Contributions
Abstract: P1226
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Multiple sclerosis (MS) is a disabling neurological disease, which largely affects women of childbearing age. The disease is not associated with an increase in spontaneous abortions, stillbirth, cesarean delivery, premature birth, or birth defects. Limited information is available on the association of disease-modifying therapies with adverse pregnancy outcomes. Teva"s global safety database includes over 8000 pregnancy cases exposed to branded GA, with more than half of them reported prospectively. Thus this database allows a unique large-scale examination of pregnancies exposed to branded GA during pregnancy. Previous comparison of rates of congenital anomalies from this database to EUROCAT and MACDP reference rates showed no increased anomalies or fetal toxicities in pregnancies exposed to branded GA.
Objective: Assess the possible impact of exposure to branded glatiramer acetate (GA, Copaxone) treatment during pregnancy on pregnancy loss (spontaneous abortions, still births and fetal demise) in patients with MS.
Methods: Data of branded GA exposure during pregnancy was retrieved from Teva"s global safety database (since product launch and until 30 June 2015). Data from prospective reports with confirmed exposure to GA 20 mg daily during pregnancy were analyzed per pregnancy outcome. The rates of pregnancy loss (spontaneous abortions, still births and fetal demise) were calculated and compared to rates from general population, derived from the center for disease control (CDC) data, the leading national public health institute of the United States.
Results: From all prospectively reported pregnancies, a cohort of 2068 cases, with confirmed GA exposure and known outcome, was used in this analysis. Outcomes included 1760 (85%) live births, 227 (11%) pregnancy loss, 63 (3%) elective pregnancy terminations, 3 (0.15%) molar and 15 (0.7%) ectopic pregnancies. The 227 pregnancy loss cases include 208 spontaneous abortions, 11 fetal deaths and 8 still births. In comparison to CDC data, GA-exposed pregnancies show no increase in the percentage of pregnancy loss (17% and 11%, respectively).
Conclusion: Using a large database, this analysis demonstrated that exposure to branded GA during pregnancy does not increase the risk for pregnancy loss compared to the reference pregnancy loss rates observed in the general population. This provides further support to the growing notion that GA is the drug of choice for women of childbearing age who consider pregnancy.
Disclosure: ON, PB, SP, NA, SK, NG are employees of Teva Pharmaceutical Industries.
Abstract: P1226
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Multiple sclerosis (MS) is a disabling neurological disease, which largely affects women of childbearing age. The disease is not associated with an increase in spontaneous abortions, stillbirth, cesarean delivery, premature birth, or birth defects. Limited information is available on the association of disease-modifying therapies with adverse pregnancy outcomes. Teva"s global safety database includes over 8000 pregnancy cases exposed to branded GA, with more than half of them reported prospectively. Thus this database allows a unique large-scale examination of pregnancies exposed to branded GA during pregnancy. Previous comparison of rates of congenital anomalies from this database to EUROCAT and MACDP reference rates showed no increased anomalies or fetal toxicities in pregnancies exposed to branded GA.
Objective: Assess the possible impact of exposure to branded glatiramer acetate (GA, Copaxone) treatment during pregnancy on pregnancy loss (spontaneous abortions, still births and fetal demise) in patients with MS.
Methods: Data of branded GA exposure during pregnancy was retrieved from Teva"s global safety database (since product launch and until 30 June 2015). Data from prospective reports with confirmed exposure to GA 20 mg daily during pregnancy were analyzed per pregnancy outcome. The rates of pregnancy loss (spontaneous abortions, still births and fetal demise) were calculated and compared to rates from general population, derived from the center for disease control (CDC) data, the leading national public health institute of the United States.
Results: From all prospectively reported pregnancies, a cohort of 2068 cases, with confirmed GA exposure and known outcome, was used in this analysis. Outcomes included 1760 (85%) live births, 227 (11%) pregnancy loss, 63 (3%) elective pregnancy terminations, 3 (0.15%) molar and 15 (0.7%) ectopic pregnancies. The 227 pregnancy loss cases include 208 spontaneous abortions, 11 fetal deaths and 8 still births. In comparison to CDC data, GA-exposed pregnancies show no increase in the percentage of pregnancy loss (17% and 11%, respectively).
Conclusion: Using a large database, this analysis demonstrated that exposure to branded GA during pregnancy does not increase the risk for pregnancy loss compared to the reference pregnancy loss rates observed in the general population. This provides further support to the growing notion that GA is the drug of choice for women of childbearing age who consider pregnancy.
Disclosure: ON, PB, SP, NA, SK, NG are employees of Teva Pharmaceutical Industries.