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December 2016; 3 (6) ArticleOpen Access

Risk of relapse after natalizumab withdrawal

Results from the French TYSEDMUS cohort

Caroline Papeix, Sandra Vukusic, Romain Casey, Nadine Debard, Bruno Stankoff, Serge Mrejen, Zoe Uhry, Eric Van Ganse, Anne Castot, Michel Clanet, Catherine Lubetzki, Christian Confavreux, For the TYSEDMUS and OFSEP Group
First published October 28, 2016, DOI: https://doi.org/10.1212/NXI.0000000000000297
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Article Information

vol. 3 no. 6 e297
DOI: 
https://doi.org/10.1212/NXI.0000000000000297
PubMed: 
27844037
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received June 8, 2016
  • Accepted in final form September 23, 2016
  • First Published October 28, 2016.
Copyright & Usage: 
© 2016 American Academy of Neurology This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.

Author Disclosures

    1. Caroline Papeix, MD*,
    2. Sandra Vukusic, MD, PhD*,
    3. Romain Casey, PhD,
    4. Nadine Debard,
    5. Bruno Stankoff, MD, PhD,
    6. Serge Mrejen, MD,
    7. Zoe Uhry,
    8. Eric Van Ganse, MD, PhD,
    9. Anne Castot, PhD,
    10. Michel Clanet, MD, PhD,
    11. Catherine Lubetzki, MD, PhD‡,
    12. Christian Confavreux, MD, PhD†,‡;
    13. For the TYSEDMUS and OFSEP Group
  1. Caroline Papeix, MD*,
    2. Scientific Advisory Boards:

    1. bayer sherring novartis teva

    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. educational activities : bayer sherring (2010), biogen idec (2005-2014), novartis (2009-2015), sanofi genzyme (2008-2015), Merk serono (2009-2012) Roche (2009-2015)

    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

  2. Sandra Vukusic, MD, PhD*,
    3. Scientific Advisory Boards:

    1. Biogen-Idec, Geneuro, Genzyme, Merck-Serono, Novartis Pharma, Roche, Sanofi Aventis, Teva Pharma

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Biogen-Idec, Geneuro, Genzyme, Merck-Serono, Novartis Pharma, Roche, Sanofi Aventis, Teva Pharma

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consultancy in board for Biogen-Idec, Geneuro, Genzyme, Merck-Serono, Novartis Pharma, Roche, Sanofi Aventis, Teva Pharma

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Biogen-Idec, Genzyme, Merck-Serono, Novartis Pharma, Roche, Sanofi Aventis, Teva Pharma

    Research Support, Government Entities:

    1. Biogen-Idec, Genzyme, Merck-Serono, Novartis Pharma, Roche, Sanofi Aventis, Teva Pharma

    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

  3. Romain Casey, PhD,
    4. 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. NONE

    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

  4. Nadine Debard,
    5. 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. NONE

    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

  5. Bruno Stankoff, MD, PhD,
    6. Scientific Advisory Boards:

    1. advisory boards for Biogen Idec, Novartis, Genzyme, Teva-Pharma and Roche

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. travel: EAN 2015 by TEVA, ECTRIMS 2016 by NOVARTIS lectures for TEVA, BIOGEN, NOVARTIS, GENZYME

    Editorial Boards:

    1. NONE

    Patents:

    1. Patent pending for the identification of a compound that stimulate demyelination

    Publishing Royalties:

    1. NONE

    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. research support from Merck-Serono and genzyme

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. research support from ANR (agence nationale de la recherche), PHRC (programme hospitalier de recherche clinique), fondation ARSEP and Progressive MS alliance

    Research Support, Foundations and Societies:

    1. grants from ARSEP fondation (association d e recherche sur la sclerose en plaques)

    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

  6. Serge Mrejen, MD,
    7. 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. NONE

    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

  7. Zoe Uhry,
    8. 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. NONE

    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

  8. Eric Van Ganse, MD, PhD,
    9. Scientific Advisory Boards:

    1. Dr. Van Ganse reports grants and personal fees from ALK ABELLO, personal fees from AstraZeneca, grants and personal fees from Bayer, grants and personal fees from BMS, personal fees from Boehringer Ingelheim, grants and personal fees from GlaxoSmithKline, personal fees from IMS, personal fees from LASER, grants and personal fees from Merck Sharp and Dohme, outside the submitted work; .

    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. NONE

    Consultancies:

    1. Dr. Van Ganse reports grants and personal fees from ALK ABELLO, personal fees from AstraZeneca, grants and personal fees from Bayer, grants and personal fees from BMS, personal fees from Boehringer Ingelheim, grants and personal fees from GlaxoSmithKline, personal fees from IMS, personal fees from LASER, grants and personal fees from Merck Sharp and Dohme, outside the submitted work; .

    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

  9. Anne Castot, PhD,
    10. 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. NONE

    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

  10. Michel Clanet, MD, PhD,
    11. Scientific Advisory Boards:

    1. Biogenidec; Genzyme, Merck Serono, Sanofi, Teva

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. ECTRIMS travel for annual meetings

    Editorial Boards:

    1. Multiple Sclerosis Journal without compensation until 2016

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    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. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. ARSEP ( Foundation for research in Multiple Sclerosis) EDMUS Eugene DEVIC Foundation

    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

  11. Catherine Lubetzki, MD, PhD‡,
    12. Scientific Advisory Boards:

    1. VERTEX , BIOGEN, NOVARTIS, GENZYME

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Associate editor BRAIN editorial board member of MSJ and MSJ and related disorders

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. BIOGEN, ROCHE, GENZYME

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. scientific collaboration with EMD SERONO

    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

  12. Christian Confavreux, MD, PhD†,‡;
    13. 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. NONE

    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

  13. For the TYSEDMUS and OFSEP Group
    1. From the Neurology Department (C.P., S.M., C.L.), Pitié-Salpêtrière Hospital, Paris; Service de Neurologie A, Hôpital Neurologique Pierre Wertheimer (S.V., C.C.), and Neuro-epidemiology and Pharmaco-epidemiology (E.V.G.), Hospices Civils de Lyon, Lyon/Bron; Centre des Neurosciences de Lyon (S.V., C.C.), INSERM 1028 et CNRS UMR5292, Equipe Neuro-oncologie et Neuro-inflammation; Université de Lyon (S.V., C.C.); Observatoire Français de la Sclérose en Plaques (R.C., N.D., Z.U.), Bron; Neurology Department (B.S.), Saint Antoine Hospital, Paris; Agence Nationale de Sécurité des Médicaments (ANSM, formerly Agence Française de Sécurité Sanitaire des Produits de Santé—AFSSAPS) (A.C.), Saint-Denis; and Neurology Department (M.C.), Purpan Hospital, Toulouse, France.
    1. Correspondence to Dr. Papeix: caroline.papeix{at}psl.aphp.fr
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