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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; 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.
Afiliação
  • Pauliat E; Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Onken M; 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.
  • Weber-Schoendorfer C; 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.
  • Rousson V; Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland.
  • Addor MC; Department of Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Baud D; Materno-Fetal and Obstetrics Research Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Théaudin M; Department of Clinical Neurosciences, Division of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Diav-Citrin O; The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel/The Hebrew University Hadassah Medical School, Jerusalem, Israel.
  • Cottin J; Centre Régional de Pharmacovigilance, Hospices Civils de Lyon, Lyon, France.
  • Agusti A; Clinical Pharmacology Service, Vall d'Hebron University Hospital, Barcelona, Spain.
  • Rollason V; Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland.
  • Kaplan YC; Terafar - Izmir Katip Celebi University Teratology Information, Research and Training Center, Izmir, Turkey.
  • Kennedy D; 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.
  • Kadioglu M; Department of Pharmacology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
  • Rothuizen LE; Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Livio F; Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Buclin T; Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
  • Panchaud A; School of Pharmaceutical Sciences, University of Geneva and University of Lausanne, Geneva, Switzerland.
  • Winterfeld U; Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Mult Scler ; 27(3): 475-478, 2021 03.
Article em En | MEDLINE | ID: mdl-32538681
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-ß-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-ß group (odds ratio, 2.2; 95% confidence interval, 0.2-24.6). The adjusted hazard ratio for spontaneous abortion in fingolimod versus interferon-ß-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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Resultado da Gravidez / Cloridrato de Fingolimode Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Resultado da Gravidez / Cloridrato de Fingolimode Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2021 Tipo de documento: Article