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Abstract

Objectives:

Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study.

Methods:

Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed.

Results:

At data cutoff (February 9, 2012), natalizumab exposure was 3,460 patient-years; a median of 56 (range 1–70) infusions were received. Serious adverse events, including progressive multifocal leukoencephalopathy, were consistent with natalizumab's known profile. Upon natalizumab re-exposure, rates of anti-natalizumab antibodies and hypersensitivity reactions were 3% and 5% overall, and 40% and 24% among patients with 1 to 2 prior natalizumab doses. Patients originally randomized to placebo/another disease-modifying therapy vs natalizumab in previous studies had significantly higher EDSS scores at STRATA baseline; this difference persisted over 240 weeks. EDSS scores generally remained stable. Patients initially randomized to natalizumab had lower annualized relapse rates over 240 weeks.

Conclusions:

Serious adverse events were consistent with natalizumab's known safety profile; short exposure with a gap before redosing was associated with higher incidences of anti-natalizumab antibodies and hypersensitivity reactions. Stability of EDSS scores and consistently low relapse rates over 5 years of natalizumab treatment are consistent with its known efficacy profile.

Classification of evidence:

This study provides Class III evidence that in patients with relapsing-remitting multiple sclerosis, natalizumab stabilizes EDSS scores, decreases relapse rates, and is associated with an increased risk of progressive multifocal leukoencephalopathy.

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Supplementary Material

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File (table_e-1.docx)

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Information & Authors

Information

Published In

Neurology®
Volume 83Number 1July 1, 2014
Pages: 78-86
PubMed: 24898925

Publication History

Received: August 1, 2013
Accepted: March 25, 2014
Published online: June 4, 2014
Published in print: July 1, 2014

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Disclosure

P. O'Connor has received consulting fees and honoraria from Bayer, Biogen Idec, Celgene, EMD Serono, Genentech, Genzyme, Novartis, Roche, Sanofi, and Teva. A. Goodman has received personal compensation for consulting services from Acorda, Biogen Idec, Genzyme/Sanofi, Novartis, and Teva and financial support for research activities from Acorda, Avanir, Biogen Idec, EMD Serono, Genzyme/Sanofi, Novartis, Ono, Roche, Sun Pharma, Takeda, and Teva. L. Kappos has received research support from Acorda, Actelion, Allozyne, BaroFold, Bayer HealthCare, Bayer Schering, Bayhill, Biogen Idec, Boehringer Ingelheim, Elan, Genmab, Glenmark, GlaxoSmithKline, Merck Serono, MediciNova, Novartis, Roche, Sanofi, Santhera, Shire, Teva, UCB, Wyeth, the European Union, the Gianni Rubatto Foundation, the Novartis and Roche Research Foundations, the Swiss MS Society, and the Swiss National Research Foundation. F. Lublin has received research support from Acorda, Biogen Idec, Celgene, Genzyme, Novartis, Sanofi, Teva, the NIH, and the National Multiple Sclerosis Society (NMSS); has received fees as a consultant and for advisory boards from Acorda, Actelion, Bayer HealthCare, Biogen Idec, Bristol-Myers Squibb, Celgene, Coronado Bioscience, EMD Serono, Genentech, Genzyme, Johnson & Johnson, MedImmune, Novartis, Pfizer, Questcor, Revalesio, Roche, Sanofi, and Teva; has current financial interests in Cognition Pharmaceuticals; and is co-chief editor for Multiple Sclerosis and Related Diseases. C. Polman has received consulting fees and honoraria from Actelion, Bayer Schering, Biogen Idec, GlaxoSmithKline, Merck Serono, Novartis, Roche, Teva, and UCB. R. Rudick has received honoraria or consulting fees from Biogen Idec, Genzyme, Novartis, and Pfizer and research funding from Biogen Idec, Genzyme, Novartis, the NIH, and the NMSS. K. Hauswirth is an employee of Infusion Communications, which received funding for writing and editorial support from Biogen Idec. L. Cristiano and F. Forrestal are employees of Biogen Idec. P. Duda was an employee of Biogen Idec at the time of the study and manuscript preparation. Go to Neurology.org for full disclosures.

