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. 2020 Mar 9:13:1756286420910310.
doi: 10.1177/1756286420910310. eCollection 2020.

Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

Kerstin Hellwig  1 , Fernando Duarte Caron  2 , Eva-Maria Wicklein  3 , Aasia Bhatti  2 , Alessandra Adamo  4
Affiliations

Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

Kerstin Hellwig et al. Ther Adv Neurol Disord. .

Abstract

Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy.

Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer's pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study.

Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78-2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population.

Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

Keywords: incidence studies; multiple sclerosis; neonatal; observational study.

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Conflict of interest statement

Conflict of interest statement: KH has received honoraria and research support from Bayer, Biogen, Teva, Novartis, Sanofi Genzyme, and Merck. FDC, EW, AB, and AA are salaried employees at Bayer AG.

Figures

Figure 1.
Figure 1.
Distribution of cases.
Figure 2.
Figure 2.
Distribution of pregnancy cases by country.
Figure 3.
Figure 3.
Pregnancy outcomes. aIncluding live births that reported events which are not congenital anomalies (for example, neonatal jaundice). bLive births where there was no complete information on child health status so congenital anomalies could not be excluded.
See this image and copyright information in PMC

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