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Final analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry
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Final analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry
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Final analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry
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Journal Article
Final analysis of pregnancy outcomes following exposure to dimethyl fumarate in a prospective international registry
2023
Overview
ObjectiveAssess pregnancy outcomes in women with multiple sclerosis (MS) exposed to dimethyl fumarate (DMF).BackgroundDMF is approved for treating people with MS, but should be used in pregnant women only if potential benefits outweigh potential fetal risks.Design/MethodsTecGistry (NCT01911767) was a prospective, international registry of women with MS exposed to DMF from the first day of their last pre-conception menstruation or during pregnancy. Outcomes included live births, pregnancy loss, ectopic/molar pregnancies, gestational weight, congenital anomalies, and postpartum infant/maternal death.ResultsEnrollment included 397 participants, with a median (range) age of 32 (19-43) years. Median (range) gestation week at first DMF exposure was 1 (0-13) and at enrollment was 10 (0-39), while median duration of gestational DMF exposure was 5 (0-40) weeks. Fifteen (3.8%) spontaneous abortions occurred. Of 360 live births, 323 (90%) were full-term and 37 (10%) were premature. Of 282 infants with gestational weight data, 32 (11.3%) were classified small, 240 (85.1%) appropriate, and 10 (3.5%) large. Overall, 8 (2.2%) had adjudicator-confirmed EUROCAT congenital anomalies. One neonatal death and no maternal deaths occurred.ConclusionsDMF exposure during pregnancy did not adversely affect pregnancy outcomes, with no increased incidence of congenital anomalies or spontaneous abortion.Support: Biogen
Publisher
BMJ Publishing Group Ltd,BMJ Publishing Group LTD
