112  Updated analysis of pregnancy outcomes in a dimethyl fumarate exposure registry. Issue 6 (27th May 2022)

• Record Type: Journal Article
• Authors: Hellwig, Kerstin; Rog, David; McGuigan, Christopher; Mokliatchouk, Oksana; Branco, Filipe; Peng, Xiaomei; Everage, Nicholas
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 93:Issue 6(2022)
• Page Start: A136
• Page End: A136
• Publication Date: 2022-05-27
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2022-ABN.437
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Introduction: Dimethyl fumarate (DMF) is not recommended for use during pregnancy and should only be used if the potential benefit justifies the 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. Generally, pregnancies end in live birth (62%), abortion (22%), or foetal loss (16%), with similar rates in MS patients. Methods: Pregnant women with MS exposed to DMF since the first day of their last menstrual period before conception/during pregnancy were included. UK/Ireland Coordinating Centres liaise directly with patients and healthcare providers. Results: As of May 2020, 345 patients (18 UK/Ireland) were enrolled. Of the reported 351 pregnancy outcomes (18 UK/Ireland), 277 (79%) represented live births (17 UK/Ireland) and 74 (21%) foetal loss. Of infants with known gestational age (n=274), 249 births (91%) were full-term (17 UK/Ireland) and 25 (9%) premature (<37 weeks). There were 17 spontaneous abortions (1 each ectopic and molar pregnancy) and 1 foetal death (at >28 weeks). No infant or maternal deaths were reported. Ten infants (4%) (2 UK/Ireland) had confirmed birth defects. Conclusions: Observed safety signals were consistent with MS and general populations. Support: Biogen. Disclosures: Included on poster 81 [e-mail]