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October 19, 2021; 97 (16) Research ArticleOpen Access

Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

Stephen L. Hauser, Ludwig Kappos, Xavier Montalban, Licinio Craveiro, Cathy Chognot, Richard Hughes, Harold Koendgen, Noemi Pasquarelli, Ashish Pradhan, Kalpesh Prajapati, Jerry S. Wolinsky
First published September 2, 2021, DOI: https://doi.org/10.1212/WNL.0000000000012700
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Article Information

vol. 97 no. 16 e1546-e1559
DOI: 
https://doi.org/10.1212/WNL.0000000000012700
PubMed: 
34475123
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received January 15, 2021
  • Accepted in final form July 29, 2021
  • First Published September 2, 2021.

Article Versions

Copyright & Usage: 
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the 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 without permission from the journal.

Author Disclosures

    1. Stephen L. Hauser, MD,
    2. Ludwig Kappos, MD,
    3. Xavier Montalban, MD, PhD, MBA,
    4. Licinio Craveiro, MD, PhD,
    5. Cathy Chognot, PhD,
    6. Richard Hughes, MD,
    7. Harold Koendgen, MD, PhD,
    8. Noemi Pasquarelli, PhD, MSc,
    9. Ashish Pradhan, MD,
    10. Kalpesh Prajapati, MSc, MPhil and
    11. Jerry S. Wolinsky, MD
  1. Stephen L. Hauser, MD,
    2. Scientific Advisory Boards:

    1. Serves on scientific advisory board for (1) Accure, (2) Alector, (3) Annexon, and (4) Molecular Stethoscope; serves on Board of Directors for (5) Neurona.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. (1) Harrison's Principles of Internal Medicine, McGraw-Hill Education

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. (1) F. Hoffmann La Roche, (2) Novartis AG; travel reimbursement and writing support for anti-CD20 related meetings and presentations.

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. (1) NIH, R35NS111644, PI

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) National Multiple Sclerosis Society, RR 2005-A-13; (2) Valhalla Foundation

    Stock/Stock Options/Board of Directors Compensation:

    1. Stock options received for service on board of directors for (1) Neurona Stock/Stock Options, Medical Equipment & Materials: Stock options received for service on scientific advisory board for (1) Accure, (2) Alector, (3) Annexon, (4) Molecular Stethoscope

    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. Ludwig Kappos, MD,
    3. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. (1)Multiple Sclerosis and Related Disorders member of the Editorial Board

    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. (1)Actelion, (2)Allmirall, (3)Bayer, (4) Baxalta, (5)Biogen, (6) CSL Behring,(7)Excemed, (8)Desitin,(9) Eisai,(10) Genzyme, (11) Japan Tobacco, (12)Merck,(13) Minoryx, (14)Novartis, (15)Pfizer,(16)Receptos/Celgene, (17)Roche,(18)sanofi-aventis,(19)Santhera,(20)Teva,

    Research Support, Government Entities:

    1. (1)the Swiss National Research Foundation, (2)the European Union, (3) Innosuisse

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1)the Swiss MS Society

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License fee payments, Technology or Inventions:

    1. (1) license fees for Neurostatus products paid directly to University Hospital Basel and used for research support

    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. Xavier Montalban, MD, PhD, MBA,
    4. Scientific Advisory Boards:

    1. (1) Actelion, (2) Alexion, (3) Biogen, (4) Bristol-Myers Squibb/Celgene, (5) EMD Serono, (6) Genzyme, (7) Hoffmann-La Roche, (8) Immunic, (9) Janssen Pharmaceuticals, (10) Medday, (11) Merck, (12) Mylan, (13) Nervgen, (14) Novartis, (15) Sanofi-Genzyme, (16) Teva Pharmaceutical, (17) TG Therapeutics

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Travel to scientific meetings: (1) Actelion, (2) Alexion, (3) Biogen, (4) Bristol- Myers Squibb/Celgene, (5) EMD Serono, (6) Genzyme, (7) Hoffmann-La Roche, (8) Immunic, (9) Janssen Pharmaceuticals, (10) Medday, (11) Merck, (12) Mylan, (13) Nervgen, (14) Novartis, (15) Sanofi-Genzyme, (16) Teva Pharmaceutical, (17) TG Therapeutics, (18) Excemed, (19) MSIF and (20) NMSS.

    Editorial Boards:

    1. Member of

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Biogen, (2) Celgene, (3) Merck, (4) Novartis, (5) Roche, (6) Sanofi-Genzyme and (7) Teva Pharmaceutical.

    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. (1) Vice-president, Multiple Sclerosis Foundation of Barcelona (FEM) and (2) Vice-president, Fundació Cemcat

    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. Licinio Craveiro, MD, PhD,
    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. Currently employed by Hoffmann La Roche (sponsor of the trial)

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. employed by Hoffmann La Roche (sponsor of the trial)

    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. I am a shareholder of Hoffmann La Roche Stock/Stock Options, Medical Equipment & Materials: I have stock options available from of Hoffmann La Roche

    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. Cathy Chognot, PhD,
    6. 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. I am an employee of Hoffmann-LaRoche LtD.

    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

  6. Richard Hughes, 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. Roche, Medical Director, 2015-2020 Biogen, Medical Director, 2020-present

    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. Harold Koendgen, MD, PhD,
    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. ​F. Hoffmann-La Roche Ltd at the time of completion of work. Currently employed at UCB Farchim

    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. ​F. Hoffmann-La Roche Ltd 2021 UCB Farchim 2022

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Noemi Pasquarelli, PhD, MSc,
    9. 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. F. Hoffmann-La Roche Ltd, Global Medical Science Director, employed since 2015 Stock/Stock Options, Medical Equipment & Materials: Shareholder of F. Hoffmann-La Roche since 2016

    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

  9. Ashish Pradhan, MD,
    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. I am a full time employee of Genentech Inc.

    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. I am a full time employee of Genentech and hold Roche stock.

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. Kalpesh Prajapati, MSc, MPhil and
    11. 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

  11. Jerry S. Wolinsky, MD
    12. Scientific Advisory Boards:

    1. Compensation for service on steering committees or data monitoring boards for Avotres, Brainstorm Cell Therapeutics, Cleveland Clinic Foundation, EMD Serono, MedDay Pharmaceuticals, NervGen Pharma Corp, Novartis Pharmaceuticals, Roche/Genentech, Sanofi/Genzyme and University of Alabama Birmingham.

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Honoraria, travel support and expenses were provided from AcademicCME and Roche for CME related activities.

    Editorial Boards:

    1. NONE

    Patents:

    1. US010363245B2; Board of Regents UT System; Methods for treating CNS lesions

    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. Royalties are received for monoclonal antibodies out-licensed through the University of Texas Health Science Center at Houston to Millipore (Chemicon International) Corporation since 1993.

    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

  1. From the Department of Neurology (S.L.H.), University of California, San Francisco; Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering (L.K.), Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Switzerland; Department of Neurology-Neuroimmunology (X.M.), Multiple Sclerosis Centre of Catalonia (CEMCAT), Vall d’Hebron University Hospital, Barcelona, Spain; F. Hoffmann-La Roche Ltd. (L.C., C.C., R.H., H.K., N.P.), Basel, Switzerland; Genentech, Inc. (A.P.), South San Francisco, CA; IQVIA Solutions Inc. (K.P.), Amsterdam, The Netherlands; and Department of Neurology (J.S.W.), McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth).
  1. Correspondence
    Dr. Hauser stephen.hauser{at}ucsf.edu
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