Pregnancy outcomes in patients with multiple sclerosis and exposure to branded glatiramer acetate during all three trimesters (P4.362)

Objective: To evaluate pregnancy, labor and neonatal complications, alongside pregnancy outcomes in patients with multiple sclerosis (MS) who were exposed to branded glatiramer acetate (GA, Copaxone ® ) during all 3 trimesters and compare them with reference data from the general population. Background: Potential pregnancy risks associated with MS disease-modifying therapies are not fully known. Accordingly, treatments are often discontinued for women who intend to become or are confirmed to be pregnant; however, in women with highly active MS there may be a need to continue therapy throughout pregnancy. Design/Methods: Pregnancy outcomes were sourced from Teva’s global pharmacovigilance database. Analyses were performed on prospective cases from clinical trials and solicited or spontaneous reports, including all patients with known outcomes and exposure to branded GA 20 mg/mL (GA20) during all 3 trimesters. Rates of congenital anomalies were compared with MACDP (Metropolitan Atlanta Congenital Defects Program) rates, a US population-based tracking system for birth defects. Gestational age, birthweight, and caesarean delivery rates were compared with the “National Vital Statistics Report; Births: Final Data for 2015,” a US population-based report. Results: All 216 cases identified resulted in live births. Seven cases of congenital anomalies were reported. The percentage of reported congenital anomalies in Teva’s database (3.2%) was similar to that in the general population (2.8%). Of pregnancies with reported gestational age, 85.6% ended after Week 37 (full gestational age) during GA20 treatment, compared with 90.4% in the general population. Of all cases with reported birthweight, 89.7% were within normal range, compared with 90.6% in the general population. Caesarean delivery occurred in 32.9% of the cases, compared with 32.0% in the general population. Conclusions: Compared with the general population, GA20 exposure during all 3 trimesters of pregnancy did not increase the risk of congenital anomalies or alter the normal course of the pregnancy. Study Supported by: Teva Pharmaceutical Industries Disclosure: Dr. Hellwig has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with speaker honoraria: Biogen Idec, Teva, Sanofi Aventis, Novartis, Bayer Healthcare, Merck Serono. Dr. Neudorfer 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 Employee of Teva. Dr. Baruch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva. Dr. Qassem has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva.