Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study. (March 2021)

• Record Type: Journal Article
• Authors: Pauliat, Emmanuelle; Onken, Marlies; Weber-Schoendorfer, Corinna; Rousson, Valentin; Addor, Marie-Claude; Baud, David; Théaudin, Marie; Diav-Citrin, Orna; Cottin, Judith; Agusti, Antonia; Rollason, Victoria; Kaplan, Yusuf C; Kennedy, Debra; Kadioglu, Mine; Rothuizen, Laura E; Livio, Françoise; Buclin, Thierry; Panchaud, Alice; Winterfeld, Ursula
• Is Part Of: Multiple sclerosis. Volume 27:Number 3(2021)
• Page Start: 475
• Page End: 478
• Publication Date: 2021-03
• Subjects: Fingolimod -- interferon -- multiple sclerosis -- pregnancy -- birth defect -- cohort study; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458520929628
• Languages: English
• ISSNs: 1352-4585

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.