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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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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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Abstract

Objective To assess possible adverse effects on breastfed infants of mothers receiving monoclonal antibodies (MAbs) during pregnancy and/or lactation.

Methods We identified 23 patients from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) who received MAbs (17 natalizumab and 6 anti-CD20) during lactation. Thirteen were already exposed to natalizumab during the third trimester of pregnancy, and 1 received ocrelizumab during pregnancy. Data were obtained from standardized, telephone-administered questionnaires completed by the mother during pregnancy and at 1, 3, 6, and 12 months postpartum. Natalizumab concentration in mother’s milk was analyzed in 3 patients and natalizumab serum concentration in 2 of these patients and their breastfed infants.

Results We did not observe a negative impact on infant health and development attributable to breast milk exposure after a median follow-up of 1 year. Infants exposed to natalizumab during the third trimester had a lower birth weight and more hospitalizations in the first year of life. The concentration of natalizumab in breast milk and serum of infants was low; B cells normal in infants breastfed under anti-CD20.

Conclusion More data on the effect of Mab exposure during pregnancy are needed. Otherwise, our data suggest that treatment with natalizumab, ocrelizumab, or rituximab during lactation might be safe for breastfed infants.

Glossary

CBC=
complete blood count;
MAb=
monoclonal antibody;
NMOSD=
neuromyelitis optica spectrum disorder;
NTZ=
natalizumab;
OCR=
ocrelizumab;
RID=
relative infant dose;
RTX=
rituximab

Footnotes

  • Go to Neurology.org/NN for full disclosures. Funding information is provided at the end of the article.

  • The Article Processing Charge was funded by the authors.

  • Received January 24, 2020.
  • Accepted in final form March 19, 2020.
  • 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.

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