Contributions
Abstract: P714
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Women of childbearing age represent a considerable proportion of pts affected by multiple sclerosis (MS). Limited data from clinical trials show no evidence of increased risk of foetal abnormalities or adverse pregnancy outcomes with exposure to dimethyl fumarate (DMF) during pregnancy.
Objectives: To assess the interim results of pregnancy outcomes in a cohort 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 in an international registry (NCT01911767).
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, or congenital anomalies that occur ≤52 wks of age, any infant death occurring ≤52 wks of age, and any maternal death occurring ≤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 or 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.
Results: As of 14 Dec 2015, 48 pts were enrolled in the registry with a mean (SD) age of 31 (5) yrs; 83% were white. Of the 38 pts with a known DMF exposure date, 92% occurred in the first trimester, 5% in the second, and 3% in the third. To date, 15 pregnancy outcomes have been reported for 16 foetuses (1 pt with multiple births), including 1 (6.7%) spontaneous abortion (< 22 wks). Of the 14 (93.3%) live births, 12 (85.7%) were full term (delivered ≥37 wks) and 2 (14.3%) premature. There were no birth defects, or maternal, neonatal, perinatal, or infant deaths reported. One foetus had unknown live birth status. Of the 7 infants with GS data, 0 were classified as small, 6 (86%) appropriate, and 1 (14%) large.
Conclusions: This currently enrolling pregnancy registry will provide essential information for women of childbearing age about the safety of DMF in pregnancy. The current data, while limited, do not suggest any adverse effects of DMF exposure on pregnancy outcomes. These findings are consistent with data on pregnancy outcomes from clinical trials and postmarketing reports. Additional data are required before drawing definite conclusions.
Disclosure:
Supported 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
Trevor Newhook: employee of and holds stock/stock options in Biogen
Claudia Prada: employee of and holds stock/stock options in Biogen
Abstract: P714
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Women of childbearing age represent a considerable proportion of pts affected by multiple sclerosis (MS). Limited data from clinical trials show no evidence of increased risk of foetal abnormalities or adverse pregnancy outcomes with exposure to dimethyl fumarate (DMF) during pregnancy.
Objectives: To assess the interim results of pregnancy outcomes in a cohort 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 in an international registry (NCT01911767).
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, or congenital anomalies that occur ≤52 wks of age, any infant death occurring ≤52 wks of age, and any maternal death occurring ≤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 or 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.
Results: As of 14 Dec 2015, 48 pts were enrolled in the registry with a mean (SD) age of 31 (5) yrs; 83% were white. Of the 38 pts with a known DMF exposure date, 92% occurred in the first trimester, 5% in the second, and 3% in the third. To date, 15 pregnancy outcomes have been reported for 16 foetuses (1 pt with multiple births), including 1 (6.7%) spontaneous abortion (< 22 wks). Of the 14 (93.3%) live births, 12 (85.7%) were full term (delivered ≥37 wks) and 2 (14.3%) premature. There were no birth defects, or maternal, neonatal, perinatal, or infant deaths reported. One foetus had unknown live birth status. Of the 7 infants with GS data, 0 were classified as small, 6 (86%) appropriate, and 1 (14%) large.
Conclusions: This currently enrolling pregnancy registry will provide essential information for women of childbearing age about the safety of DMF in pregnancy. The current data, while limited, do not suggest any adverse effects of DMF exposure on pregnancy outcomes. These findings are consistent with data on pregnancy outcomes from clinical trials and postmarketing reports. Additional data are required before drawing definite conclusions.
Disclosure:
Supported 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
Trevor Newhook: employee of and holds stock/stock options in Biogen
Claudia Prada: employee of and holds stock/stock options in Biogen