Pregnancy and fetal outcomes following maternal exposure to glatiramer acetate in all three trimesters of pregnancy

Abstract

BackgroundData on disease modifying therapy (DMT) exposure throughout pregnancy in patients with multiple sclerosis are scarce. This analysis assesses pregnancy and fetal outcomes following glatiramer acetate (GA) maternal exposure in all three trimesters among cases reported between 1997−2020.MethodsPregnancy reports of maternal exposure to in‐utero 20 and 40 mg/mL GA in all three trimesters from 1997−2020 were eligible. Prospective pregnancy data reported prior to knowledge of pregnancy outcome and retrospective data were included. The primary endpoint was major congenital malformations (MCM) using the European Surveillance of Congenital Anomalies and Twins (EUROCAT) classification. Additional endpoints included fetal death, preterm birth, and low birth weight. MCM rate was compared to EUROCAT background rate.ResultsA total of 618 GA‐exposed pregnancies in all three trimesters resulted in 634 fetuses, including 14 twin pregnancies. There was one fetal death reported. All 414 prospective fetuses, with data reported prior to knowledge of pregnancy outcome, were live births and no fetal death was reported. Preterm birth was reported in 23/213 (10.8%) pregnancies with known gestational age. Low birth weight was reported in 13/203 (6.4%) infants with known birth weight. The prevalence of major congenital malformation in prospective live births ranged from 2.2‐2.4%, which was similar to background rates (2.1‐3.0%). The frequency of these pregnancy and infant outcomes was comparable across GA doses.ConclusionsIn‐utero exposure to 20 and 40 mg/mL GA in three trimesters of pregnancy does not appear to be related to adverse pregnancy or infant outcomes.