Article Text
Abstract
Introduction Dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies potential foetal risk. Given limited pregnancy data, the UK and Ireland have enrolled DMF-exposed pregnant women in an ongoing international registry assessing pregnancy outcomes. In the general population, 62% of pregnancies end in live birth, 22% in abortion, and 16% in foetal loss, with similar rates in multiple sclerosis (MS) patients.
Methods Women with MS exposed to DMF since the first day of their last menstrual period before con- ception/during pregnancy were included. UK/Ireland Coordinating Centres liaised directly with patients and healthcare providers.
Results As of March 2021, 403 patients (19 UK/Ireland) were enrolled. Of 350 reported pregnancy outcomes (19 UK/Ireland), 329 (94%) represented live births (100% UK/Ireland). Of 326 infants with known gestational age,
298 births (91%) were full-term (100% UK/Ireland) and 28 (9%) premature (<37 weeks). Of the 21 (6%) cases of foetal loss, 19 were spontaneous abortions (1 each ectopic and molar pregnancy) and 2 foetal deaths (>28 weeks). There was one neonatal death. Nine infants (2 UK/Ireland) had EUROCAT-confirmed birth defects.
Conclusions The observations are consistent with MS and general populations.
Support Biogen. Disclosures on poster.