Abstract Details

Title Pregnancy Outcomes From an International Registry of Patients Treated With Delayed-release Dimethyl Fumarate

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-095

Objective To assess pregnancy outcomes in an ongoing international registry (NCT01911767) of women with multiple sclerosis (MS) exposed to delayed-release dimethyl fumarate (DMF) since the first day of their last menstrual period prior to conception or at any time during pregnancy.

Background Data from clinical trials and post-marketing reports show no safety signals with DMF exposure during pregnancy; however, the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Design/Methods In this interim analysis, DMF-exposed women were prospectively evaluated for live births, pregnancy loss, ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks postdelivery. Data were collected at baseline (enrollment), 6–7 months of gestation, 4 weeks after the estimated delivery date, and 4/12/52 weeks after birth. Potential birth defects were adjudicated by an external expert.

Results As of 15 December 2017, 199 patients were enrolled in the registry; mean (SD) age was 32 (4) years. Earliest DMF exposure occurred in the first (99%, 186/187), second (<1%, 1/187), and third (0%) trimester in patients with a known exposure date. To date, 132 pregnancy outcomes have been reported, including: 6 (5%) spontaneous abortions (<22 weeks) and 126 (95%) live births: 115 (91%) full term (delivered ≥37 weeks) and 8 (6%) premature. Four (3%) infants had adjudicator-confirmed birth defects: 1 with pyloric stenosis; 1 with transposition of the great vessels; and 2 with ventricular septal defect. No ectopic or molar pregnancies, maternal, neonatal, perinatal, infant deaths or still births were reported. Median (min, max) gestational weight was 3300 (1450, 4660) grams.

Conclusions

Consistent with previous reports, there was no safety signal for DMF exposure on pregnancy outcomes based on data from this ongoing registry.

Study Supported by: Biogen

Authors/Disclosures
Nicholas J. Everage PRESENTER	No disclosure on file
Cynthia Jones, PhD	Dr. Jones has received personal compensation for serving as an employee of Biogen. Dr. Jones has received stock or an ownership interest from Biogen.
Kerstin Hellwig (St. Josef Hospital Bochum)	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 BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 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 Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . 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 $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . 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 BMS .
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 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 Sanofi Genzyme. Dr. Rog has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Rog has received research support from Merck. The institution of Dr. Rog has received research support from Novartis. The institution of Dr. Rog has received research support from TG Therapeutics. Dr. Rog has received research support from Janssen-Cilag.
Shifang Liu	No disclosure on file
JIANI MOU	No disclosure on file
Claudia Prada	No disclosure on file
Jerome Hanna	No disclosure on file

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