Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study

Mult Scler. 2021 Mar;27(3):475-478. doi: 10.1177/1352458520929628. Epub 2020 Jun 15.


This prospective multicentre cohort study investigated pregnancy outcomes after fingolimod use for multiple sclerosis during pregnancy. Pregnancy outcomes of 63 fingolimod and 62 interferon-β-exposed pregnancies were compared. Rates of major congenital anomalies (MCA) were 4.8% (2/42) in the fingolimod group versus 2.3% (1/44) in the interferon-β group (odds ratio, 2.2; 95% confidence interval, 0.2-24.6). The adjusted hazard ratio for spontaneous abortion in fingolimod versus interferon-β-exposed pregnancies was 0.6 (95% confidence interval, 0.2-1.8). Further studies are needed to definitely rule out a moderately increased MCA risk after fingolimod exposure during pregnancy.

Keywords: Fingolimod; birth defect; cohort study; interferon; multiple sclerosis; pregnancy.