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Observational Study
. 2020 Jun;267(6):1715-1723.
doi: 10.1007/s00415-020-09762-y. Epub 2020 Feb 26.

Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry

Kerstin Hellwig  1 , Yvonne Geissbuehler  2 , Meritxell Sabidó  3 , Catrinel Popescu  4 , Alessandra Adamo  5 , Joachim Klinger  6 , Asher Ornoy #  7 , Peter Huppke #  8 ; European Interferon-beta Pregnancy Study Group
Collaborators, Affiliations
Observational Study

Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry

Kerstin Hellwig et al. J Neurol. 2020 Jun.

Abstract

Background: Family 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.

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. 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.

Results: Between 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.

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.

Keywords: Congenital anomalies; Disease-modifying drugs; Interferon-beta; Multiple sclerosis; Pregnancy; Spontaneous abortions.

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Conflict of interest statement

KH has received honoraria and research support from Bayer, Biogen, Teva, Novartis, Sanofi Genzyme, and Merck KGaA. YG is an employee of Novartis Pharma AG. MS is an employee of Merck Healthcare KGaA, Darmstadt, Germany. CP is an employee of Biogen. AA is an employee of Bayer AG. JK is an employee of SynteractHCR GmbH. PH has received honoraria and research support from Bayer, Biogen, Novartis, and Merck KGaA, and is a member of the European Interferon-beta Pregnancy Study Group. AO has nothing to disclose.

Figures

Fig. 1
Fig. 1
Total number of pregnancy cases by presence of outcome for all reported individual case safety reports
Fig. 2
Fig. 2
Prevalence of pregnancy and infant outcomes in women exposed to IFN-beta: all cases, in HCP-confirmed cases of pregnancy with confirmed diagnosis of MS, and the general population. Prevalence data are shown with 95% confidence interval for each population from the European IFN-beta Pregnancy Registry. *HCP-confirmed spontaneously reported pregnancy cases with confirmed diagnosis of MS. †Values denote the maximum estimate from the general population as obtained from available literature. aWang et al. [23]; bBuss et al. [18]; cCongenital Malformations Registry [21]; dQueisser-Luft et al. [22]. HCP healthcare professional, MS multiple sclerosis, TOPFA termination of pregnancy for foetal anomaly
See this image and copyright information in PMC

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