Pregnancy Outcomes From an International Registry of Patients Treated With Delayed-release Dimethyl Fumarate

Introduction Available data from clinical trials and post-marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy. Objectives To assess pregnancy outcomes in an ongoing international registry of women with multiple sclerosis exposed to DMF. Patients and methods In this interim analysis, DMF-exposed women were prospectively evaluated for live births and pregnancy loss. Potential birth defects were adjudicated by an external expert. Gestational size was classified as small (  90th) based on WHO or country-specific growth charts. Results As of 15 December 2017, 132 pregnancy outcomes have been reported, including 126 (95%) live births and 6 (5%) spontaneous abortions ( Discussion No ectopic or molar pregnancies were reported. No maternal, neonatal, perinatal, infant deaths or still births were reported. Of the 105 infants with gestational size data, 9 (9%) were classified as small, 87 (83%) as appropriate, and 9 (9%) as large and median (min, max) gestational weight was 3300 (1450, 4660) grams. Conclusion Consistent with previous reports, there was no safety signal for DMF exposure on pregnancy outcomes based on data from this ongoing registry.