دورية أكاديمية
Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database
| العنوان: | Adverse events associated with JAK inhibitors in 126,815 reports from the WHO pharmacovigilance database |
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| المؤلفون: | Léa Hoisnard, Bénédicte Lebrun-Vignes, Sébastien Maury, Matthieu Mahevas, Khalil El Karoui, Lydia Roy, Anissa Zarour, Marc Michel, José L. Cohen, Aurélien Amiot, Pascal Claudepierre, Pierre Wolkenstein, Philippe Grimbert, Emilie Sbidian |
| المصدر: | Scientific Reports, Vol 12, Iss 1, Pp 1-10 (2022) |
| بيانات النشر: | Nature Portfolio, 2022. |
| سنة النشر: | 2022 |
| المجموعة: | LCC:Medicine LCC:Science |
| مصطلحات موضوعية: | Medicine, Science |
| الوصف: | Abstract Increasing number of Janus kinase (JAK) inhibitors have been approved for chronic haematopoietic neoplasms and inflammatory/autoimmune diseases. We aimed to assess safety of the first three approved JAK inhibitors: ruxolitinib, tofacitinib and baricitinib. In this retrospective observational study, pharmacovigilance data were extracted from the World Health Organization database. Adverse events are classified according to Medical Dictionary for Regulatory Activities hierarchy. Until February 28, 2021, all Individual Case Safety Reports [ICSRs] with the suspected drug ruxolitinib, tofacitinib or baricitinib were included. Disproportionality analysis was performed and the information component (IC) was estimated. Adverse events were considered a significant signal if the lower end of the 95% credibility interval of the IC (IC025) was positive. We identified 126,815 ICSRs involving JAK inhibitors. Ruxolitinib, tofacitinib and baricitinib were associated with infectious adverse events (IC025 1.7, especially with viral [herpes and influenza], fungal, and mycobacterial infectious disorders); musculoskeletal and connective tissue disorders (IC025 1.1); embolism and thrombosis (IC025 0.4); and neoplasms (IC025 0.8, especially malignant skin neoplasms). Tofacitinib was associated with gastrointestinal perforation events (IC025 1.5). We did not find a significant increase in the reporting of major cardiovascular events. We identified significant association between adverse events and ruxolitinib, tofacinitib and baricitinib in international pharmacovigilance database. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2045-2322 |
| العلاقة: | https://doaj.org/toc/2045-2322Test |
| DOI: | 10.1038/s41598-022-10777-w |
| الوصول الحر: | https://doaj.org/article/2ca98a65657442a48f5704f32414808bTest |
| رقم الانضمام: | edsdoj.2ca98a65657442a48f5704f32414808b |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 20452322 |
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| DOI: | 10.1038/s41598-022-10777-w |