Pregnancy Outcomes From an International Registry of Patients Treated With Delayed-release Dimethyl Fumarate (P4.2-095)

Objective: To assess pregnancy outcomes in an ongoing international registry (NCT01911767) of women with multiple sclerosis (MS) exposed to delayed-release dimethyl fumarate (DMF) since the first day of their last menstrual period prior to conception or at any time during pregnancy.

Background: Data from clinical trials and post-marketing reports show no safety signals with DMF exposure during pregnancy; however, the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Design/Methods: In this interim analysis, DMF-exposed women were prospectively evaluated for live births, pregnancy loss, ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks postdelivery. Data were collected at baseline (enrollment), 6–7 months of gestation, 4 weeks after the estimated delivery date, and 4/12/52 weeks after birth. Potential birth defects were adjudicated by an external expert.

Results: As of 15 December 2017, 199 patients were enrolled in the registry; mean (SD) age was 32 (4) years. Earliest DMF exposure occurred in the first (99%, 186/187), second (<1%, 1/187), and third (0%) trimester in patients with a known exposure date. To date, 132 pregnancy outcomes have been reported, including: 6 (5%) spontaneous abortions (<22 weeks) and 126 (95%) live births: 115 (91%) full term (delivered ≥37 weeks) and 8 (6%) premature. Four (3%) infants had adjudicator-confirmed birth defects: 1 with pyloric stenosis; 1 with transposition of the great vessels; and 2 with ventricular septal defect. No ectopic or molar pregnancies, maternal, neonatal, perinatal, infant deaths or still births were reported. Median (min, max) gestational weight was 3300 (1450, 4660) grams.

Conclusions: Consistent with previous reports, there was no safety signal for DMF exposure on pregnancy outcomes based on data from this ongoing registry.

Study Supported by: Biogen

Disclosure: Dr. Everage has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Everage holds stock and/or stock options in Biogen, which sponsored research in which Dr. Everage was involved as an investigator. Dr. Everage holds stock and/or stock options in Biogen. Dr. Jones has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Jones holds stock and/or stock options in Biogen, which sponsored research in which Dr. Jones was involved as an investigator. Dr. Jones holds stock and/or stock options in Biogen. Dr. Hellwig has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, Sanofi, Teva, Roche, Novartis, Merck. Dr. Hellwig has received research support from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme, Teva. Dr. Rog has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consulting fees from Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience. Dr. Rog has received research support from research support from Biogen, Merck Serono, Novartis, Sanofi, and Teva Neuroscience. Dr. Liu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Liu holds stock and/or stock options in Biogen. Dr. MOU has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. MOU holds stock and/or stock options in Biogen, which sponsored research in which Dr. MOU was involved as an investigator. Dr. MOU holds stock and/or stock options in Biogen. Dr. Prada has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Prada holds stock and/or stock options in Biogen. Dr. Hanna has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Hanna holds stock and/or stock options in Biogen which sponsored research in which Dr. Hanna was involved as an investigator. Dr. Hanna holds stock and/or stock options in Biogen.