Pregnancy outcomes in patients with multiple sclerosis and exposure to branded glatiramer acetate

Objective: To assess the overall impact of branded GA exposure and all cases of confirmed exposure during all three trimesters on pregnancy outcomes Background: Multiple sclerosis is not associated with an increase in spontaneous abortions, stillbirth, cesarean delivery, premature birth, or birth defects. Limited information is available on the association of disease-modifying therapies with adverse pregnancy outcomes. Accordingly, these treatments are often discontinued for women with MS who intend to become or are confirmed pregnant. Design/Methods: Rates of pregnancy loss (spontaneous abortions, still births and fetal demise) and birth defects were calculated from Teva’s global safety database and compared with MACDP (Metropolitan Atlanta Congenital Defects Program) rates. Results: From all prospectively reported pregnancies, a primary cohort (n=2061) with confirmed GA exposure and known outcomes was analyzed. Outcomes included 1760 (85%) live births, 227 (11%) pregnancy loss, 63 (3%) elective pregnancy terminations, 3 (0.15%) molar and 15 (0.7%) ectopic pregnancies. The 227 pregnancy loss cases include 208 spontaneous abortions, 11 fetal deaths and 8 still births. In comparison to MACDP rates, GA-exposed pregnancies show no increase in the percentage of pregnancy loss (17% and 11 %, respectively). All 216 cases in the sub-cohort of exposure during all 3 trimesters resulted in live births. Seven cases of congenital anomalies were reported (3.2%), which is similar to that in the general population (2.8%). Full term (i.e gestational age >37 weeks), normal birthweight, and Caesarean delivery rates were all similar to rates in the general population (85.6% vs. 90.4%, 89.7% vs. 90.6% and 32.9% vs. 32.0%, respectively). Conclusions: Analysis of 2061 cases with confirmed exposure to branded GA demonstrated no increased risk for pregnancy loss. Among 216 cases where exposure throughout all three trimesters of pregnancy was confirmed, GA did not increase the risk of congenital anomalies or alter the normal course of pregnancy. Disclosure: Dr. Qassem has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva. Dr. Melamed-Gal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva. Dr. Baruch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva.