Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding

Sigal Kaplan (), Mikhail Zeygarnik and Tal Stern
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Sigal Kaplan: Teva Pharmaceutical Industries Ltd.
Mikhail Zeygarnik: Teva Pharmaceutical Industries Ltd.
Tal Stern: Teva Pharmaceutical Industries Ltd.

Drug Safety, 2022, vol. 45, issue 4, No 4, 345-357

Abstract: Abstract Introduction Published data support the safety of glatiramer acetate in patients with multiple sclerosis who are pregnant or breastfeeding, but long-term data are limited. Objective We aimed to assess pregnancy, fetal, and infant outcomes following maternal exposure to glatiramer acetate. Methods In-utero glatiramer acetate-exposed postmarketing pregnancy reports from 2019 to 2021 were extracted from Teva’s pharmacovigilance database. Pregnancy data acquired prior to knowledge of pregnancy outcome or detection of congenital malformation (prospective reports) were used to estimate pregnancy and infant outcome rates for glatiramer acetate 20- and 40-mg/mL exposure. A subgroup of cases completed follow-up questionnaires and were analyzed separately. Results Prospective cases with 702 fetuses had known outcomes with 647 (92.2%) live births, 47 (6.7%) spontaneous abortions, 4 (0.6%) induced abortions, 2 (0.3%) ectopic pregnancies, and 2 (0.3%) fetal deaths. Rates of major congenital malformation (1.1%), preterm births (7.2%), and low/very low birth weight (4.8%), and parameters of growth were within background rates. No infant developmental delay was reported. Overall, pregnancy and infant outcomes were similar across glatiramer acetate doses. Conclusions Maternal exposure to glatiramer acetate does not appear to be related to adverse pregnancy, fetal, or infant outcomes. These data further support the safety of both glatiramer acetate 20-mg/mL and 40-mg/mL treatments during pregnancy and breastfeeding.

Date: 2022
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DOI: 10.1007/s40264-022-01168-1

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