Director of Epidemiology Teva Pharmaceutical Industries Ltd Netanya, Israel
Background: Information about the effects of in-utero exposure to glatiramer acetate (GA) on pregnancy outcomes and offspring of women treated with GA during all 3 trimesters of pregnancy is limited.
Objectives: To assess pregnancy and fetal outcomes among women reporting exposure to GA during three trimesters of pregnancy
Methods: Postmarketing reports were extracted between November 1, 1997 to December 31, 2020 from Teva global safety database using the following criteria: (1) exposure to GA in all three trimesters of pregnancy; (2) prospectively reported pregnancy; and (3) known pregnancy outcome. Pregnancy exposure data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination were considered prospective pregnancy reports. Major congenital malformations were classified based on the Metropolitan Atlanta Congenital Defects Program (MACDP) classification as well as the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and adjudicated by a medical physician. Additional endpoints included fetal death (≥22 weeks gestation), preterm birth ( < 37 weeks), and low birth weight ( < 2500 gram). The rates of major congenital malformations and other endpoints were compared to the general population rates.
Results: A total of 403 prospective pregnancy cases exposed to GA in three trimesters were retrieved from the safety database. The regions with the highest number of reports were North America and Europe (55.1% and 25.6%, respectively). The mean age (n=364/403) was 32 years (standard deviation [SD]= 4.8). The most common indications reported was multiple sclerosis (84.1%, 339/403) followed by relapsing remitting multiple sclerosis (7.9%, 32/403) and unknown (7.9%, n=32/403). The majority of cases were solicited (94.3%) and were mainly reported by patients (82.6%). There was no fetal death reported. Preterm birth was reported in 23/213 (10.8%) pregnancies with known gestational age at birth. Low birth weight was reported in 13/203 (6.4%) infants with known birth weight. Both preterm birth and low birth weight rates were comparable to the rates in the general population (10.23% and 8.31%, respectively). The prevalence of MCM among prospective live births, was 2.4% (10/414 fetuses) according to MACDP classification, which was slightly lower than background rate (3%), and 2.2% (9/414 fetuses) according to EUROCAT classification, which was similar to the background rate (2.1%).
Conclusions: These findings suggest that the rate of major congenital anomalies and other pregnancy and fetal outcomes in prospective pregnancies in women exposed to GA during all 3 trimesters of pregnancy is consistent with background rates.
