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

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.

Déclaration de conflit d'intérêts

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: K.H. participated on scientific advisory boards for Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva; received speaker honoraria and research support from Bayer, Biogen, Genzyme, Merck, Novartis, Sanofi, and Teva; received support for congress participation from Bayer, Biogen, Genzyme, Merck, Roche, and Teva. D.R. received consulting and/or speaker fees from Biogen, Celgene, Hikma, Janssen, MedDay, Merck, Novartis, Roche, Sanofi and Teva; research support (paid to institutional fund) from Actelion, Biogen, Janssen, Merck, Mitsubishi, Novartis, Sanofi, Teva and TG Therapeutics. C.M. received honoraria for consultancy work and/or research funding from Actelion, Biogen, Merck, Novartis, Roche, Sandoz, and Sanofi-Genzyme. M.K.H. participated on advisory boards for Biogen, Merck, Novartis, Roche, Sanofi, and Teva; received research support from Biogen, Genzyme, and Merck. D.R.B. participated on advisory boards for Biogen, Celgene, EMDSerono, Genentech, Novartis, and Sanofi-Genzyme. O.M., S.L., N.E., and X.L. are full-time employees of and hold stock/stock options in Biogen. F.B. was a full-time employee of and held stock/stock options in Biogen at the time the research was conducted.