Contributions
Abstract: EP1732
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS in 70 countries, with more than 71,000 patients currently being treated with teriflunomide worldwide. Teriflunomide is contraindicated in pregnancy based on embryo-foetal toxicity in rats and rabbits. Despite the requirement to use effective contraception during teriflunomide clinical trials, pregnancies did occur. There were no signs of structural or functional deficits in newborns and data from the clinical programme, although limited due to the low number of pregnancies, showed no signal for human teratogenicity. It is, therefore, important to continue to collect data on teriflunomide exposure in pregnancy.
Objective(s): The International Teriflunomide Pregnancy Exposure Registry will compare rates of birth defects (congenital malformations, foetal deaths, termination due to foetal abnormality) in teriflunomide-exposed pregnant women with those reported by the European Surveillance of Congenital Anomalies (EUROCAT).
Methods: The registry is a voluntary, multinational, prospective, observational, exposure-registration study. Pregnant women with MS with teriflunomide exposure (any dose, any time after Day 1 of last menstrual period until pregnancy end) can enrol. National Coordinators will liaise with healthcare professionals to collect information on teriflunomide-exposed pregnancies and coordinate patient enrolment in the registry. Target recruitment is 196 women to achieve 104 live births, providing an 80% power to detect a 3.95-fold increase in risk ratio of birth defects associated with teriflunomide exposure vs EUROCAT. Pregnancy outcome data including birth defects and infant characteristics during the first year of life will be collected.
Results: As of April 26, 2017, 14 patients have been recruited from 7 countries in Europe. 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 by 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 counselling for women exposed to teriflunomide during pregnancy.
Disclosure: Study supported by Sanofi Genzyme.
CL-F: Consulting fees, honoraria, or scientific committee support (Biogen, Genzyme, Merck Serono, Novartis, Teva).
DR: Consulting fees (Bayer Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, Teva Neuroscience); research support (Biogen Idec, Genzyme, GW Pharma, Merck Serono, Mitsubishi, Novartis, Teva Neuroscience).
MB and SJ: Employees of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
AG: Consultancy fees (Allmiral, Biogen Idec, Genzyme, Merck Serono, Mylan); travel grants or grants as speaker (Merck Serono, Novartis, Sanofi/Genzyme, Teva Neuroscience).
Abstract: EP1732
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS in 70 countries, with more than 71,000 patients currently being treated with teriflunomide worldwide. Teriflunomide is contraindicated in pregnancy based on embryo-foetal toxicity in rats and rabbits. Despite the requirement to use effective contraception during teriflunomide clinical trials, pregnancies did occur. There were no signs of structural or functional deficits in newborns and data from the clinical programme, although limited due to the low number of pregnancies, showed no signal for human teratogenicity. It is, therefore, important to continue to collect data on teriflunomide exposure in pregnancy.
Objective(s): The International Teriflunomide Pregnancy Exposure Registry will compare rates of birth defects (congenital malformations, foetal deaths, termination due to foetal abnormality) in teriflunomide-exposed pregnant women with those reported by the European Surveillance of Congenital Anomalies (EUROCAT).
Methods: The registry is a voluntary, multinational, prospective, observational, exposure-registration study. Pregnant women with MS with teriflunomide exposure (any dose, any time after Day 1 of last menstrual period until pregnancy end) can enrol. National Coordinators will liaise with healthcare professionals to collect information on teriflunomide-exposed pregnancies and coordinate patient enrolment in the registry. Target recruitment is 196 women to achieve 104 live births, providing an 80% power to detect a 3.95-fold increase in risk ratio of birth defects associated with teriflunomide exposure vs EUROCAT. Pregnancy outcome data including birth defects and infant characteristics during the first year of life will be collected.
Results: As of April 26, 2017, 14 patients have been recruited from 7 countries in Europe. 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 by 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 counselling for women exposed to teriflunomide during pregnancy.
Disclosure: Study supported by Sanofi Genzyme.
CL-F: Consulting fees, honoraria, or scientific committee support (Biogen, Genzyme, Merck Serono, Novartis, Teva).
DR: Consulting fees (Bayer Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, Teva Neuroscience); research support (Biogen Idec, Genzyme, GW Pharma, Merck Serono, Mitsubishi, Novartis, Teva Neuroscience).
MB and SJ: Employees of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
AG: Consultancy fees (Allmiral, Biogen Idec, Genzyme, Merck Serono, Mylan); travel grants or grants as speaker (Merck Serono, Novartis, Sanofi/Genzyme, Teva Neuroscience).