Study Funding

Biogen Idec provided funding for editorial support in the development of this manuscript.

Authors

Affiliations & Disclosures

Paul O'Connor, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
Novartis Fingolimod Steering Committee--member--2007- Present Teriflunomide Steering Committee ( sanofi aventis)-- chairman--2006-present Bayer BEYOND study steering committee--chairman--2007- 2009 BRAVO (laquinimod) study DMC--chairman--2007-present Genentech advisory board--member Roche advisory board Receptos advisory board Actelion advisory board
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
1 Biogen Idec-ECTRIMS meeting Dusseldorf--2009-- presentations of data from two studies 2 Teva--Meeting in London--advise and present data on safety of MS drugs--2009 3 Advisory board meeting in Montreal 2010 4 Advisory board meeting in Toronto 2013
Editorial Boards:
1.
1 MS Journal. Editorial advisory board . July 2012-- March 2013
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Biogen Idec consultant 2007-2012 Actelion consultant 2010 Bayer Consultant 2007-2009 EMD Serono Consultant 2009-11 Teva Consultant 2007-2013 Genentech Consultant 2007-2008 Sanofi Genzyme Consultant 2002-2013 Novartis Consultatn 2005-2013 Warburg Pincus Consultant 2009
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
1 Bayer--study grant support for BEYOND study--2006-8 2 Novartis--study grant support for FREEDOMS, TRANSFORMS and INFORMS study--2006-2012 3 BIOMS--study grant support 2006-9 4 Sanofi Aventis-grant supprot for TEMSO, phase 2, CIS and nerispirdine studies 5 ROCHE; grant supprot for phase 2 OCRELIZUMAB study 6 Biogen Idec: grant support for ASCEND and JEMS study 7 Roche grant support for OPERA and ORATORIO studies 8 Novartis support for INFORMS study of PPMS
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
National Scientific and Clinical Advisor to to the MS Society of Canada. 2008-2014(ongoing)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Andrew Goodman, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
Biogen-Idec Cleveland Clinic Foundation Vaccinex
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Received travel expenses and/or honoraria for lectures or educational activities not funded by industry. Received travel expenses and/or honoraria for consuting activities funded by industry:1.Acorda:consultant 2.Biogen- Idec:consultant 3. Genzyme-sanofi:consultant 4.Teva: consultant 5.GW Pharma: consultant
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
1.Acorda:consultant 2.Alexion:consultant 3.Biogen- Idec:consultant 4.Genzyme-sanofi:consultant 5 Mylan:consultant; 6 Novartis:consultant;7 Otsuka:consultant; 8 Teva: consultant; Vaccinex; consultant
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
1.Acorda:research support;2.Biogen-Idec:research support 3.EMD-Serono:research support;4.Genzyme-sanofi:research support;5. Novartis: research support 6.Teva:research support; 7.Ono:research support;8. Takeda:research support, 2010; 11. Ono Pharmaceuticals 2010-2011; 12. Avanir: research support 2012-2014; 13. Sun Pharma:research support 2012-2014; 14. Roche:research support 2012-2014
Research Support, Government Entities:
1.
1 NYSTEM (State of New York): Human glial progenitor cells delivery in MS Currently Funded Grants/Contracts co- PI $4,418,204.00 03/01/2013 02/28/2017 20.0% The goal of this study is to establish a clinical trial of human glial progenitor cells in secondary progressive multiple sclerosis.
Research Support, Academic Entities:
1.
1. Mount Sinai School of Medicine; subcontract from NIH for research support. 2. FUNDING AGENCY Mass Gen Hosp/NeuroNEXT (NINDS) Goodman (Site-PI NAME) Fox (PPI) DATES OF ACTIVE/PENDING AWARD 9/1/13-8/31/18 ANTIC TOTAL COSTS $151,880 PERCENT EFFORT 2% TITLE OF PROJECT (OR SUBPROJECT) A Randomized D-B, P-C Study to Evaluate the Safety, Tolerability & Activity of Ibudilast (MN-66) in Subjects with Progressive Multiple Sclerosis. 3. FUNDING AGENCY John Hopkins University GRANT/CONTRACT NUMBER, (PI NAME) Andrew Goodman, MD DATES OF ACTIVE/PENDING AWARD : : 7/15/2011-3/31/2014 ANTIC TOTAL COSTS $0 PERCENT EFFORT 2% TITLE OF PROJECT (OR SUBPROJECT) A Randomized Controlled Trial of Vitamin D in Multiple Sclerosis 3. UNIV/SUNY Buffalo:Establish NYS Multiple Sclerosis Consortium Currently Funded Grants/Contracts Andrew Goodman $0.00 $67,866.00 03/01/1995 10/31/2014 0% The goal of this study is to develop an ongoing, centralized, uniform database of MS patient information and specimens for member centers.
