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July 2020; 7 (4) ArticleOpen Access

Rituximab, MS, and pregnancy

Jessica B. Smith, Kerstin Hellwig, Katharina Fink, Deirdre J. Lyell, Fredrik Piehl, Annette Langer-Gould
First published May 1, 2020, DOI: https://doi.org/10.1212/NXI.0000000000000734
Jessica B. Smith
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Kerstin Hellwig
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Katharina Fink
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Deirdre J. Lyell
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Fredrik Piehl
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Annette Langer-Gould
From the Department of Research & Evaluation (J.B.S.), Kaiser Permanente Southern California; Department of Neurology (K.H.), St. Josef Hospital, Bochum, Germany; Department of Clinical Neuroscience (K.F., F.P.), Karolinska Institute; Center for Neurology (K.F.), Academic Specialist Center, Stockholm, Sweden; Department of Obstetrics & Gynecology – Maternal Fetal Medicine (D.J.L.), Stanford University School of Medicine, Stanford, CA; Department of Neurology (F.P.), Karolinska University Hospital, Stockholm, Sweden; and Department of Neurology (A.L.-G.), Los Angeles Medical Center, Southern California Permanente Medical Group, Los Angeles, CA.
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Citation
Rituximab, MS, and pregnancy
Jessica B. Smith, Kerstin Hellwig, Katharina Fink, Deirdre J. Lyell, Fredrik Piehl, Annette Langer-Gould
Neurol Neuroimmunol Neuroinflamm Jul 2020, 7 (4) e734; DOI: 10.1212/NXI.0000000000000734

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Abstract

Objective To describe the safety and efficacy of rituximab (RTX) in MS and pregnancy, we conducted a retrospective cohort study of 74 pregnancies among 55 women treated with RTX for MS and their offspring.

Methods We used prospectively collected information from the electronic health record at Kaiser Permanente Southern California between 2012 and 2019 of mother and baby to identify treatment history, pregnancy outcomes, and relapses.

Results Last RTX exposure before conception occurred between 1.8 and 5.2 months in 32 (49%) of 65 pregnancies and accidentally during the first trimester in 9 (12%). Among 38 live births, adverse pregnancy outcomes were as follows: 3 preterm deliveries (including 1 set of twins), 1 neonatal death (preterm twin), and 1 perinatal stroke (full-term). No stillbirths, chorioamnionitis, or major malformations were found. Fifteen (27%) women had at least one first-trimester miscarriage, of whom 8 (53%) had a history of infertility. Cumulative dose or timing of last RTX infusion was not associated with an increased risk of miscarriage. Only 2 (5.4%) women experienced relapses, one during pregnancy and the other postpartum.

Conclusion We observed no increase in adverse pregnancy outcomes compared with expected national incidence rates and remarkably little disease activity in RTX-treated women with MS, particularly when compared with periconceptional natalizumab-treated cohorts. However, larger studies are needed to fully assess the safety of RTX use before pregnancy, especially risks associated with prolonged B-cell depletion and hypogammaglobulinemia. Until these data are available, we recommend restricting RTX use before pregnancy to women who require highly effective MS treatments.

Classification of evidence This study provides Class IV evidence that for pregnant women with MS, RTX controls disease activity and does not increase adverse pregnancy outcomes.

Glossary

BMI=
body mass index;
CIS=
clinically isolated syndrome;
DMT=
disease-modifying treatment;
EDD=
expected delivery date;
EHR=
electronic health record;
gw=
gestational week;
IQR=
interquartile range;
KPSC=
Kaiser Permanente Southern California;
LMP=
last menstrual period;
RA=
rheumatoid arthritis;
RCT=
randomized controlled trial;
RIS=
radiologically isolated syndrome;
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 December 26, 2019.
  • Accepted in final form March 24, 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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