Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study,Multiple Sclerosis Journal

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Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study
Multiple Sclerosis Journal ( IF 4.8 ) Pub Date : 2020-06-15 , DOI: 10.1177/1352458520929628
Emmanuelle Pauliat ₁ , Marlies Onken ₂ , Corinna Weber-Schoendorfer ₂ , Valentin Rousson ₃ , Marie-Claude Addor ₄ , David Baud ₅ , Marie Théaudin ₆ , Orna Diav-Citrin ₇ , Judith Cottin ₈ , Antonia Agusti ₉ , Victoria Rollason ₁₀ , Yusuf C Kaplan ₁₁ , Debra Kennedy ₁₂ , Mine Kadioglu ₁₃ , Laura E Rothuizen ₁ , Françoise Livio ₁ , Thierry Buclin ₁ , Alice Panchaud ₁₄ , Ursula Winterfeld ₁

Affiliation

Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
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.
Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland.
Department of Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Materno-Fetal and Obstetrics Research Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Department of Clinical Neurosciences, Division of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel/The Hebrew University Hadassah Medical School, Jerusalem, Israel.
Centre Régional de Pharmacovigilance, Hospices Civils de Lyon, Lyon, France.
Clinical Pharmacology Service, Vall d'Hebron University Hospital, Barcelona, Spain.
Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland.
Terafar - Izmir Katip Celebi University Teratology Information, Research and Training Center, Izmir, Turkey.
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.
Department of Pharmacology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
School of Pharmaceutical Sciences, University of Geneva and University of Lausanne, Geneva, Switzerland.

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.

中文翻译：

妊娠早期暴露于芬戈莫德后的妊娠结果：一项协作性 ENTIS 研究

这项前瞻性多中心队列研究调查了妊娠期间使用芬戈莫德治疗多发性硬化症后的妊娠结局。比较了 63 名芬戈莫德和 62 名干扰素-β 暴露妊娠的妊娠结局。芬戈莫德组的主要先天性异常 (MCA) 率为 4.8% (2/42)，而干扰素-β 组为 2.3% (1/44)（优势比，2.2；95% 置信区间，0.2-24.6）。芬戈莫德与干扰素-β 暴露妊娠中自然流产的调整风险比为 0.6（95% 置信区间，0.2-1.8）。需要进一步的研究来明确排除怀孕期间芬戈莫德暴露后 MCA 风险适度增加的可能性。

更新日期：2020-06-15

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