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

Pauliat, Emmanuelle; Onken, Marlies; Weber-Schoendorfer, Corinna; Rousson, Valentin; Addor, Marie-Claude; Baud, David; Theaudin, Marie; Diav-Citrin, Orna; Cottin, Judith; Agusti, Antonia; Rollason, Victoria; Kaplan, Yusuf; Kennedy, Debra; Kadioglu, MİNE; Rothuizen, Laura; Livio, Francoise; Buclin, Thierry; Panchaud, Alice; Winterfeld, Ursula

doi:10.1177/1352458520929628

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

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Pauliat E., Onken M., Weber-Schoendorfer C., Rousson V., Addor M., Baud D., ...More

MULTIPLE SCLEROSIS JOURNAL, vol.27, pp.475-478, 2021 (SCI-Expanded)

Publication Type: Article / Article
Volume: 27
Publication Date: 2021
Doi Number: 10.1177/1352458520929628
Journal Name: MULTIPLE SCLEROSIS JOURNAL
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, PASCAL, BIOSIS, EMBASE, MEDLINE
Page Numbers: pp.475-478
Keywords: Fingolimod, interferon, multiple sclerosis, pregnancy, birth defect, cohort study, MATERNAL EXPOSURE
Karadeniz Technical University Affiliated: Yes

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-beta-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-beta group (odds ratio, 2.2; 95% confidence interval, 0.2-24.6). The adjusted hazard ratio for spontaneous abortion in fingolimod versus interferon-beta-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.