IntroductionClinical trials and post marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy; however, these data are limited and the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the foetus. We assessed pregnancy outcomes in an ongoing international registry (NCT01911767) of women with MS exposed to DMF since the first day of their last menstrual period prior to conception or at any time during pregnancy.MethodsDMF-exposed women were prospectively evaluated for live births and 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 post-delivery, were reported. Data were collected at baseline (enrolment), 6–7 months of gestation, 4 weeks after the estimated delivery date, and 4, 12, and 52 weeks after birth. Potential birth defects were adjudicated by an external expert.ResultsAs of 30, Sept 2016 104 patients were enrolled in the registry; mean (SD) age was 315 years. DMF exposure occurred in the first (95%), second (1%), and third (0%) trimester in the 94 patients with a known exposure date. To date, 58 pregnancy outcomes have been reported, including 52 patients with 54 live births and 4 (7%) spontaneous abortions (<22 weeks). Of the 54 (93%) live births, 47 (87%) were full term (delivered ≥37 weeks) and four (7%) premature. Two (4%) infants had adjudicator-confirmed birth defects; one with pyloric stenosis, and one with transposition of the great vessels/patent ductus arteriosus. No maternal, neonatal, perinatal, or infant deaths were reported.ConclusionThe results from this ongoing registry did not identify a safety signal for DMF exposure on pregnancy outcomes, are consistent with previous reports, and provide essential information concerning exposure to DMF during pregnancy.
Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study)
