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Interferon beta-1a
Last updated:
19 Apr 2016
Interferon beta-1a
Summary
Trade name:
Avonex
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Rebif
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
CinnoVex (approved as a generic in Iran)
(3)
CinnoVex home page
CinnaGen
Accessed on 15 Mar 2012 from http://www.cinnovex.com/.
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
Plegridy (peginterferon beta-1a)
(66)
Positive year one results from Biogen Idec's Phase 3 advance trial of PLEGRIDY™ (peginterferon beta-1a) presented at AAN meeting
Biogen Idec,
20 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1798258.
Class:
Immunomodulator
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Target:
Interferon beta receptor
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
T cell differentiation pathways
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
Pathways regulating transfer of Inflammatory cells across the blood brain barrier
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
Status for MS:
Approved
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Administration:
Intramuscular
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Subcutaneous
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Plegridy dose is 125 microg injected subcutaneously once every 2 weeks, according to information from the manufacturer
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
Missing a dose within the first month of observation is associated with reduced adherence to treatment and increased chance of relapse
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Commercial:
Avonex was developed and is manufactured and marketed by Biogen Idec
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Rebif is manufactured by EMD Serono and is co-marketed by Serono and Pfizer in the US as of 2003
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Plegridy (a form of interferon beta-1a that is pegylated to increase its half-life, allowing dosing less frequently) was developed by Biogen Idec
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
CinnoVex was engineered and developed by the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Germany in a collaboration with CinnaGen in Iran
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
CinnoVex has been approved as a biogeneric by the Iranian Food and Drug Administration (2006)
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
CinnoVex is manufactured and marketed by CinnaGen
(3)
CinnoVex home page
CinnaGen
Accessed on 15 Mar 2012 from http://www.cinnovex.com/.
Rebif Rebidose (a single-use auto-injector for interferon beta-1a) has been approved by the US Food and Drug Administration (3 January 2013)
(54)
EMD Serono and Pfizer announce FDA approval of Rebif® Rebidose® (interferon beta-1a)
EMD Serono,
3 Jan 2013
Accessed on 7 Jan 2013 from http://www.emdserono.com/cmg.emdserono_us/en/images/121204-183958_Rebif%20Rebidose%20Approval%20Press%20Release_FINAL_tcm115_104286.pdf.
Biologics License Application for Plegridy has been submitted to the US Food and Drug Administration by Biogen Idec (21 May 2013)
(74)
Biogen Idec submits application to FDA for approval of PLEGRIDY™ (peginterferon beta-1a) in multiple sclerosis
Biogen Idec,
21 May 2013
Accessed on 31 May 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1822494.
Biologics License Application for marketing approval of Plegridy has been accepted by the US Food and Drug Administration; a standard review timeline (about 10 months) will be used (19 July 2013)
(84)
US and EU regulatory authorities accept PLEGRIDY™ (peginterferon beta-1a) marketing applications for review
Biogen Idec,
19 Jul 2013
Accessed on 25 Jul 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1839270.
(85)
Biogen Idec's long-acting beta interferon moves ahead in MS
PMLiVE,
23 Jul 2013
Accessed on 25 Jul 2013 from http://www.pmlive.com/pharma_news/biogen_idecs_long-acting_beta_interferon_moves_ahead_in_ms_491668.
Marketing Authorisation Application for review of Plegridy in the EU has been accepted by the European Medicines Agency (19 July 2013)
(84)
US and EU regulatory authorities accept PLEGRIDY™ (peginterferon beta-1a) marketing applications for review
Biogen Idec,
19 Jul 2013
Accessed on 25 Jul 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1839270.
Rebif will lose patent protection at the end of 2013
(102)
3 Blockbuster Drugs Losing Patent Protection in 2013's Final Months
Carroll D, Daily Finance,
31 Oct 2013
Accessed on 6 Nov 2013 from http://www.dailyfinance.com/2013/10/31/3-blockbuster-drugs-losing-patent-protection-in-20/.
Date for review of the Biologics License Application for marketing approval of Plegridy by the US Food and Drug Administration has been extended by three months (March 2014)
(117)
Biogen Idec receives notification of PDUFA date extension for PLEGRIDY™ (peginterferon beta-1a)
Biogen Idec,
18 Mar 2014
Accessed on 18 Mar 2014 from https://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2293&M=NewsV2&PID=61997.
Plegridy has been recommended for approval for treating RRMS by the Committee for Medicinal Products for Human Use of the European Medicines Agency (23 May 2014)
(135)
CHMP adopts positive opinion for PLEGRIDY™ (peginterferon beta-1a) as a treatment for multiple sclerosis in the European Union
Biogen Idec,
23 May 2014
Accessed on 26 May 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2332&M=NewsV2&PID=61997.
Plegridy has been approved in the EU for treating adults with RRMS (23 July 2014)
(146)
PLEGRIDY™ (peginterferon beta-1a) approved in the European Union for the treatment of multiple sclerosis
Biogen Idec,
23 Jul 2014
Accessed on 24 Jul 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2367&M=NewsV2&PID=61997.
Plegridy has been approved in the US for treating individuals with relapsing forms of MS (15 August 2014)
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
Biogen Idec, which markets Avonex and Plegridy, has changed its name to Biogen (23 March 2015)
(211)
Biogen Idec Becomes Biogen
Biogen,
23 Mar 2015
Accessed on 7 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/corporate/biogen-idec-becomes-biogen.
Plegridy has been approved in Canada for treating adults with RRMS (13 August 2015)
(229)
Health Canada Approves PLEGRIDY™ (peginterferon beta-1a) for Adults with Relapsing Remitting Multiple Sclerosis
PR Newswire,
13 Aug 2015
Accessed on 18 Aug 2015 from https://www.virtualpressoffice.com/publicsiteContentFileAccess?fileContentId=2102825&fromOtherPageToDisableHistory=Y&menuName=News&sId=&sInfo=.
Sole rights to Rebif in the US have been taken on by EMD Serono as of 1 January 2016
(251)
EMD Serono Takes on Exclusive Promotion of Rebif® (interferon beta-1a) in the US
EMD Serono,
19 Jan 2016
Accessed on 19 Jan 2016 from http://www.emdserono.com/ms.country.us/en/images/January%20NDD%202016%20release_Final_tcm115_146142.pdf?Version=.
Names
Name:
Interferon beta-1a
Trade name:
Avonex
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Rebif
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
CinnoVex (approved as a generic in Iran)
(3)
CinnoVex home page
CinnaGen
Accessed on 15 Mar 2012 from http://www.cinnovex.com/.
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
Plegridy (peginterferon beta-1a)
(66)
Positive year one results from Biogen Idec's Phase 3 advance trial of PLEGRIDY™ (peginterferon beta-1a) presented at AAN meeting
Biogen Idec,
20 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1798258.
Synonyms:
Avonex
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
BIIB017 (PEGylated interferon beta-1a)
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
CinnoVex
(3)
CinnoVex home page
CinnaGen
Accessed on 15 Mar 2012 from http://www.cinnovex.com/.
Genfaxon
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Interferon beta-1a
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Neoferon
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Recombinant human interferon beta 1a
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-XRO4566Q4R
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Rebif
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Systematic name:
Interferon beta1 (human fibroblast protein moiety)
(4)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class:
Immunomodulator
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Target:
Interferon beta receptor
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
T cell differentiation pathways
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
Pathways regulating transfer of Inflammatory cells across the blood brain barrier
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
Properties:
Molecular weight: ~22,500 daltons
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Produced in genetically engineered Chinese Hamster Ovary cells expressing a human beta interferon gene
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Glycoprotein
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Distinct glycoforms (all derived from Chinese Hamster Ovary cell culture), with different glycan antennarity (branching), have been characterized relative to biological activity in vitro; forms with higher antennarity appear to sustain bioactivity better
(154)
In vitro Biological Characterization of IFN-β-1a major Glycoforms.
Mastrangeli R, Rossi M, Mascia M, Palinsky W, Datola A, Terlizzese M, Bierau H
Glycobiology
. 2014 Aug 11.
PMID: 25117008.
Abstract
Cytokine
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Avonex exhibits specific activity of 200 million international units of antiviral activity per mg
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Rebif exhibits specific activity of 270 million international units of antiviral activity per mg
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Pharmacokinetic and pharmacodynamic properties have been described in healthy volunteers
(5)
Comparative pharmacokinetics and pharmacodynamics of two recombinant human interferon beta-1a (IFN beta-1 a) products administered intramuscularly in healthy male and female volunteers.
Alam J, Goelz S, Rioux P, Scaramucci J, Jones W, McAllister A, Campion M, Rogge M
Pharm Res
. 1997 Apr; 14(4):546-9.
PMID: 9144748.
Abstract
(6)
Pharmacokinetics and pharmacodynamics of IFN-beta 1a in healthy volunteers.
Buchwalder PA, Buclin T, Trinchard I, Munafo A, Biollaz J
J Interferon Cytokine Res
. 2000 Oct; 20(10):857-66.
PMID: 11054273.
Abstract
(7)
Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon beta-1a after intramuscular and subcutaneous administration.
Munafo A, Trinchard-Lugan I, Nguyen TX, Buraglio M
Eur J Neurol
. 1998 Mar; 5(2):187-193.
PMID: 10210831.
Abstract
Pharmacokinetics and pharmacodynamics of peginterferon beta-1a have been compared in individuals with normal versus impaired renal function; the results do not indicate that the dose should be adjusted in those with impaired renal function
(161)
Pharmacokinetics, pharmacodynamics, and safety of peginterferon beta-1a in subjects with normal or impaired renal function.
Hu X, Seddighzadeh A, Stecher S, Zhu Y, Goyal J, Matson M, Marbury T, Smith W, Nestorov I, Hung S
J Clin Pharmacol
. 2014 Sep 4.
PMID: 25187030.
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 higher aggregate levels correlate with higher reported rates of neutralizing-antibody formation for Betaseron and Rebif
(53)
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
Pharmacokinetics and pharmacodynamics of peginterferon beta-1a have been evaluated in participants in the ADVANCE trial
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
Accumulation of peginterferon beta-1a was not observed in participants in the ADVANCE trial
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
Peak serum concentrations of peginterferon beta-1a occur 1 to 1.5 days post-dosing, based on analysis of data from the ADVANCE trial
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
Peginterferon beta-1a exhibits a median half-life of about 2 to 3 days, based on analysis of data from the ADVANCE trial
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
Each dose of peginterferon beta-1a is associated with increased levels of neopterin (a biomarker of pharmacological activity that is induced by the drug) for 10 to 14 days, based on analysis of data from the ADVANCE trial
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
A single dose of peginterferon beta-1a is associated with 60% greater drug exposure than six subcutaneous interferon beta-1a (Rebif) doses given over two weeks, as shown in a crossover study involving 30 healthy individuals
(269)
COMPARE: pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects.
Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B
Br J Clin Pharmacol
. 2016 Apr 8.
PMID: 27060836.
Abstract
Mechanisms/Effects
Human:
Specific mechanism unknown
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Enhances CD4+ regulatory T cell function and boosts CD4+ regulatory T cell number
(8)
Interferon beta-1a therapy enhances CD4+ regulatory T-cell function: an ex vivo and in vitro longitudinal study in relapsing-remitting multiple sclerosis.
de Andrés C, Aristimuño C, de Las Heras V, Martínez-Ginés LM, Bartolomé M, Arroyo R, Navarro J, Giménez-Roldán S, Fernández-Cruz E, Sánchez-Ramón S
J Neuroimmunol
. 2007 Jan; 182(1-2):204-11. Epub 2006 Dec 08.
PMID: 17157927.
Abstract
Reduces levels of activated T cells
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
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
(67)
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 (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
(60)
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 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
(153)
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
Affects the expression of proteins regulating antigen presentation and cell recognition between T cells and antigen presenting cells
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
Promotes cell death by downregulating anti-apoptosis protein FLIP
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
Shifts T cell differentiation toward the Th2 (anti-inflammatory) response
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
Inhibits CD4+ T cell expression of genes encoding Th22 and Th17 cytokines, including the Th22 cell transcription factor aryl hydrocarbon receptor, the Th1 cell transcription factor T-bet, and the Th17 cell transcription factor retinoic acid–related orphan nuclear hormone receptor C, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Enhances CD4+ T cell expression of the gene encoding the Th2 transcription factor GATA3, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Inhibits CD4+ T cell expression of genes encoding interleukin 17F (IL-17F), IL-21, and IL-27Rα, and enhances expression of the IL-21R gene, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Reduces the fraction of CD4+ T cells expressing interleukin 22 (IL-22) and IL-17F and of CD8+ T cells expressing IL-17A and IL-17F, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Reduces the fraction of CD4+ T cells expressing interleukin 17F, a change that correlates with decreased demyelination, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Increases the fraction of CD4+ and CD8+ T cells expressing interleukin 10, a change that correlates with increased remyelination in normal-appearing brain tissue, as seen in a 6-month study involving 23 individuals with RRMS
(245)
Immunologic and MRI markers of the therapeutic effect of IFN-β-1a in relapsing-remitting MS.
Tao Y, Zhang X, Zivadinov R, Dwyer MG, Kennedy C, Bergsland N, Ramasamy D, Durfee J, Hojnacki D, Hayward B, et al.
Neurol Neuroimmunol Neuroinflamm
. 2015 Dec; 2(6):e176. Epub 2015 Nov 12.
PMID: 26601116.
Abstract
Reduces serum levels of interleukin 17A (IL-17A) in individuals with RRMS who are treated early in the course of the disease (≤1 year from onset), and this reduction is greater than in those treated later; IL-17A levels are increased in treatment naïve individuals with RRMS versus healthy controls
(265)
An Intricate Mechanism of Action of Avonex in Relapsing Remitting Multiple Sclerosis Patients: Variation of Serum Titre of Interleukin-17A, Interleukin-10 and Transforming Growth Factor-β.
Balasa R, Maier S, Voidazan S, Hutanu A, Bajko Z, Motataianu A
CNS Neurol Disord Drug Targets
. 2015; 14(6):804-10.
PMID: 25801840.
Abstract
Interferon beta does not affect the frequency of CD27+CD43+ B1 cells, which is reduced in RRMS
(134)
B1 cells are unaffected by immune modulatory treatment in remitting-relapsing multiple sclerosis patients.
Rovituso D, Heller S, Schroeter M, Kleinschnitz C, Kuerten S
J Neuroimmunol
. 2014 Apr 24.
PMID: 24814390.
Abstract
Reduces serum nitrite levels (by 77%) and the annual relapse rate (by 70%), 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 20 RRMS patients receiving intramuscular interferon beta-1a as monotherapy
(77)
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
Causes upregulation of Toll-like receptor 7 when applied to cultured dendritic cells
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
(11)
IFN-beta1a inhibits the secretion of Th17-polarizing cytokines in human dendritic cells via TLR7 up-regulation.
Zhang X, Jin J, Tang Y, Speer D, Sujkowska D, Markovic-Plese S
J Immunol
. 2009 Mar 15; 182(6):3928-36.
PMID: 19265172.
Abstract
Long-term treatment with Rebif reduces the percentage of circulating 6-sulfo LacNAc(+) dendritic cells, proinflammatory cells that are present in demyelinated brain lesions and are often present in cerebrospinal fluid in individuals with MS
(173)
Accumulation and therapeutic modulation of 6-sulfo LacNAc(+) dendritic cells in multiple sclerosis.
Thomas K, Dietze K, Wehner R, Metz I, Tumani H, Schultheiß T, Günther C, Schäkel K, Reichmann H, Brück W, et al.
Neurol Neuroimmunol Neuroinflamm
. 2014 Oct; 1(3):e33. Epub 2014 Sep 18.
PMID: 25340085.
Abstract
Reduces the secretion of tumor necrosis factor-alpha, interleukin 1beta (IL-1beta), IL-6, and IL-12p70 by isolated, stimulated sulfo LacNAc(+) dendritic cells, proinflammatory cells that are present in demyelinated brain lesions and are often present in cerebrospinal fluid in individuals with MS
(173)
Accumulation and therapeutic modulation of 6-sulfo LacNAc(+) dendritic cells in multiple sclerosis.
Thomas K, Dietze K, Wehner R, Metz I, Tumani H, Schultheiß T, Günther C, Schäkel K, Reichmann H, Brück W, et al.
Neurol Neuroimmunol Neuroinflamm
. 2014 Oct; 1(3):e33. Epub 2014 Sep 18.
PMID: 25340085.
Abstract
Inhibits the ability of isolated, stimulated sulfo LacNAc(+) dendritic cells, proinflammatory cells that are present in demyelinated brain lesions and are often present in cerebrospinal fluid in individuals with MS, to promote differentiation and proliferation of T cells
(173)
Accumulation and therapeutic modulation of 6-sulfo LacNAc(+) dendritic cells in multiple sclerosis.
Thomas K, Dietze K, Wehner R, Metz I, Tumani H, Schultheiß T, Günther C, Schäkel K, Reichmann H, Brück W, et al.
