR Newswire, 25 Sep 2015
Accessed on 29 Sep 2015 from http://www.prnewswire.com/news-releases/bayer-receives-fda-approval-for-betaconnect---first-and-only-electronic-autoinjector-in-relapsing-remitting-multiple-sclerosis-rrms-treatment-300149438.html.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) (publ 2006, 2014, 2015)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(118)
Vitamin D as an Early Predictor of Multiple Sclerosis Activity and Progression.
Ascherio A, Munger KL, White R, Köchert K, Simon K C, Polman CH, Freedman MS, Hartung H-P, Miller DH, Montalbán X, et al.
JAMA Neurol. 2014 Jan 20. PMID: 24445558. Abstract
(189)
No association of multiple sclerosis activity and progression with EBV or tobacco use in BENEFIT.
Munger KL, Fitzgerald KC, Freedman MS, Hartung H-P, Miller DH, Montalbán X, Edan G, Barkhof F, Suarez G, Radue E-W, et al.
Neurology. 2015 Oct 9. PMID: 26453645. Abstract
Phase: 
Phase III trial
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
Study Design: 
Multicenter, randomized, double-blind, placebo-controlled trial to determine the effects of interferon beta-1b (250 microg, given subcutaneously every other day) on delaying conversion to clinically definite MS
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
Disease Stage: 
CIS
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
Enrollment/Number of Patients: 
468
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
Duration: 
2 years, or until MS was diagnosed
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
Status/Outcome: 
Interferon beta-1b reduced the risk of conversion to clinically definite MS (from 45% in the placebo group to 28% in the interferon beta-1b group)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
; low levels of a marker of vitamin D status in the first 12 months of the study were found to be a strong risk factor for increased MS disease activity and faster progression over 5 years among individuals primarily treated with interferon beta-1b
(118)
Vitamin D as an Early Predictor of Multiple Sclerosis Activity and Progression.
Ascherio A, Munger KL, White R, Köchert K, Simon K C, Polman CH, Freedman MS, Hartung H-P, Miller DH, Montalbán X, et al.
JAMA Neurol. 2014 Jan 20. PMID: 24445558. Abstract
; among participants, neither higher Epstein-Barr virus antibody levels nor higher cotinine levels (an indicator of tobacco use) correlated with a higher risk of conversion to MS, and over a 5-year followup, were not correlated with MS progression or activity
(189)
No association of multiple sclerosis activity and progression with EBV or tobacco use in BENEFIT.
Munger KL, Fitzgerald KC, Freedman MS, Hartung H-P, Miller DH, Montalbán X, Edan G, Barkhof F, Suarez G, Radue E-W, et al.
Neurology. 2015 Oct 9. PMID: 26453645. Abstract
Trial name: 
Barkhof et al., Arch. Neurol., September 2007 trial
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Phase: 
Phase III trial
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Study Design: 
Industry-sponsored, double-blind, placebo-controlled, randomized, parallel-group, multicenter study to examine detailed MRI findings from participants in the BENEFIT trial, in which patients received interferon beta-1b (250 microg, given subcutaneously every other day) or placebo
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Disease Stage: 
CIS
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Enrollment/Number of Patients: 
404
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Duration: 
2 years, or until MS was diagnosed
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Status/Outcome: 
Drug was associated with a 60% relative reduction in the median cumulative number of newly active lesions (2 versus 5), with lower cumulative numbers of new T2 lesions (1 versus 3) and new gadolinium-enhancing lesions (0 versus 1)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(16)
Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results.
Barkhof F, Polman CH, Radue E-W, Kappos L, Freedman MS, Edan G, Hartung H-P, Miller DH, Montalbán X, Poppe P, et al.
Arch Neurol. 2007 Sep; 64(9):1292-8. PMID: 17846268. Abstract
Trial name: 
Panitch et al., Neurology, November 2004 (North American SPMS) trial
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Phase: 
Phase III trial
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Study Design: 
Multicenter, double-blind, placebo-controlled, randomized trial to test the effects of interferon beta-1b (250 microg or 160 microg per m2 of body surface area, given subcutaneously every other day) on time to progression [at least 1.0 point increase on the Expanded Disability Status Scale (EDSS), or 0.5 point increase if the baseline was 6.0 or 6.5] (primary outcome) and on mean change in EDSS score, measures related to relapse, MRI activity, and results of a neuropsychological test (secondary outcomes)
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Disease Stage: 
SPMS
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Enrollment/Number of Patients: 
939
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Duration: 
3 years
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
Status/Outcome: 
Drug (at either dose) was not associated with a significant change in the time to confirmed progression of EDSS scores, but both doses were associated with benefits to relapse- and MRI-related measures
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
; retrospective combined analyses of the results of the European SPMS trial (1998) and the North American SPMS trial (2004) to determine reasons for the discrepancy in outcomes determined that the the European SPMS trial included patients with an earlier stage of SPMS and with more active disease, which might be relevant to the different results of the two studies
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
(25)
Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials.
Kappos L, Weinshenker B, Pozzilli C, Thompson AJ, Dahlke F, Beckmann K, Polman C, McFarland H, European(EU-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent Advis, North American(NA-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent
Neurology. 2004 Nov 23; 63(10):1779-87. PMID: 15557490. Abstract
Trial name: 
European Study Group, Lancet, November 1998 (European SPMS) trial
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Phase: 
Phase III trial
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Study Design: 
Multicenter, double-masked, randomized, placebo-controlled trial to test the effects of interferon beta-1b [8 million IU (250 microg), given subcutaneously every other day] on the time to confirmed progression of disability [1.0 point increase on the Expanded Disability Status Scale (EDSS), or a 0.5 point increase if the baseline was 6.0 or 6.5]
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Disease Stage: 
SPMS
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Enrollment/Number of Patients: 
718, with 661 undergoing followup
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Duration: 
2 to 3 years
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
Status/Outcome: 
Drug was associated with a reduced time to confirmed progression of disability, such that disability was delayed by 9 to 12 months during the study period of 2 to 3 years
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
; retrospective combined analyses of the results of the European SPMS trial (1998) and the North American SPMS trial (2004) to determine reasons for the discrepancy in outcomes determined that the the European SPMS trial included patients with an earlier stage of SPMS and with more active disease, which might be relevant to the different results of the two studies
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
(14)
Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study.
Panitch H, Miller A, Paty D, Weinshenker B, North American Study Group on Interferon beta-1b in Secondary Progressive MS
Neurology. 2004 Nov 23; 63(10):1788-95. PMID: 15557491. Abstract
(25)
Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials.
Kappos L, Weinshenker B, Pozzilli C, Thompson AJ, Dahlke F, Beckmann K, Polman C, McFarland H, European(EU-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent Advis, North American(NA-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent
Neurology. 2004 Nov 23; 63(10):1779-87. PMID: 15557490. Abstract
Trial name: 
The IFNB Multiple Sclerosis Study Group, Neurology, April 1993 trial
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Phase: 
Phase II trial
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Study Design: 
Multicenter, randomized, double-blind, placebo-controlled trial to test the effects of interferon beta-1b (50 microg or 250 microg, administered subcutaneously every other day) on the annual exacerbation rate and on the proportion of exacerbation-free patients (primary endpoints)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Disease Stage: 
RRMS
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Enrollment/Number of Patients: 
372, with efficacy analysis based on data from 338
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Duration: 
2 years
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
Status/Outcome: 
250 microg interferon beta-1b was associated with a lower annual exacerbation rate (0.84) than was 50 microg interferon beta-1b (1.17) or placebo (1.27); a larger fraction of patients in the 250 microg group (31%) were exacerbation free at 2 years as compared to those in the 50 microg group (21%) or placebo group (16%); the 250 microg dose significantly reduced the median time to first relapse; the 250 microg dose also reduced the number of new lesions per year and MRI-detected burden of disease (in a cohort of 52 patients undergoing frequent MRIs)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(26)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group.
Paty DW, Li DK
Neurology. 1993 Apr; 43(4):662-7. PMID: 8469319. Abstract
Trial name: 
The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group, Neurology, July 1995 trial (extension of IFNB 1993 trial)
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Phase: 
Phase II trial
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Study Design: 
Double-blind extension of a multicenter, randomized, double-blind, placebo-controlled trial to test the effects of interferon beta-1b (50 microg or 250 microg, administered subcutaneously every other day) on the exacerbation rate and the MRI burden of disease
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Disease Stage: 
RRMS
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Enrollment/Number of Patients: 
372 in original study, with 218 completing this study
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Duration: 
5 years
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Status/Outcome: 
250 microg interferon beta-1b caused a one-third reduction in the annual exacerbation rate compared to placebo in each of 5 years, but the difference was not statistically significant after the second year
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Trial name: 
Knobler et al., J. Interferon Res., October 1993 study
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Phase: 
Pilot study
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Study Design: 
Placebo-controlled pilot study to test the safety and determine the side effects of recombinant human interferon beta-1b, in which patients were treated with interferon beta-1b [0.8, 4, 8, or 16 million units (mU), given subcutaneously 3 times per week] or placebo
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Disease Stage: 
RRMS
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Enrollment/Number of Patients: 
30 enrolled; 15 patients remained in the study for over 6 years
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Duration: 
6 years
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Status/Outcome: 
Dose-related trend in reduction of the exacerbation frequency was seen and the 8 mU dose was selected for further study at 24 weeks (such that 15 patients received the 8 mU dose for over 6 years); side effects decreased over time
(34)
Systemic recombinant human interferon-beta treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up.
