Contributions
Abstract: EP1736
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Data from clinical trials and post marketing reports show no safety signals with exposure to delayed-release dimethyl fumarate (DMF) 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.
Objectives: To assess interim pregnancy outcomes in an 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.
Methods: DMF-exposed women with MS participating in the registry were prospectively evaluated for live births and pregnancy loss, defined as elective or therapeutic pregnancy terminations, spontaneous abortions, and foetal death including stillbirth. Ectopic and molar pregnancies, birth defects, any congenital anomalies or infant death occurring at ≤52 wks of age, and any maternal death at ≤12 wks postdelivery, were reported. Baseline data were collected at enrolment; follow-ups were conducted at 6-7 mos of gestation and 4 wks after the estimated delivery date, and 4, 12, and 52 wks after birth. Gestational size (GS) was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based on WHO or country-specific growth charts. Potential birth defects were adjudicated by an external teratology expert.
Results: As of 30 Sept 2016, 104 patients (pts) were enrolled in the registry; mean (SD) age was 31 (5) yrs. Of the 94 pts with a known DMF exposure date, 95% occurred in the first trimester, 1% in the second, and 0% in the third. To date, 58 pregnancy outcomes have been reported, including 52 pts with 54 live births and 4 (7%) spontaneous abortions (< 22 wks). Of the 54 (93%) live births, 47 (87%) were full term (delivered ≥37 wks) and 4 (7%) premature. Two (4%) infants had adjudicator-confirmed birth defects: 1 with pyloric stenosis, and 1 with transposition of the great vessels and patent ductus arteriosus. No maternal, neonatal, perinatal, or infant deaths were reported. Of the 40 infants with GS data, 3 (8%) were classified as small, 34 (85%) as appropriate, and 3 (8%) as large.
Conclusions: The limited interim results from this ongoing registry did not identify a safety signal for DMF exposure on pregnancy outcomes, consistent with previous reports. Final results will provide essential information for women of childbearing age concerning the safety of DMF during pregnancy.
Supported by: Biogen
Disclosure:
Supported by: this study was supported by Biogen (Cambridge, MA, USA). Editorial support was provided by Excel Scientific Solutions (Horsham, UK): funding was provided by Biogen.
Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Shifang Liu: employee of and holds stock/stock options in Biogen
Jang Yun: 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: EP1736
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Data from clinical trials and post marketing reports show no safety signals with exposure to delayed-release dimethyl fumarate (DMF) 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.
Objectives: To assess interim pregnancy outcomes in an 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.
Methods: DMF-exposed women with MS participating in the registry were prospectively evaluated for live births and pregnancy loss, defined as elective or therapeutic pregnancy terminations, spontaneous abortions, and foetal death including stillbirth. Ectopic and molar pregnancies, birth defects, any congenital anomalies or infant death occurring at ≤52 wks of age, and any maternal death at ≤12 wks postdelivery, were reported. Baseline data were collected at enrolment; follow-ups were conducted at 6-7 mos of gestation and 4 wks after the estimated delivery date, and 4, 12, and 52 wks after birth. Gestational size (GS) was classified as small (< 10th percentile), appropriate (10th-90th), or large (>90th) based on WHO or country-specific growth charts. Potential birth defects were adjudicated by an external teratology expert.
Results: As of 30 Sept 2016, 104 patients (pts) were enrolled in the registry; mean (SD) age was 31 (5) yrs. Of the 94 pts with a known DMF exposure date, 95% occurred in the first trimester, 1% in the second, and 0% in the third. To date, 58 pregnancy outcomes have been reported, including 52 pts with 54 live births and 4 (7%) spontaneous abortions (< 22 wks). Of the 54 (93%) live births, 47 (87%) were full term (delivered ≥37 wks) and 4 (7%) premature. Two (4%) infants had adjudicator-confirmed birth defects: 1 with pyloric stenosis, and 1 with transposition of the great vessels and patent ductus arteriosus. No maternal, neonatal, perinatal, or infant deaths were reported. Of the 40 infants with GS data, 3 (8%) were classified as small, 34 (85%) as appropriate, and 3 (8%) as large.
Conclusions: The limited interim results from this ongoing registry did not identify a safety signal for DMF exposure on pregnancy outcomes, consistent with previous reports. Final results will provide essential information for women of childbearing age concerning the safety of DMF during pregnancy.
Supported by: Biogen
Disclosure:
Supported by: this study was supported by Biogen (Cambridge, MA, USA). Editorial support was provided by Excel Scientific Solutions (Horsham, UK): funding was provided by Biogen.
Nicholas J. Everage: employee of and holds stock/stock options in Biogen
Shifang Liu: employee of and holds stock/stock options in Biogen
Jang Yun: 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