Abstract
BackgroundFamily planning is an important consideration for women with multiple sclerosis (MS), who are often diagnosed during their reproductive years. Currently, limited data are available on pregnancy outcomes in patients exposed to interferon-beta (IFN-beta) before or during pregnancy. Here, we present the cumulative pregnancy exposure data and prevalence of pregnancy and infant outcomes in IFN-beta-exposed pregnant women with MS from the European IFN-beta Pregnancy Registry.MethodsUsing spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. The outcomes collected by the registry included ectopic pregnancies, spontaneous abortions, elective terminations, live, and stillbirths with or without congenital anomalies. The prevalence of pregnancy outcomes was put in context with those reported in the general population.ResultsBetween 2009 and 2017, the registry collected 948 pregnancy reports with a known pregnancy outcome. Overall, 82.0% (777/948) of pregnancies resulted in live birth without congenital anomaly. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs. 10–21%) and congenital anomalies in live births (2.1% vs. 2.1–4.1%) were found to be within reported ranges.ConclusionsThe data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions.
Highlights
Planning is an important consideration for female patients with multiple sclerosis (MS) who are receiving treatment with disease modifying drugs (DMDs) that may be contraindicated in pregnancy
Between 2009 and 2017, a total of 948 pregnancy cases with known outcomes were identified in which the prevalence of spontaneous abortions, congenital anomalies in live births and live births, still births, and elective terminations remained within the ranges reported in the general population (10.7% vs. up to 10–21% [18], 2.1% vs. 2.1–4.1% [19, 21] and 2.8% vs. 2.6–6.9% [22], respectively) (Fig. 2)
A number of systematic literature reviews and observational studies have been published on the effect of IFN-beta exposure during pregnancy and the related pregnancy outcomes
Summary
Planning is an important consideration for female patients with multiple sclerosis (MS) who are receiving treatment with disease modifying drugs (DMDs) that may be contraindicated in pregnancy. Methods Using spontaneous and solicited reports, the registry collected data from 26 countries of the European Economic Area, consisting of information on women with MS identifying themselves to one of the Marketing Authorisation Holders (Bayer, Biogen, Merck KGaA, and Novartis) or healthcare professionals as pregnant and exposed to IFN-beta during pregnancy or within 1 month before conception. When comparing IFN-beta-exposed pregnancies with the general population, the prevalence of spontaneous abortions (10.7% vs 10–21%) and congenital anomalies in live births (2.1% vs 2.1–4.1%) were found to be within reported ranges. Conclusions The data gathered from these pregnancy cases suggest no evidence that IFN-beta exposure before conception and/or during pregnancy adversely increases the rate of congenital anomalies or spontaneous abortions
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