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

Mult Scler. 2024 Feb;30(2):209-215. doi: 10.1177/13524585231220232. Epub 2024 Jan 2.

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.

Keywords: Multiple sclerosis; dimethyl fumarate; disease-modifying therapy; pregnancy; registry.

MeSH terms

  • Abortion, Spontaneous* / chemically induced
  • Abortion, Spontaneous* / epidemiology
  • Adult
  • Dimethyl Fumarate / adverse effects
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Pregnancy
  • Pregnancy Outcome / epidemiology
  • Premature Birth* / chemically induced
  • Premature Birth* / epidemiology
  • Prospective Studies
  • Registries
  • Young Adult

Substances

  • Dimethyl Fumarate