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Ludwig Kappos, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
(1)Multiple Sclerosis Journal, (2)Multiple Sclerosis and Related Disorders (3)Journal of Neurology
Patents:
1.
NONE
Publishing Royalties:
1.
all less than 500 USD
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1)Actelion, (2)Advancell, (3)Allozyne, (4)BaroFold, (5) Bayer Health Care Pharmaceuticals, (6)Bayer Schering Pharma, (7)Bayhill, (8)Biogen Idec, (9)BioMarin, (10)CLC Behring, (11)Elan, (12)Genmab, (13)Genmark, (14)GeNeuro SA, (15)GlaxoSmithKline, (16)Lilly, (17)Merck Serono, (18) MediciNova, (19)Novartis, (20)Novonordisk, (21) Peptimmune, (22)Sanofi-aventis, (23)Santhera, (24)Roche, (25)Teva, (26)UCB, (27)Wyeth I have also lectured at medical conferences or in public on various aspects of the diagnosis and management of multiple sclerosis. In many cases these talks have been sponsored by non-restricted educational grants from one or another of the above listed companies. Honoraria and other payments for all these activities have been exclusively used for funding of research of my department.Research and the clinical operations (nursing and patient care services) of the MS Center in Basel have been supported by non-restricted grants from one or more of these companies.
Research Support, Government Entities:
1.
Research support by the Swiss National Research Foundation and the European Union
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
The Swiss MS Society,the Gianni Rubatto Foundation (Zurich)and Novartis and Roche Research Foundations.
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Fred Lublin, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
Bayer HealthCare Pharmaceuticals; Biogen Idec; EMD Serono, Inc.; Novartis; Teva Neuroscience; Actelion; Sanofi-Aventis; Acorda; Questcor; Roche, Genentech; Celgene; Johnson & Johnson; Revalesio; Coronado Bioscience, Genzyme, MedImmune; Bristol-Myers Squibb, Xenoport, Receptos; Forward Pharma
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Most, if not all, consulting activity and scientific boards listed above and below involved travel that was either paid for directly or reimbursed.
Editorial Boards:
1.
Co-Chief Editor; Multiple Sclerosis and Related Disorders
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Same as Advisory Boards
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Biogen Idec & Teva Neuroscience provide study drug for an NIH sponsored clinical trial that I am the PI of. Also, Acorda Therapeutics, Inc.; Biogen Idec; Novartis Pharmaceuticals Corp; Teva Neuroscience, Inc.; Genzyme; Sanofi; Celgene; NMSS
Research Support, Government Entities:
1.
1) NIH/NINDS- PI, 2008-14
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
1) National Multiple Sclerosis Society- PI, 2008-13 2) National Multiple Sclerosis Society- PI, 2014-2019
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
I provide occassional patent and medico-legal opinions
Chris Polman, MD, PhD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
Biogen Idec, Bayer Schering, Merck Serono, Novartis, UCB, Roche, Actelion, Morphosys
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Biogen Idec, Bayer Schering, Merck Serono, Novartis, UCB, Roche, Actelion, Morphosys
Editorial Boards:
1.
Many journals like Lancet Neurology, Multiple Sclerosis
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Biogen Idec, Bayer Schering, Merck Serono, Novartis, UCB, Roche, Actelion, Morphosys
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Grant support Biogen Idec, Merck Serono, Novartis, UCB
Research Support, Government Entities:
1.
European Community Brussels
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
