(P-144) Pregnancy and fetal outcomes following maternal exposure to Glatiramer Acetate

Background: Information about the effects on the offspring of women treated with glatiramer acetate (GA) during pregnancy are limited.

Objectives: To assess pregnancy and fetal outcomes among women reporting exposure to GA during pregnancy

Methods: Postmarketing reports were extracted between April 1, 2019 to March 31, 2020 from Teva global safety database using the following criteria: (1) exposure to GA during pregnancy; (2) latest safety report received date of cases: 01 April 2019 to 31 March 2020, with an initial safety report received date from 01 June 2018.
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, and data acquired after the outcome of the pregnancy was known or after the detection of a congenital malformation or prenatal test were considered retrospective 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. The rate of major congenital malformations was compared to the general population rate.

Results: A total of 1246 pregnancy cases were retrieved from the safety database. The countries with the highest number of reports were USA (23.8%), Germany (16.0%), and the UK (10.6%).
In the prospective group, patients (n=661/849) had a mean age of 32 years (standard deviation [SD]= 4.4). The most common indications reported was MS (66%, 557/849) or relapsing remitting multiple sclerosis (RRMS) (13%, 110/849). (18.7%, 159/849). The majority of patients with known trimester of exposure (95%, 634/666) reported exposure to GA during the first trimester.
Of 849 prospective pregnancies, 350 had known pregnancy outcomes at cut-off date. Of 355 fetuses, there were 325 live births, 24 spontaneous abortions, 5 induced abortions and 1 fetal death. The rate of major congenital malformations (based on either MACDP or EUROCAT classifications) in live births was 0.92%, 3/325 (95% confidence interval, 0.31-2.68), which is below the background prevalence rates of 3% the general population according to MACDP and 1.82 per 100 live births according to EUROCAT. The preterm birth rate was 6.1% and low birth weight rate was 3.9%, both rates within the general population rates reported in the literature.

Conclusions: These findings suggest that the rate of major congenital anomalies in prospective pregnancies in women exposed to GA during pregnancy is within the normal range as compared to background rate values.