| アブストラクト | Janus kinase inhibitors (JAKIs) are immunomodulatory drugs used for autoimmune and inflammatory conditions. Their potential impact on pregnancy and fetal development remains a concern due to placental transfer and potential disruption of cytokine and growth factor signaling, with limited human data. This study analyzed VigiBase, the World Health Organization global pharmacovigilance database of individual case safety reports (ICSRs), to assess signals of disproportionate reporting (SDRs) for pregnancy-related adverse drug reactions (ADRs) reported with systemic JAKIs, including abrocitinib, baricitinib, deucravacitinib, fedratinib, filgotinib, itacitinib, momelotinib, pacritinib, peficitinib, ritlecitinib, ruxolitinib, tofacitinib, and upadacitinib. As of May 26, 2024, 163 ICSRs met inclusion criteria, mainly from North America (41.7%) and Europe (39.3%). The most frequently reported JAKIs were tofacitinib (44.8%) and upadacitinib (34.4%), primarily indicated for rheumatoid arthritis (29.4%). Among 213 pregnancy-related ADRs, spontaneous abortion was the most frequently reported event (47.9%) without representing an SDR compared with other drugs in the database (reporting odds ratio [ROR] 0.37, 95% confidence interval [CI] 0.30-0.46). Congenital anomalies were reported in 16.0% of ICSRs (43 events), but no specific organ-related patterns were identified. Prematurity occurred in 9.2% of ICSRs, without SDR compared to the full database (ROR 0.07, 95% CI 0.04-0.11). Current pharmacovigilance data from VigiBase do not indicate SDRs for spontaneous abortion or prematurity following JAKI exposure during pregnancy. Findings should be interpreted cautiously given the limitations of spontaneous reporting systems and the exploratory nature of the analysis. Further studies are needed to better characterize the JAKI safety in pregnancy. |
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| ジャーナル名 | Clinical and translational science |
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| Pubmed追加日 | 2025/11/27 |
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| 投稿者 | Abolhassani, Nazanin; Noseda, Roberta; Dao, Kim; Girardin, Francois R; Bedussi, Francesca; Ceschi, Alessandro; Panchaud, Alice; Winterfeld, Ursula |
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| 組織名 | Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.;Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological;Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano,;Switzerland.;Swiss Teratogen Information Service (STIS) and Clinical Pharmacology Service,;Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne,;Lausanne, Switzerland.;Clinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, Switzerland.;Faculty of Biomedical Sciences, Universita della Svizzera Italiana, Lugano,;Service of Pharmacy, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41305879/ |
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