Background: Prior publications on pregnancy outcomes in mothers exposed to glatiramer acetate (GA) showed that the prevalence of major fetal defects was comparable to background rates in the general population. Building on existing data, this analysis provides a cumulative 4-year update on the safety of GA during pregnancy.
Objectives: To assess pregnancy and fetal outcomes among women reporting exposure to GA during pregnancy
Methods: Teva’s global safety database was searched between April 1, 2019 and March 31, 2023 for postmarketing reports of maternal exposure to GA during pregnancy or up to 30 days prior to pregnancy. A subset of women who completed the 1- and/or 12-month follow-up questionnaires were also examined for infant growth parameters, adverse events, and breastfeeding practices. Reports were classified as prospective when pregnancy exposure data acquired prior to the pregnancy outcome knowledge or detection of a congenital malformation at a prenatal test and as retrospective when pregnancy exposure data were acquired after knowledge of the pregnancy outcome or after detection of a congenital malformation. Major congenital malformations (MCM) were classified based on the Metropolitan Atlanta Congenital Defects Program (MACDP) and the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) classifications. Pregnancy outcome rates were compared with the general population rates.
Results: A total of 3514 pregnancy cases, 2242 (63.8%) prospective and 1272 (36.2%) retrospective, were retrieved. In the prospective group, the majority of patients (94.3%) reported exposure to GA during the first trimester. Of 1239 prospective fetuses (1211 pregnancies) with known pregnancy outcomes, there were 1138 (91.9%) live births, 83 (6.7%) spontaneous abortions, 10 (0.8%) induced abortions, 4 (0.3%) ectopic pregnancies, 2 (0.2%) stillbirths, and 2 (0.2%) fetal deaths at unknown gestational age. MCM rate (MACDP or EUROCAT) in live births was 1.5%, which is below the background prevalence rates of 3% (MACDP) and 2.0% (EUROCAT). Among prospective live births, preterm birth rate was 7.2% and low birth weight rate was 4.8%, both rates are within the general population rates. Among 694 women with a live birth who completed the follow-up questionnaires, 214 (30.8%) reported breastfeeding. Among those with available corresponding data, the rates of organ system abnormalities (3.9%), hospitalizations (7.5%) and parameters of growth were within background rates.
Conclusions: These findings suggest that the rate of major congenital anomalies and other pregnancy and fetal outcomes in women exposed to GA during pregnancy is consistent with background rates.
