No increased risk with IFN-β use during pregnancy

Data from the Middle East shows that exposure to subcutaneous interferon-beta (IFN-β) before and/or during pregnancy, especially in the first trimester, does not adversely affect pregnancy or infant outcomes. These findings are consistent with data collected from other registries and from the global safety database of the drug company.

Women with multiple sclerosis (MS) are often diagnosed and treated at childbearing age. Therefore, family planning is an important consideration for female patients undergoing treatment. IFN-β has been recently approved for use during pregnancy and lactation. Data from different registries has shown that exposure to IFN-β before and/or during pregnancy, especially during the first trimester, did not adversely affect pregnancy or infant outcomes [1].

The objective of the presented study was to carry out a descriptive analysis of data from the safety database of the drug company in the Gulf Cooperation Council region (GCC: United Arab Emirates, Saudi Arabia, Oman, Qatar, Kuwait, Bahrain, Yemen), regarding pregnancy outcomes in MS patients receiving subcutaneous IFN-β [2].

During the period between 2015 to 2019, a total of 224 adverse events (AEs) related to pregnancy and/or childbirth were identified in 114 cases. The majority (83.9%) of these AEs were not serious. Most common serious AEs were premature baby (n=5), premature delivery (n=5), low birth weight (n=5), and spontaneous abortion (n=4). Normal newborn outcome was identified with the highest frequency. In comparison with the global analysis of all pregnancy cases, no abnormal AE trend was identified for the GCC regions.

1. Hellwig K, et al. J Neurol. 2020;267:1715–1723.
2. Boshra A, et al. Pregnancy safety outcomes in subcutaneous interferon-beta-exposed patients with multiple sclerosis: Results from GCC region. ECF 28^th Annual Meeting. Abstract 13.

Posted on 16 December 202015 February 2024