Abstract Details

Title Final Analysis of Pregnancy Outcomes Following Exposure to Dimethyl Fumarate in a Prospective International Registry

Topic Multiple Sclerosis

Presentation(s) S31 - MS Clinical Decision Making and Special Populations (4:06 PM-4:18 PM)

Poster/Presentation
Number 004

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.

Objective To assess pregnancy outcomes and DMF exposure in a completed international registry (NCT01911767, TecGistry) of women with MS exposed to dimethyl fumarate (DMF).

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 (<10^th, 10^th−90^th, >90^th), 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.

Authors/Disclosures
Kerstin Hellwig (St. Josef Hospital Bochum) PRESENTER	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for INC research . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from TEVA.
David Rog, MBBS	Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MedDay. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen-Cilag. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi Genzyme. The institution of Dr. Rog has received research support from Actelion. The institution of Dr. Rog has received research support from Biogen. The institution of Dr. Rog has received research support from MedDay. The institution of Dr. Rog has received research support from Merck. The institution of Dr. Rog has received research support from Mitsubishi. The institution of Dr. Rog has received research support from Novartis. The institution of an immediate family member of Dr. Rog has received research support from Sanofi Genzyme. The institution of Dr. Rog has received research support from TG Therapeutics. Dr. Rog has received research support from Janssen-Cilag.
Christopher McGuigan, MD (Department of Neurology, St. Vincent's University Hospital)	Dr. McGuigan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. McGuigan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. McGuigan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. The institution of Dr. McGuigan has received research support from Biogen. The institution of Dr. McGuigan has received research support from Novartis. The institution of Dr. McGuigan has received research support from Roche.
Maria K. Houtchens, MD	Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Dr. Houtchens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Serono. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Cravath. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Beasley . Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Biogen. The institution of Dr. Houtchens has received research support from Genzyme. The institution of Dr. Houtchens has received research support from Biogen. The institution of Dr. Houtchens has received research support from Genentech.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Seth N. Levin, MD (Biogen)	Dr. Levin has received personal compensation for serving as an employee of Biogen. Dr. Levin has received stock or an ownership interest from Biogen.
	No disclosure on file