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. 2023 Jan;30(1):162-171.
doi: 10.1111/ene.15559. Epub 2022 Oct 1.

Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis

Johanna Balslev Andersen  1 , Finn Sellebjerg  2   3 , Melinda Magyari  1   2   3
Affiliations

Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis

Johanna Balslev Andersen et al. Eur J Neurol. 2023 Jan.

Abstract

Background and purpose: Data on pregnancy outcomes following fetal exposure to disease-modifying drugs (DMDs) in women with multiple sclerosis (MS) are sparse although growing.

Methods: Data from the Danish Multiple Sclerosis Registry were linked with nationwide registries enabling an investigation of adverse pregnancy outcomes in newborns of women with MS following fetal exposure to injectable first-line treatments, dimethyl fumarate, glatiramer acetate, or natalizumab. Logistic regression models accounting for clustered data were used to estimate odds ratios (ORs) with 95% confidence intervals (CIs) for individual and composite adverse outcomes after adjusting for relevant covariates.

Results: A total of 1009 DMD-exposed pregnancies were compared with 1073 DMD-unexposed pregnancies as well as 91,112 pregnancies from the general population. No association of an increased risk of any perinatal outcome was found when comparing newborns with fetal exposure with the general population, including preterm birth (OR = 1.19, 95% CI = 0.86-1.64), small for gestational age (OR = 1.38, 95% CI = 0.92-2.07), spontaneous abortion (OR = 1.04, 95% CI = 0.84-1.27), congenital malformation (OR = 0.99, 95% CI = 0.68-1.45), low Apgar score (OR = 0.62, 95% CI = 0.23-1.65), stillbirth (OR = 1.05, 95% CI = 0.33-3.31), placenta complication (OR = 0.53, 95% CI = 0.22-1.27), and any adverse event (OR = 1.10, 95% CI = 0.93-1.30). Similar results were found when comparing DMD-exposed pregnancies with DMD-unexposed pregnancies.

Conclusions: We found no increased association of adverse pregnancy outcomes in newborns with fetal exposure to DMDs when compared with either DMD-unexposed pregnancies or the general population.

Keywords: adverse pregnancy outcomes; fetal exposure; multiple sclerosis.

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Conflict of interest statement

J.B.A. has received travel and congress participation funds from Merck. F.S. has served on scientific advisory boards, been on the steering committees of clinical trials, served as a consultant, received support for congress participation, received speaker honoraria, or received research support for his laboratory from Biogen, Merck, Novartis, Roche, Sanofi and Genzyme, and Teva. M.M. has served on scientific advisory board for Biogen, Sanofi, Teva, Roche, Novartis, and Merck; has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi and Genzyme; and has received research support and support for congress participation from Biogen, Genzyme, Teva, Roche, Merck, and Novartis.

Figures

FIGURE 1
FIGURE 1
Inclusion flowchart of exposed pregnancies
FIGURE 2
FIGURE 2
Pregnancy outcomes. Any AE, any adverse event, placenta; CM, congenital malformation; CS, cesarean section; Ectopic; ectopic pregnancy; El. abortion, elective abortion; Preterm, preterm birth; SGA, small for gestational age; Sp. abortion, spontaneous abortion
See this image and copyright information in PMC

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