The New summary of product characteristics state:

“If clinically needed, the use of AVONEX may be considered during pregnancy and breast-feeding.” 1

Until now, a lack of consensus in the literature regarding MS treatment with interferon beta up to and during pregnancy has put doubts in the minds of HCPs.

To address this lack of evidence, a European interferon beta pregnancy registry was established and a population-based cohort study conducted using healthcare register data from Finland and Sweden.2

The principal findings were:2

A large amount of data (more than 1000 pregnancy outcomes) from pregnancy registries and post-marketing experience indicate no adverse effect on pregnancy or infant outcomes, after exposure to interferon beta before conception and/or during pregnancy.2

A prospective European interferon beta pregnancy registry contained 948 known pregnancy outcomes. The reported overall rate of congenital anomalies in live births and of spontaneous abortions was in line with the rates observed both in the general population and in MS patients not receiving any treatment.2

In a retrospective register-based study, data from 3054 pregnancy outcomes from women with MS were analysed. No evidence was found of an increased risk of serious adverse pregnancy outcomes, including spontaneous abortions and major congenital anomalies, after exposure to interferon beta before and/or during pregnancy compared to the women with MS that were unexposed to any MS disease modifying drug within the study. Further it was found that interferon beta exposure does not affect the mean birth weight and risk of preterm birth.2

“The European IFNß Pregnancy Registry showed no evidence that IFNß exposure before conception and/or during pregnancy adversely affected pregnancy or infant outcomes”2

Biogen-36608. Date of preparation: January 2020