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February 09, 2021; 96 (6) ArticleOpen Access

Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis

A Phase 2 Randomized Control Trial

Vera Bril, Michael Benatar, Henning Andersen, John Vissing, Melissa Brock, Bernhard Greve, Peter Kiessling, Franz Woltering, Laura Griffin, Peter Van den Bergh, on behalf of the MG0002 Investigators
First published November 20, 2020, DOI: https://doi.org/10.1212/WNL.0000000000011108
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Article Information

vol. 96 no. 6 e853-e865
DOI: 
https://doi.org/10.1212/WNL.0000000000011108
PubMed: 
33219142
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Print ISSN: 
0028-3878
Online ISSN: 
1526-632X
History: 
  • Received February 3, 2020
  • Accepted in final form October 7, 2020
  • First Published November 20, 2020.

Article Versions

Copyright & Usage: 
© 2020 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-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share 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. Vera Bril, MD, FRCP,
    2. Michael Benatar, MD, PhD,
    3. Henning Andersen, MD, PhD,
    4. John Vissing, MD, PhD,
    5. Melissa Brock, PharmD,
    6. Bernhard Greve, MD,
    7. Peter Kiessling, PhD,
    8. Franz Woltering, MSc,
    9. Laura Griffin, PhD,
    10. Peter Van den Bergh, MD, PhD;
    11. on behalf of the MG0002 Investigators
  1. Vera Bril, MD, FRCP,
    2. Scientific Advisory Boards:

    1. (1) CSL Behring(2) Argenyx(3) UCB(4) Alexion(5) Immunovant(6) Alnylam(7) Akcea(8) Takeda(9) Sanofi(10) Ionis

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. (1) CSL Behring(2) Akcea

    Editorial Boards:

    1. (1) PLoS One, editorial board member starting 2016

    Patents:

    1. With CSL Behring, role of electrophysiology in predicting response to subcutaneous immunoglobulin therapy in CIDP.

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Alnylam (2) Alexion (3) Akcea (4) Pfizer (5) CSL Behring(6) Grifols(7) Octapharma(8) Powell Mansfield Inc, (9) Argenyx(10) UCB(11) Immunovant(12) Takeda (Shire)(13) Momenta(14) Sanofi

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) CSL Behring(2) Baxalta(3) Grifols(4) Argenyx(5) Octapharma(6) Takeda (Shire)(7) UCB(8) Immunovant(9) Momenta

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Toronto General/Toronto Western Hospital Foundation(2) GBS/CIDP Foundation International

    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. Michael Benatar, MD, PhD,
    3. Scientific Advisory Boards:

    1. (1) Mitsubishi-Tanabe(2) Avexis(3) Biogen(4) Prilenia(5) Genentech(6) Viela Bio(7) Immunovant(8) SwanBio(9) Roche

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. US Provisional Patent Application. Determining onset of amyotrophic lateral sclerosis

    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) Biogen(2) Orphazyme

    Research Support, Government Entities:

    1. (1) National Institutes of Health (U24 NS107376), PI, 2018-2023(2 National Institutes of Health (U54 NS092091), PI, 2014-2024(3) National Institutes of Health (U01 NS107027), PI, 2018-2023(4) National Institutes of Health (R01 NS205479), PI, 2018-2023(5) National Institutes of Health (R21 NS111275), Co-I, 2019-2021

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) ALS Association (16-TACL-242)(2) MDA (376132)(3) Target ALS

    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. Henning Andersen, MD, PhD,
    4. Scientific Advisory Boards:

    1. CommercialNMD Pharma

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Commercial. Alexion, Sanofi Genzyme, NOVO.

    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. John Vissing, MD, PhD,
    5. Scientific Advisory Boards:

    1. Has served on advisory boards for Roche, Viela Bio, Biogen, Amicus Therapeutics, PTC Therapeutics, Sanofi/Genzyme, Ultragenyx Pharmaceutical, Fulcrum Therapeutics, ML Bio Solutions, Sarepta Therapeutics, Novartis Pharma AG, Stealth Biotherapeutics and Lupin Limited within the last 3 years

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Travel and speaker honoraria from UCB Pharma, Edgewise Therapeutics, Sanofi/Genzyme, Fulcrum Therapeutics and Alexion Pharmaceuticals

    Editorial Boards:

    1. Editorial Board member for the journals, NeuromuscularDisorders, Acta Neurologica Scandinavica and Journal ofNeuromuscular Diseases.

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consultant on advisory boards for Roche, Viela Bio, Biogen, Amicus Therapeutics, PTC Therapeutics, Sanofi/Genzyme, Ultragenyx Pharmaceutical, Fulcrum Therapeutics, ML Bio Solutions, Sarepta Therapeutics, Novartis Pharma AG, Stealth Biotherapeutics and Lupin Limited within the last 3 years

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Grants from Lundbeck Foundation, NOVO foundation,

    Research Support, Government Entities:

    1. Danish Medical Research Council, University of Copenhagen,The research Committee of the National Hospital, Rigshospitalet, EU commission, EIT health

    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. Melissa Brock, PharmD,
    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. Employee of UCB BioSciences, Inc.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. Stock options as employee of UCB BioSciences, Inc.

    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. Bernhard Greve, 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. Bernhard Greve is an employee of UCB Biosciences GmbH 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. Bernhard Greve is an employee of UCB Biosciences GmbH since 2016

    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. Peter Kiessling, 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. UCB Biosciences, Senior Clinical Program Director, 8 years

    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. UCB Biosciences, 8 years

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. UCB Biosciences, full time employee of the study sponsor, 8 years

  8. Franz Woltering, 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. UCB Biosciences, Principal Statistician, 13

    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. Laura Griffin, 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. iMed Communications, Senior Medical Writer, 4.5 years

    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. Peter Van den Bergh, MD, PhD;
    11. Scientific Advisory Boards:

    1. Commercial GenzymeCommercial AlnylamCommercial CSL

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Commercial LFBCommercial CSLCommercial Alnylam

    Editorial Boards:

    1. Neuromuscular Disorders

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Commercial TakedaCommercial CSLCommercial Pfizer

    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. on behalf of the MG0002 Investigators
  1. From Toronto General Hospital (V.B.), University Health Network, University of Toronto, Canada; Department of Neurology (M. Benatar), Miller School of Medicine, University of Miami, FL; Department of Neurology (H.A.), Aarhus University Hospital; Department of Neurology, Rigshospitalet (J.V.), University of Copenhagen, Denmark; UCB Pharma (M. Brock), Raleigh, NC; UCB Pharma (B.G., P.K., F.W.), Monheim-am-Rhein, Germany; iMed Communications (L.G.), Macclesfield, UK; and Neuromuscular Reference Centre, Department of Neurology (P.V.d.B.), University Hospital Saint-Luc, University of Louvain, Brussels, Belgium.
  1. Correspondence
    Dr. Bril Vera.bril{at}utoronto.ca
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