Neurol Neuroimmunol Neuroinflamm
. 2014 Oct; 1(3):e33. Epub 2014 Sep 18.
PMID: 25340085.
Abstract
Interferon beta increases serum levels of endogenous secretory receptor for advanced glycation end-products (esRAGE); serum esRAGE levels are reduced during clinical relapse
(180)
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
(191)
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
(191)
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
(191)
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
(244)
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
May decrease the ability of T cells to cross the blood brain barrier by lowering levels of trophic chemokines that draw Th1 cells to the blood vessel wall
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
Downregulates the expression of matrix metalloproteinases by activated T cells, which limits their ability to cross the blood brain barrier
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
Stabilizes the blood brain barrier in human cell lines as well as cow, pig, and mouse cell lines
(10)
Subcutaneous recombinant interferon-β-1a (Rebif®): a review of its use in the treatment of relapsing multiple sclerosis.
Sanford M, Lyseng-Williamson KA
Drugs
. 2011 Oct 1; 71(14):1865-91.
PMID: 21942977.
Abstract
(12)
Interferon-beta stabilizes barrier characteristics of the blood-brain barrier in four different species in vitro.
Kraus J, Voigt K, Schuller AM, Scholz M, Kim KS, Schilling M, Schäbitz WR, Oschmann P, Engelhardt B
Mult Scler
. 2008 Jul; 14(6):843-52. Epub 2008 May 27.
PMID: 18505778.
Abstract
Might block cytotoxic molecules involved in demyelination
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
Causes the formation of neutralizing antibodies, which may decrease treatment efficacy
(13)
Persistency of neutralizing antibodies depends on titer and interferon-beta preparation.
Hegen H, Schleiser M, Gneiss C, Di Pauli F, Ehling R, Kuenz B, Lutterotti A, Berger T, Deisenhammer F
Mult Scler
. 2011 Oct 19.
PMID: 22013146.
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
(107)
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)
(223)
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
(223)
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 controlled trial data indicated that interferon beta-1a (Avonex) is least likely to lead to the formation of such antibodies (in 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)
(230)
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
Interferon beta is associated with the formation of neutralizing antibodies; a systematic review and meta-analysis of controlled trial data indicated the risk of such antibodies is dose-dependent, such that the risk at the 30 microg dose of interferon beta-1a (Avonex) is 64% less that at the 60 microg dose
(230)
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
Reverts the mature forms of the lysosomal proteases, cathepsin S and D, to the precursor forms in CD34+ hematopoietic stem cells from RRMS patients, the state seen in healthy individuals
(64)
Expression of cathepsins S and D signals a distinctive biochemical trait in CD34+ hematopoietic stem cells of relapsing-remitting multiple sclerosis patients.
Martino S, Montesano S, di Girolamo I, Tiribuzi R, Di Gregorio M, Orlacchio A, Datti A, Calabresi P, Sarchielli P, Orlacchio A
Mult Scler
. 2013 Feb 25.
PMID: 23439581.
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
(86)
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
Reduces serum levels of interleukin 16, which are elevated in individuals with MS, and this reduction begins after 2 months of therapy
(116)
Interferon β-1a reduces increased interleukin-16 levels in multiple sclerosis patients.
Nischwitz S, Faber H, Sämann PG, Domingues HS, Krishnamoorthy G, Knop M, Müller-Sarnowski F, Yassouridis A, Weber F
Acta Neurol Scand
. 2014 Jan 25.
PMID: 24571587.
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
(133)
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
Increases expression of interleukin 10, decreases expression of inducible nitric oxide synthase, and does not affect expression of matrix metallopeptidase 9 or the metallopeptidase inhibitor TIMP-1 at the RNA level in human astrocytoma cells
(249)
Direct immunomodulatory influence of IFN-β on human astrocytoma cells.
Mohsenzadegan M, Fayazi M R, Abdolmaleki M, Bakhshayesh M, Seif F, Mousavizadeh K
Immunopharmacol Immunotoxicol
. 2015 Apr; 37(2):214-9. Epub 2015 Feb 18.
PMID: 25689952.
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
(142)
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
(142)
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
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
(195)
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
Induces a transcriptional response in blood in 60% of individuals with SPMS, which is similar to a gene expression signature in individuals with RRMS who respond to interferon beta-1a treatment, as shown in a study of 50 individuals with SPMS, 20 of whom were treated with interferon beta-1a
(246)
Transcriptional response to interferon beta-1a treatment in patients with secondary progressive multiple sclerosis.
Gurevich M, Miron G, Falb R Z, Magalashvili D, Dolev M, Stern Y, Achiron A
BMC Neurol
. 2015; 15(1):240. Epub 2015 Nov 21.
PMID: 26589141.
Abstract
Treatment may reconstitute inadequate endogenous interferon beta control of pathogenic Th17 cytokine production by CD4+ T cells in RRMS
(155)
The Role of Endogenous IFN-β in the Regulation of Th17 Responses in Patients with Relapsing-Remitting Multiple Sclerosis.
Tao Y, Zhang X, Chopra M, Kim M-J, Buch KR, Kong D, Jin J, Tang Y, Zhu H, Jewells V, et al.
J Immunol
. 2014 May 21.
PMID: 24850724.
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
(125)
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 3.6% (Avonex) or 15.2% (Rebif) 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
(80)
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
(143)
[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
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
(151)
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
(240)
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
Among individuals with clinically isolated syndrome treated with intramuscular interferon beta-1a, several MRI outcomes, measured at baseline and 6 months, were associated with increased risk for clinical disease progression over 48 months in a prospective observational study of 210 individuals
(210)
Early magnetic resonance imaging predictors of clinical progression after 48 months in clinically isolated syndrome patients treated with intramuscular interferon β-1a.
Uher T, Horakova D, Kalincik T, Bergsland N, Tyblova M, Ramasamy DP, Seidl Z, Vaneckova M, Krasensky J, Havrdova E, et al.
Eur J Neurol
. 2015 Apr 22.
PMID: 25904020.
Abstract
Intramuscular version reduces gray matter atrophy (which is associated with sustained disability progression) but not white matter atrophy, as shown by retrospective analysis of placebo-controlled clinical trial data from 140 individuals with RRMS; the reduction in gray matter atrophy was seen during year 2 of treatment
(227)
Effect of intramuscular interferon beta-1a on gray matter atrophy in relapsing-remitting multiple sclerosis: A retrospective analysis.
Fisher E, Nakamura K, Lee J-C, You X, Sperling B, Rudick RA
Mult Scler
. 2015 Aug 3.
PMID: 26238463.
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
(262)
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
(55)
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
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
(83)
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)
(183)
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
(130)
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
(181)
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
Effects on MRI activity and systemic markers of inflammation do not appear to be influenced by serum vitamin D levels, as shown by a study of 88 individuals with RRMS
(212)
Vitamin D status and effect of interferon-β1a treatment on MRI activity and serum inflammation markers in relapsing-remitting multiple sclerosis.
Røsjø E, Myhr K-M, Løken-Amsrud KI, Bakke SJ, Beiske AG, Bjerve KS, Hovdal H, Lilleås F, Midgard R, Pedersen T, et al.
J Neuroimmunol
. 2015 Mar 15; 280:21-8. Epub 2015 Feb 11.
PMID: 25773151.
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
(271)
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
(213)
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:
Promotes neuronal growth and survival in cultured mouse cells
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
(14)
Alpha/beta interferon is a neuronal growth factor.
Plioplys AV, Massimini N
Neuroimmunomodulation
. 1995 Jan-Feb; 2(1):31-5.
PMID: 7614258.
Abstract
Promotes the release of nerve growth factor in cultured astrocyte cells
(9)
Mechanisms of action for treatments in multiple sclerosis: Does a heterogeneous disease demand a multi-targeted therapeutic approach?
Chofflon M
BioDrugs
. 2005; 19(5):299-308.
PMID: 16207071.
Abstract
(15)
Interferon-beta is a potent promoter of nerve growth factor production by astrocytes.
Boutros T, Croze E, Yong VW
J Neurochem
. 1997 Sep; 69(3):939-46.
PMID: 9282915.
Abstract
Protects neurons against injury induced by a mitochondrial complex I toxin, but not injury induced by a complex II toxin, as determined by studying rat brain striatal slices using electrophysiological techniques
(97)
Interferon-β1a protects neurons against mitochondrial toxicity via modulation of STAT1 signaling: Electrophysiological evidence.
Di Filippo M, Tozzi A, Tantucci M, Arcangeli S, Chiasserini D, Ghiglieri V, de Iure A, Calabresi P
Neurobiol Dis
. 2013 Oct 14.
PMID: 24135008.
Abstract
Neuroprotective effect against mitochondrial complex I inhibition requires STAT1 signaling, as shown by studies of rat brain striatal slices
(97)
Interferon-β1a protects neurons against mitochondrial toxicity via modulation of STAT1 signaling: Electrophysiological evidence.
Di Filippo M, Tozzi A, Tantucci M, Arcangeli S, Chiasserini D, Ghiglieri V, de Iure A, Calabresi P
Neurobiol Dis
. 2013 Oct 14.
PMID: 24135008.
Abstract
Neuroprotective effect against mitochondrial complex I inhibition occurs in striatal brain slices from experimental autoimmune encephalomyelitis (EAE) mice as well as in slices from control mice, even though the toxicity of such inhibition is more extreme in EAE
(97)
Interferon-β1a protects neurons against mitochondrial toxicity via modulation of STAT1 signaling: Electrophysiological evidence.
Di Filippo M, Tozzi A, Tantucci M, Arcangeli S, Chiasserini D, Ghiglieri V, de Iure A, Calabresi P
Neurobiol Dis
. 2013 Oct 14.
PMID: 24135008.
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
(122)
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
(144)
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
(191)
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
(191)
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
(191)
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
(191)
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
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Highest status achieved (for any condition):
Approved
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Other uses:
Early stage trials for Alzheimer’s disease
(27)
A Pilot Trial of Interferon beta-1a in Alzheimer's Disease
ClinicalTrials.gov,
March 2005
Accessed on 13 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT01075763.
Has been studied for HTLV-1-associaed myelopathy
(28)
Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)
ClinicalTrials.gov,
3 Mar 2008
Accessed on 15 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00001785.
Early stage trials for stroke
(29)
Safety Study of Interferon Beta-1a for Acute Stroke
ClinicalTrials.gov,
3 Jun 2011
Accessed on 15 Mar 2012 from http://clinicaltrials.gov/ct2/show/NCT00097318.
Administration:
Intramuscular
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Subcutaneous
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Plegridy dose is 125 microg injected subcutaneously once every 2 weeks, according to information from the manufacturer
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
Missing a dose within the first month of observation is associated with reduced adherence to treatment and increased chance of relapse
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Negative effects:
Peginterferon beta-1a is associated with lower frequencies of adverse events than subcutaneous interferon beta-1a (Rebif), as shown in a crossover study involving 30 healthy individuals
(269)
COMPARE: pharmacokinetic profiles of subcutaneous peginterferon beta-1a and subcutaneous interferon beta-1a over 2 weeks in healthy subjects.
Hu X, Shang S, Nestorov I, Hasan J, Seddighzadeh A, Dawson K, Sperling B, Werneburg B
Br J Clin Pharmacol
. 2016 Apr 8.
PMID: 27060836.
Abstract
Abdominal pain
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Asthenia (weakness)
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Autoimmune disorders
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Cardiovascular events
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Reversible cerebral vasoconstriction syndrome has been reported in an individual with MS treated with interferon beta-1a
(266)
Reversible cerebral vasoconstriction syndrome associated with interferon beta-1a use for multiple sclerosis.
Strohm T, Chaudhry B, Willis MA, Shook S
Mult Scler
. 2016 Mar 24.
PMID: 27012659.
Abstract
Chills
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Depression
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Fever
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Flu syndrome
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Associated with flu-like syndrome (FLS); individuals carrying a G>C polymorphism at position -174 in the interleukin 6 (IL-6) promoter in at least 1 copy of the IL-6 gene exhibit reduced levels of serum IL-6 and are less likely to develop FLS (which is less severe when it does occur), as shown in a prospective observational study involving 190 individuals with MS beginning treatment with intramuscular interferon beta-1a
(231)
Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position -174 of the IL-6 Promoter Gene.
Bertoli D, Serana F, Sottini A, Cordioli C, Maimone D, Amato M P, Centonze D, Florio C, Puma E, Capra R, et al.
PLoS One
. 2015; 10(8):e0135441. Epub 2015 Aug 18.
PMID: 26285213.
Abstract
Associated with flu-like syndrome (FLS); individuals carrying a G>A polymorphism at position -376 in the tumor necrosis factor-alpha promoter do not exhibit a reduced risk for FLS, as shown in a prospective observational study involving 190 individuals with MS beginning treatment with intramuscular interferon beta-1a
(231)
Less Frequent and Less Severe Flu-Like Syndrome in Interferon Beta-1a Treated Multiple Sclerosis Patients with at Least One Allele Bearing the G>C Polymorphism at Position -174 of the IL-6 Promoter Gene.
Bertoli D, Serana F, Sottini A, Cordioli C, Maimone D, Amato M P, Centonze D, Florio C, Puma E, Capra R, et al.
PLoS One
. 2015; 10(8):e0135441. Epub 2015 Aug 18.
PMID: 26285213.
Abstract
Associated with tip variant focal segmental glomerulosclerosis in one individual with MS
(194)
Tip variant focal segmental glomerulosclerosis associated with interferon-β treatment of multiple sclerosis.
Evans R, Rudd P, Bass P, Harber M
BMJ Case Rep
. 2014; 2014.
PMID: 24503666.
Abstract
Headache
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Rebif was associated with the development of an autoimmune hepatitis-like syndrome after therapy began in one individual
(129)
Autoimmune Hepatitis-like reaction developing in a patient treated with Interferon beta 1a.
Mishra A, Guindi M, Kandel G, Streutker CJ
Histopathology
. 2014 May 5.
PMID: 24796493.
Abstract
Associated with severe acute autoimmune hepatitis in two individuals with MS
(192)
Interferon beta 1a-induced severe autoimmune hepatitis in patients with multiple sclerosis: report of two cases and review of the literature.
Villamil A, Mullen E, Casciato P, Gadano A
Ann Hepatol
. 2015 Mar-Apr; 14(2):273-80.
PMID: 25671839.
Abstract
Injection site reactions
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Long-term use (≥2 years) is associated with a high prevalence (82% for subcutaneous administration and 41% for intramuscular administration) of individuals exhibiting ≥1 cutaneous adverse event at a given point in time, based on a cross-sectional study
(168)
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
Leukopenia
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Myalgia
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Can induce the production of neutralizing antibodies (NABs) against interferon beta, which might suppress the anti-viral effects of endogenous interferon beta, as suggested by a case study in which a woman with MS exhibited genital herpes reactivation after stopping and re-starting interferon beta-1a treatment; she displayed high NAB titers
(197)
Do neutralising antibodies against exogenous interferon-beta inhibit endogenous signalling pathways?
Fine D, Dattani A, Moreira I, Giovannoni G, Marta M
Mult Scler Relat Disord
. 2015 Jan; 4(1):88-91. Epub 2014 Nov 28.
PMID: 25787060.
Abstract
Seizures
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Elevated liver enzymes
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Severe liver injury
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
(26)
Avonex drug warning letter, severe hypatic injury
Food and Drug Administration,
Mar 2005
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164412.pdf.
Associated with acute liver failure, which occurred 4 weeks after initiation of treatment with interferon beta-1a, in an individual with MS
(248)
Acute liver failure and liver transplantation in a patient with multiple sclerosis treated with interferon beta.
Kozielewicz D, Pawłowska M
Neurol Neurochir Pol
. 2015; 49(6):451-5. Epub 2015 Sep 09.
PMID: 26652882.
Abstract
Pulmonary arterial hypertension has been reported in two individuals with RRMS on long-term interferon beta-1a therapy; symptoms stabilized in one case after interferon beta-1a treatment ceased
(242)
Interferon beta-1a long-term therapy related to pulmonary arterial hypertension in multiple sclerosis patients.
Fok A, Williams T, McLean CA, Butler E
Mult Scler
. 2015 Nov 12.
PMID: 26564996.
Abstract
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
(57)
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
May have promoted the relapse of non-seminomatous testicular cancer in the lung and lymph nodes in one individual with MS
(170)
Late relapse of non-seminomatous testicular cancer during treatment of multiple sclerosis with interferon β-1a: A case report.
Blancas I, Cárdenas N, Delgado M, Jurado J M, Legeren M, Villaescusa A, Galvez F, Yelamos M
Oncol Lett
. 2014 Nov; 8(5):2179-2182. Epub 2014 Sep 10.
PMID: 25289098.
