Contributions
Abstract: P603
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Available data from clinical trials and post-marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy; however, the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Objective: To assess pregnancy outcomes in an ongoing international registry (NCT01911767) of women with multiple sclerosis (MS) exposed to DMF since the first day of their last menstrual period prior to conception or at any time during pregnancy.
Methods: In this interim analysis, DMF-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 postdelivery, were reported. Data were collected at baseline (enrollment), 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. Gestational size was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based on WHO or country-specific growth charts.
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 the 187 patients with a known exposure date. To date, 132 pregnancy outcomes have been reported, including 126 (95%) live births and 6 (5%) spontaneous abortions (< 22 weeks). Of the 126 live births, 115 (91%) were 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 infants had ventricular septal defect. No ectopic or molar pregnancies were reported. No maternal, neonatal, perinatal, infant deaths or still births were reported. Of the 105 infants with gestational size data, 9 (9%) were classified as small, 87 (83%) as appropriate, and 9 (9%) as large and 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. This registry continues to provide essential information concerning exposure to DMF during pregnancy.
Supported by: Biogen
Disclosure: Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Cynthia C. Jones: employee of and holds stock/stock options in Biogen
Kerstin Hellwig: has served on scientific advisory board for Bayer, Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received speaker honoraria and research support from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme, Teva has received support for congress participation from Bayer, Biogen, Genzyme, Teva, Roche and Merck
David Rog: received consulting fees from Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience; research support from Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience
Shifang Liu: employee of and holds stock/stock options in Biogen
Jiani Mou: employee of and holds stock/stock options in Biogen
Claudia Prada: employee of and holds stock/stock options in Biogen
Jerome Hanna: employee of and holds stock/stock options in Biogen
Abstract: P603
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Available data from clinical trials and post-marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy; however, the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Objective: To assess pregnancy outcomes in an ongoing international registry (NCT01911767) of women with multiple sclerosis (MS) exposed to DMF since the first day of their last menstrual period prior to conception or at any time during pregnancy.
Methods: In this interim analysis, DMF-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 postdelivery, were reported. Data were collected at baseline (enrollment), 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. Gestational size was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based on WHO or country-specific growth charts.
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 the 187 patients with a known exposure date. To date, 132 pregnancy outcomes have been reported, including 126 (95%) live births and 6 (5%) spontaneous abortions (< 22 weeks). Of the 126 live births, 115 (91%) were 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 infants had ventricular septal defect. No ectopic or molar pregnancies were reported. No maternal, neonatal, perinatal, infant deaths or still births were reported. Of the 105 infants with gestational size data, 9 (9%) were classified as small, 87 (83%) as appropriate, and 9 (9%) as large and 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. This registry continues to provide essential information concerning exposure to DMF during pregnancy.
Supported by: Biogen
Disclosure: Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Cynthia C. Jones: employee of and holds stock/stock options in Biogen
Kerstin Hellwig: has served on scientific advisory board for Bayer, Biogen, Sanofi, Teva, Roche, Novartis, Merck, has received speaker honoraria and research support from Bayer, Biogen, Merck, Novartis, Sanofi, Genzyme, Teva has received support for congress participation from Bayer, Biogen, Genzyme, Teva, Roche and Merck
David Rog: received consulting fees from Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience; research support from Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience
Shifang Liu: employee of and holds stock/stock options in Biogen
Jiani Mou: employee of and holds stock/stock options in Biogen
Claudia Prada: employee of and holds stock/stock options in Biogen
Jerome Hanna: employee of and holds stock/stock options in Biogen