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

Author:

Pauliat Emmanuelle1,Onken Marlies2,Weber-Schoendorfer Corinna2,Rousson Valentin3,Addor Marie-Claude4,Baud David5,Théaudin Marie6,Diav-Citrin Orna7,Cottin Judith8,Agusti Antonia9,Rollason Victoria10ORCID,Kaplan Yusuf C11,Kennedy Debra12,Kadioglu Mine13,Rothuizen Laura E1,Livio Françoise1,Buclin Thierry1,Panchaud Alice14,Winterfeld Ursula1

Affiliation:

1. Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

2. Charité – Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany

3. Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland

4. Department of Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

5. Materno-Fetal and Obstetrics Research Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

6. Department of Clinical Neurosciences, Division of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

7. The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel/The Hebrew University Hadassah Medical School, Jerusalem, Israel

8. Centre Régional de Pharmacovigilance, Hospices Civils de Lyon, Lyon, France

9. Clinical Pharmacology Service, Vall d’Hebron University Hospital, Barcelona, Spain

10. Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland

11. Terafar – Izmir Katip Celebi University Teratology Information, Research and Training Center, Izmir, Turkey

12. Mothersafe, The Royal Hospital for Women, Sydney, NSW, Australia/School of Women’s and Children’s Health, University of New South Wales, Sydney, NSW, Australia

13. Department of Pharmacology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey

14. School of Pharmaceutical Sciences, University of Geneva and University of Lausanne, Geneva, Switzerland

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.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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