Contributions
Abstract: P765
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Objective: To evaluate pregnancy outcomes in patients with multiple sclerosis (MS) who were exposed to branded glatiramer acetate (GA, Copaxone®) during all three trimesters and compare them with reference data from the general population.
Background: Although MS does not increase the rate of adverse pregnancy outcomes, information regarding the potential pregnancy risks associated with MS disease-modifying therapies is insufficient. Thus, these treatments are often discontinued for women with MS who intend to become or are confirmed pregnant. However, in women with highly active MS, there is a need to continue DMT therapy throughout pregnancy. In such cases, the benefits to the mother should be weighed against the risk to the fetus. Previous analyses indicated no overall increase in malformative or fetal/neonatal toxicity or pregnancy loss among women treated with branded GA as compared with the reference rates. In those analyses, GA was discontinued in most cases once pregnancy was confirmed.
Methods: Data on pregnancy outcomes were sourced from Teva's global pharmacovigilance database. Retrospective analyses were performed on prospective cases from clinical trials and solicited or spontaneous reports, including patients with known outcomes and exposure to branded GA 20 mg/mL (GA20) during all three trimesters. Rates of congenital anomalies were compared with those in EUROCAT, a European network of population-based registries for the epidemiologic surveillance of congenital anomalies.
Results: All 216 cases identified resulted in live births. No late-stage intrauterine deaths or stillbirths were observed. There were no abortions or early stillbirths, which may be due to the selection criteria requiring patients with exposure to GA during all three trimesters. Seven cases of congenital anomalies were reported, with an extrapolated rate of 3240.7 per 100,000 births, similar to the reference prevalence rate of 2514.6 per 100,000 births according to EUROCAT data (2010-2014). The standardized incidence ratio of congenital anomalies associated with GA20 exposure was 1.29 (95% confidence interval: 0.52, 2.66).
Conclusions: As compared with the general population, GA20 exposure during all three trimesters of pregnancy did not significantly increase the risk of congenital anomalies.
Disclosure:
Kerstin Hellwig: Research support and speaker honoraria from Bayer, Biogen, Merck, Novartis, Teva, and Sanofi Genzyme.
Orit Neudorfer, Sigal Melamed-Gal, and Peleg Baruch: Employees of Teva Pharmaceutical Industries.
Abstract: P765
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Objective: To evaluate pregnancy outcomes in patients with multiple sclerosis (MS) who were exposed to branded glatiramer acetate (GA, Copaxone®) during all three trimesters and compare them with reference data from the general population.
Background: Although MS does not increase the rate of adverse pregnancy outcomes, information regarding the potential pregnancy risks associated with MS disease-modifying therapies is insufficient. Thus, these treatments are often discontinued for women with MS who intend to become or are confirmed pregnant. However, in women with highly active MS, there is a need to continue DMT therapy throughout pregnancy. In such cases, the benefits to the mother should be weighed against the risk to the fetus. Previous analyses indicated no overall increase in malformative or fetal/neonatal toxicity or pregnancy loss among women treated with branded GA as compared with the reference rates. In those analyses, GA was discontinued in most cases once pregnancy was confirmed.
Methods: Data on pregnancy outcomes were sourced from Teva's global pharmacovigilance database. Retrospective analyses were performed on prospective cases from clinical trials and solicited or spontaneous reports, including patients with known outcomes and exposure to branded GA 20 mg/mL (GA20) during all three trimesters. Rates of congenital anomalies were compared with those in EUROCAT, a European network of population-based registries for the epidemiologic surveillance of congenital anomalies.
Results: All 216 cases identified resulted in live births. No late-stage intrauterine deaths or stillbirths were observed. There were no abortions or early stillbirths, which may be due to the selection criteria requiring patients with exposure to GA during all three trimesters. Seven cases of congenital anomalies were reported, with an extrapolated rate of 3240.7 per 100,000 births, similar to the reference prevalence rate of 2514.6 per 100,000 births according to EUROCAT data (2010-2014). The standardized incidence ratio of congenital anomalies associated with GA20 exposure was 1.29 (95% confidence interval: 0.52, 2.66).
Conclusions: As compared with the general population, GA20 exposure during all three trimesters of pregnancy did not significantly increase the risk of congenital anomalies.
Disclosure:
Kerstin Hellwig: Research support and speaker honoraria from Bayer, Biogen, Merck, Novartis, Teva, and Sanofi Genzyme.
Orit Neudorfer, Sigal Melamed-Gal, and Peleg Baruch: Employees of Teva Pharmaceutical Industries.