Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study
Emmanuelle Pauliat, Marlies Onken, Corinna Weber‐Schoendorfer, Valentin Rousson, Marie‐Claude Addor, David Baud, Marie Théaudin, Orna Diav‐Citrin, Judith Cottin, Antònia Agustí, Victoria Rollason, Yusuf Cem Kaplan, Debra Kennedy, Mine Kadıoğlu, Laura E. Rothuizen, Françoise Livio, Thierry Buclin, Alice Panchaud, Ursula Winterfeld
Abstract
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.