Teriflunomide (Aubagio®) International Pregnancy Registry: Enrollment Update (P4.371)

Objective: The International Teriflunomide Pregnancy Exposure Registry will compare rates of birth defects (congenital malformations, fetal deaths, termination due to fetal abnormality) in teriflunomide-exposed pregnant women with those reported by the European Surveillance of Congenital Anomalies (EUROCAT).

Background: Teriflunomide is approved for treatment of relapsing forms of MS in 80 countries, with ~162,000 patient years of exposure since approval. Teriflunomide is contraindicated in pregnancy based on embryo-fetal toxicity in animals. Despite the requirement for effective contraception during teriflunomide clinical trials, a small number of pregnancies occurred. No signs of structural or functional deficits were reported in newborns, and the data showed no signal for human teratogenicity. Further data collection from teriflunomide-exposed pregnancies will provide additional information about teriflunomide in pregnancy.

Design/Methods: The registry is an ongoing, voluntary, multinational, prospective, observational, exposure-registration study. Pregnant women with MS and teriflunomide exposure (any dose, any time after Day 1 of last menstrual period until pregnancy end) can enroll. National coordinators liaise with healthcare professionals to collect data on teriflunomide-exposed pregnancies and coordinate patient enrollment. Target recruitment is 196 women to achieve 104 live births, providing 80% power to detect a 3.95-fold increase in risk ratio of birth defects associated with teriflunomide exposure vs EUROCAT. Outcome collection includes birth defects and infant characteristics during the first year of life.

Results: As of April 26, 2017, 14 patients have been recruited from 7 European countries. Six healthy babies have been born with no abnormality reported to date. One patient had an elective termination that was not motivated by either an abnormal result of a prenatal test or any concerns regarding potential birth defect.

Conclusions: This registry aims to provide data on pregnancy outcomes and infant development during the first year of life from teriflunomide-exposed pregnancies, and will help physicians to provide better counseling for women exposed to teriflunomide during pregnancy.

Study Supported by: Sanofi.

Disclosure: Dr. Lebrun-Freney has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting fees, honoraria or scientific committee support: Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Teva. Dr. Rog has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting fees (Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, Teva Neuroscience). Dr. Rog has received research support from Research support (Biogen Idec, Genzyme, GW Pharma, Merck Serono, Mitsubishi, Novartis, Teva Neuroscience). Dr. Benamor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Jurgensen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Jurgensen has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Truffinet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Truffinet has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Ghezzi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Merk-Serono, Novartis, Genzyme, TEVA, Serono Symposia Int Found., Almirall,.