| アブストラクト | BACKGROUND: Upadacitinib is an oral Janus kinase 1 (JAK1) selective inhibitor approved for the treatment of rheumatoid arthritis (RA) and other immune-mediated inflammatory diseases. Concerns have emerged regarding a potential increased risk of venous thromboembolism (VTE) with JAK inhibitors (JAKi), though real-world evidence remains limited. OBJECTIVE: To assess the post-marketing safety profile of upadacitinib in relation to VTE using global pharmacovigilance data. METHODS: We conducted a disproportionality analysis using Individual Case Safety Reports (ICSRs) from VigiBase, accessed via VigiLyze, including all reports up to February 20, 2025. Upadacitinib was compared with: (i) all other medicines; (ii) other second-line advanced RA therapies (bDMARDs and tsDMARDs); and (iii) other JAKi (baricitinib, tofacitinib, filgotinib). Reporting Odds Ratios (ROR) and Information Components (IC), with 95% confidence intervals, were calculated. RESULTS: Descriptive analyses identified 678 VTE cases with upadacitinib, predominantly affecting women (68.1%), with a median age of 63 years. Most were classified as serious (91.2%), although fatal outcomes were less frequent than with comparators. In disproportionality analyses, upadacitinib showed a significant signal versus all medicines (ROR: 2.08; IC: 1.04) and versus other second-line therapies (ROR: 1.40; IC: 0.41), but not versus other JAKi (ROR: 0.98; IC: -0.04). In 2023, disproportionality declined, particularly relative to other JAKi (ROR: 0.57; IC: -0.38). CONCLUSION: Upadacitinib-related VTE cases display distinct clinical characteristics. These findings support continued pharmacovigilance and the need for robust real-world studies to clarify absolute and comparative risks, inform regulation, and guide personalised therapeutic strategies in RA. |
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| ジャーナル名 | Frontiers in medicine |
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| Pubmed追加日 | 2025/12/17 |
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| 投稿者 | Ferreira-da-Silva, Renato; Lobo, Mariana; Abreu, Ana Rafaela; Pereira-Macedo, Juliana; Mos, Beatriz; Rodriguez, Carolina Ameijeiras; Lourenco, Ines Mariana; Vieira, Isabel; Polonia, Jorge Junqueira; Gouveia, Luis; Silva, Lurdes; Morato, Manuela; Pinto, Manuela; Forrester, Mario; Pereira, Marta; Rodrigues, Nuno; Biase, Tayanny; Ribeiro, Ines |
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| 組織名 | Porto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto,;Porto, Portugal.;RISE-Health, Department of Community Medicine, Information and Health Decision;Sciences, Faculty of Medicine of the University of Porto, Porto, Portugal.;RISE-Health, Department of Surgery and Physiology, Faculty of Medicine,;University of Porto, Porto, Portugal.;RISE-Health, Department of Medicine, Faculty of Medicine of the University of;Porto, Porto, Portugal.;LAQV@REQUIMTE, Laboratory of Pharmacology, Department of Drug Sciences, Faculty;of Pharmacy of the University of Porto, Porto, Portugal.;Local Health Unit of Sao Joao, E.P.E., Porto, Portugal.;Local Health Unit of Santo Antonio, E.P.E., Porto, Portugal.;Local Health Unit of Vila Nova de Gaia/Espinho, E.P.E., Porto, Portugal. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41404585/ |
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