Final analysis of 379 pregnancy outcomes after exposure to dimethyl fumarate in a prospective international registry

Abstract

Background: Dimethyl fumarate (DMF) has a favorable benefit–risk profile treating people with multiple sclerosis and should be used in pregnant women only if the potential benefits outweigh potential risks to the fetus. Objective: Assess pregnancy outcomes in a completed international registry (TecGistry) of women with MS exposed to DMF. Methods: TecGistry included pregnant women with MS exposed to DMF, with data collected at enrollment, 6–7 months gestation, 4 weeks after estimated due date, and at postpartum weeks 4, 12, and 52. Outcomes included live births, gestational size, pregnancy loss, ectopic/molar pregnancies, birth defects, and infant/maternal death. Results: Of 397 enrolled, median (range) age was 32 years (19–43). Median (range) gestational week at enrollment was 10 (0–39) and at first DMF exposure was 1 (0–13). Median (range) duration of gestational DMF exposure was 5 weeks (0–40). Fifteen (3.8%) spontaneous abortions occurred. Of 360 (89.1%) live births, 323 were full term and 37 were premature. One neonatal death and no maternal deaths occurred. Adjudicator-confirmed EUROCAT birth defects were found in 2.2%. Conclusion: DMF exposure during pregnancy did not adversely affect pregnancy outcomes; birth defects, preterm birth, and spontaneous abortion were in line with rates from the general population.