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
(63)
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
Rebif has been associated with an unanticipated number of cases of thrombotic microangiopathy linked with severe hypertension; the cases have occurred in individuals with MS who had been treated for years with this drug but who did not exhibit other potential causal factors, including genetic factors
(119)
Thrombotic microangiopathy associated with use of interferon-beta.
Olea T, Díaz-Mancebo R, Picazo M-L, Martínez-Ara J, Robles A, Selgas R
Int J Nephrol Renovasc Dis
. 2012; 5:97-100. Epub 2012 Jun 15.
PMID: 22815645.
Abstract
Rebif has been linked with 4 cases of thrombotic microangiopathy associated with severe or malignant hypertension in Scotland; in each case, the individuals had previously tolerated treatment well for years
(124)
Thrombotic microangiopathy associated with interferon beta.
Hunt D, Kavanagh D, Drummond I, Weller B, Bellamy C, Overell J, Evans S, Jackson A, Chandran S
N Engl J Med
. 2014 Mar 27; 370(13):1270-1.
PMID: 24670186.
Abstract
Association of interferon beta drugs with thrombotic microangiopathy and nephrotic syndrome has led the European Medicines Agency to require stronger label warnings for Avonex, Plegridy, and Rebif (August 2014)
(156)
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.
The rate of thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and hemolytic uremic syndrome reports associated with subcutaneous interferon beta-1a was found to be 7.2 per 100,000 patient-years in a cumulative review of a global safety database
(206)
Cumulative review of thrombotic microangiopathy, thrombotic thrombocytopenic purpura and hemolytic uremic syndrome reports with SC interferon beta-1a.
Amor AF, Trochanov A, Johnson J
Mult Scler Relat Disord
. 2014 Nov; 3(6):756-7. Epub 2014 Nov 21.
PMID: 25891600.
Abstract
Warning about a risk of thrombotic microangiopathy has been added to the patient package insert of Avonex, Plegridy, and Rebif by the US Food and Drug Administration (December 2015)
(253)
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
(113)
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
(184)
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
Does not affect thyroid or salivary gland function in individuals with RRMS, as assessed with quantitative salivary gland scintigraphy
(141)
Assessment of the effect of interferon-beta1a therapy on thyroid and salivary gland functions in patients with multiple sclerosis using quantitative salivary gland scintigraphyz.
Erhamamcı S, Horasanlı B, Aktaş A
Mol Imaging Radionucl Ther
. 2014 Jun; 23(2):43-7. Epub 2014 Jun 05.
PMID: 24963444.
Abstract
Exposure to interferon beta during pregnancy does not seem to be a major teratogenic risk, based on an analysis of 78 pregnancies
(46)
Multiple sclerosis and pregnancy: experience from a nationwide database in Germany.
Hellwig K, Haghikia A, Rockhoff M, Gold R
Ther Adv Neurol Disord
. 2012 Sep; 5(5):247-53.
PMID: 22973421.
Abstract
Exposure 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
(118)
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
(137)
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
(250)
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)
(109)
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
(178)
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
Does not appear to affect pure-tone hearing sensitivity at test frequencies ranging from 250 to 6000 Hz, but it is unclear whether there is an ototoxic effect at 8000 Hz
(179)
Does interferon Beta-1a impact pure-tone hearing sensitivity among individuals with multiple sclerosis?
Lewis SM, McMillan GP, Hutter M, Folmer RL, Wilmington D, Casiana L, Fitzpatrick M, Lilly DJ, Bourdette D, Overs S, et al.
J Neurosci Nurs
. 2014 Dec; 46(6):351-60.
PMID: 25365049.
Abstract
Commercial:
Avonex was developed and is manufactured and marketed by Biogen Idec
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Rebif is manufactured by EMD Serono and is co-marketed by Serono and Pfizer in the US as of 2003
(2)
Rebif approval application
Food and Drug Administration,
May 2003
Accessed on 12 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm106178.pdf.
Plegridy (a form of interferon beta-1a that is pegylated to increase its half-life, allowing dosing less frequently) was developed by Biogen Idec
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
CinnoVex was engineered and developed by the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Germany in a collaboration with CinnaGen in Iran
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
CinnoVex has been approved as a biogeneric by the Iranian Food and Drug Administration (2006)
(167)
Generic interferon-beta
Fraunhofer Institute for Interfacial Engineering and Biotechnology
Accessed on 3 Oct 2014 from http://www.igb.fraunhofer.de/en/competences/molecular-biotechnology/therapeutic-proteins/generic-interferon.html.
CinnoVex is manufactured and marketed by CinnaGen
(3)
CinnoVex home page
CinnaGen
Accessed on 15 Mar 2012 from http://www.cinnovex.com/.
Rebif Rebidose (a single-use auto-injector for interferon beta-1a) has been approved by the US Food and Drug Administration (3 January 2013)
(54)
EMD Serono and Pfizer announce FDA approval of Rebif® Rebidose® (interferon beta-1a)
EMD Serono,
3 Jan 2013
Accessed on 7 Jan 2013 from http://www.emdserono.com/cmg.emdserono_us/en/images/121204-183958_Rebif%20Rebidose%20Approval%20Press%20Release_FINAL_tcm115_104286.pdf.
Biologics License Application for Plegridy has been submitted to the US Food and Drug Administration by Biogen Idec (21 May 2013)
(74)
Biogen Idec submits application to FDA for approval of PLEGRIDY™ (peginterferon beta-1a) in multiple sclerosis
Biogen Idec,
21 May 2013
Accessed on 31 May 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1822494.
Biologics License Application for marketing approval of Plegridy has been accepted by the US Food and Drug Administration; a standard review timeline (about 10 months) will be used (19 July 2013)
(84)
US and EU regulatory authorities accept PLEGRIDY™ (peginterferon beta-1a) marketing applications for review
Biogen Idec,
19 Jul 2013
Accessed on 25 Jul 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1839270.
(85)
Biogen Idec's long-acting beta interferon moves ahead in MS
PMLiVE,
23 Jul 2013
Accessed on 25 Jul 2013 from http://www.pmlive.com/pharma_news/biogen_idecs_long-acting_beta_interferon_moves_ahead_in_ms_491668.
Marketing Authorisation Application for review of Plegridy in the EU has been accepted by the European Medicines Agency (19 July 2013)
(84)
US and EU regulatory authorities accept PLEGRIDY™ (peginterferon beta-1a) marketing applications for review
Biogen Idec,
19 Jul 2013
Accessed on 25 Jul 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1839270.
Rebif will lose patent protection at the end of 2013
(102)
3 Blockbuster Drugs Losing Patent Protection in 2013's Final Months
Carroll D, Daily Finance,
31 Oct 2013
Accessed on 6 Nov 2013 from http://www.dailyfinance.com/2013/10/31/3-blockbuster-drugs-losing-patent-protection-in-20/.
Date for review of the Biologics License Application for marketing approval of Plegridy by the US Food and Drug Administration has been extended by three months (March 2014)
(117)
Biogen Idec receives notification of PDUFA date extension for PLEGRIDY™ (peginterferon beta-1a)
Biogen Idec,
18 Mar 2014
Accessed on 18 Mar 2014 from https://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2293&M=NewsV2&PID=61997.
Plegridy has been recommended for approval for treating RRMS by the Committee for Medicinal Products for Human Use of the European Medicines Agency (23 May 2014)
(135)
CHMP adopts positive opinion for PLEGRIDY™ (peginterferon beta-1a) as a treatment for multiple sclerosis in the European Union
Biogen Idec,
23 May 2014
Accessed on 26 May 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2332&M=NewsV2&PID=61997.
Plegridy has been approved in the EU for treating adults with RRMS (23 July 2014)
(146)
PLEGRIDY™ (peginterferon beta-1a) approved in the European Union for the treatment of multiple sclerosis
Biogen Idec,
23 Jul 2014
Accessed on 24 Jul 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2367&M=NewsV2&PID=61997.
Plegridy has been approved in the US for treating individuals with relapsing forms of MS (15 August 2014)
(152)
Biogen Idec's PLEGRIDY™ (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Biogen Idec,
15 Aug 2014
Accessed on 19 Aug 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997.
Biogen Idec, which markets Avonex and Plegridy, has changed its name to Biogen (23 March 2015)
(211)
Biogen Idec Becomes Biogen
Biogen,
23 Mar 2015
Accessed on 7 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/corporate/biogen-idec-becomes-biogen.
Plegridy has been approved in Canada for treating adults with RRMS (13 August 2015)
(229)
Health Canada Approves PLEGRIDY™ (peginterferon beta-1a) for Adults with Relapsing Remitting Multiple Sclerosis
PR Newswire,
13 Aug 2015
Accessed on 18 Aug 2015 from https://www.virtualpressoffice.com/publicsiteContentFileAccess?fileContentId=2102825&fromOtherPageToDisableHistory=Y&menuName=News&sId=&sInfo=.
Sole rights to Rebif in the US have been taken on by EMD Serono as of 1 January 2016
(251)
EMD Serono Takes on Exclusive Promotion of Rebif® (interferon beta-1a) in the US
EMD Serono,
19 Jan 2016
Accessed on 19 Jan 2016 from http://www.emdserono.com/ms.country.us/en/images/January%20NDD%202016%20release_Final_tcm115_146142.pdf?Version=.
Key Clinical Trials
Placebo-controlled Trials:
Trial name:
Sørensen et al., Eur. J. Neurol., February 2016 trial (RECYCLINE)
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
Phase:
Phase II trial
(255)
Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] (RECYCLINE)
ClinicalTrials.gov,
2 Dec 2013
Accessed on 12 Feb 2016 from https://www.clinicaltrials.gov/ct2/show/NCT01134627.
Study Design:
Industry-sponsored, double-blind, randomized, multicenter, placebo-controlled trial to compare the effects of a combination of minocycline (100 mg twice a day) and subcutaneous interferon beta-1a (44 microg 3 times a week) versus interferon beta-1a and placebo on the time to first relapse (primary endpoint) and the annualized relapse rate and MRI measures (secondary endpoints)
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
(255)
Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] (RECYCLINE)
ClinicalTrials.gov,
2 Dec 2013
Accessed on 12 Feb 2016 from https://www.clinicaltrials.gov/ct2/show/NCT01134627.
Disease Stage:
RRMS
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
Enrollment/Number of Patients:
304
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
Duration:
96 weeks
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
Status/Outcome:
Minocycline did not affect the time to first relapse or other efficacy measures in a statistically significant manner; more participants in the minocycine versus placebo groups discontinued because of adverse events
(254)
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Sørensen PS, Sellebjerg F, Lycke J, Färkkilä M, Créange A, Lund CG, Schluep M, Frederiksen JL, Stenager E, Pfleger C, et al.
Eur J Neurol
. 2016 Feb 5.
PMID: 26848561.
Abstract
Trial name:
Fox et al., Neurology, April 2014 study (RESTORE)
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
(247)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol
. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09.
PMID: 25381458.
Abstract
Phase:
Exploratory study
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
Study Design:
Industry-funded, randomized, partially placebo-controlled exploratory study to examine disease activity in individuals who had been treated with natalizumab (with no relapse activity during the previous year and no gadolinium-enhancing lesions at the time of screening) during an interruption of natalizumab treatment; participants received either natalizumab, interferon beta-1a, glatiramer acetate, methylprednisolone, or placebo during the interruption
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
(247)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol
. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09.
PMID: 25381458.
Abstract
Disease Stage:
RRMS
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
Enrollment/Number of Patients:
175
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
Duration:
24 weeks (length of interruption)
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
Status/Outcome:
Interruption in natalizumab treatment was associated with an increased risk of MRI and relapse activity even when other therapies were used; relapses occurred in 4% of participants receiving natalizumab versus 15% to 29% of participants in other arms of the study
(121)
MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study.
Fox RJ, Cree BAC, De Sèze J, Gold R, Hartung H-P, Jeffery D, Kappos L, Kaufman M, Montalbán X, Weinstock-Guttman B, et al.
Neurology
. 2014 Apr 9. Epub 2014 Mar 28.
PMID: 24682966.
Abstract
; during the randomized treatment period, gadolinium-enhancing lesions were observed in 0% of individuals receiving natalizumab, 48% of those receiving other treatments, and 61% of those on placebo; such lesions were primarily observed at week 16 or later
(247)
Radiologic MS disease activity during natalizumab treatment interruption: findings from RESTORE.
Kaufman M, Cree BAC, De Sèze J, Fox RJ, Gold R, Hartung H-P, Jeffery D, Kappos L, Montalbán X, Weinstock-Guttman B, et al.
J Neurol
. 2015 Feb; 262(2):326-36. Epub 2014 Nov 09.
PMID: 25381458.
Abstract
Trial name:
ADVANCE (press releases, 2013, 2014; publ 2014)
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
(66)
Positive year one results from Biogen Idec's Phase 3 advance trial of PLEGRIDY™ (peginterferon beta-1a) presented at AAN meeting
Biogen Idec,
20 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1798258.
(89)
New data analyses show significant clinical and MRI improvements with PLEGRIDY™ (peginterferon beta-1a)
Biogen Idec,
1 Oct 2013
Accessed on 5 Oct 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1860099.
(162)
PLEGRIDY™ (peginterferon beta-1a) two-year data confirm maintenance of efficacy and safety in multiple sclerosis patients
Biogen Idec,
11 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2375&M=NewsV2&PID=61997.
(126)
Biogen Idec to present new two-year data from the PLEGRIDY™ (peginterferon beta-1a) Phase III advance study at AAN annual meeting
Biogen Idec,
29 Apr 2014
Accessed on 15 May 2014 from https://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2319&M=NewsV2&PID=61997.
(162)
PLEGRIDY™ (peginterferon beta-1a) two-year data confirm maintenance of efficacy and safety in multiple sclerosis patients
Biogen Idec,
11 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2375&M=NewsV2&PID=61997.
(189)
Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis.
Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S
BMC Neurol
. 2014 Dec 31; 14(1):1058. Epub 2014 Dec 31.
PMID: 25551571.
Abstract
Phase:
Phase III trial
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
Study Design:
Company-sponsored, global, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial to test the safety and efficacy of peginterferon beta-1a, a form of interferon beta-1a that is pegylated to increase its half-life, given subcutaneously at a dose of 125 microg either once every 2 weeks or once every 4 weeks; the primary endpoint is the annualized relapse rate (ARR) at 1 year
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
; trial was placebo-controlled for the first year
(162)
PLEGRIDY™ (peginterferon beta-1a) two-year data confirm maintenance of efficacy and safety in multiple sclerosis patients
Biogen Idec,
11 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2375&M=NewsV2&PID=61997.
Disease Stage:
RRMS
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
Enrollment/Number of Patients:
1516
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
Duration:
2 years
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
Status/Outcome:
Peginterferon beta-1a was associated with a significant reduction in ARR at one year (35.6% for the two-week dosing and 27.5% for the four-week dosing) as compared to placebo
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
; also at 1 year, peginterferon beta-1a decreased the percentage of patients who relapsed (by 39%), the number of new T2-hyperintense lesions (by 67%), and the risk of 12-week confirmed disability progression (by 38%) as compared to placebo
(66)
Positive year one results from Biogen Idec's Phase 3 advance trial of PLEGRIDY™ (peginterferon beta-1a) presented at AAN meeting
Biogen Idec,
20 Mar 2013
Accessed on 21 Mar 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1798258.
; from baseline to week 48, peginterferon beta-1a increased the percentage of patients who displayed no measured disease activity (33.9% for the 2-week dose and 21.5% for the 4-week dose versus 15.1% for placebo)
(189)
Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis.
Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S
BMC Neurol
. 2014 Dec 31; 14(1):1058. Epub 2014 Dec 31.
PMID: 25551571.
Abstract
and, at 48 weeks, reduced the number of new T1-hypointense lesions (by 53% and 18% for the 2- and 4-week doses) and new active lesions (by 67% and 35% for the 2- and 4-week doses)
(89)
New data analyses show significant clinical and MRI improvements with PLEGRIDY™ (peginterferon beta-1a)
Biogen Idec,
1 Oct 2013
Accessed on 5 Oct 2013 from http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1860099.
; at 2 years, the ARR was 0.221 for the 2-week dose (a reduction relative to the ARR from year 1), 0.291 for the 4-week dose, and 0.351 for placebo
(126)
Biogen Idec to present new two-year data from the PLEGRIDY™ (peginterferon beta-1a) Phase III advance study at AAN annual meeting
Biogen Idec,
29 Apr 2014
Accessed on 15 May 2014 from https://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2319&M=NewsV2&PID=61997.
(127)
Study shows promising efficacy for peginterferon beta-1a in multiple sclerosis
Oakes K, HCP Live,
30 Apr 2014
Accessed on 15 May 2014 from http://www.hcplive.com/conferences/2014-aan/Study-Shows-Promising-Efficacy-for-Peginterferon-Beta-1a-in-Multiple-Sclerosis.
; post-hoc analysis showed that the peginterferon beta-1a's effects on disease activity and disability were maintained at 2 years; additionally, individuals who received peginterferon beta-1a for both years exhibited better clinical and MRI results after 2 years than did those who switched to drug after a year of placebo
(162)
PLEGRIDY™ (peginterferon beta-1a) two-year data confirm maintenance of efficacy and safety in multiple sclerosis patients
Biogen Idec,
11 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2375&M=NewsV2&PID=61997.
; pharmacokinetic and pharmacodynamic profiles established during this trial provide a potential rationale for the increased efficacy of dosing every 2 weeks
(169)
Title: Pharmacokinetics and Pharmacodynamics of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis in the Randomised ADVANCE Study.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S
Br J Clin Pharmacol
. 2014 Sep 29.
PMID: 25265472.
Abstract
Trial name:
Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) (publ 2006)
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Phase:
Phase III trial
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Study Design:
Industry-sponsored, multinational, randomized, double-blind, placebo-controlled, parallel-group trial to determine if natalizumab (300 mg intravenously every 4 weeks) together with interferon beta-1a (30 microg intramuscularly every week) is more effective than interferon beta-1a alone in reducing breakthrough disease activity in patients who had received interferon beta-1a treatment for at least 12 months before randomization in study (with at least one relapse in the 12 months before randomization), with the rate of clinical relapse at 1 year and the cumulative probabilty of disability progression at 2 years the primary end points
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Disease Stage:
RRMS
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Enrollment/Number of Patients:
1171, with 1003 completing the study
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Duration:
2 years
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
Status/Outcome:
Combination therapy was associated with a 23% cumulative probability of sustained disability progression at 2 years versus 29% with interferon beta-1a alone; combination therapy reduced the risk of sustained disability progression by 24% and reduced the annualized rate of relapse by 54% (at 1 year) and 55% (at 2 years) as compared to interferon beta-1a alone; trial was stopped 1 month early because of two cases of progressive multifocal leukoencephalopathy, one of which was fatal
(160)
Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue E-W, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, et al.
N Engl J Med
. 2006 Mar 2; 354(9):911-23.
PMID: 16510745.
Abstract
; retrospective analysis of AFFIRM (natalizumab), SENTINEL (natalizumab and interferon beta-1a), and IMPACT (interferon beta-1a) trial data showed that 20% to 25% decreases in speed in the timed 25-foot walk correspond to clinically-meaningful reductions in physical component summary scores
(159)
The Clinical Meaning of Walking Speed as Measured by the Timed 25-Foot Walk in Patients With Multiple Sclerosis.
Cohen JA, Krishnan AV, Goodman AD, Potts J, Wang P, Havrdova E, Polman C, Rudick RA
JAMA Neurol
. 2014 Sep 1.
PMID: 25178496.
Abstract
Trial name:
Cohen et al., Neurology, September 2002 trial [International MS Secondary Progressive Avonex Controlled Trial (IMPACT)]
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
Phase:
Phase III trial
(158)
Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Jak AJ, Kniker JE, Kooijmans MF, Lull JM, Sandrock AW, et al.
Arch Neurol
. 2001 Jun; 58(6):961-7.
PMID: 11405811.
Abstract
Study Design:
Industry-sponsored, randomized, double-blind, placebo-controlled, two-arm, multinational trial to examine the effects of interferon beta-1a (60 microg, given intramuscularly once per week) on changes in the MS Functional Composite (MSFC), a clinical outcome measure encompasing a timed 25-foot walk and tests of arm function and cognition (primary outcome measure)
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
(158)
Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Jak AJ, Kniker JE, Kooijmans MF, Lull JM, Sandrock AW, et al.
Arch Neurol
. 2001 Jun; 58(6):961-7.
PMID: 11405811.
Abstract
Disease Stage:
SPMS
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
Enrollment/Number of Patients:
436
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
Duration:
2 years
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
Status/Outcome:
Interferon beta-1a was associated with reduced MSFC progression (primarily through an effect on measures of arm function and cognition), reduced relapses, and improved quality of life; the drug was not associated with benefits to Expanded Disability Status Scale scores (which primarily reflect walking ability in these individuals)
(157)
Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.
Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, Sandrock AW, Rudick RA, Simon JH, Simonian NA, et al.
Neurology
. 2002 Sep 10; 59(5):679-87.
PMID: 12221157.
Abstract
; retrospective analysis of AFFIRM (natalizumab), SENTINEL (natalizumab and interferon beta-1a), and IMPACT (interferon beta-1a) trial data showed that 20% to 25% decreases in speed in the timed 25-foot walk correspond to clinically-meaningful reductions in physical component summary scores
(159)
The Clinical Meaning of Walking Speed as Measured by the Timed 25-Foot Walk in Patients With Multiple Sclerosis.
Cohen JA, Krishnan AV, Goodman AD, Potts J, Wang P, Havrdova E, Polman C, Rudick RA
JAMA Neurol
. 2014 Sep 1.
PMID: 25178496.
Abstract
Trial name:
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon Beta-1a in MS (SPECTRIMS) trial (publ 2001)
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
(20)
Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results.
Li DK, Zhao GJ, Paty DW, University of British Columbia MS/MRI Analysis Research Group. The SPECTRIMS Study Group
Neurology
. 2001 Jun 12; 56(11):1505-13.
PMID: 11402107.
Abstract
Phase:
Phase III trial
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
Study Design:
Randomized, placebo-controlled, multicenter parallel-group study to determine whether interferon beta-1a (subcutaneous, 22 or 44 micrograms 3x weekly) increased time to confirmed progression of disability (primary endpoint)
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
Disease Stage:
SPMS
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
Enrollment/Number of Patients:
618
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
Duration:
3 years
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
Status/Outcome:
No significant effect on disability progression, although there appeared to be greater benefit in women; caused significant improvement on MRI measures, particularly in patients who had experienced relapses in the past two years
(19)
Randomized controlled trial of interferon- beta-1a in secondary progressive MS: Clinical results.
Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS(SPECTRIMS) Study Group
Neurology
. 2001 Jun 12; 56(11):1496-504.
PMID: 11402106.
Abstract
(20)
Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results.
Li DK, Zhao GJ, Paty DW, University of British Columbia MS/MRI Analysis Research Group. The SPECTRIMS Study Group
Neurology
. 2001 Jun 12; 56(11):1505-13.
PMID: 11402107.
Abstract
Trial name:
Controlled High Risk Avonex Multiple Sclerosis (CHAMPS) trial (publ 2001)
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Phase:
Phase III trial
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Study Design:
A randomized, double-blind, placebo-controlled, multicenter trial to determine whether weekly injections of drug (intramuscular) in patients experiencing a single demyelinating event lowered the incidence of MS (primary endpoint)
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Disease Stage:
CIS
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Enrollment/Number of Patients:
383 individuals who had experienced a first demyelinating event and showed MRI evidence of two or more clinically silent lesions of the brain
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Duration:
3 years
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
Status/Outcome:
After 3 years of treatment, the probability that patients had developed clinically defined MS was 35% for the interferon group and 50% for the placebo group; patients on interferon also showed a relative reduction in the volume of brain lesions, fewer new or enlarging lesions, and fewer gadolinium-enhancing lesions
(21)
Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.
Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, Simonian NA, Slasor PJ, Sandrock AW
N Engl J Med
. 2000 Sep 28; 343(13):898-904.
PMID: 11006365.
Abstract
; high levels of MRI activity (≥2 new T2 and/or ≥2 gadolinium-enhancing lesions) 6 months after initiation of treatment was found to predict nonresponse to interferon beta-1a
(208)
Early MRI activity predicts treatment nonresponse with intramuscular interferon beta-1a in clinically isolated syndrome.
Kinkel RP, Simon JH, O'Connor P, Hyde R, Pace A
Mult Scler Relat Disord
. 2014 Nov; 3(6):712-9. Epub 2014 Aug 27.
PMID: 25891550.
Abstract
Trial name:
Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) trial (publ 1998)
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Phase:
Phase III trial
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Study Design:
Randomized, double-blind, placebo-controlled, multicenter study to test the efficacy of two doses (22 micrograms and 44 micrograms) of subcutaneous interferon beta-1a therapy, with the primary endpont the relapse rate
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Disease Stage:
RRMS
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Enrollment/Number of Patients:
560 patients
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Duration:
2 years
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Status/Outcome:
Treatment significantly reduced relapse rate (mean number per patient: 1.82 at 22 micrograms; 1.73 at 44 micrograms; 2.56 for placebo); time to first relapse was extended by 3 (22 micrograms) and 5 (44 micrograms) months
(22)
Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group.
Lancet
. 1998 Nov 7; 352(9139):1498-504.
PMID: 9820297.
Abstract
Trial name:
Multiple Sclerosis Collaborative Research Group, Ann. Neurol., March 1996 trial
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Phase:
Phase III trial
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Study Design:
Randomized, placebo-controlled, multicenter trial examining whether interferon beta-1a (30 micrograms/week, intramuscularly) could delay time to sustained sustained disability progression of at least one point on the Kurtzke Expanded Disability Status Scale (primary endpoint)
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Disease Stage:
RRMS
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Enrollment/Number of Patients:
301 patients enrolled; because the study was stopped prematurely, just 282 completed 1 year, 172 completed 2 years
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
(1)
Avonex approval application
Food and Drug Administration,
31 Jan 2003
Accessed on 15 Mar 2012 from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm086060.pdf.
Duration:
2 years
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Status/Outcome:
34.9% of patients progressed on placebo, whereas 21.9% progressed on drug; annual exacerbation rate was 0.90 with placebo and 0.61 with drug
(23)
Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG)
Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, Fischer JS, Goodkin DE, Granger CV, Simon JH, et al.
Ann Neurol
. 1996 Mar; 39(3):285-94.
PMID: 8602746.
Abstract
Head-to-Head Trials:
Trial name:
Relapsing Multiple Sclerosis (OPERA I) (press release, June 2015; meeting report, October 2015)
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(219)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech,
19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(220)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech,
29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
(237)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today,
9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Phase:
Phase III trial
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Study Design:
Company-funded, randomized, double-blind, double-dummy parallel-group, multicenter, multinational study comparing the effect of ocrelizumab (600 mg) to interferon beta-1a on annualized relapse rate (primary endpoint); participants received either intravenous ocrelizumab (600 mg every 24 weeks) plus subcutaneous interferon beta-1a placebo 3x per week or interferon beta-1a 3x per week plus ocrelizumab placebo every 24 weeks
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Disease Stage:
RRMS
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Enrollment/Number of Patients:
Estimated enrollment, 800
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Duration:
96 weeks
(217)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Status/Outcome:
Ocrelizumab was associated with reduced annualized relapse rate, disability progression, and lesion number as compared with interferon beta-1a (press release, June 2015)
(220)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech,
29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
; compared with interferon beta-1a, ocrelizumab reduced the ARR by ~50% over 2 years (0.292 versus 0.156) and slowed disease progression by a relative 40% (meeting report, October 2015)
(237)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today,
9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Trial name:
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis (OPERA II) (press release, June 2015; meeting report, October 2015)
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
(219)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech,
19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(220)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech,
29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
(237)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today,
9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Phase:
Phase III trial
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Study Design:
Company-funded, randomized, double-blind, double-dummy parallel-group, multicenter, multinational study comparing the effect of ocrelizumab (600 mg) to interferon beta-1a on annualized relapse rate (primary endpoint); participants received either intravenous ocrelizumab (600 mg every 24 weeks) plus subcutaneous interferon beta-1a placebo 3x per week or interferon beta-1a 3x per week plus ocrelizumab placebo every 24 weeks
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Disease Stage:
RRMS
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Enrollment/Number of Patients:
Estimated enrollment, 800
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Duration:
96 weeks
(218)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov,
1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Status/Outcome:
Ocrelizumab was associated with reduced annualized relapse rate, disability progression, and lesion number as compared with interferon beta-1a (press release, June 2015)
(220)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech,
29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
; compared with interferon beta-1a, ocrelizumab reduced the ARR by ~50% over 2 years (0.290 versus 0.155) and slowed disease progression by a relative 40% (meeting report, October 2015)
(237)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today,
9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Trial name:
Kappos et al., N. Engl. J. Med., October 2015 trial (DECIDE) (press releases, meeting reports, 2014, 2015; publ 2015)
(138)
Biogen Idec and Abbott Announce Enrollment of First Patient in Global Phase III Study of Daclizumab for Relapse Remitting Multiple Sclerosis
Abbot,
24 May 2010
Accessed on 3 Dec 2011 from http://www.abbott.com/news-media/press-releases/Press_Release_0863.htm.
(139)
Biogen Idec and AbbVie announce positive top-line results from Phase 3 study investigating daclizumab high-yield process in multiple sclerosis
Biogen Idec,
16 Jun 2014
Accessed on 19 Jun 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2358&M=NewsV2&PID=61997.
(140)
Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis ((DECIDE))
ClinicalTrials.gov,
12 Sep 2013
Accessed on 19 Jun 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01064401.
(163)
Detailed results from Biogen Idec and AbbVie's pivotal Phase 3 DECIDE study further define the efficacy and safety profile of ZINBRYTA™ (daclizumab high-yield process)
Biogen Idec,
12 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2377&M=NewsV2&PID=61997.
(235)
Novel MS Drugs Advance
Gever J, MedPage Today,
4 Nov 2014
Accessed on 11 Nov 2014 from http://www.medpagetoday.com/Neurology/MultipleSclerosis/48404.
(236)
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, et al.
N Engl J Med
. 2015 Oct 8; 373(15):1418-28.
PMID: 26444729.
Abstract
Phase:
Phase III trial
(138)
Biogen Idec and Abbott Announce Enrollment of First Patient in Global Phase III Study of Daclizumab for Relapse Remitting Multiple Sclerosis
Abbot,
24 May 2010
Accessed on 3 Dec 2011 from http://www.abbott.com/news-media/press-releases/Press_Release_0863.htm.
(139)
Biogen Idec and AbbVie announce positive top-line results from Phase 3 study investigating daclizumab high-yield process in multiple sclerosis
Biogen Idec,
16 Jun 2014
Accessed on 19 Jun 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2358&M=NewsV2&PID=61997.
Study Design:
Company-sponsored, multinational, double-blind, randomized, parallel-group, active-control trial to compare the efficacy of daclizumab high-yield process (HYP) (150 mg given subcutaneously once every 4 weeks) and intramuscular interferon beta-1a (30 microg given once every week); participants received daclizumab and an interferon beta-1a placebo or interferon beta-1a and a daclizumab placebo; the primary endpoint was the change in the annualized relapse rate (ARR) and the secondary endpoints were the number of new or newly enlarging T2-hyperintense lesions at week 96 and the risk of 3-month confirmed disability progression, measured by the Expanded Disability Status Scale (EDSS)
(138)
Biogen Idec and Abbott Announce Enrollment of First Patient in Global Phase III Study of Daclizumab for Relapse Remitting Multiple Sclerosis
Abbot,
24 May 2010
Accessed on 3 Dec 2011 from http://www.abbott.com/news-media/press-releases/Press_Release_0863.htm.
(139)
Biogen Idec and AbbVie announce positive top-line results from Phase 3 study investigating daclizumab high-yield process in multiple sclerosis
Biogen Idec,
16 Jun 2014
Accessed on 19 Jun 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2358&M=NewsV2&PID=61997.
(140)
Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis ((DECIDE))
ClinicalTrials.gov,
12 Sep 2013
Accessed on 19 Jun 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01064401.
(236)
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, et al.
N Engl J Med
. 2015 Oct 8; 373(15):1418-28.
PMID: 26444729.
Abstract
Disease Stage:
RRMS
(138)
Biogen Idec and Abbott Announce Enrollment of First Patient in Global Phase III Study of Daclizumab for Relapse Remitting Multiple Sclerosis
Abbot,
24 May 2010
Accessed on 3 Dec 2011 from http://www.abbott.com/news-media/press-releases/Press_Release_0863.htm.
Enrollment/Number of Patients:
>1800
(163)
Detailed results from Biogen Idec and AbbVie's pivotal Phase 3 DECIDE study further define the efficacy and safety profile of ZINBRYTA™ (daclizumab high-yield process)
Biogen Idec,
12 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2377&M=NewsV2&PID=61997.
Duration:
96 to 144 weeks
(138)
Biogen Idec and Abbott Announce Enrollment of First Patient in Global Phase III Study of Daclizumab for Relapse Remitting Multiple Sclerosis
Abbot,
24 May 2010
Accessed on 3 Dec 2011 from http://www.abbott.com/news-media/press-releases/Press_Release_0863.htm.
Status/Outcome:
Daclizumab HYP was associated with a 45% reduction in the ARR [0.216 versus 0.393 for interferon beta-1a
(235)
Novel MS Drugs Advance
Gever J, MedPage Today,
4 Nov 2014
Accessed on 11 Nov 2014 from http://www.medpagetoday.com/Neurology/MultipleSclerosis/48404.
] and a 54% reduction in the number of new or newly enlarging T2-hyperintense lesions over 96 weeks [4.3 versus 9.4 for interferon beta-1a
(235)
Novel MS Drugs Advance
Gever J, MedPage Today,
4 Nov 2014
Accessed on 11 Nov 2014 from http://www.medpagetoday.com/Neurology/MultipleSclerosis/48404.
(236)
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, et al.
N Engl J Med
. 2015 Oct 8; 373(15):1418-28.
PMID: 26444729.
Abstract
]; differences in EDSS were not significant
(139)
Biogen Idec and AbbVie announce positive top-line results from Phase 3 study investigating daclizumab high-yield process in multiple sclerosis
Biogen Idec,
16 Jun 2014
Accessed on 19 Jun 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2358&M=NewsV2&PID=61997.
; at week 96, 73% of participants on daclizumab HYP were relapse free versus 59% on interferon beta-1a
(163)
Detailed results from Biogen Idec and AbbVie's pivotal Phase 3 DECIDE study further define the efficacy and safety profile of ZINBRYTA™ (daclizumab high-yield process)
Biogen Idec,
12 Sep 2014
Accessed on 15 Sep 2014 from http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2377&M=NewsV2&PID=61997.
; at week 144, 67% of participants on daclizumab HYP were relapse free versus 51% on interferon beta-1a
(235)
Novel MS Drugs Advance
Gever J, MedPage Today,
4 Nov 2014
Accessed on 11 Nov 2014 from http://www.medpagetoday.com/Neurology/MultipleSclerosis/48404.
; at week 144, the estimated incidence of disability progression confirmed at 12 weeks was not significantly different for the two drugs
(236)
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, et al.
N Engl J Med
. 2015 Oct 8; 373(15):1418-28.
PMID: 26444729.
Abstract
; serious adverse events occurred more frequently for those on daclizumab HYP (reported in 15% of participants) versus interferon beta-1a (10% of participants)
(236)
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, et al.
N Engl J Med
. 2015 Oct 8; 373(15):1418-28.
PMID: 26444729.
Abstract
; posthoc analysis showed that daclizumab-HYP was associated with more improvement in a composite of functional measures, including ambulation and cognition, than was interferon beta-1a
(215)
Novel MS Drug Offers Good Functional Outcomes
Fiore K, MedPage Today,
2 Jun 2015
Accessed on 9 Jun 2015 from http://www.medpagetoday.com/MeetingCoverage/CMSC/51896.
Trial name:
Safety and Efficacy of Oral Fingolimod Versus Interferon Beta-1a in Pediatric Patients With Multiple Sclerosis (PARADIGMS) (recruiting as of May 2014)
(131)
New data at AAN to confirm efficacy of Novartis' Gilenya® across four key measures of MS disease activity, including brain volume loss
GlobeNewswire,
23 Apr 2014
Accessed on 17 May 2014 from http://www.nasdaq.com/press-release/new-data-at-aan-to-confirm-efficacy-of-novartis-gilenya-across-four-key-measures-of-ms-disease-20140423-00020.
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Phase:
Phase III trial
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Study Design:
Company-sponsored, double-blind, randomized, multicenter, active-controlled study to examine the safety and effectiveness of oral fingolimod versus intramuscular interferon beta-1a in pediatric patients, such that participants either receive weekly interferon beta-1a injections and daily placebo capsules or daily fingolimod capsules (0.5 mg or 0.25 mg depending on body weight) and weekly placebo injections, with the frequency of relapses the primary outcome measure
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Disease Stage:
Relapsing MS
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Enrollment/Number of Patients:
190 (estimated)
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Duration:
24 months
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Status/Outcome:
Estimated study completion date, May 2017
(132)
Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
ClinicalTrials.gov,
6 May 2014
Accessed on 17 May 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01892722.
Trial name:
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO) (halted as of February 2014)
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
(101)
Active Biotech's partner Teva initiates a further clinical trial in multiple sclerosis
Active Biotech,
4 Nov 2013
Accessed on 6 Nov 2013 from http://www.activebiotech.com/press-releases-1?pressurl=http://cws.huginonline.com/A/1002/PR/201311/1740139.xml.
(114)
Change in the clinical development program for laquinimod
Active Biotech,
19 Feb 2014
Accessed on 20 Feb 2014 from http://www.activebiotech.com/press-releases-1?pressurl=http://cws.huginonline.com/A/1002/PR/201402/1763038.xml.
Phase:
Phase III trial
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
Study Design:
Industry-sponsored, multinational, multicenter, randomized, double-blind, parallel-group trial to examine the safety, tolerability, and efficacy of oral laquinimod (0.6 or 1.2 mg per day) versus interferon beta-1a (given intramuscularly once per week), with the primary outcome the effect on brain atrophy
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
Disease Stage:
RRMS
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
Enrollment/Number of Patients:
600 (estimated)
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
Duration:
12 months
(100)
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) (LIBRETTO)
ClinicalTrials.gov,
28 Oct 2013
Accessed on 6 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01975298.
Status/Outcome:
Teva has decided against proceeding to the randomization stage of this trial, because of a lack of alignment between trial design and regulatory strategy (19 February 2014)
(114)
Change in the clinical development program for laquinimod
Active Biotech,
19 Feb 2014
Accessed on 20 Feb 2014 from http://www.activebiotech.com/press-releases-1?pressurl=http://cws.huginonline.com/A/1002/PR/201402/1763038.xml.
Trial name:
Benefit-Risk Assessment of Avonex and Laquinimod (BRAVO) (publ 2014)
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Phase:
Phase III trial
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Study Design:
Company-sponsored, randomized, multicenter, double-blind, parallel-group, placebo-controlled trial designed to compare the effects of a daily oral dose of laquinimod (0.6 mg) versus placebo and compare risk-benefit profiles of laquinimod and interferon beta-1a (Avonex) (30 mcg intramuscular injection once weekly); the primary outcome measure was the annualized relapse rate (ARR) and secondary outcome measures included 3-month confirmed worsening of disability and the percent brain volume change
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Disease Stage:
RRMS
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Enrollment/Number of Patients:
1331
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Duration:
2 years
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Status/Outcome:
Laquinimod did not significantly reduce the ARR or progression of disability, but did reduce brain atrophy relative to placebo, whereas interferon beta-1a reduced the ARR (by 26%) but did not affect brain volume loss
(115)
A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis.
Vollmer TL, Sorensen PS, Selmaj K, Zipp F, Havrdova E, Cohen JA, Sasson N, Gilgun-Sherki Y, Arnold DL, On behalf of the BRAVO Study Group
J Neurol
. 2014 Feb 18. Epub 2014 Feb 18.
PMID: 24535134.
Abstract
Trial name:
Calabrese et al., Mult. Scler., April 2012 trial
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Phase:
Postmarketing
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Study Design:
Randomized study to compare the effects of subcutaneous (sc) interferon beta-1a (44 mcg three times weekly), intramuscular (im) interferon beta-1a (30 mcg weekly), and glatiramer acetate (20 mg daily) on the development of cortical lesions and cortical atrophy
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Disease Stage:
RRMS
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Enrollment/Number of Patients:
165 treated patients and 50 untreated patients, with 141 treated patients completing the study
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Duration:
24 months
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Status/Outcome:
Interferon beta-1a and glatiramer acetate significantly decreased the development of new cortical lesions and the progression of cortical atrophy, with the most pronounced effects seen with sc interferon beta-1a, such that at 12 months, one or more new cortical lesions were seen in 26% of patients receiving sc interferon beta-1a, 64% of patients receiving im interferon beta-1a, 50% of patients receiving glatiramer acetate, and 74% of untreated patients
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
Trial name:
Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) (results described at meeting, July 2012, publ February 2013)
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
Phase:
Phase III trial
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
Study Design:
NIH-funded, randomized, double-blind, controlled study to examine whether a combination of interferon beta-1a (30 microg, intramuscularly, per week) and glatiramer acetate (20 mg per day) is more effective than either treatment alone plus placebo, with a reduction in the annualized relapse rate (ARR) the primary endpoint; time to confirmed disability, the Multiple Sclerosis Functional Composite (MSFC) score, and MRI measures were among the secondary endpoints
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
(70)
Extension CombiRx data show no benefit of combined MS drugs
Medscape Medical News,
21 Mar 2013
Accessed on 25 Mar 2013 from http://www.medscape.com/viewarticle/781153.
Disease Stage:
RRMS
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
Enrollment/Number of Patients:
1008
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
Duration:
3 years
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
Status/Outcome:
Combination therapy did not reduce the risk of relapse as compared to glatiramer acetate alone, but both of those treatments were superior to interferon beta-1a in this regard; combination therapy did not reduce confirmed progression of the Extended Disability Status Scale or MSFC score as compared to either therapy alone, but combination therapy was better than either therapy alone in reducing the accumulation of lesions and new lesion activity
(62)
Randomized study combining interferon & glatiramer acetate in multiple sclerosis.
Lublin FD, Cofield SS, Cutter GR, Conwit R, Narayana PA, Nelson F, Salter AR, Gustafson T, Wolinsky JS, for the CombiRx Investigators.
Ann Neurol
. 2013 Feb 19. Epub 1969 Dec 31.
PMID: 23424159.
Abstract
; combination therapy resulted in a half-point benefit on the 22-point scale measuring bladder control
(41)
Combination therapy in patients with relapsing-remitting multiple sclerosis (MS) CombiRx
ClinicalTrials.gov,
18 Apr 2012
Accessed on 23 Jul 2012 from http://www.clinicaltrials.gov/ct2/show/NCT00211887.
(42)
CombiRx for MS not better than monotherapy
Otto AM, Family Practice News,
16 Jul 2012
Accessed on 23 Jul 2012 from http://www.familypracticenews.com/news/more-top-news/single-view/combirx-for-ms-not-better-than-monotherapy/dd2e57672c1b60f9b1c27729a5800e12.html.
; a Markov model using efficacy data from the CombiRx study indicated that, from the perspective of the Spanish National Health Service, glatiramer acetate was associated with a lower annual cost as well as greater effectiveness than interferon beta-1a or the combination therapy
(172)
Cost-effectiveness of glatiramer acetate and interferon beta-1a for relapsing-remitting multiple sclerosis, based on the CombiRx study.
Darbà J, Kaskens L, Sánchez-de la Rosa R
J Med Econ
. 2014 Mar; 17(3):215-22.
PMID: 24494728.
Abstract
Trial name:
Rinaldi et al., Mult. Scler., May 2012 trial
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Phase:
Postmarketing
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Study Design:
Prospective study to determine the efficacy of natalizumab versus interferon beta-1a or glatiramer acetate in reducing the accumulation of new cortical lesions
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Disease Stage:
RRMS
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Enrollment/Number of Patients:
120
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Duration:
2 years
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Status/Outcome:
Natalizumab reduced the accumulation of new cortical lesions and the progression of cortical atrophy as compared to interferon beta-1a, glatiramer acetate, or no treatment
(32)
Natalizumab strongly suppresses cortical pathology in relapsing-remitting multiple sclerosis.
Rinaldi F, Calabrese M, Seppi D, Puthenparampil M, Perini P, Gallo P
Mult Scler
. 2012 May 8.
PMID: 22570359.
Abstract
Trial name:
Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I (CARE-MS I) (reported 2011, 2013; publ October 2012)
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
(90)
Low-contrast visual tests reveal better alemtuzumab efficacy
Keller DM, Medscape,
8 Oct 2013
Accessed on 10 Oct 2013 from http://www.medscape.com/viewarticle/812227.
Phase:
Phase III trial
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
Study Design:
Industry-sponsored, randomized, multicenter, rater-blinded, controlled trial to compare the effects of two cycles of intravenous alemtuzumab (12 mg per day, once a day for 5 consecutive days at baseline and once a day for 3 days at 12 months) with interferon beta1a (44 mcg given subcutaneously three times a week) on relapse rate and time to 6 month sustained accumulation of disability (coprimary endpoints)
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
Disease Stage:
Treatment-naïve, early, active RRMS
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
Enrollment/Number of Patients:
581 patients who had received no prior MS therapy
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
Duration:
2 years
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
Status/Outcome:
In the group receiving alemtuzumab (376 patients included in the primary analyses), 82 (22%) relapsed, whereas in the group receiving interferon beta-1a (195 patients included in the primary analyses), 75 (40%) relapsed, which corresponds to a 54.9% improvement with alemtuzumab; at 2 years, 78% in the alemtuzumab group were relapse free versus 59% in the interferon beta-1a group; 30 (8%) in the alemtuzumab group displayed sustained accumulation of disability versus 20 (11%) in the interferon beta-1a group
(33)
Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab (Lemtrada) in Multiple Sclerosis
Genzyme,
11 Jul 2011
Accessed on 6 Dec 2011 from http://www.businesswire.com/news/genzyme/20110710005114/en.
(50)
Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Fisher E, et al.
Lancet
. 2012 Oct 31.
PMID: 23122652.
Abstract
; over 24 months, the alemtuzumab group displayed improvements in visual acuity at low contrast levels, unlike the interferon beta-1a group
(90)
Low-contrast visual tests reveal better alemtuzumab efficacy
Keller DM, Medscape,
8 Oct 2013
Accessed on 10 Oct 2013 from http://www.medscape.com/viewarticle/812227.
Trial name:
Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE-MS II) (reported November 2011; publ October 2012; conference report May 2013)
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
(79)
Alemtuzumab benefits hard-to-treat MS patients
Anderson P, Medscape Today,
2 Jun 2013
Accessed on 8 Jun 2013 from http://www.medscape.com/viewarticle/805173.
Phase:
Phase III trial
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
Study Design:
Industry-sponsored, randomized, multicenter, rater-blinded, controlled trial to compare the effects of two cycles of intravenous alemtuzumab [either 24 mg (a dose that was discontinued) or 12 mg per day, once a day for 5 consecutive days at baseline and once a day for 3 days at 12 months] with interferon beta-1a (44 mcg given subcutaneously three times a week) on relapse rate and time to 6 month sustained accumulation of disability (coprimary endpoints)
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
Disease Stage:
RRMS, relapsed while on prior therapy
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
Enrollment/Number of Patients:
840 patients who had experienced relapse while on prior therapy
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
Duration:
2 years
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
Status/Outcome:
In the group receiving alemtuzumab (12 mg dose) (426 patients included in the primary analyses), 147 (35%) relapsed, whereas in the group receiving interferon beta-1a (202 patients included in the primary analyses), 104 (51%) relapsed, which corresponds to a 49.4% improvement with alemtuzumab; at 2 years, 278 (65%) in the alemtuzumab group were relapse free versus 94 (47%) in the interferon beta-1a group; 54 (13%) in the alemtuzumab group displayed sustained accumulation of disability versus 40 (20%) in the interferon beta-1a group
(34)
Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA TM*) in Multiple Sclerosis
Sanofi,
11 Nov 2011
Accessed on 7 Dec 2011 from http://en.sanofi.com/Images/29137_20111114_CARE_en.pdf.
(51)
Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, et al.
Lancet
. 2012 Oct 31.
PMID: 23122650.
Abstract
; in a subgroup of patients with the most active disease who received alemtuzumab, 24.2% were free of disease activity after 2 years, versus 0% of a subgroup of similar patients who received interferon beta-1a
(79)
Alemtuzumab benefits hard-to-treat MS patients
Anderson P, Medscape Today,
2 Jun 2013
Accessed on 8 Jun 2013 from http://www.medscape.com/viewarticle/805173.
Trial name:
Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TErifluNomidE and REbif, TENERE) (meeting report, 2012; publ, 2013)
(93)
Development of oral immunomodulatory agents in the management of multiple sclerosis.
Nicholas R, Giannetti P, Alsanousi A, Friede T, Muraro PA
Drug Des Devel Ther
. 2011; 5:255-74. Epub 2011 May 10.
PMID: 21625416.
Abstract
(94)
A study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis (TENERE)
ClinicalTrials.gov,
10 Oct 2011
Accessed on 5 Jan 2012 from http://clinicaltrials.gov/show/NCT00883337.
(96)
Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
Vermersch P, Czlonkowska A, Grimaldi LME, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, et al.
Mult Scler
. 2013 Oct 14.
PMID: 24126064.
Abstract
Phase:
Phase III trial
(93)
Development of oral immunomodulatory agents in the management of multiple sclerosis.
Nicholas R, Giannetti P, Alsanousi A, Friede T, Muraro PA
Drug Des Devel Ther
. 2011; 5:255-74. Epub 2011 May 10.
PMID: 21625416.
Abstract
(94)
A study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis (TENERE)
ClinicalTrials.gov,
10 Oct 2011
Accessed on 5 Jan 2012 from http://clinicaltrials.gov/show/NCT00883337.
Study Design:
Company-funded, randomized, parallel-group, single-blind trial to compare the effects of oral teriflunomide (7 mg or 14 mg daily) and subcutaneous interferon beta-1a (44 microg 3 times a week) on time to treatment failure (primary endpoint; defined as relapse or permanent discontinuation of drug) and annualized relapse rate (ARR, a secondary endpoint)
(93)
Development of oral immunomodulatory agents in the management of multiple sclerosis.
Nicholas R, Giannetti P, Alsanousi A, Friede T, Muraro PA
Drug Des Devel Ther
. 2011; 5:255-74. Epub 2011 May 10.
PMID: 21625416.
Abstract
(94)
A study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis (TENERE)
ClinicalTrials.gov,
10 Oct 2011
Accessed on 5 Jan 2012 from http://clinicaltrials.gov/show/NCT00883337.
(95)
Teriflunomide modest help but safe for MS
Medpage Today,
4 Jun 2012
Accessed on 12 Jun 2012 from http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/33059.
(96)
Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
Vermersch P, Czlonkowska A, Grimaldi LME, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, et al.
Mult Scler
. 2013 Oct 14.
PMID: 24126064.
Abstract
Disease Stage:
RRMS
(93)
Development of oral immunomodulatory agents in the management of multiple sclerosis.
Nicholas R, Giannetti P, Alsanousi A, Friede T, Muraro PA
Drug Des Devel Ther
. 2011; 5:255-74. Epub 2011 May 10.
PMID: 21625416.
Abstract
Enrollment/Number of Patients:
324
(95)
Teriflunomide modest help but safe for MS
Medpage Today,
4 Jun 2012
Accessed on 12 Jun 2012 from http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/33059.
Duration:
48 to 115 weeks (depending, in part, on whether the patient continues with the open-label extension period)
(94)
A study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis (TENERE)
ClinicalTrials.gov,
10 Oct 2011
Accessed on 5 Jan 2012 from http://clinicaltrials.gov/show/NCT00883337.
(95)
Teriflunomide modest help but safe for MS
Medpage Today,
4 Jun 2012
Accessed on 12 Jun 2012 from http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/33059.
Status/Outcome:
Treatment failure occurred in 37.8% of patients in the 14 mg teriflunomide group, 48.6% in the 7 mg teriflunomide group, and 42.3% in the beta interferon-1a group (the difference between the 14 mg teriflunomide and beta interferon-1a groups is not statistically significant); permanent discontinuations of drug were less common, relapses were more common, and patient-reported satisfaction was higher for teriflunomide versus interferon beta-1a
(95)
Teriflunomide modest help but safe for MS
Medpage Today,
4 Jun 2012
Accessed on 12 Jun 2012 from http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/33059.
; teriflunomide (both doses) and interferon beta-1a had similar effects on time to treatment failure, such that at week 48, the cumulative percentage of failures was 37% (interferon beta-1a), 36% (teriflunomide, 7 mg), and 33% (teriflunomide, 14 mg); interferon beta-1a and teriflunomide (14 mg) had similar effects on the ARR (0.22 versus 0.26, respectively), whereas teriflunomide (7 mg) was associated with a significantly higher ARR (0.41); treatment satisfaction was significantly higher with either dose of teriflunomide versus interferon beta-1a
(96)
Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
Vermersch P, Czlonkowska A, Grimaldi LME, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, et al.
Mult Scler
. 2013 Oct 14.
PMID: 24126064.
Abstract
; German Institute for Quality and Efficiency in Health Care does not consider the conclusion that teriflunomide gives an added benefit relative to interferon beta-1a as proven on the basis of this trial
(108)
Teriflunomide in multiple sclerosis: Added benefit not proven
Institute for Quality and Efficiency in Health Care,
2 Jan 2014
Accessed on 10 Jan 2014 from https://www.iqwig.de/en/press/press_releases/press_releases/teriflunomide_in_multiple_sclerosis_added_benefit_not_proven.5368.html.
Trial name:
Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS) (publ 2010, 2013, 2014)
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
(68)
New analysis shows Novartis drug Gilenya® significantly reduced rate of brain volume loss across three large Phase III studies
Novartis,
21 Mar 2013
Accessed on 25 Mar 2013 from http://www.novartis.com/newsroom/media-releases/en/2013/1686799.shtml.
(73)
Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS.
Cohen JA, Barkhof F, Comi G, Izquierdo G, Khatri B, Montalban X, Pelletier J, Eckert B, Häring DA, Francis G
J Neurol
. 2013 Apr 30.
PMID: 23632946.
Abstract
(78)
New data at ENS show Novartis drug Gilenya benefited patients by improving all four key measures of multiple sclerosis
Novartis,
5 Jun 2013
Accessed on 8 Jun 2013 from http://www.novartis.com/newsroom/media-releases/en/2013/1707070.shtml.
(120)
Fingolimod Therapy in Early Multiple Sclerosis: An Efficacy Analysis of the TRANSFORMS and FREEDOMS Studies by Time Since First Symptom.
Agius M, Meng X, Chin P, Grinspan A, Hashmonay R
CNS Neurosci Ther
. 2014 Mar 31.
PMID: 24684973.
Abstract
(128)
The influence of patient demographics, disease characteristics and treatment on brain volume loss in Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS), a phase 3 study of fingolimod in multiple scl
Barkhof F, de Jong R, Sfikas N, de Vera A, Francis G, Cohen J, on behalf of the TRANSFORMS study group
Mult Scler
. 2014 May 8.
PMID: 24812043.
Abstract
Phase:
Phase III trial
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
Study Design:
Industry-sponsored, multicenter, randomized, double-blind, double-dummy, parallel group trial to compare the efficacy of a daily oral dose of fingolimod (1.25 mg or 0.5 mg) versus a weekly intramuscular dose of interferon beta-1a (30 micrograms); the primary endpoint was the annualized relapse rate (ARR) and secondary endpoints included the number of new or enlarged lesions and progression of disability
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
Disease Stage:
RRMS
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
Enrollment/Number of Patients:
1292 (with 1153 completing study)
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
Duration:
12 months
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
Status/Outcome:
Fingolimod was associated with a lower ARR than interferon beta-1a [0.20 (1.25 mg dose) or 0.16 (0.5 mg dose) for fingolimod versus 0.33 for interferon beta-1a] and with significantly fewer lesions in MRI scans at 12 months than interferon beta-1a, whereas no differences in time to confirmed progression of disability were seen
(69)
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, et al.
N Engl J Med
. 2010 Feb 4; 362(5):402-15. Epub 2010 Jan 20.
PMID: 20089954.
Abstract
; over 1 year, fingolimod decreased the rate of brain volume loss by -32% as compared to interferon beta-1a
(68)
New analysis shows Novartis drug Gilenya® significantly reduced rate of brain volume loss across three large Phase III studies
Novartis,
21 Mar 2013
Accessed on 25 Mar 2013 from http://www.novartis.com/newsroom/media-releases/en/2013/1686799.shtml.
; when specific subgroups (defined on the basis of demographics, baseline disease characteristics, and previous responses to therapy) were analyzed, fingolimod reduced the ARR over 1 year by 32 to 59% relative to interferon beta-1a in all subgroups based on demographics or baseline disease characteristics; in patients with high levels of disease activity during interferon beta treatment in the previous year (before the study), fingolimod reduced the ARR by 61% as compared to interferon beta-1a
(73)
Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS.
Cohen JA, Barkhof F, Comi G, Izquierdo G, Khatri B, Montalban X, Pelletier J, Eckert B, Häring DA, Francis G
J Neurol
. 2013 Apr 30.
PMID: 23632946.
Abstract
; a higher percentage of patients on fingolimod were free of disease after 1 year as compared to those on interferon beta-1a
(78)
New data at ENS show Novartis drug Gilenya benefited patients by improving all four key measures of multiple sclerosis
Novartis,
5 Jun 2013
Accessed on 8 Jun 2013 from http://www.novartis.com/newsroom/media-releases/en/2013/1707070.shtml.
; posthoc subgroup analyses showed that in individuals with early MS (who exhibited their first symptom <3 years before randomization), fingolimod reduced the ARR by 73.4% as compared with interferon beta-1a; in individuals who exhibited their first symptom ≥3 years before randomization, the reduction was 45.4%
(120)
Fingolimod Therapy in Early Multiple Sclerosis: An Efficacy Analysis of the TRANSFORMS and FREEDOMS Studies by Time Since First Symptom.
Agius M, Meng X, Chin P, Grinspan A, Hashmonay R
CNS Neurosci Ther
. 2014 Mar 31.
PMID: 24684973.
Abstract
; fingolimod was associated with reduced loss of brain volume over 12 months as compared with interferon beta-1a in all subgroups examined, including those with and without baseline gadolinium-enhancing lesions; the number of gadolinium-enhancing T1 lesions at baseline was the factor that was most predictive of the percentage brain volume change
(128)
The influence of patient demographics, disease characteristics and treatment on brain volume loss in Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS), a phase 3 study of fingolimod in multiple scl
Barkhof F, de Jong R, Sfikas N, de Vera A, Francis G, Cohen J, on behalf of the TRANSFORMS study group
Mult Scler
. 2014 May 8.
PMID: 24812043.
Abstract
; posthoc analysis indicated that fingolimod (0.5 mg) reduced the ARR by 35% relative to interferon beta-1a (0.22 versus 0.34) in Hispanic individuals
(166)
Efficacy and Safety of Fingolimod in Hispanic Patients with Multiple Sclerosis: Pooled Clinical Trial Analyses.
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N
Adv Ther
. 2014 Sep 23. Epub 2014 Sep 23.
PMID: 25245812.
Abstract
; participants in the fingolimod group were two times more likely than those in the interferon beta-1a group to show no evidence of disease activity on the basis of 4 measures (no relapses, MRI lesions, progression of disabilty, or MS-related brain volume loss)
(204)
Data at AAN showed Gilenya® high efficacy in achieving 'no evidence of disease activity' in previously-treated highly-active MS patients
Novartis,
21 Apr 2015
Accessed on 21 Apr 2015 from http://www.novartis.com/newsroom/media-releases/en/2015/1912676.shtml.
; posthoc subgroup analysis indicated that fingolimod reduced the ARR more than interferon beta-1a regardless of previous interferon beta treatment or the duration or efficacy of previous treatment
(207)
Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multipl
Khatri BO, Pelletier J, Kappos L, Hartung H-P, Comi G, Barkhof F, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, et al.
Mult Scler Relat Disord
. 2014 May; 3(3):355-63. Epub 2013 Dec 12.
PMID: 25876473.
Abstract
Trial name:
International Campath-1H in Multiple Sclerosis (CAMMS223) (publ 2008, 2011, 2013, 2016)
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
(36)
Alemtuzumab versus interferon beta-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes.
Coles AJ, Fox E, Vladic A, Gazda SK, Brinar V, Selmaj KW, Bass A D-D, Wynn DR, Margolin DH, Lake SL, et al.
Lancet Neurol
. 2011 Apr; 10(4):338-48.
PMID: 21397567.
Abstract
(99)
Alemtuzumab-Related Thyroid Dysfunction in a Phase 2 Trial of Patients with Relapsing-Remitting Multiple Sclerosis.
Daniels GH, Vladic A, Brinar V, Zavalishin I, Valente W, Oyuela P, Palmer J, Margolin DH
J Clin Endocrinol Metab
. 2013 Oct 29.
PMID: 24170099.
Abstract
(264)
Alemtuzumab improves neurological functional systems in treatment-naive relapsing-remitting multiple sclerosis patients.
Fox EJ, Wynn D, Coles AJ, Palmer J, Margolin DH, CAMMS223 Investigators
J Neurol Sci
. 2016 Apr 15; 363:188-94. Epub 2016 Feb 12.
PMID: 27000249.
Abstract
Phase:
Phase II trial
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
Study Design:
Industry-sponsored, randomized, multicenter, rater-blinded trial to compare the efficacy of an annual infusion of alemtuzumab (12 mg or 24 mg) to thrice-weekly subcutaneous interferon beta-1a (44 micrograms)
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
Disease Stage:
Early, active RRMS; participants were treatment-naive
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
(264)
Alemtuzumab improves neurological functional systems in treatment-naive relapsing-remitting multiple sclerosis patients.
Fox EJ, Wynn D, Coles AJ, Palmer J, Margolin DH, CAMMS223 Investigators
J Neurol Sci
. 2016 Apr 15; 363:188-94. Epub 2016 Feb 12.
PMID: 27000249.
Abstract
Enrollment/Number of Patients:
334 (with 333 completing the study)
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
Duration:
36 months
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
Status/Outcome:
Alemtuzumab was associated with a lower rate of sustained disability accumulation (9.0% versus 26.2% for interferon beta-1a) and a lower annualized relapse rate (0.10 versus 0.36 for interferon beta-1a) (primary endpoints); alemtuzumab was also associated with a greater reduction in lesions (T2-weighted MRI) than interferon beta-1a and an increase in brain volume (compared to a decrease with interferon beta-1a); alemtuzumab was associated with a higher proportion of patients who were relapse-free after 3 years (80% for alemtuzumab versus 52% for interferon beta-1a) (secondary endpoints), but was associated with immune thrombocytopenic purpura in 3 patients, leading to suspension of alemtuzumab therapy during the trial
(35)
Alemtuzumab vs. interferon beta-1a in early multiple sclerosis.
CAMMS223 Trial Investigators, Coles AJ, Compston ADS, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK
N Engl J Med
. 2008 Oct 23; 359(17):1786-801.
PMID: 18946064.
Abstract
; posthoc analysis showed that alemtuzumab benefited patients equally in all subgroups of CAMMS223 cohort studied, including age, sex, geographical region, MRI-T1 brain volume, MRI-T2 lesion volume, disease duration, number of previous relapses within 2 years, and Expanded Disability Status Scale (EDSS) score
(36)
Alemtuzumab versus interferon beta-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes.
Coles AJ, Fox E, Vladic A, Gazda SK, Brinar V, Selmaj KW, Bass A D-D, Wynn DR, Margolin DH, Lake SL, et al.
Lancet Neurol
. 2011 Apr; 10(4):338-48.
PMID: 21397567.
Abstract
; additional analyses (after a median followup of 57.3 months) showed that 34% of individuals on alemtuzumab experienced thyroid dysfunction (with 22% with Graves' hyperthyroidism, 7% with hypothyroidism, and 4% with subacute thyroiditis) versus 6.5% of individuals on interferon beta-1a; serious episodes were rare
(99)
Alemtuzumab-Related Thyroid Dysfunction in a Phase 2 Trial of Patients with Relapsing-Remitting Multiple Sclerosis.
Daniels GH, Vladic A, Brinar V, Zavalishin I, Valente W, Oyuela P, Palmer J, Margolin DH
J Clin Endocrinol Metab
. 2013 Oct 29.
PMID: 24170099.
Abstract
; alemtuzumab was associated with broad improvement in preexisting disability, resulting in better outcomes than interferon beta-1a in most individual functional system scores (FSSs), especially sensory, pyramidal, and cerebellar FSSs, of the EDSS at month 36
(264)
Alemtuzumab improves neurological functional systems in treatment-naive relapsing-remitting multiple sclerosis patients.
Fox EJ, Wynn D, Coles AJ, Palmer J, Margolin DH, CAMMS223 Investigators
J Neurol Sci
. 2016 Apr 15; 363:188-94. Epub 2016 Feb 12.
PMID: 27000249.
Abstract
Trial name:
Evidence of Interferon Dose-response-European North American Comparative Efficacy (EVIDENCE) study (publ 2007)
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Phase:
Phase IV/Postmarketing trial
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Study Design:
Multicenter, randomized roll-over comparison of efficacy (primary endpoint: proportion of patients remaining free from relapses) of two doses (44 micrograms subcutaneously, 3x week vs 30 micrograms intramuscularly 1x week) of interferon beta-1a
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Disease Stage:
RRMS
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Enrollment/Number of Patients:
677 patients enrolled; 605 patients completed the comparative phase and 439 completed the roll-over phase
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Duration:
1-2 years
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Status/Outcome:
High-dose subcutaneous treatment showed a stronger reduction of clinical and imaging measures
(24)
Full results of the Evidence of Interferon Dose-Response-European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon beta-1a ...
Schwid SR, Panitch HS
Clin Ther
. 2007 Sep; 29(9):2031-48.
PMID: 18035202.
Abstract
(30)
Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial.
Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, Monaghan E, Li D, Weinshenker B, EVIDENCE Study Group. EVidence of Interferon Dose-response: Europian North American Compartative Efficacy, et al.
Neurology
. 2002 Nov 26; 59(10):1496-506.
PMID: 12451188.
Abstract
(31)
Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study.
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, Panitch H, Goodin D, Li D, Chang P, et al.
Arch Neurol
. 2005 May; 62(5):785-92.
PMID: 15883267.
