Final Analysis of Pregnancy Outcomes Following Exposure to Dimethyl Fumarate in a Prospective International Registry
Kerstin Hellwig1, David Rog2, Christopher McGuigan3, Maria Houtchens4, Denise Bruen5, Oksana Mokliatchouk6, Filipe Branco6, Seth Levin6, Xiaochen Lin6
1St. Josef Hospital Bochum, 2Manchester Centre for Clinical Neurosciences, 3University College Dublin and St. Vincent’s University Hospital, 4The Partners MS Center, Brigham and Women’s Hospital, Harvard Medical School, 5Adult Neurology Clinic, 6Biogen Inc.
Objective:
To assess pregnancy outcomes and DMF exposure in a completed international registry (NCT01911767, TecGistry) of women with MS exposed to dimethyl fumarate (DMF).
Background:
Oral delayed-release DMF has a favorable benefit-risk profile in treating people with multiple sclerosis (PwMS) and should be used in pregnant women only if the potential benefits outweigh the potential risk to the fetus.
Design/Methods:
TecGistry includes women with MS exposed to DMF from the first day of their last menstrual period before conception or during pregnancy, with data collected at enrollment, 6-7 months gestation, 4 weeks after estimated due date, and at 4, 12, and 52 weeks postpartum. Outcomes collected included live births, pregnancy loss, ectopic/molar pregnancies, birth defects and anomalies, and infant or maternal death after delivery. Gestational weight was classified by percentile (<10th, 10th−90th, >90th), which was based on standardized growth charts.
Results:
As of 13 May 2022, 397 women with MS were enrolled, with a median age of 32 years (range: 19, 43). Median gestation week at first DMF exposure was 1 (range: 0, 13) and at enrollment was 10 (range: 0, 39). Median duration of gestational DMF exposure was 5 weeks (range: 0, 40). Among DMF discontinuations, one was due to serious AE. Fifteen (3.8%) spontaneous abortions occurred. Of the 360 live births, 323 (90%) were full term and 37 (10%) were premature (<37 weeks). Gestational weight data was available for 282 infants, in which 32 (11.3%) were classified as small, 240 (85.1%) as appropriate, and 10 (3.5%) as large. One neonatal death and no maternal deaths occurred. Overall, 13 (3.6%) infants had adjudicator-confirmed MACDP birth defects and 8 (2.2%) had adjudicator-confirmed EUROCAT birth defects.
Conclusions:
Dimethyl fumarate exposure during pregnancy did not adversely affect pregnancy outcomes, with no increased incidence of birth defects and no increased rate of spontaneous abortion.