Knobler RL, Greenstein JI, Johnson KP, Lublin FD, Panitch HS, Conway K, Grant-Gorsen SV, Muldoon J, Marcus SG, Wallenberg JC
J Interferon Res. 1993 Oct; 13(5):333-40. PMID: 8301153. Abstract
Head-to-Head Trials: 
Trial name: 
Zecca et al., BMC Neurol., February 2014 study
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Phase: 
Post-marketing study
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Study Design: 
Prospective, randomized, rater-blinded, parallel-group study to examine treatment satisfaction in individuals who had been treated with intravenous natalizumab (300 mg monthly) for at least 12 months (and had increased risk or fear of progressive multifocal leukoencephalopathy), who were then randomly assigned to either subcutaneous interferon beta-1b (250 microg every other day) or continued natalizumab treatment
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Disease Stage: 
RRMS
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Enrollment/Number of Patients: 
19, with 17 completing the study
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Duration: 
1 year
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Status/Outcome: 
Switching from natalizumab to interferon beta-1b was well accepted and tolerated by most individuals, and was associated with stable cognitive and fatigue measures
(124)
Treatment satisfaction, adherence and behavioral assessment in patients de - escalating from natalizumab to interferon beta.
Zecca C, Riccitelli GC, Calabrese P, Pravatà E, Candrian U, Guttmann CRG, Gobbi C
BMC Neurol. 2014; 14(1):38. Epub 2014 Feb 28. PMID: 24576156. Abstract
Trial name: 
BEtaseron vs COpaxone in Multiple Sclerosis with Triple-Dose Gadolinium and 3-Tesla MRI Endpoints (BECOME) (publ 2009)
(22)
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 trial
(23)
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
(22)
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
(22)
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
(22)
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
(22)
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 or glatiramer acetate showed similar numbers of combined active lesions per patient for first year (primary outcome) and similar numbers of relapses for 2 years
(22)
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: 
Betaferon Efficiency Yielding Outcomes of a New Dose (BEYOND) (publ 2009, 2014, 2015)
(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
(117)
Effects of Inhibitors of the Renin-Angiotensin System on the Efficacy of Interferon beta-1b: A post hoc Analysis of the BEYOND Study.
Doerner M, Beckmann K, Knappertz V, Kappos L, Hartung HP, Filippi M, O'Connor PW, Arnason B, Cook S, Jeffery D, et al.
Eur Neurol. 2014 Jan 21; 71(3-4):173-179. Epub 2014 Jan 21. PMID: 24457374. Abstract
(123)
Efficacy and safety of interferon beta-1b sc in older RRMS patients--a posthoc analysis of the BEYOND study.
Lampl C, Nagl S, Arnason B, Comi G, O Connor P, Cook S, Jeffery D, Kappos L, Filippi M, Beckmann K, et al.
J Neurol. 2013 Jul; 260(7):1838-45. Epub 2013 Mar 17. PMID: 23504050. Abstract
(180)
Predictors of disease activity in 857 patients with MS treated with interferon beta-1b.
Hartung H-P, Kappos L, Goodin DS, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Petkau J, et al.
J Neurol. 2015 Aug 5. Epub 2015 Aug 05. PMID: 26239222. Abstract
(188)
Association of Vitamin D Levels With Multiple Sclerosis Activity and Progression in Patients Receiving Interferon Beta-1b.
Fitzgerald KC, Munger KL, Köchert K, Arnason BGW, Comi G, Cook S, Goodin DS, Filippi M, Hartung H-P, Jeffery DR, et al.
JAMA Neurol. 2015 Oct 12:1-8. PMID: 26458124. Abstract
Phase: 
Phase III trial
(24)
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, randomized, 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
; posthoc analysis showed that individuals who were concomitantly treated with interferon beta-1b and angiotensin receptor blockers (n=22) or angiotensin-converting enzyme inhibitors (n=49) tended to have a higher relapse rate than those treated with interferon beta-1b alone
(117)
Effects of Inhibitors of the Renin-Angiotensin System on the Efficacy of Interferon beta-1b: A post hoc Analysis of the BEYOND Study.
Doerner M, Beckmann K, Knappertz V, Kappos L, Hartung HP, Filippi M, O'Connor PW, Arnason B, Cook S, Jeffery D, et al.
Eur Neurol. 2014 Jan 21; 71(3-4):173-179. Epub 2014 Jan 21. PMID: 24457374. Abstract
; further posthoc analysis of the 250 microg group showed that interferon beta-1b was as effective and safe in older (≥50 years) participants as it was in younger (<50 years) participants
(123)
Efficacy and safety of interferon beta-1b sc in older RRMS patients--a posthoc analysis of the BEYOND study.
Lampl C, Nagl S, Arnason B, Comi G, O Connor P, Cook S, Jeffery D, Kappos L, Filippi M, Beckmann K, et al.
J Neurol. 2013 Jul; 260(7):1838-45. Epub 2013 Mar 17. PMID: 23504050. Abstract
; a higher number of relapses in year 1, as well as a higher number in the previous 2 years and ≥3 new brain lesions in year 1, are predictors of future relapses, whereas age, the presence of neutralizing antibodies, and MRI activity during year 1 are predictive of MRI activity in the future, as shown by regression analysis of 857 individuals (for clinical outcomes) and 765 individuals (for MRI outcomes) from this trial who were treated with the 250 microg interferon beta-1b dose
(180)
Predictors of disease activity in 857 patients with MS treated with interferon beta-1b.
Hartung H-P, Kappos L, Goodin DS, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Petkau J, et al.
J Neurol. 2015 Aug 5. Epub 2015 Aug 05. PMID: 26239222. Abstract
; among 1482 participants receiving interferon beta-1b treatment, higher levels of serum 25-hydroxyvitamin D (measured at baseline, 6 months, and 12 months) were associated with a lower cumulative number of new active lesions observed between baseline and the last MRI, but serum 25-hydroxyvitamin D levels were not significantly associated with clinical disease progression or brain atrophy
(188)
Association of Vitamin D Levels With Multiple Sclerosis Activity and Progression in Patients Receiving Interferon Beta-1b.
Fitzgerald KC, Munger KL, Köchert K, Arnason BGW, Comi G, Cook S, Goodin DS, Filippi M, Hartung H-P, Jeffery DR, et al.
JAMA Neurol. 2015 Oct 12:1-8. PMID: 26458124. Abstract
Trial name: 
Etemadifar et al., Acta Neurol. Scand., May 2006 trial
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Phase: 
Phase IV/Postmarketing trial
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Study Design: 
Randomized, single-blind trial to compare the effects of interferon beta-1b (subcutaneous injection), interferon beta-1a (intramuscular injection), and interferon beta-1a (subcutaneous injection)
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Disease Stage: 
RRMS
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Enrollment/Number of Patients: 
90
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Duration: 
2 years
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Status/Outcome: 
In the interferon beta-1b group, 43.3% of the patients remained relapse-free, as compared to 56.7% in the interferon beta-1a (subcutaneous) and 20% in the interferon beta-1a (intramuscular) groups; the Expanded Disability Status Scale score decreased in the interferon beta-1b and interferon beta-1a (subcutaneous) groups, but remained stable in the interferon beta-1a (intramuscular) group
(33)
Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing-remitting multiple sclerosis.
Etemadifar M, Janghorbani M, Shaygannejad V
Acta Neurol Scand. 2006 May; 113(5):283-7. PMID: 16629762. Abstract
Trial name: 
Koch-Henriksen et al., Neurology, April 2006 trial
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Phase: 
Phase IV/Postmarketing trial
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Study Design: 
Multicenter, controlled, open-label, randomized, head-to-head trial to compare the effects of interferon beta-1a (22 microg administered subcutaneously once a week) versus interferon beta-1b (250 microg administered subcutaneously every other day) on the annualized relapse rate and the time to first relapse (primary endpoints) and the time to sustained progression (secondary endpoint)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Disease Stage: 
RRMS
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Enrollment/Number of Patients: 
301
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Duration: 
2 years
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Status/Outcome: 
Both drug regimes were associated with virtually equal annual relapse rates (0.70 for interferon beta-1a; 0.71 for interferon beta-1b), times to first relapse, and time to sustained progression
(10)
A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis.
