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July 2020; 7 (4) ArticleOpen Access

Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder

Andrea Ines Ciplea, Annette Langer-Gould, Annick de Vries, Tiny Schaap, Sandra Thiel, Marius Ringelstein, Ralf Gold, Kerstin Hellwig
First published April 23, 2020, DOI: https://doi.org/10.1212/NXI.0000000000000723
Andrea Ines Ciplea
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Annette Langer-Gould
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Annick de Vries
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Tiny Schaap
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Sandra Thiel
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Marius Ringelstein
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Ralf Gold
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Kerstin Hellwig
From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
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Full PDF
Citation
Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder
Andrea Ines Ciplea, Annette Langer-Gould, Annick de Vries, Tiny Schaap, Sandra Thiel, Marius Ringelstein, Ralf Gold, Kerstin Hellwig
Neurol Neuroimmunol Neuroinflamm Jul 2020, 7 (4) e723; DOI: 10.1212/NXI.0000000000000723

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Article Information

vol. 7 no. 4 e723
DOI: 
https://doi.org/10.1212/NXI.0000000000000723
PubMed: 
32327455

Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received January 24, 2020
  • Accepted in final form March 19, 2020
  • First Published April 23, 2020.

Copyright & Usage: 
Copyright © 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-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. Andrea Ines Ciplea,
    2. Annette Langer-Gould, MD, PhD,
    3. Annick de Vries, PhD,
    4. Tiny Schaap, BSc,
    5. Sandra Thiel, PhD,
    6. Marius Ringelstein, MD,
    7. Ralf Gold, MD and
    8. Kerstin Hellwig, MD
  1. Andrea Ines Ciplea,
  2. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. (1) Sanofi-Genzyme, funding for travel(2) Teva, funding for travel(3) Novartis, funding for travel(4) Bayer Healthcare, speaker honoraria

    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

  3. Annette Langer-Gould, MD, PhD,
  4. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for Travel or Speaker Honoraria:
    1. NONE

    Editorial Boards:
    1. My husband, Michael Gould, serves as the Deputy Editor for Annals of the American Thoracic Society for the past 2.5 years

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. NONE

    Other activities:
    1. I am a voting panel member of California Technology Assessment Forum, a core program of the Institute for Clinical and Economic Review (ICER) and have served as expert evaluator for ICER's evaluation of MS DMTs. ICER has paid for my travel for the round table meetings.

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. NONE

    Research Support, Government Entities:
    1. My husband currently receives grant support from the NIH, PCORI and NCI

    Research Support, Academic Entities:
    1. I received grant support from the National Institutes of Health (NIH NINDS RO1) and currently an award from PCORI

    Research Support, Foundations and Societies:
    1. I received grant and contract support from the National Multiple Sclerosis Society

    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. Annick de Vries, 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. 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. Tiny Schaap, BSc,
  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

  9. Sandra Thiel, PhD,
  10. Scientific Advisory Boards:
    1. NONE

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Bayer Healthcare, speaker honoraria

    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. Marius Ringelstein, MD,
  12. Scientific Advisory Boards:
    1. 1. Roche Pharma GmbH, served on a national scientific advisory board.

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. 1. Novartis, funding for speaking at a conference. 2. Ipsen, funding for speaking at a conference. 3. Bayer Healthcare, funding for travel to a conference. 4. Biogen Idec, funding for travel to a conference. 5. Genzyme, funding for travel to a conference. 6. TEVA, funding for travel to a conference. 7. Merz, funding for travel to a conference. 8. Merck, funding for travel to a conference.

    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. Ralf Gold, MD and
  14. Scientific Advisory Boards:
    1. (1) TEVA Laquinimod DSMB

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. Speaker honoraria from Biogen, Genzyme, TEVA, Merckserono, BayerSchering,Celgene, Novartis

    Editorial Boards:
    1. SAGE Journal TAND, Experimental Neurology

    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. From Roche From Merck From Bayer

    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

  15. Kerstin Hellwig, MD
  16. Scientific Advisory Boards:
    1. (1) Novartis (2) Genzyme (3) Teva (4) Merck (5) Roche

    Gifts:
    1. NONE

    Funding for travel or speaker honoraria:
    1. (1) Biogen, funding for travel (2) Novartis, funding for travel (3) Merck, funding for travel (4) Biogen Idec Germany, speaker honoraria (5) Teva, speaker honoraria (6) Sanofi Genzyme, speaker honoraria (7) Novartis, speaker honoraria (8) Bayer Healthcare, speaker honoraria (9) Merck Serono, speaker honoraria (10) Roche, speaker honoraria

    Editorial Boards:
    1. NONE

    Patents:
    1. NONE

    Publishing Royalties:
    1. NONE

    Employment, Commercial Entity:
    1. NONE

    Consultancies:
    1. NONE

    Speakers' Bureaus:
    1. Honoraria from Biogen, Bayer Healthcare, Teva, Sanofi, Merck and Novartis

    Other Activities:
    1. NONE

    Clinical Procedures or Imaging Studies:
    1. NONE

    Research Support, Commercial Entities:
    1. Biogen, Bayer Healthcare, Teva, Merck, Roche, Sanofi-Genzyme and Novartis

    Research Support, Government Entities:
    1. (1) Fund of the Federal Joint Committee

    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

  1. From the Department of Neurology (A.I.C., S.T., R.G., K.H.), St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University, Dusseldorf, Germany; Southern California Permanente Medical Group/Kaiser Permanente (A.L.-G.), Los Angeles Medical Center, Neurology Department, Los Angeles, CA; Sanquin Diagnostic Services (A.V., T.S.), Sanquin, Amsterdam, the Netherlands; Department of Neurology (M.R.), Medical Faculty, Heinrich Heine University; and Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum, Heinrich Heine University Düsseldorf, Germany.
  1. Correspondence
    Dr. Hellwig k.hellwig{at}klinikum-bochum.de
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Neurology - Neuroimmunology Neuroinflammation: 10 (3)

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Neurology: Neuroimmunology & Neuroinflammation
Online ISSN: 2332-7812

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