MS Research Foundation Netherlands
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Richard A. Rudick, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Consulting, Genzyme (2) Consulting, Novartis (3) Consulting, Biogen Idec
Editorial Boards:
1.
Editorial Board, Lancet Neurology 2008-present Editorial Board, Neurotherapeutics, 2010-present
Patents:
1.
Biomarker for interferon response in multiple sclerosis. Patent pending
Publishing Royalties:
1.
Multiple Sclerosis Therapeutics, Third Edition, Cohen, JA, Rudick RA (Eds). Informa Healthcare, UK, 2007
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Biogen Idec Consultation x 1, 2012 Genzyme Consultation x 2, 2012, 2013 Novartis Consultation x 1, 2013
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Biomarkers for the therapeutic response to IFNb. Measuring gene expression before and after IFNb injections in 85 patients (original study sponsored by NIH - PO1NS38667 - current extension of that study sponsored by Genzyme). Innovative Outcomes Assessment in Gilenya Treated MS Patients. Study sponsored by Novartis
Research Support, Government Entities:
1.
NIH - PO1NS38667 (2004-2009)Director, Project 4 NIH - UL1RR024989 (2007-2011)Co-Principal Investigator NIH - KL2RR024990 (2007-2011) Principal Investigator
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
National Multiple Sclerosis Society, Research Program Advisory Committee American Society for Experimental Neurotherapeutics (Member, Board of Directors) National Multiple Sclerosis Society, National Board of Directors, Member
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Kathy Hauswirth, RN, MSN
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Medical Writer, Infusion Communications, 2009-2013
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Lynda M. Cristiano, MD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Biogen Idec, Inc., Senior Medical Director, Safety and Benefit Risk Management, since 2006
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
Biogen Idec (employment compensation)
Legal Proceedings:
1.
NONE
Fiona Forrestal, MSc
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Permanent employee at Biogen Idec (Principal Biostatistician since Feb 2014; Lead Biostatistician Oct. 2011-Jan 2014;) Contract employee at Biogen Idec (Senior Biostatistician Aug. 2008-Oct. 2011)
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Petra Duda, MD, PhD
From the Department of Neurology (P.O.), St. Michael's Hospital, Toronto, Canada; Department of Neurology (A.G.), University of Rochester, NY; Departments of Neurology and Biomedicine (L.K.), University Hospital Basel, Switzerland; Corinne Goldsmith Dickinson Center for MS at The Icahn School of Medicine at Mount Sinai (F.L.), New York, NY; Department of Neurology (C.P.), VU Medical Centre, Amsterdam, the Netherlands; Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R.), Cleveland Clinic Foundation, OH; Infusion Communications (K.H.), Haddam, CT; Departments of Safety and Benefit-Risk Management (L.M.C.) and Biostatistics (F.F.), Biogen Idec Inc., Cambridge; and Sarepta Therapeutics (P.D.), Cambridge, MA; P.D., a former employee of Biogen Idec Inc., was at the company during study conduct.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Medical Director at Biogen Idec 2007- 2013 Medical Director ar Sarepta Therapeutics 2013 - current
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
Biogen Idec
Legal Proceedings:
1.
NONE

Notes

Correspondence to Dr. O'Connor:[email protected]
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

Drafting/revising the manuscript for content, including medical writing for content: P.O., A.G., L.K., F.L., C.P., R.R., K.H., L.C., F.F., P.D. Study concept or design: P.O., A.G., L.K., F.L., C.P., R.R., F.F., P.D. Analysis or interpretation of data: P.O., A.G., L.K., F.L., C.P., R.R., L.C., F.F., P.D. Acquisition of data: P.O., A.G., L.K., F.L., C.P., R.R. Statistical analysis: F.F. Study supervision or coordination: P.O., A.G., L.K., F.L., C.P., R.R., L.C., F.F., P.D.

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