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

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

Kerstin Hellwig  1 , David Rog  2 , Christopher McGuigan  3 , Maria K Houtchens  4 , Denise R Bruen  5 , Oksana Mokliatchouk  6 , Filipe Branco  6 , Seth Levin  6 , Nicholas Everage  6 , Xiaochen Lin  6
Affiliations

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

Kerstin Hellwig et al. Mult Scler. 2024 Feb.

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.

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Conflict of interest statement

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.

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