Pregnancy outcomes following maternal or paternal exposure to teriflunomide in the Danish MS population

Abstract

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Maternal Multiple Sclerosis and Health Outcomes Among the Children: A Systematic Review

“…The studies were all cohort studies and several of them were population-based cohorts, and they represented four continents (North and South America, Asia and Europe). There were 15 European studies and eight of them were based on Scandinavian nationwide registers: Andersen et al studied the Danish population 18 , 24 , 39 , 40 Dahl et al and Strom et al studied the Norwegian population, 11 , 25 , 26 and Korjagina et al used data from Finland and Sweden in their register study. 27 Two of the three German studies were based on the same dataset, but with different timeslots and exposures, 28 , 29 and the two studies from Italy came from the same registry, but with different timeslots.…”

“…Only a few additional papers have been published in this category since the study by Lopez-Leon et al 21 Three studies, published in the period January 2019 to February 2023, met our inclusion criteria. A Swedish cohort study focused on interferon-β-exposed children (n=718), 27 and one Danish cohort study focused on teriflunomide-exposed children (n=49) 39 and another on injectable first-line treatments, dimethyl fumarate and natalizumab-exposed children (n=711 liveborns). 18 None of the three studies found significant differences in the risk of adverse short-term birth outcome between DMT-exposed and unexposed children.…”

Fertility, pregnancy and childbirth in women with multiple sclerosis: a population-based study from 2018 to 2020

“…While we found that pregnancies exposed to DMTs with unknown/negative safety profile were associated with birth defects, we have to acknowledge that the low number of events overall and the absence of events in the pregnancy safe DMTs/untreated group is not representative of the general population and might have affected the accuracy of the results. Also, we decided to classify DMT safety using European regulatory agency reports, while did not include more recent evidence nor clinical recommendations that were not available at the time of study conduction (2018–2020) 2 9 20–24. Looking at our cases of birth defects, lip/palate and heart defects are among the most common malformations in both MS and general population,17 and were found in pregnancies exposed to fingolimod (9.1% of exposed pregnancies), natalizumab (6.6% of exposed pregnancies) or dimethyl fumarate (9.5% of exposed pregnancies).…”

Updates and Advances in Multiple Sclerosis Neurotherapeutics

“…Teriflunomide is considered teratogenic even if the patient is male; therefore, counseling regarding reliable contraception is warranted prior to treatment initiation. However, reassuring pregnancy observational data have been reported, including absence of spontaneous abortions and absence of increased prevalence of major malformations in teriflunomide-exposed newborns [ 50 ].…”