Abstract
Trial name:
Koch-Henriksen et al., Neurol., April 2006 trial
(25)
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
(25)
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:
Open-label, multi-center, randomized, head-to-head trial comparing annualized relapse rate, time to first relapse, and neutralizing antibody formation (primary endpoints) in patients taking interferon beta-1a (22 micrograms weekly) versus interferon beta-1b (250 micrograms every other day)
(25)
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
Disease Stage:
RRMS
(25)
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:
421
(25)
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:
Two years
(25)
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:
No clinical difference was observed between the two treatments
(25)
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
Other Trials:
Trial name:
Borets et al., Zh. Nevrol. Psikhiatr. Im. S. S. Korsakova, 2016 study
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Phase:
Observational/open-label study
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Study Design:
Observational study to compare the effects of three forms of interferon beta-1a (CinnoVex, Genfaxon, and Rebif) in clinical practice in Russia
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Disease Stage:
MS
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Enrollment/Number of Patients:
80 (CinnoVex, 20; Genfaxon, 30; Rebif, 30)
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Duration:
N/A
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Status/Outcome:
In 25% of individuals treated with CinnoVex, the number of relapses did not decrease, leading to the withdrawal of these individuals from the study; Genfaxon was associated with a significant decrease in relapses, but there was a high frequency of side effects causing some individuals to withdraw; Rebif was also associated with a significant decrease in relapses, with frequent adverse events during the first year
(268)
[A comparison analysis of the use of intravenous β-interferon-1a 30 mcg and subcutaneous β-interferon-1a 44 mcg in routine clinical practice of treatment in patients with multiple sclerosis].
Borets OG, Govorukhina NF, Zverev KV, Boiko AN
Zh Nevrol Psikhiatr Im S S Korsakova
. 2016; 116(2. Vyp. 2. Rassejannyyj skleroz):63-67.
PMID: 27070363.
Abstract
Trial name:
Signori et al., Mult. Scler. Relat. Disord., March 2016 study
(267)
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
(267)
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
(267)
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
(267)
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
(267)
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
(267)
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
(267)
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
(263)
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
(263)
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
(263)
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
(263)
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
(263)
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
(263)
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
(263)
Cost-Effectiveness of Treatments for Relapsing Remitting Multiple Sclerosis: A French Societal Perspective.
Chevalier J, Chamoux C, Hammès F, Chicoye A
PLoS One
. 2016; 11(3):e0150703. Epub 2016 Mar 17.
PMID: 26987055.
Abstract
Trial name:
Hernandez et al., J. Med. Econ., March 2016 study
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Phase:
Economic analysis
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Study Design:
Company-sponsored study to compare the cost-effectiveness, from the viewpoint of a US payer, of peginterferon beta-1a (125 microg, once every 2 weeks), interferon beta-1a (44 microg, three times a week), and glatiramer acetate (20 mg, once a day) using a Markov cohort economic model that predicts relapse occurrence, disability progression, and adverse events and converts them to quality-adjusted life years (QALYs) and costs; data from the ADVANCE trial (peginterferon beta-1a) placebo arm, the London Ontario database, and a population-based MS survey were used; costs in 2014 US dollars were obtained from literature and public databases; and network meta-analysis was used to obtain the comparative efficacy of each therapy versus placebo
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Disease Stage:
RRMS
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Enrollment/Number of Patients:
N/A
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Duration:
10 year time horizon
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Status/Outcome:
Peginterferon beta-1a was found to be less costly and more effective compared to the other two drugs, with an estimated cost-savings of $22,070 and $19,163 and an additional 0.06 and 0.07 QALYs relative to interferon beta-1a (44 microg) and glatiramer acetate, respectively
(261)
Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States.
Hernandez L, Guo S, Kinter E, Fay M
J Med Econ
. 2016 Mar 7:1-12.
PMID: 26947984.
Abstract
Trial name:
Devonshire et al., BMC Res. Notes, March 2016 study
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Phase:
Observational/open-label, Phase IV study
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Study Design:
Company-sponsored, observational, single-arm, multicenter study to examine adherence to use of the RebiSmart electronic autoinjection device (which records injections given) for administering interferon beta-1a (44 microg three times a week)
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Disease Stage:
Relapsing MS
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Enrollment/Number of Patients:
162
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Duration:
Maximum, 96 weeks
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Status/Outcome:
At weeks 12 and 24, 91.8% and 82.9% of participants had administered ≥80% of scheduled injections; 69.9% of participants were less fearful of the injections by week 24
(260)
Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study.
Devonshire VA, Feinstein A, Moriarty P
BMC Res Notes
. 2016; 9(1):148. Epub 2016 Mar 08.
PMID: 26951043.
Abstract
Trial name:
Lugaresi et al., Expert Opin. Drug Deliv., February 2016 study (RIVER study)
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Phase:
Extension of the Phase IV BRIDGE study
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Study Design:
Real-life extension of the short-term (12 week) BRIDGE study to examine long-term adherence to use of the RebiSmart electronic autoinjection device for administering interferon beta-1a; data were analyzed retrospectively after being collected prospectively via RebiSmart
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Disease Stage:
RRMS
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Enrollment/Number of Patients:
57
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Duration:
19 to 26 months, with a mean of 20.5 months
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Status/Outcome:
Overall adherence was 79.8%; 63.2% of participants gave ≥80% of the scheduled doses
(259)
Long-term adherence of patients with relapsing-remitting multiple sclerosis to subcutaneous self-injections of interferon β-1a using an electronic device: the RIVER study.
Lugaresi A, De Robertis F, Clerico M, Brescia Morra V, Centonze D, Borghesan S, Maniscalco G T, Maniscalco G T
Expert Opin Drug Deliv
. 2016 Feb 24:1-5.
PMID: 26909646.
Abstract
Trial name:
Vidal-Jordana et al., J. Neuroimaging, March 2016 study
(257)
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
(257)
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
(257)
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
(257)
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
(257)
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
(257)
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
(257)
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:
Paolicelli et al., Expert Opin. Drug Deliv., February 2016 study (TRACER study)
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Phase:
Retrospective data review
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Study Design:
Retrospective study of data from individuals administering subcutaneous interferon beta-1a using the RebiSmart device, which records injections that are performed, to look for predictors of adherence; participants with ≥80% of completed doses at the 12th month were considered "treatment adherents"
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Disease Stage:
RRMS
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Enrollment/Number of Patients:
384
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Duration:
≥12 months
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Status/Outcome:
Overall, 89.3% of participants were adherent after 12 months; factors at baseline that were associated with the highest levels of adherence were an age of 26 to 40 years and an Expanded Disability Status Scale score <4; higher long-term adherence was predicted by being treatment adherent during the first 3 months
(256)
Exploratory analysis of predictors of patient adherence to subcutaneous interferon beta-1a in multiple sclerosis: TRACER study.
Paolicelli D, Cocco E, Lecce V D, Direnzo V, Moiola L, Lanzillo R, Perini P, Malucchi S, Borriello G, Portaccio E, et al.
Expert Opin Drug Deliv
. 2016 Mar 12:1-7.
PMID: 26922837.
Abstract
Trial name:
Spelman et al., Eur. J. Neurol., January 2016 study
(252)
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
(252)
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
(252)
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
(252)
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)
(252)
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
(252)
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
(252)
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:
Dwyer et al., BMC Neurol., November 2015 study
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Phase:
Observational/open-label study
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Study Design:
Industry-sponsored, open-label, two-arm study to examine the effects of interferon beta-1a (44 microg, given subcutaneously 3 times per week) on brain volume atrophy, with changes measured from baseline to 3 months, 3 to 6 months, and baseline to 6 months
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Disease Stage:
RRMS
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Enrollment/Number of Patients:
23 (with RRMS), plus 15 healthy controls
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Duration:
6 months
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Status/Outcome:
Interferon beta-1a was associated with reductions in the whole brain volume and gray matter volume during the early phase of treatment; such decreased volume correlated with reduced expression of interleukin 17 F by T cells from baseline to 6 months, suggesting that inflammation resolution after treatment begins is responsible for this pseudoatrophy effect
(243)
Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial.
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, et al.
BMC Neurol
. 2015; 15:232. Epub 2015 Nov 11.
PMID: 26559139.
Abstract
Trial name:
Rotstein et al., Neurol. Neuroimmunol. Neuroinflamm., October 2015 study
(241)
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
(241)
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
(241)
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
(241)
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
(241)
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
(241)
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
(241)
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
(234)
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
(234)
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
(234)
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
(234)
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
(234)
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
(234)
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
(234)
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.
Tramacere I, Giovane C D, Salanti G, D'Amico R, Filippini G
Cochrane Database Syst Rev
. 2015 Sep 18; 9:CD011381.
PMID: 26384035.
Abstract
Trial name:
Iaffaldano et al., Brain, September 2015 study
(233)
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
(233)
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
(233)
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
(233)
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
(233)
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
(233)
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
(233)
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:
Moccia et al., Expert Opin. Drug Deliv., September 2015
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Phase:
Observational study
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Study Design:
Study to examine factors that predict adherence to interferon beta-1a, in which participants used the RebiSmart auto-injector through which real-time adherence data were recorded; adherence data were retrospectively evaluated and clinical relapses were prospectively recorded
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Disease Stage:
RRMS
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Enrollment/Number of Patients:
114
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Duration:
1.5 years (average)
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Status/Outcome:
Participants who missed their first dose in the first month of observation were more likely to exhibit lower adherence as compared to participants who missed their first dose later than the first month or who were fully adherent; they were also fourfold more likely to exhibit a clinical relapse
(232)
How many injections did you miss last month? A simple question to predict interferon β-1a adherence in multiple sclerosis.
Moccia M, Palladino R, Russo C, Massarelli M, Nardone A, Triassi M, Lugaresi A, Brescia Morra V
Expert Opin Drug Deliv
. 2015 Sep 15:1-7.
PMID: 26371561.
Abstract
Trial name:
Smith et al., J. Manag. Care Spec. Pharm., August 2015 study
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Phase:
Retrospective, observational administrative claims analysis
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Study Design:
Retrospective study to examine the postmarketing safety profile of subcutaneous interferon beta-1a (given 3 times per week) using data from US health care administrative claims databases
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Disease Stage:
MS
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Enrollment/Number of Patients:
Not described in abstract
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Duration:
From date of first prescription for interferon beta-1a to discontinuation, end of insurance, or end of observation period
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Status/Outcome:
Safety profile was found to be similar to that on the US label; the most common adverse events were influenza-like symptoms [incidence rate (IR) per 100 person-years, 15.65], malaise (IR, 15.33), fatigue (IR, 15.02), abdominal pain (IR, 10.18), chest pain (IR, 8.48), and depression (IR, 7.75)
(228)
Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.
Smith MY, Sabidó-Espin M, Trochanov A, Samuelson M, Guedes S, Corvino FA, Richy FF
J Manag Care Spec Pharm
. 2015 Aug; 21(8):650-60.
PMID: 26233537.
Abstract
Trial name:
Lus et al., Eur. J. Neurol., July 2015 study
(226)
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
(226)
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
(226)
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
(226)
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
(226)
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
(226)
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
(226)
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
(225)
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
(225)
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
(225)
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
(225)
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
(225)
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
(225)
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)
(225)
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:
Kleinschnitz et al., Int. J. Mol. Sci., July 2015 study [Avonex as Treatment Option for Untreated MS Patients (AXIOM)]
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Phase:
Observational/open-label study
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Study Design:
Open-label, non-interventional study, with both prospective and retrospective components, to examine the efficacy of intramuscular interferon beta-1a, newly-initiated after a ≥3 month treatment-free interval, in a routine-care setting in Germany
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Disease Stage:
RRMS
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Enrollment/Number of Patients:
235
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Duration:
12 months
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Status/Outcome:
Intramuscular interferon beta-1a was associated with a decrease in the mean relapse rate from 1.1 (in the 3 month period before baseline) to 0.2 per quarter (during the observational period), an improvement in the MS Functional Composite score, fewer injection site reactions relative to previous disease-modifying therapies used, and no change in the Expanded Disability Status Scale score
(224)
Interferon Beta-1a (AVONEX®) as a Treatment Option for Untreated Patients with Multiple Sclerosis (AXIOM): A Prospective, Observational Study.
Kleinschnitz C, Niemczyk G, Rehberg-Weber K, Wernsdörfer C
Int J Mol Sci
. 2015; 16(7):15271-86.
PMID: 26154767.
Abstract
Trial name:
Johnson et al., CNS Drugs, June 2015 study
(221)
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
(221)
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
(221)
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
(221)
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
(221)
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
(221)
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)
(221)
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:
Bayas et al., Expert Opin. Drug Deliv., June 2015 study (SMART study)
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Phase:
Observational/open-label study
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Study Design:
Industry-sponsored, multicenter, observational study to examine adherence to and effectiveness of subcutaneous interferon beta-1a (44 or 22 microg 3 times per week) administered with the RebiSmart electronic multidose autoinjector, with the primary endpoint the cumulative adherence measured by the device
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Disease Stage:
Relapsing MS
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Enrollment/Number of Patients:
912, with 823 completing the 12-month visit
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Duration:
1 year
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Status/Outcome:
RebiSmart was associated with mean cumulative adherence of 97.1%, with 79.5% of participants free of relapses, at month 12; 68.3% of a subgroup of 353 who rated convenience considered injecting very easy
(216)
Adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Bayas A, Ouallet J C, Kallmann B, Hupperts R, Fulda U, Marhardt K, SMART study group
Expert Opin Drug Deliv
. 2015 Jun 22:1-12.
PMID: 26098143.
Abstract
Trial name:
Tolley et al., PLoS One, June 2015 study
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Phase:
Retrospective analysis
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Study Design:
Industry-sponsored, retrospective network meta-analysis to assess indirectly the efficacy, safety, and tolerability of peginterferon beta-1a (125 microg given once every 2 weeks) relative to other injectable therapies [interferon beta-1a (30, 44, and 22 microg), interferon beta-1b, and glatiramer acetate]; randomized controlled trials that evaluated 1 or more treatments were examined in the analysis
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Disease Stage:
RRMS
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Enrollment/Number of Patients:
N/A
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Duration:
N/A
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Status/Outcome:
Network meta-analysis indicated that, relative to placebo, peginterferon beta-1a decreases the annualized relapse rate (ARR) and 3-and 6-month confirmed disability progression (CDP); a trend indicated that this treatment may be more favorable than other injectable treatments with respect to the ARR and CPD
(214)
A Network Meta-Analysis of Efficacy and Evaluation of Safety of Subcutaneous Pegylated Interferon Beta-1a versus Other Injectable Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis.
Tolley K, Hutchinson M, You X, Wang P, Sperling B, Taneja A, Siddiqui M K, Kinter E
PLoS One
. 2015; 10(6):e0127960. Epub 2015 Jun 03.
PMID: 26039748.
Abstract
Trial name:
Spelman et al., Ann. Clin. Transl. Neurol., April 2015 study
(209)
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
(209)
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
(209)
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
(209)
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
(209)
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
(209)
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
(209)
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
(203)
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
(203)
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)
(203)
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
(203)
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%
(203)
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
(203)
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)
(203)
Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.
Zhornitsky S, Greenfield J, Koch MW, Patten SB, Harris C, Wall W, Alikhani K, Burton J, Busche K, Costello F, et al.
PLoS One
. 2015; 10(4):e0123824. Epub 2015 Apr 13.
PMID: 25867095.
Abstract
Trial name:
Rinaldi et al., Mult. Scler. Int., February 2015 study
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Phase:
Extension of a postmarketing study
(43)
Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing-remitting multiple sclerosis.
Calabrese M, Bernardi V, Atzori M, Mattisi I, Favaretto A, Rinaldi F, Perini P, Gallo P
Mult Scler
. 2012 Apr; 18(4):418-24. Epub 2011 Jan 12.
PMID: 21228025.
Abstract
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Study Design:
Extension study to compare the effects of subcutaneous (sc) interferon beta-1a (44 mcg three times weekly), intramuscular (im) interferon beta-1a (30 mcg weekly), and glatiramer acetate (20 mg daily) on the development of cortical lesions and cortical atrophy; 50 individuals in a reference population were untreated for the first 24 months, after which time 43 of them switched to one of the three disease-modifying drugs (DMDs)
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Disease Stage:
RRMS
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Enrollment/Number of Patients:
165, plus 50 initially untreated individuals
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Duration:
24 months in the original study, plus 24 months in the extension
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Status/Outcome:
At 48 months, sc interferon beta-1a use was associated with a lower mean standard deviation number of new cortical lesions (1.4 ± 1) than either im interferon beta-1a (2.3 ± 1.3) or glatiramer acetate (2.2 ± 1.5); cortical lesion accumulation and development was reduced in those individuals who began using DMDs after month 24, as compared with the previous 24 month period
(196)
Disease-modifying drugs reduce cortical lesion accumulation and atrophy progression in relapsing-remitting multiple sclerosis: results from a 48-month extension study.
Rinaldi F, Perini P, Atzori M, Favaretto A, Seppi D, Gallo P
Mult Scler Int
. 2015; 2015:369348. Epub 2015 Feb 23.
PMID: 25802758.