Koch-Henriksen N, Sørensen PS, Christensen T, Frederiksen J, Ravnborg M, Jensen K, Heltberg A, Kristensen O, Stenager E, Petersen T, et al.
Neurology. 2006 Apr 11; 66(7):1056-60. Epub 2006 Mar 01. PMID: 16510769. Abstract
Trial name: 
INdependent COMparison of INterferon (INCOMIN) (publ 2002)
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Phase: 
Phase IV/Postmarketing trial
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Study Design: 
Prospective, randomized, open-label multicenter study to compare the effects of two different interferon beta preparations and dosing schedules [interferon beta-1a (30 microg administered intramuscularly once a week) versus interferon beta-1b (250 microg administered subcutaneously on alternate days)] on the proportion of patients free from relapses and free from new T2 lesions (primary outcome measures)
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
(30)
Interferon-beta1b for the treatment of multiple sclerosis.
Lam S, Wang S, Gottesman M
Expert Opin Drug Metab Toxicol. 2008 Aug; 4(8):1111-7. PMID: 18680445. Abstract
Disease Stage: 
RRMS
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Enrollment/Number of Patients: 
188
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Duration: 
2 years
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Status/Outcome: 
The interferon beta-1b regime was more effective than the interferon beta-1a regime; the proportion of patients who remained relapse free over 2 years was 51% for interferon beta-1b versus 36% for interferon beta-1a and the proportion of patients who remained free from new T2 lesions was 55% for interferon beta-1b versus 26% for interferon beta-1a
(9)
Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN).
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, Montanari E, Zaffaroni M, Independent Comparison of Interferon(INCOMIN) Trial Study Group
Lancet. 2002 Apr 27; 359(9316):1453-60. PMID: 11988242. Abstract
Other Trials: 
Trial name: 
Signori et al., Mult. Scler. Relat. Disord., March 2016 study
(202)
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
(202)
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
(202)
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
(202)
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
(202)
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
(202)
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
(202)
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
(201)
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
(201)
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
(201)
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
(201)
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
(201)
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
(201)
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
(201)
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: 
Vidal-Jordana et al., J. Neuroimaging, March 2016 study
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Phase: 
Observational/open-label study
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Study Design: 
Prospective, observational study to examine changes in brain volume during the first year of interferon beta therapy, with MRI scans at baseline (3 months before) and 12 months after therapy began
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Disease Stage: 
MS
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Enrollment/Number of Patients: 
123 enrolled; results from 84 analyzed
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Duration: 
1 year
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Status/Outcome: 
Brain volume measurements appear to be affected by inflammatory activity, such that a higher number of gadolinium-enhancing lesions at baseline was associated with greater reductions in brain volume and white matter volume (but not grey matter volume) over the first year of treatment
(199)
Brain Volume Loss during the First Year of Interferon-Beta Treatment: Baseline Inflammation and Tissue-Specific Volume Dynamics.
Vidal-Jordana A, Sastre-Garriga J, Pérez-Miralles F, Pareto D, Rio J, Auger C, Tintoré M, Rovira A, Montalban X
J Neuroimaging. 2016 Mar 2. PMID: 26935253. Abstract
Trial name: 
Spelman et al., Eur. J. Neurol., January 2016 study
(197)
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
(197)
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
(197)
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
(197)
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)
(197)
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
(197)
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
(197)
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: 
Rotstein et al., Neurol. Neuroimmunol. Neuroinflamm., October 2015 study
(193)
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
(193)
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
(193)
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
(193)
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
(193)
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
(193)
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
(193)
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: 
Tramacere et al., Cochrane Database Syst. Rev., September 2015 study
(186)
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
(186)
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
(186)
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
(186)
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
(186)
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
(186)
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
(186)
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: 
Kuhle et al., Mult. Scler., September 2015 study
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Phase: 
Long-term followup of the European SPMS Phase III trial
(13)
Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS.
Lancet. 1998 Nov 7; 352(9139):1491-7. PMID: 9820296. Abstract
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Study Design: 
Study to examine the long-term effects of interferon beta-1b treatment
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Disease Stage: 
SPMS
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Enrollment/Number of Patients: 
362
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Duration: 
10 years
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Status/Outcome: 
The Expanded Disability Status Scale (EDSS) score at baseline and the change in this score during the randomized controlled trial were the best means of predicting the EDSS score after 10 years; interferon beta-1b treatment during the controlled trial was not convincingly associated with a favorable long-term outcome
(185)
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.
Kuhle J, Hardmeier M, Disanto G, Gugleta K, Ecsedi M, Lienert C, Amato MP, Baum K, Buttmann M, Bayas A, et al.
Mult Scler. 2015 Sep 11. PMID: 26362898. Abstract
Trial name: 
Iaffaldano et al., Brain, September 2015 study
(184)
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
(184)
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
(184)
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
(184)
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
(184)
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
(184)
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
(184)
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: 
Lus et al., Eur. J. Neurol., July 2015 study
(179)
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
(179)
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
(179)
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
(179)
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
(179)
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
(179)
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
(179)
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
(177)
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
(177)
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
(177)
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
(177)
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
(177)
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
(177)
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)
(177)
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
(175)
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
(175)
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
(175)
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
(175)
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
(175)
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
(175)
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)
(175)
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: 
Piñol, Neurologia, May 2015 study
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Phase: 
Cost-effectiveness analysis
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Study Design: 
Analysis to estimate the cost-effectiveness of early versus delayed treatment with interferon beta-1b in Spain, using data from the BENEFIT trial (in which individuals with CIS received interferon beta-1b or placebo for 2 years, followed by interferon beta-1b for all participants)
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
, a Markov model to consider the social perspective, and cost estimates from the literature
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Disease Stage: 
CIS
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Enrollment/Number of Patients: 
1000
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Duration: 
2 years to lifetime (range of time horizons in the Markov model)
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Status/Outcome: 
Early versus delayed interferon beta-1b treatment after CIS was found to be more effective and less costly based on a social perspective, but not necessarily based on the perspective of the Spanish Health System, for which non health-related costs are not a factor
(173)
Cost-effectiveness analysis of interferon beta-1b as treatment for patients with clinically isolated syndrome suggestive of multiple sclerosis in Spain.
Piñol C
Neurologia. 2015 May 11. PMID: 25976942. Abstract
Trial name: 
Spelman et al., Ann. Clin. Transl. Neurol., April 2015 study
(170)
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
(170)
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
(170)
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
(170)
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
(170)
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
(170)
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
(170)
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: 
Zhornitsky et al., PLoS One, April 2015 study
(168)
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
(168)
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)
(168)
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
(168)
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%
(168)
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
(168)
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)
(168)
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: 
He et al., JAMA Neurol., February 2015 study
(163)
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
(163)
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
(163)
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
(163)
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)
(163)
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)
(163)
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
(163)
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: 
Cohen et al., Mult. Scler. Relat. Disord., January 2015 study [Therapy Optimization in MS (TOP MS)]
(165)
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
(165)
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
(165)
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
(165)
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
(165)
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
(165)
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)
(165)
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: 
Kalincik et al., Mult. Scler., December 2014 study
(155)
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
(155)
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
(155)
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
(155)
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
(155)
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
(155)
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
(155)
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: 
Rossi et al., CNS Neurosci. Ther., August 2014 study
(166)
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
(166)
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
(166)
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
(166)
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
(166)
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
(166)
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)
(166)
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
(139)
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
(158)
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
(139)
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
(139)
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
(139)
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)
(139)
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)
(139)
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
(139)
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: 
Bergvall et al., J. Med. Econ., July 2014 study
(138)
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
(138)
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
(138)
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
(138)
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)]
(138)
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
(138)
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
(138)
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: 
Coyle et al., BMJ Open., May 2104 study
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Phase: 
Observational/open-label study
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Study Design: 
Prospective, observational study that monitored women exposed to interferon beta-1b during pregnancy to determine rates of negative outcomes; women were enrolled in an observational registry between 2006 and 2011
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Disease Stage: 
MS
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Enrollment/Number of Patients: 
99, with 3 lost to followup
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Duration: 
Before conception or during pregnancy through 4 months after birth
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Status/Outcome: 
Drug was not associated with significant changes in rates of birth defects or spontaneous abortions relative to rates in population comparators
(132)
Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM, Albano JD, Rametta MJ
BMJ Open. 2014; 4(5):e004536. PMID: 24821713. Abstract
Trial name: 
Mokhber et al., J. Neurol. Sci., February 2014 study
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Phase: 
Observational/open-label study
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Study Design: 
Three-arm, randomized, parallel study to compare the effects of different interferon beta preparations [Avonex and Rebif (interferon beta-1a) and Betaferon (interferon beta-1b)] on cognitive function, which was assessed at baseline and after 12 months of treatment using the Brief Repeatable Battery of Neuropsychological Tests
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Disease Stage: 
Newly diagnosed MS
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Enrollment/Number of Patients: 
90
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Duration: 
12 months
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Status/Outcome: 
Interferon beta-1a preparations were associated with greater improvement in cognitive function than was interferon beta-1b
(133)
Cognitive dysfunction in patients with multiple sclerosis treated with different types of interferon beta: A randomized clinical trial.
Mokhber N, Azarpazhooh A, Orouji E, Rao SM, Khorram B, Sahraian M A, Foroghipoor M, Gharavi M M, Kakhi S, Nikkhah K, et al.
J Neurol Sci. 2014 Feb 4. PMID: 24841321. Abstract
Trial name: 
Bergvall et al., PLoS One, February 2014 study
(121)
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
(121)
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
(121)
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
(121)
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)
(121)
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
(121)
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
(121)
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
(145)
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
(146)
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.
(167)
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
(145)
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
(146)
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.
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
(145)
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
(146)
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.
(167)
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
(145)
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
(146)
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)
(146)
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)
(146)
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.
(167)
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
(167)
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
(146)
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.
(167)
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: 
Prosperini et al., Eur. Neurol., January 2014 study
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Phase: 
Observational/open-label study
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Study Design: 
Observational study to examine whether a reduction in the recommended frequency of administration of subcutaneous interferon beta-1a or -1b, or a change to once-weekly intramuscular interferon beta-1a, affects clinical and MRI outcomes in individuals who had been treated with the recommended frequency of subcutaneous interferon beta for 24 months
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Disease Stage: 
MS
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Enrollment/Number of Patients: 
308 (recommended frequency group, 201; reduced frequency group, 70; change to intramuscular interferon beta-1a, 37)
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Duration: 
24 months after switch
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Status/Outcome: 
Reducing the frequency of subcutaneous interferon beta was associated with increased relapse risk and MRI activity, whereas changing to intramuscular interferon beta-1a was associated with increased relapse risk but not MRI activity; younger age was a risk factor for the restart of disease activity after the reduction in administration frequency
(159)
From High- to Low-Frequency Administered Interferon-Beta for Multiple Sclerosis: A Multicenter Study.
Prosperini L, Mancinelli C R, Pozzilli C, Grasso M G, Clemenzi A, Collorone S, Pontecorvo S, Francia A, Villani V, Koudriavtseva T, et al.
Eur Neurol. 2014 Jan 25; 71(5-6):135-143. Epub 2014 Jan 25. PMID: 24480868. Abstract
Trial name: 
Fox et al., Int. J. MS Care, Winter 2013 study
(119)
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
(119)
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
(119)
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
(119)
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)
(119)
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
(119)
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
(119)
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: 
Walker et al., Curr. Med. Res. Opin., December 2013 study
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Phase: 
Benefit-risk analysis
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Study Design: 
Study to evaluate the net risks and benefits of natalizumab versus fingolimod, interferon beta, or no treatment over sub-groups with different progressive multifocal leukoencephalopathy (PML) risk; a Markov cohort model was designed to examine the effects of treatment on quality-adjusted life years
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Disease Stage: 
RRMS
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Enrollment/Number of Patients: 
N/A
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Duration: 
2 year and 20 year timeframes were examined
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Status/Outcome: 
Natalizumab was associated with more quality-adjusted life years than fingolimod, interferon beta, or no treatment over both short- and long-term timeframes and across PML risk subgroups
(112)
A benefit-risk analysis of natalizumab in the treatment of patients with multiple sclerosis when considering the risk of progressive multifocal leukoencephalopathy.
Walker A, Watson C, Alexopoulos ST, Deniz B, Arnold R, Bates D
Curr Med Res Opin. 2013 Dec 5. PMID: 24289170. Abstract
Trial name: 
Kirzinger et al., Int. J. MS Care, Fall 2013 study
(120)
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
(120)
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
(120)
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
(120)
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
(120)
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
(120)
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
(120)
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: 
Boeru et al., Med. Devices (Auckl.), November 2013 study
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Phase: 
Observational/open-label study
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Study Design: 
Industry-sponsored, prospective, observational, noninterventional, multinational, real-world study to examine ease of use of the ExtaviJect® 30G device, an autoinjector for self-administration of subcutaneous interferon beta-1b (Extavia), as well as compliance with treatment while using this device
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Disease Stage: 
MS
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Enrollment/Number of Patients: 
582 enrolled, with 542 attending the follow-up visit at 12 weeks
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Duration: 
12 weeks
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Status/Outcome: 
Device was associated with a high level of compliance with treatment (97% over the course of the whole study), with a majority of patients and nurses agreeing that the device was easy and quick to use
(111)
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study.
Boeru G, Milanov I, De Robertis F, Kozubski W, Lang M, Rojas-Farreras S, Tomlinson M
Med Devices (Auckl). 2013; 6:175-184. Epub 2013 Nov 15. PMID: 24255602. Abstract
Trial name: 
Edan et al., J. Neurol. Neurosurg. Psychiatry, November 2013 study (observational extension of the BENEFIT trial)
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
(150)
Long-Term Results Underscore Value of Early MS Treatment
Melville NA, Medscape, 3 Nov 2014
Accessed on 4 Nov 2014 from http://www.medscape.com/viewarticle/834278.
(152)
Evidence for the efficacy of interferon beta-1b in delaying the onset of clinically definite multiple sclerosis in individuals with clinically isolated syndrome.
Freedman MS
Ther Adv Neurol Disord. 2014 Nov; 7(6):279-88. PMID: 25371710. Abstract
(171)
Long-term Impact of Early MS Treatment with Interferon Beta-1b (IFNB-1b): Clinical, MRI, Employment, and Patient-Reported Outcomes (PROs) at the 11-Year Follow-up of BENEFIT (BENEFIT 11)
Edan G, Freedman M, Montalban X, Miller D, Hartung H, Hemmer B, Fox E, Barkhof F, Schippling S, Schulze A, et al., Neurology 2015 Apr; 84(14) Supplement P7.012
Accessed on 19 May 2015 from http://www.neurology.org/content/84/14_Supplement/P7.012.short?rss=1.
Phase: 
Phase III trial extension
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
Study Design: 
Industry-sponsored, non-interventional extension study to examine the long-term effects of early treatment with interferon beta-1b in individuals who had experienced a first neurological event suggestive of MS; patients enrolled in the original trial received either interferon beta-1b (250 microg every other day) or placebo, whereas all patients had the option of receiving interferon beta-1b in an extension for up to 5 years (patients and study personnel remained unaware of the initial treatment group)
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
, after which patients entered this observational extension in which treatment decisions were made by individual physicians and patients
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
Disease Stage: 
CIS (at the time the original BENEFIT trial began)
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
Enrollment/Number of Patients: 
468 enrolled in the BENEFIT trial; 284 enrolled in the extension study and 94.2% were receiving interferon beta-1b
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
Duration: 
≤8.7 years
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
; further analysis described 11-year followup
(150)
Long-Term Results Underscore Value of Early MS Treatment
Melville NA, Medscape, 3 Nov 2014
Accessed on 4 Nov 2014 from http://www.medscape.com/viewarticle/834278.
(171)
Long-term Impact of Early MS Treatment with Interferon Beta-1b (IFNB-1b): Clinical, MRI, Employment, and Patient-Reported Outcomes (PROs) at the 11-Year Follow-up of BENEFIT (BENEFIT 11)
Edan G, Freedman M, Montalban X, Miller D, Hartung H, Hemmer B, Fox E, Barkhof F, Schippling S, Schulze A, et al., Neurology 2015 Apr; 84(14) Supplement P7.012
Accessed on 19 May 2015 from http://www.neurology.org/content/84/14_Supplement/P7.012.short?rss=1.
Status/Outcome: 
Individuals who had received interferon beta-1b (early treatment) versus placebo (delayed treatment) in the placebo-controlled phase displayed a 32.2% lower risk of developing clinically definite MS (CDMS) over the 8 years of observation, an increased median time to CDMS (by 1345 days), a reduced annualized relapse rate (0.196 versus 0.255), and better cognitive outcomes
(110)
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.
Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung H-P, Miller D, Barkhof F, Herrmann J, Lanius V, et al.
J Neurol Neurosurg Psychiatry. 2013 Nov 11. PMID: 24218527. Abstract
; assessments 3, 5, and 8 years after randomization showed that early treatment was associated with advantages for most clinical and MRI parameters, but the median Expanded Disability Status Scale score was the same for early treatment and delayed treatment groups
(152)
Evidence for the efficacy of interferon beta-1b in delaying the onset of clinically definite multiple sclerosis in individuals with clinically isolated syndrome.
Freedman MS
Ther Adv Neurol Disord. 2014 Nov; 7(6):279-88. PMID: 25371710. Abstract
; at 11 years, 278 of the original 468 individuals were enrolled; the early treatment group continued to show benefits versus the delayed treatment group; benefits included a reduced risk for MS (65.2% versus 75%), a reduced risk for SPMS (4.5% versus 8.3%), more time to the first relapse, and a reduced annualized relapse rate
(150)
Long-Term Results Underscore Value of Early MS Treatment
Melville NA, Medscape, 3 Nov 2014
Accessed on 4 Nov 2014 from http://www.medscape.com/viewarticle/834278.
(171)
Long-term Impact of Early MS Treatment with Interferon Beta-1b (IFNB-1b): Clinical, MRI, Employment, and Patient-Reported Outcomes (PROs) at the 11-Year Follow-up of BENEFIT (BENEFIT 11)
Edan G, Freedman M, Montalban X, Miller D, Hartung H, Hemmer B, Fox E, Barkhof F, Schippling S, Schulze A, et al., Neurology 2015 Apr; 84(14) Supplement P7.012
Accessed on 19 May 2015 from http://www.neurology.org/content/84/14_Supplement/P7.012.short?rss=1.
Trial name: 
Kappos et al., Lancet Neurol., November 2009 trial (active treatment extension of the BENEFIT trial)
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
; further analysis publ 2013
(96)
Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome.
Nagtegaal G J, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung H-P, Miller D, Montalban X, Kappos L, Edan G, et al.
Mult Scler. 2013 Jul 10. PMID: 23842212. Abstract
Phase: 
Phase III trial extension
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
Study Design: 
Industry-sponsored, prospectively planned, open-label follow-up study to compare the effects of early versus delayed interferon beta-1b treatment on the time to clinically definite MS and on other measures such as disability progression; patients enrolled in the original trial received either interferon beta-1b (250 microg every other day) or placebo, whereas all patients had the option of receiving interferon beta-1b in the extension (patients and study personnel remained unaware of the initial treatment group)
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
Disease Stage: 
CIS (at the time the original BENEFIT trial began)
(8)
Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes.
Kappos L, Polman CH, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Bauer L, Jakobs P, et al.
Neurology. 2006 Oct 10; 67(7):1242-9. Epub 2006 Aug 16. PMID: 16914693. Abstract
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
Enrollment/Number of Patients: 
468 enrolled in the BENEFIT trial; 358 completed the extension
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
Duration: 
5 years
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
Status/Outcome: 
Early treatment with interferon beta-1b reduced the risk of conversion to clinically definite MS by 37% as compared to delayed treatment with interferon beta-1b, but early treatment did not change long-term disability outcomes; early treatment was, however, associated with more improvement in cognition
(2)
Interferon-β-1b: a review of its use in multiple sclerosis.
Plosker GL
CNS Drugs. 2011 Jan; 25(1):67-88. PMID: 21128695. Abstract
(17)
Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial.
Kappos L, Freedman MS, Polman CH, Edan G, Hartung H-P, Miller DH, Montalbán X, Barkhof F, Radü E-W, Metzig C, et al.
Lancet Neurol. 2009 Nov; 8(11):987-97. Epub 2009 Sep 10. PMID: 19748319. Abstract
; further analysis of 435 patients showed that, during both phases of the trial, the number of persisting T1 hypointensities (also known as persistent black holes) per patient was lower in the early versus delayed treatment arm
(96)
Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome.
Nagtegaal G J, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung H-P, Miller D, Montalban X, Kappos L, Edan G, et al.
Mult Scler. 2013 Jul 10. PMID: 23842212. Abstract
Trial name: 
Hutchinson et al., Curr. Med. Res. Opin., November 2013 study
(109)
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
(109)
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
(109)
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
(109)
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
(109)
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
(109)
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
(109)
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
(108)
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
(108)
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
(108)
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
(108)
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
(108)
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
(108)
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
(108)
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
(107)
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
(107)
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
(107)
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
(107)
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)
(107)
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
(107)
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
(107)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(105)
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
(105)
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
(105)
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
(105)
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
(105)
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
(105)
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
(105)
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
(127)
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
(127)
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
(127)
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
(127)
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
(127)
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
(127)
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
(127)
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
(104)
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
(104)
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)
(104)
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
(104)
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)
(104)
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
(104)
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)
(104)
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: 
Zettl et al., BMC Neurol., September 2013 study
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Phase: 
Observational/open-label study
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Study Design: 
Prospective national multicenter cohort study to examine how the use of electronic versus paper diaries to document self-administered injections of interferon beta-1b might affect adherence to that treatment
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Disease Stage: 
CIS or RRMS
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Enrollment/Number of Patients: 
700
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Duration: 
2 years
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Status/Outcome: 
Demographic characteristics of the two cohorts at baseline have been established (September 2013)
(103)
Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study.
Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V
BMC Neurol. 2013 Sep 6; 13(1):117. Epub 2013 Sep 06. PMID: 24011220. Abstract
Trial name: 
Hadjigeorgiou et al., J. Clin. Pharm. Ther., August 2013 study
(102)
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
(102)
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
(102)
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
(102)
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
(102)
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
(102)
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
(102)
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: 
Gobbi et al., BMC Neurol., August 2013 study
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Phase: 
Observational/open-label study
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Study Design: 
Randomized, prospective, parallel-group, rater-blinded pilot study to compare disease activity in individuals who switched from natalizumab to interferon beta-1b to activity in those who remained on natalizumab; participants in the study had been free of disease activity on natalizumab for at least 6 months
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Disease Stage: 
RRMS
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Enrollment/Number of Patients: 
19
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Duration: 
1 year
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Status/Outcome: 
78% of those who switched to interferon beta-1b remained free of relapses and 25% did not display new T2 lesions; the group who remained on natalizumab had more favorable outcomes (either statistically significant or showing a trend) for a number of endpoints, such as number of relapses, proportion of patients without a relapse, and the number of new T2 lesions at month 6, but the time to the first relapse was not significantly different between the two treatment groups
(99)
Interferon beta 1b following natalizumab discontinuation: one year, randomized, prospective, pilot trial.
Gobbi C, Meier DS, Cotton F, Sintzel M, Leppert D, Guttmann CRG, Zecca C
BMC Neurol. 2013; 13:101. Epub 2013 Aug 02. PMID: 23915113. Abstract
Trial name: 
Zhang et al., Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi, July 2013 study
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Phase: 
Observational/open-label study
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Study Design: 
Study to evaluate the relationship between peripheral blood levels of Th17 cells and the efficacy of interferon beta-1b (250 microg dose), as measured by changes in the Expanded Disability Status Scale score and T2 lesion number between baseline and the end of the study period
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Disease Stage: 
RRMS
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Enrollment/Number of Patients: 
11
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Duration: 
6 months
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Status/Outcome: 
Interferon beta-1b was considered effective for some but not all patients; those for whom treatment was ineffective also displayed an increase in Th17 cells before treatment, suggesting that RRMS mediated by Th17 cells is not responsive to this drug
(97)
[Th17-mediated relapsing-remitting multiple sclerosis is nonresponsive to interferon-β1b].
Zhang X, Zhang Q, Shi X, Yin R, Zhang Z, Hou X
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013 Jul; 29(7):751-3. PMID: 23837989. Abstract
Trial name: 
Filippini et al., Cochrane Database Syst. Rev., June 2013 study
(91)
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
(91)
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
(91)
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
(91)
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
(91)
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)
(91)
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
(91)
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
(88)
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
(88)
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
(88)
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
(88)
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
(88)
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
(88)
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
(88)
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: 
Lacy et al., Mult. Scler., May 2013 study
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Phase: 
Observational/open-label study
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Study Design: 
Longitudinal study to monitor the effects of long-term interferon beta-1b on cognition; patients originally participated in a pivotal interferon beta-1b trial published in 1993/1995, with 9 receiving interferon beta-1b and 7 receiving placebo; after 5 years, all received interferon beta-1b
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Disease Stage: 
RRMS
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Enrollment/Number of Patients: 
16
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Duration: 
16 years
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Status/Outcome: 
Over 16 years, cognitive function was relatively stable, indicating that the drug has positive effects on cognition; visual memory performance was better in the placebo/interferon beta-1b group, whereas verbal memory was better in the interferon beta-1b treatment group
(87)
The effects of long-term interferon- beta-1b treatment on cognitive functioning in multiple sclerosis: a 16-year longitudinal study.
Lacy M, Hauser M, Pliskin N, Assuras S, Valentine MO, Reder A
Mult Scler. 2013 May 7. PMID: 23652214. Abstract
Trial name: 
Jokubaitis et al., PLoS One, March 2013 study
(84)
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
(84)
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
(84)
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
(84)
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
(84)
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)
(84)
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
(84)
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: 
Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (press release, 18 March 2013)
(82)
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
(82)
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
(82)
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
(82)
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
(82)
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
(82)
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
(82)
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
(80)
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
(80)
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
(80)
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
(80)
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
Enrollment/Number of Patients: 
594
(80)
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
Duration: 
2 years
(80)
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
Status/Outcome: 
Later age at disease onset, a lower level of disability, and a lower number of gadolinium-enhancing lesions at baseline were predictors of response, on the basis of a multivariate analysis
(80)
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
Trial name: 
Brandes et al., J. Med. Econ., February 2013 study
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Phase: 
Observational study
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Study Design: 
Analysis to assess the effect of real-world adherence (estimated from a study of a single claims database of a national pharmacy benefit manager) on the cost-effectiveness (the cost per avoided relapse) of fingolimod, subcutaneous interferon beta-1b (Extavia or Betaseron) and interferon beta-1a, glatiramer acetate, and intramuscular interferon beta-1a
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Disease Stage: 
MS
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Enrollment/Number of Patients: 
N/A
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Duration: 
N/A
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Status/Outcome: 
Costs per relapse avoided were estimated at $90,566 (fingolimod), $127,024 (Extavia), $137,492 (Betaseron), $144,016 (subcutaneous inferferon beta-1a), $160,314 (glatiramer acetate), and $312,629 (intramuscular interferon beta-1a)
(77)
Implications of Real-world Adherence on Cost-effectiveness Analysis in Multiple Sclerosis.
J Med Econ. 2013 Feb 7. PMID: 23391123. Abstract
Trial name: 
RNF and Betaseron Tolerability Study (REFORMS) (publ December 2012)
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
(93)
RNF and Betaseron® Tolerability Study (REFORMS)
ClinicalTrials.gov, 8 Sep 2010
Accessed on 20 Jun 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00428584.
Phase: 
Phase IIIb, open-label study
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
Study Design: 
Industry-sponsored, randomized, parallel-group, multicenter, open-label study to examine the tolerability, effects at injection site, and efficacy of a serum-free version of interferon beta-1a (produced without fetal bovine serum and lacking the excipient human serum albumin) versus interferon beta-1b; patients received either interferon beta-1a titrated to 44 microg subcutaneously three times weekly or interferon beta-1b titrated to 250 microg subcutaneously every other day over 12 weeks, followed by interferon beta-1a (44 microg three times weekly) for all patients for 82 to 112 weeks; the mean change in patient-reported pain at the injection site over the first 21 injections at full dose was the primary endpoint
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
(93)
RNF and Betaseron® Tolerability Study (REFORMS)
ClinicalTrials.gov, 8 Sep 2010
Accessed on 20 Jun 2013 from http://www.clinicaltrials.gov/ct2/show/NCT00428584.
Disease Stage: 
RRMS, interferon beta-treatment-naïve patients
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
Enrollment/Number of Patients: 
129
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
Duration: 
94 to 124 weeks
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
Status/Outcome: 
Both versions of interferon beta were well tolerated and generally associated with low-level pain at the injection site
(92)
Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonβ-1a versus subcutaneous interferonβ-1b: results of the randomized, multicenter, Phase IIIb REFORMS study.
Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F, REFORMS Study Group
BMC Neurol. 2012; 12:154. Epub 2012 Dec 06. PMID: 23216674. Abstract
Trial name: 
Portaccio et al., Eur. J. Neurol., October 2012 study
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Phase: 
Pilot study
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Study Design: 
Prospective, non-randomized, pilot study to examine the possible benefits of natalizumab versus interferon beta on cognitive changes
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Disease Stage: 
RRMS
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Enrollment/Number of Patients: 
26; 12 were treated with natalizumab and 14 with interferon beta
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Duration: 
1.5 years (mean follow-up time)
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Status/Outcome: 
Natalizumab treatment was associated with a significantly lower mean number of neuropsychological tests that indicated deteriorating performance, and a significantly lower percentage brain volume change, than was interferon beta treatment, suggesting that natalizumab might help cognitive function by reducing brain atrophy
(69)
Natalizumab may reduce cognitive changes and brain atrophy rate in relapsing-remitting multiple sclerosis: a prospective, non-randomized pilot study.
Portaccio E, Stromillo M, Goretti B, Hakiki B, Giorgio A, Rossi F, De Leucio A, De Stefano N, Amato MP
Eur J Neurol. 2012 Oct 11. PMID: 23057658. Abstract
Trial name: 
Dhib-Jalbut et al., J. Neuroimmunol., September 2012 study
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Phase: 
Phase IV study
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Study Design: 
Part of a larger, open-label, multicenter, prospective, observational Phase IV clinical study (titled Success of Titration, analgesics, and BETA nurse support on Acceptance Rates to early MS Treatment with Betaseron®, or START); this particular analysis looked for correlations between the response to interferon beta-1b and immune markers
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Disease Stage: 
CIS and RRMS
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Enrollment/Number of Patients: 
32 enrolled; 30 were treated
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Duration: 
12 months
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Status/Outcome: 
At month 6, interleukin-17 levels were higher in relapsing versus relapse-free patients; at month 3, brain-derived neurotrophic factor levels were higher in relapse-free versus relapsing patients; furthermore, changes in interleukin-4 levels inversely correlated with disability score and changes in the interleukin-10/interferon-gamma ratio inversely correlated with relapse occurrence
(68)
Immune response during interferon beta-1b treatment in patients with multiple sclerosis who experienced relapses and those who were relapse-free in the START study.
Dhib-Jalbut S, Sumandeep S, Valenzuela R, Ito K, Patel P, Rametta M
J Neuroimmunol. 2012 Sep 18. PMID: 22999187. Abstract
Trial name: 
Jacques et al., Mult. Scler. Int., August 2012 study
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Phase: 
Phase IIa pilot study
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Study Design: 
Randomized, open-label, multicenter, two-arm pilot study to evaluate the safety and tolerability of a combination of the immunosuppressant tacrolimus [orally two times per day at a dose to reach either low (1-5 ng/ml) or high (5-10 ng/ml) blood levels] with interferon beta-1b therapy (250 microg given subcutaneously every other day); the idea is to target more than one autoimmune process by using two drugs
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Disease Stage: 
RRMS and SPMS
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Enrollment/Number of Patients: 
25
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Duration: 
38 weeks
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Status/Outcome: 
Combination therapy appeared to be safe and well tolerated
(64)
Combination therapy of interferon Beta-1b and tacrolimus: a pilot safety study.
Jacques F, Gaboury I, Christie S, Grand'maison F
Mult Scler Int. 2012; 2012:935921. Epub 2012 Aug 15. PMID: 22966460. Abstract
Trial name: 
Lu et al., Neurology, August 2012 study
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Phase: 
Retrospective literature review
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Study Design: 
Systematic review of the literature for information about the effects of interferon beta, glatiramer acetate, or natalizumab on the offspring of MS patients who used these disease-modifying drugs (DMDs) during pregnancy
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Disease Stage: 
MS
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Enrollment/Number of Patients: 
761 interferon beta-exposed pregnancies were identified
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Duration: 
N/A
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Status/Outcome: 
Interferon beta exposure during pregnancy was associated with preterm birth and lower mean birth weight and length, but not with low birth weight (<2500 g), cesarean delivery, spontaneous abortion, or congenital anomalies; discontinuing DMD use before conception continues to be recommended
(61)
Disease-modifying drugs for multiple sclerosis in pregnancy: A systematic review.
Lu E, Wang B W, Guimond C, Synnes A, Sadovnick D, Tremlett H
Neurology. 2012 Aug 29. PMID: 22933738. Abstract
Trial name: 
Shirani et al., JAMA, July 2012 study
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Phase: 
Retrospective cohort study
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Study Design: 
Retrospective cohort study, based on prospectively collected data, to compare the effects of interferon beta (-1a or -1b) versus placebo on the progression to disability, such that the main outcome measure was time from eligibility for treatment with interferon beta to a confirmed sustained score of 6 on the Expanded Disability Status Scale (EDSS)
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Disease Stage: 
RRMS
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Enrollment/Number of Patients: 
2656 [868 treated with interferon beta (from 1995 to 2004), 829 untreated (who met criteria to receive interferon beta in that time period), 959 from historical cohorts (who met the same criteria before interferon beta therapies were available)]
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Duration: 
N/A
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Status/Outcome: 
Interferon beta was not associated with a reduction in the progression of disability, such that 10.8% of patients in the treated group, 5.3% in the contemporary untreated group, and 23.1% in the historical untreated group reached an EDSS score of 6
(59)
Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis.
Shirani A, Zhao Y, Karim M E, Evans C, Kingwell E, van der Kop ML, Oger J, Gustafson P, Petkau J, Tremlett H
JAMA. 2012 Jul 18; 308(3):247-56. Epub 1969 Dec 31. PMID: 22797642. Abstract
Trial name: 
Roskell et al., Curr. Med. Res. Opin., May 2012 study
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Phase: 
Retrospective trial review
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Study Design: 
Meta-analysis of placebo-controlled and head-to-head trials, which evaluated the effects of one or more drugs (fingolimod, interferon beta-1a, interferon beta-1b, and/or glatiramer acetate), to compare the effects of fingolimod versus the other treatments on the annualized relapse rate (ARR)
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Disease Stage: 
RRMS
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Enrollment/Number of Patients: 
N/A
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Duration: 
N/A
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Status/Outcome: 
Meta-analyses indicated that fingolimod significantly reduced the ARR as compared to the other drugs; the relative ARRs for each drug versus fingolimod were 1.43 (glatiramer acetate, 20 mg dose), 1.51 (interferon beta-1b, 250 microg dose), 1.55 (interferon beta-1a, 44 microg dose), 1.67 (interferon beta-1a, 22 microg dose), 1.93 (interferon beta-1a, 30 microg dose), and 2.32 (placebo)
(67)
Annualized relapse rate of first-line treatments for multiple sclerosis: a meta-analysis, including indirect comparisons versus fingolimod.
Roskell NS, Zimovetz EA, Rycroft CE, Eckert BJ, Tyas DA
Curr Med Res Opin. 2012 May; 28(5):767-80. Epub 2012 Apr 24. PMID: 22462530. Abstract
Trial name: 
Del Santo et al., Eur. J. Clin. Pharmacol., April 2012 study
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Phase: 
Retrospective trial review
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Study Design: 
Review of 10 randomized trials that tested interferon, glatiramer acetate, natalizumab, or fingolimod in RRMS, such that the relapse-free rates at 12 months were compared, either directly or through network meta-analysis
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Disease Stage: 
RRMS
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Enrollment/Number of Patients: 
N/A
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Duration: 
N/A
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Status/Outcome: 
Fingolimod was determined to have the most favorable profile with respect to relapse-free rate at the follow-up assessment at 1 year
(57)
Treatments for relapsing-remitting multiple sclerosis: summarising current information by network meta-analysis.
Del Santo F, Maratea D, Fadda V, Trippoli S, Messori A
Eur J Clin Pharmacol. 2012 Apr; 68(4):441-8. Epub 2011 Nov 05. PMID: 22057838. Abstract
Trial name: 
Basiri et al., Acta Med. Iran, 2012 study
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Phase: 
Open-label study
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Study Design: 
Open-label study to evaluate the effectiveness and tolerability of interferon beta in patients younger than 16 years; patients were treated with either interferon beta-1a (30 microg, intramuscularly once a week) or interferon beta-1b (250 microg, subcutaneously every other day)
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Disease Stage: 
RRMS
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Enrollment/Number of Patients: 
13
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Duration: 
9 months
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Status/Outcome: 
Use of interferon beta appears safe in pediatric patients over the short term; drugs were also associated with a decrease in the expanded disability status scale score
(52)
Interferon-beta in pediatric multiple sclerosis patients: safety in short-term prescription.
Basiri K, Etemadifar M, Derakhshan F, Ashtari F, Shaygannejad V, Fatehi Z, Maghzi A H, Fatehi F
Acta Med Iran. 2012; 50(2):97-100. PMID: 22359077. Abstract
Trial name: 
Goodin et al., Neurology, April 2012 study
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Phase: 
Observational study
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Study Design: 
Randomized, long-term cohort study to compare all-cause mortality over 21 years between patients who received either 250 microg interferon beta-1b (administered subcutaneously every other day for up to 5 years) or placebo in a pivotal interferon beta-1b trial published in 1993/1995
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Disease Stage: 
RRMS
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Enrollment/Number of Patients: 
366 (of the 372 who were originally enrolled)
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Duration: 
21 years (time from enrollment in the original trial to present analysis)
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
Status/Outcome: 
Patients who were originally randomly assigned to 250 microg interferon beta-1b had a significant reduction in all-cause mortality over 21 years as compared with those receiving placebo, such that the hazard rate of death was reduced 46.8% among the treated patients
(58)
Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.
Goodin DS, Reder AT, Ebers GC, Cutter G, Kremenchutzky M, Oger J, Langdon D, Rametta M, Beckmann K, Desimone TM, et al.
Neurology. 2012 Apr 24; 78(17):1315-22. Epub 2012 Apr 11. PMID: 22496198. Abstract
; additional cost-effectiveness analyses indicate that early treatment with interferon beta-1b increases quality-adjusted life-years and is probably a cost-effective therapy for MS
(60)
Long-Term Cost-Effectiveness Model of Interferon Beta-1b in the Early Treatment of Multiple Sclerosis in the United States.
Pan F, Goh J W, Cutter G, Su W, Pleimes D, Wang C
Clin Ther. 2012 Aug 17. PMID: 22906738. Abstract
; additional analyses showed that the excessive deaths among patients who received placebo during the original randomized controlled trial were primarily related to MS, particularly MS-related pulmonary infections (81 deaths had been recorded among the 366 patients; the cause of death and/or its relationship to MS were determined for 71/81 of the deaths)
(70)
Cause of death in MS: long-term follow-up of a randomised cohort, 21 years after the start of the pivotal IFNβ-1b study.
Goodin DS, Ebers GC, Cutter G, Cook SD, O'Donnell T, Reder AT, Kremenchutzky M, Oger J, Rametta M, Beckmann K, et al.
BMJ Open. 2012; 2(6). PMID: 23204140. Abstract
Trial name: 
Meca-Lallana et al., J. Neurol. Sci., April 2012 study (Escala study)
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
(191)
Cost analysis of glatiramer acetate versus interferon-β for relapsing-remitting multiple sclerosis in patients with spasticity: the Escala study.
Sánchez-de la Rosa R, García-Bujalance L, Meca-Lallana J
Health Econ Rev. 2015 Dec; 5(1):30. Epub 2015 Oct 16. PMID: 26475277. Abstract
Phase: 
Observational study
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
Study Design: 
Observational, multicenter study to evaluate changes in spasticity after a switch from interferon beta to glatiramer acetate treatment, with the primary endpoint made up of changes in the Penn Spasm Frequency Scale, Modified Ashworth Scale, Adductor Tone Rating Scale, and Global Pain Score at 3 and 6 months after the switch
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
Disease Stage: 
RMMS, with spasticity
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
Enrollment/Number of Patients: 
68
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
Duration: 
6 months
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
Status/Outcome: 
Switching to glatiramer acetate led to statistically significant improvement in spasm frequency, muscle tone, and pain after 3 and 6 months
(71)
Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-β to glatiramer acetate: the Escala Study.
Meca-Lallana JE, Balseiro JJ, Lacruz F, Guijarro C, Sanchez O, Cano A, Costa-Frossard L, Hernández-Clares R, Sanchez-De la Rosa R, Escala Study Group
J Neurol Sci. 2012 Apr 15; 315(1-2):123-8. Epub 2011 Nov 30. PMID: 22133480. Abstract
; an analysis from the Spanish National Health System perspective showed that costs during interferon beta treatment were 1.5 times higher than those during glatiramer acetate treatment; switching to glatiramer acetate was associated with reduced costs of therapy and management of relapses, as well as reduced need for spasticity treatment
(191)
Cost analysis of glatiramer acetate versus interferon-β for relapsing-remitting multiple sclerosis in patients with spasticity: the Escala study.
Sánchez-de la Rosa R, García-Bujalance L, Meca-Lallana J
Health Econ Rev. 2015 Dec; 5(1):30. Epub 2015 Oct 16. PMID: 26475277. Abstract
Trial name: 
Goodin et al., J. Neurol. Neurosurg. Psychiatry, March 2012 study
(28)
Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis.
Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC, et al.
J Neurol Neurosurg Psychiatry. 2012 Mar; 83(3):282-287. Epub 2011 Dec 21. PMID: 22193561. Abstract
Phase: 
Observational study
(28)
Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis.
Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC, et al.
J Neurol Neurosurg Psychiatry. 2012 Mar; 83(3):282-287. Epub 2011 Dec 21. PMID: 22193561. Abstract
Study Design: 
Industry-sponsored, cross-sectional, observational, cohort study to evaluate the long-term benefit of interferon beta-1b therapy in patients who participated in a pivotal interferon beta-1b trial published in 1993/1995 (involving 50 microg or 250 microg interferon beta-1b, administered subcutaneously every other day for up to 5 years), such that treatment and disease status after 16 years was assessed, but interferon beta-1b was not administered as part of this study
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
(28)
Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis.
Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC, et al.
J Neurol Neurosurg Psychiatry. 2012 Mar; 83(3):282-287. Epub 2011 Dec 21. PMID: 22193561. Abstract
(29)
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov, 27 Aug 2010
Accessed on 26 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00206635.
Disease Stage: 
RRMS
(29)
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov, 27 Aug 2010
Accessed on 26 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00206635.
Enrollment/Number of Patients: 
432
(29)
Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov, 27 Aug 2010
Accessed on 26 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00206635.
Duration: 
16 years
(28)
Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis.
Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC, et al.
J Neurol Neurosurg Psychiatry. 2012 Mar; 83(3):282-287. Epub 2011 Dec 21. PMID: 22193561. Abstract
Status/Outcome: 
Physical and cognitive outcomes after 16 years correlated with baseline disability; physical outcome but not cognition correlated with disability accrual and annualized relapse rates during the randomised controlled trial, whereas cognitive but not physical outcomes correlated with baseline measures of lesion burden and atrophy as measured by MRI; given that better correlations were seen for several baseline measures, long term outcomes might be determined mostly early during the course of the disease
(28)
Relationship between early clinical characteristics and long term disability outcomes: 16 year cohort study (follow-up) of the pivotal interferon β-1b trial in multiple sclerosis.
Goodin DS, Traboulsee A, Knappertz V, Reder AT, Li D, Langdon D, Wolf C, Beckmann K, Konieczny A, Ebers GC, et al.
J Neurol Neurosurg Psychiatry. 2012 Mar; 83(3):282-287. Epub 2011 Dec 21. PMID: 22193561. Abstract
Trial name: 
La Mantia et al., Cochrane Database Syst. Rev., January 2012 study
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
; similar analysis publ April 2013
(86)
Interferon β for secondary progressive multiple sclerosis: a systematic review.
La Mantia L, Vacchi L, Rovaris M, Di Pietrantonj C, Ebers G, Fredrikson S, Filippini G
J Neurol Neurosurg Psychiatry. 2013 Apr; 84(4):420-6. Epub 2012 Sep 05. PMID: 22952326. Abstract
Phase: 
Retrospective trial review
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
Study Design: 
Results from five randomized, placebo-controlled trials (RTCs) were selected for further analysis after assessment of all RTCs that evaluated the efficacy of interferon beta-1a and -1b in SPMS; the goal was to determine whether interferon beta can safely reverse or slow SPMS
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
Disease Stage: 
SPMS
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
Enrollment/Number of Patients: 
3122 patients contributed to the studies involved in the analysis
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
Duration: 
Analyzed 3 years of treatment
(86)
Interferon β for secondary progressive multiple sclerosis: a systematic review.
La Mantia L, Vacchi L, Rovaris M, Di Pietrantonj C, Ebers G, Fredrikson S, Filippini G
J Neurol Neurosurg Psychiatry. 2013 Apr; 84(4):420-6. Epub 2012 Sep 05. PMID: 22952326. Abstract
Status/Outcome: 
In SPMS, interferon beta was not observed to stop the development of permanent physical disability, but significantly reduced the risk of relapse and of short-term disability related to relapse
(55)
Interferon beta for secondary progressive multiple sclerosis.
La Mantia L, Vacchi L, Di Pietrantonj C, Ebers G, Rovaris M, Fredrikson S, Filippini G
Cochrane Database Syst Rev. 2012; 1:CD005181. PMID: 22258960. Abstract
Trial name: 
Khan et al., J. Neurol. Sci., January 2012 study
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Phase: 
Retrospective medical record review
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Study Design: 
Study to measure the effects of glatiramer acetate (20 mg, injected subcuraneously once a day; 121 patients), interferon beta-1a (30 mcg, injected intramuscularly once a week; 53 patients), and interferon beta-1b (250 mcg, injected subcutaneously every other day; 101 patients), with treatments given for five years, on the loss of brain volume in previously treatment-naïve patients with relatively early RRMS (of less than or equal to five years duration when the study began); patients received brain MRI scans on the same scanner with the same protocol at baseline and year 5
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Disease Stage: 
RRMS
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Enrollment/Number of Patients: 
275
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Duration: 
5 years
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Status/Outcome: 
The disease-modifying therapies were associated with an adjusted (for pseudoatrophy in the first year) percentage change in brain volume (PCBV) over five years of -2.27% (glatiramer acetate), -2.62% (interferon beta-1a), and -3.21% (interferon beta-1b), which were all significantly reduced as compared to the PCBV (-4.75%) for 34 patients who were untreated for 8 to 24 months
(63)
Effect of disease-modifying therapies on brain volume in relapsing-remitting multiple sclerosis: results of a five-year brain MRI study.
Khan O, Bao F, Shah M, Caon C, Tselis A, Bailey R, Silverman B, Zak I
J Neurol Sci. 2012 Jan 15; 312(1-2):7-12. Epub 2011 Sep 13. PMID: 21920559. Abstract
Trial name: 
Garcia-Montojo et al., Eur. J. Neurol., Aug 2011 study
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Phase: 
Observational study
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Study Design: 
Observational, multicentric study to evaluate whether the efficacy of interferon beta-1b in MS might be related to its antiviral properties, as assessed by its effect on human herpes virus 6 (HHV-6) and Epstein-Barr virus (EBV)
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Disease Stage: 
MS
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Enrollment/Number of Patients: 
54
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Duration: 
24 months
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Status/Outcome: 
The presence of HHV-6 in serum during treatment with interferon beta-1b was associated with a higher risk of severe relapse; no association was found between EBV and various clinical measures
(49)
Human herpesvirus 6 and effectiveness of interferon β1b in multiple sclerosis patients.
Garcia-Montojo M, De Las Heras V, Dominguez-Mozo M, Bartolome M, Garcia-Martinez MA, Arroyo R, Alvarez-Lafuente R, HHV-6 and Multiple Sclerosis Study Group
Eur J Neurol. 2011 Aug; 18(8):1027-35. Epub 2011 Apr 25. PMID: 21518144. Abstract
Trial name: 
Reder et al., Neurology, June 2010 study
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Phase: 
Observational study
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Study Design: 
Cross-sectional followup study to assess the long-term safety of interferon beta-1b in patients who participated in a pivotal interferon beta-1b trial published in 1993/1995 (involving 50 microg or 250 microg interferon beta-1b, administered subcutaneously every other day for up to 5 years), such that adverse events that occurred in the 16 years since the pivotal trial were recorded, but no particular therapy was stipulated as part of this study
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
(7)
Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group.
Neurology. 1993 Apr; 43(4):655-61. PMID: 8469318. Abstract
(27)
Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.
Neurology. 1995 Jul; 45(7):1277-85. PMID: 7617182. Abstract
Disease Stage: 
RRMS
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Enrollment/Number of Patients: 
328
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Duration: 
16 years
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Status/Outcome: 
Adverse events related to treatment (such as leukopenia and liver and thyroid dysfunction) were reported and in agreement with previously observed effects; no new interferon beta-1b-related adverse effects were seen; and a higher percentage of patients from the placebo group in the pivotal study had died (18.3%) than from the interferon beta-1b groups (8.3% for the 50 microg group and 5.4% for the 250 microg group), all of which support the long-term safety of this drug
(4)
Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
Reder AT, Ebers GC, Traboulsee A, Li D, Langdon D, Goodin DS, Bogumil T, Beckmann K, Konieczny A, Investigators of the 16-Year Long-Term Follow-Up Study
Neurology. 2010 Jun 8; 74(23):1877-85. PMID: 20530324. Abstract
Trial name: 
OPTimisation of Interferon for MS (OPTIMS) (publ 2008)
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
Phase: 
Phase II trial
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
Study Design: 
University-sponsored, prospective, multicenter, randomized trial to test the effects of a high dose of interferon beta-1b (375 microg, given subcutaneously every other day) as compared to the usual dose (250 microg, given subcutaneously every other day) in patients with a suboptimal response to the 250 microg dose; trial had a 6-month run-in phase (to identify suboptimal responders) when all participants received the 250 microg dose and a 6-month open-label clinical and blinded MRI follow-up in which suboptimal responders were randomized to the two doses, with the primary outcome the proportion of patients without MRI activity during months 9 to 12
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
(32)
Optimizing IFN Beta - 1B Dose (Optims)
ClinicalTrials.gov, 11 May 2007
Accessed on 27 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00473213?term=OPTIMS&rank=2.
Disease Stage: 
RRMS
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
Enrollment/Number of Patients: 
216 entered study; 76 suboptimal responders were included in the analysis
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
Duration: 
1 year
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
Status/Outcome: 
375 microg dose was more frequently associated with no new MRI activity during months 9 to 12 than the 250 microg dose (30/36 versus 16/40)
(31)
The OPTimization of interferon for MS study: 375 microg interferon beta-1b in suboptimal responders.
Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Ferrero B, Rivoiro C, Ferrero C, Picco E, et al.
J Neurol. 2008 Sep; 255(9):1315-23. Epub 2008 Sep 25. PMID: 18825438. Abstract
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

Note: Compound name must be entered under "Substance Identification" and then "Names and Synonyms" selected to view synonyms.