Abstract
Trial name:
Cohen et al., Mult. Scler. Relat. Disord., January 2015 study [Therapy Optimization in MS (TOP MS)]
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Phase:
Observational/open-label study
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Study Design:
Observational, prospective, cohort study to examine the connection between adherence to MS disease-modifying therapies (DMTs, which included interferon beta and glatiramer acetate) and the risk of relapse; participants were recruited by specific pharmacies and the medication possession ratio (MPR, derived from pharmacy shipment records) was used as a measure of adherence; electronic data capture was also used and involved monthly entries by participants
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Disease Stage:
MS
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Enrollment/Number of Patients:
3151, with 2410 completing the 2-year study
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Duration:
2 years
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Status/Outcome:
Higher DMT adherence was associated with better clinical results, such that the odds of relapse for an individual in a higher adherence group (MPR >0.9) were 64% that of an individual in a lower adherence group (MPR <0.5)
(198)
Therapy Optimization in Multiple Sclerosis: A cohort study of therapy adherence and risk of relapse.
Cohen BA, Coyle PK, Leist T, Oleen-Burkey MA, Schwartz M, Zwibel H
Mult Scler Relat Disord
. 2015 Jan; 4(1):75-82. Epub 2014 Oct 07.
PMID: 25787057.
Abstract
Trial name:
He et al., JAMA Neurol., February 2015 study
(193)
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
(193)
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
(193)
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
(193)
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)
(193)
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)
(193)
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
(193)
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:
Kalincik et al., Mult. Scler., December 2014 study
(182)
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
(182)
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
(182)
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
(182)
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
(182)
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
(182)
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
(182)
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:
Bakhtiiarova et al., Zh. Nevrol. Psikhiatr. Im. S. S. Korsakova, November 2014 study
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Phase:
Observational/open-label study
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Study Design:
Study to examine the safety and efficacy of genfaxon, an interferon beta-1a biosimilar, in routine practice in the Russian Federation; participants who had or had not been previously treated with a disease-modifying therapy were followed
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Disease Stage:
MS
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Enrollment/Number of Patients:
649
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Duration:
12 months
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Status/Outcome:
Efficacy of genfaxon was found to be similar to that previously reported for Rebif; no serious adverse events were reported
(177)
[Experience of using genfaxon for treating patients with relapsing-remitting multiple sclerosis in the Russian Federation.]
Bakhtiiarova KZ, Bragina OV, Vlasov IV, Greshnova IV, Evdoshenko EP, Ivanishenkova EI, Kairbekova EI, Karnaukhova EN, Korotkevich NA, Leliukhina AV, et al.
Zh Nevrol Psikhiatr Im S S Korsakova
. 2014; 114(8):39-45.
PMID: 25345629.
Abstract
Trial name:
Zhang et al., CNS Drugs, October 2014 study
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Phase:
Economic analysis
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Study Design:
Study to compare the cost-effectiveness of fingolimod, teriflunomide, dimethyl fumarate, and intramuscular interferon beta-1a from a US societal perspective using a Markov model; the incremental net monetary benefit (INMB) was the primary outcome; $150,000 (in 2012 US dollars) per quality-adjusted life year was assumed to be the base case INMB willingness-to-pay (WTP) threshold
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Disease Stage:
RRMS
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Enrollment/Number of Patients:
N/A
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Duration:
5 year time horizon
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Status/Outcome:
Dimethyl fumarate was the optimal treatment for >90% of the simulations across a wide range of WTP values; relative to intramuscular interferon beta-1a, fingolimod, teriflunomide, and dimethyl fumarate had INMBs that were estimated to be $36,567, $49,780, and $80,611, respectively, at a WTP of $150,000
(171)
Cost Effectiveness of Fingolimod, Teriflunomide, Dimethyl Fumarate and Intramuscular Interferon-β1a in Relapsing-Remitting Multiple Sclerosis.
Zhang X, Hay JW, Niu X
CNS Drugs
. 2014 Oct 19.
PMID: 25326785.
Abstract
Trial name:
La Mantia et al., Cochrane Database Syst. Rev., July 2014 study
(150)
Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
Cochrane Database Syst Rev
. 2014; 7:CD009333. Epub 1969 Dec 31.
PMID: 25062935.
Abstract
; similar paper published December 2014
(188)
Comparative efficacy of interferon β versus glatiramer acetate for relapsing-remitting multiple sclerosis.
La Mantia L, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A
J Neurol Neurosurg Psychiatry
. 2014 Dec 30.
PMID: 25550414.
Abstract
Phase:
Retrospective clinical trials review
(150)
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
(150)
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
(150)
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)
(150)
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)
(150)
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
(150)
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:
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN) (publ 2014)
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
(149)
Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA
Expert Opin Drug Deliv
. 2014 Jul 29:1-8.
PMID: 25073663.
Abstract
(205)
PLEGRIDY® (Peginterferon Beta-1a) Three-Year Data Presented at AAN Annual Meeting Support Long-Term Safety and Efficacy in Multiple Sclerosis Patients
Biogen,
21 Apr 2015
Accessed on 21 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/neurology/plegridy-peginterferon-beta-1a-three-year-data-presented-aan-annual-meeting-.
Phase:
Phase IIIb; extension of the Phase III ADVANCE trial
(58)
Biogen Idec announces positive top-line results from Phase 3 study of peginterferon beta-1a in multiple sclerosis
Biogen Idec,
24 Jan 2013
Accessed on 29 Jan 2013 from http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1777510.
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
(149)
Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA
Expert Opin Drug Deliv
. 2014 Jul 29:1-8.
PMID: 25073663.
Abstract
Study Design:
Industry-sponsored, global, multicenter, dose-frequency blinded extension study to examine the long-term safety and tolerability of pegylated interferon beta-1a (125 microg every 2 weeks or every 4 weeks, given subcutaneously), with the number of participants with adverse events and laboratory abnormalities the primary outcome measure; effects on MS-related outcomes over the long term, such as the annualized relapse rate, among individuals first treated in the original study are the secondary outcome measures
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
Disease Stage:
RRMS
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
Enrollment/Number of Patients:
Estimated enrollment, 1500
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
Duration:
≥96 weeks
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
Status/Outcome:
Estimated study completion date, September 2015
(148)
Long-Term Safety and Efficacy Study of BIIB017 (PEGylated Interferon Beta-1a) (ATTAIN)
ClinicalTrials.gov,
25 Jul 2014
Accessed on 4 Aug 2014 from http://www.clinicaltrials.gov/ct2/show/NCT01332019.
; substudy to examine safety, tolerability, and patient satisfaction with a single-use autoinjector versus a manual pre-filled syringe in a 39 participants over 8 weeks showed that the safety and tolerability profiles were similar and that participants found the autoinjector convenient and easy to use
(149)
Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.
Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA
Expert Opin Drug Deliv
. 2014 Jul 29:1-8.
PMID: 25073663.
Abstract
; data from the first year of the extension indicated that efficacy, safety, and tolerability were comparable with results from the ADVANCE trial; 48.7% of participants in the intent-to-treat population exhibited no evidence of disease activity after year 1, versus 34.8% and 54.3% in years 1 and 2 of ADVANCE (April, 2015)
(205)
PLEGRIDY® (Peginterferon Beta-1a) Three-Year Data Presented at AAN Annual Meeting Support Long-Term Safety and Efficacy in Multiple Sclerosis Patients
Biogen,
21 Apr 2015
Accessed on 21 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/neurology/plegridy-peginterferon-beta-1a-three-year-data-presented-aan-annual-meeting-.
Trial name:
Glanz et al., Int. J. MS Care, Summer 2014 study
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Phase:
Observational/open-label study
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Study Design:
Study to compare patient satisfaction with intramuscular interferon beta-1a, subcutaneous interferon beta-1a, glatiramer acetate, and natalizumab and to compare links between therapy adherence and satisfaction; the Treatment Satisfaction Questionnaire for Medicine and multivariable models were used
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Disease Stage:
MS
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Enrollment/Number of Patients:
226
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Duration:
N/A
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Status/Outcome:
Overall, the drugs were associated with similar levels of satisfaction; compared to intramuscular interferon beta-1a, natalizumab was associated with more satisfaction with the ability of the drug to treat or prevent MS and was considered more convenient; natalizumab was considered easier to use than either form of interferon beta or glatiramer acetate; intramuscular interferon beta-1a was associated with less satisfaction with ease of planning than the other drugs; and for subcutaneous interferon beta-1a and glatiramer acetate, lower convenience scores were linked with reduced adherence
(147)
Treatment satisfaction in multiple sclerosis.
Glanz BI, Musallam A, Rintell DJ, Chitnis T, Weiner HL, Healy BC
Int J MS Care
. 2014 Summer; 16(2):68-75.
PMID: 25061430.
Abstract
Trial name:
Bergvall et al., J. Med. Econ., July 2014 study
(145)
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
(145)
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
(145)
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
(145)
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)]
(145)
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
(145)
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
(145)
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:
Zivadinov et al., PLoS One, March 2014 study
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
; additional analyses published 2015
(202)
Associations between changes in ferritin levels and susceptibility-weighted imaging filtered phase in patients with relapsing-remitting multiple sclerosis over 24weeks of therapy with subcutaneous interferon beta-1a three times weekly.
Dwyer MG, Zivadinov R, Markovic-Plese S, Bergsland N, Heininen-Brown M, Carl E, Kennedy C, Weinstock-Guttman B, Hayward B, Dangond F
J Neuroimmunol
. 2015 Apr 15; 281:44-50. Epub 2015 Mar 05.
PMID: 25867467.
Abstract
Phase:
Phase IV study
(201)
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
ClinicalTrials.gov,
2 Aug 2013
Accessed on 16 Apr 2015 from https://clinicaltrials.gov/show/NCT01085318.
Study Design:
Company-sponsored, open-label, non-randomized, parallel assignment, pilot study to examine the effects of interferon beta-1a (44 mcg 3 times a week, given subcutaneously) on remyelination and demyelination in normal appearing brain tissue and lesions, gray matter volume, and central nervous system iron deposition, as assessed by MRI techniques such as measuring the voxel-wise magnetization transfer ratio (VW-MTR)
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
(201)
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
ClinicalTrials.gov,
2 Aug 2013
Accessed on 16 Apr 2015 from https://clinicaltrials.gov/show/NCT01085318.
Disease Stage:
RRMS
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
(201)
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
ClinicalTrials.gov,
2 Aug 2013
Accessed on 16 Apr 2015 from https://clinicaltrials.gov/show/NCT01085318.
Enrollment/Number of Patients:
38 (23 individuals with RRMS and 15 healthy controls)
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
Duration:
24 weeks
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
Status/Outcome:
A significant increase in normal appearing brain tissue volume with apparent increasing myelination (as assessed by VW-MTR) was observed at week 12 in individuals with RRMS versus healthy controls, and a trend in this direction was observed at week 24
(200)
Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study.
Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, et al.
PLoS One
. 2014; 9(3):e91098. Epub 2014 Mar 13.
PMID: 24625687.
Abstract
; subanalysis showed a short-term increase in serum ferritin (which was not associated with increased iron) that occurred with the start of interferon beta-1a, and this increased ferritin correlated with decreased numbers of lesions but not with deep gray matter iron
(202)
Associations between changes in ferritin levels and susceptibility-weighted imaging filtered phase in patients with relapsing-remitting multiple sclerosis over 24weeks of therapy with subcutaneous interferon beta-1a three times weekly.
Dwyer MG, Zivadinov R, Markovic-Plese S, Bergsland N, Heininen-Brown M, Carl E, Kennedy C, Weinstock-Guttman B, Hayward B, Dangond F
J Neuroimmunol
. 2015 Apr 15; 281:44-50. Epub 2015 Mar 05.
PMID: 25867467.
Abstract
Trial name:
Mokhber et al., J. Neurol. Sci., February 2014 study
(136)
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 [11139]]
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
(136)
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
(136)
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
(136)
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
(136)
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
(136)
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
(112)
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
(112)
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
(112)
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
(112)
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)
(112)
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
(112)
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
(112)
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
(164)
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
(165)
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.
(199)
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
(164)
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
(165)
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
(164)
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
(165)
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.
(199)
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
(164)
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
(165)
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)
(165)
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)
(165)
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.
(199)
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
(199)
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
(165)
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.
(199)
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
(190)
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
(190)
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 the previous 24 months
(190)
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
(190)
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)
(190)
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
(190)
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
(190)
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
(110)
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
(110)
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
(110)
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
(110)
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)
(110)
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
(110)
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
(110)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(106)
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
(111)
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
(111)
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
(111)
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
(111)
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
(111)
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
(111)
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
(111)
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:
An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™ (PERSIST) (meeting report, 2013)
(104)
An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™ (PERSIST)
ClinicalTrials.gov,
13 Sep 2012
Accessed on 25 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01405872.
(105)
New data show positive results from Phase 4 study of Avonex Pen for treatment of RRMS patients
News-Medical.net,
13 Nov 2013
Accessed on 25 Nov 2013 from http://www.news-medical.net/news/20131113/New-data-show-positive-results-from-Phase-4-study-of-Avonex-Pen-for-treatment-of-RRMS-patients.aspx.
Phase:
Phase IV study
(104)
An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™ (PERSIST)
ClinicalTrials.gov,
13 Sep 2012
Accessed on 25 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01405872.
Study Design:
Industry-sponsored, observational, prospective cohort study to examine persistence with the once-weekly Avonex Pen (primary outcome measure), a device for injecting interferon beta-1a (Avonex), as well as the tolerability and ease of use of the Avonex Pen (secondary outcome measures)
(104)
An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™ (PERSIST)
ClinicalTrials.gov,
13 Sep 2012
Accessed on 25 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01405872.
(105)
New data show positive results from Phase 4 study of Avonex Pen for treatment of RRMS patients
News-Medical.net,
13 Nov 2013
Accessed on 25 Nov 2013 from http://www.news-medical.net/news/20131113/New-data-show-positive-results-from-Phase-4-study-of-Avonex-Pen-for-treatment-of-RRMS-patients.aspx.
Disease Stage:
RRMS
(105)
New data show positive results from Phase 4 study of Avonex Pen for treatment of RRMS patients
News-Medical.net,
13 Nov 2013
Accessed on 25 Nov 2013 from http://www.news-medical.net/news/20131113/New-data-show-positive-results-from-Phase-4-study-of-Avonex-Pen-for-treatment-of-RRMS-patients.aspx.
Enrollment/Number of Patients:
280 (estimated)
(104)
An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™ (PERSIST)
ClinicalTrials.gov,
13 Sep 2012
Accessed on 25 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01405872.
Duration:
12 months
(104)
An observational study to assess persistence, adherence, quality of life, and treatment satisfaction in patients beginning therapy with the Avonex® PEN™ (PERSIST)
ClinicalTrials.gov,
13 Sep 2012
Accessed on 25 Nov 2013 from http://www.clinicaltrials.gov/ct2/show/NCT01405872.
Status/Outcome:
Pen was associated with high persistence rates (92% at 12 months), according to preliminary data (meeting report, November 2013)
(105)
New data show positive results from Phase 4 study of Avonex Pen for treatment of RRMS patients
News-Medical.net,
13 Nov 2013
Accessed on 25 Nov 2013 from http://www.news-medical.net/news/20131113/New-data-show-positive-results-from-Phase-4-study-of-Avonex-Pen-for-treatment-of-RRMS-patients.aspx.
Trial name:
Hutchinson et al., Curr. Med. Res. Opin., November 2013 study
(103)
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
(103)
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
(103)
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
(103)
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
(103)
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
(103)
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
(103)
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
(98)
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
(98)
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
(98)
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
(98)
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
(98)
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
(98)
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
(98)
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:
Fragoso et al., CNS Drugs, October 2013 study
(92)
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
(92)
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
(92)
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
(92)
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
(92)
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
(92)
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
(92)
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
(91)
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
(91)
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
(91)
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
(91)
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
(91)
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
(91)
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
(91)
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
(123)
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
(123)
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
(123)
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
(123)
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
(123)
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
(123)
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
(123)
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
(88)
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
(88)
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)
(88)
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
(88)
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)
(88)
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
(88)
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)
(88)
Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis.
Bergvall N, Makin C, Lahoz R, Agashivala N, Pradhan A, Capkun G, Petrilla A, Karkare SU, Balderston McGuiness C, Korn JR
Curr Med Res Opin
. 2013 Oct 1. Epub 1969 Dec 31.
PMID: 24059944.
Abstract
Trial name:
Hadjigeorgiou et al., J. Clin. Pharm. Ther., August 2013 study
(87)
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
(87)
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
(87)
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
(87)
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
(87)
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
(87)
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
(87)
A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.
Hadjigeorgiou GM, Doxani C, Miligkos M, Ziakas P, Bakalos G, Papadimitriou D, Mprotsis T, Grigoriadis N, Zintzaras E
J Clin Pharm Ther
. 2013 Aug 20.
PMID: 23957759.
Abstract
Trial name:
Filippini et al., Cochrane Database Syst. Rev., June 2013 study
(80)
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: