Zhang Huiling, Huang Yaping, Ke Chengjie, Chen Maohua
Department of Pharmacy, The First People's Hospital of Nanning, Nanning, China.
Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, Fujian, China.
Front Oncol. 2025 Jul 28;15:1618267. doi: 10.3389/fonc.2025.1618267. eCollection 2025.
Pacritinib, a selective Janus kinase (JAK) inhibitor, is approved for the treatment of myelofibrosis in adults with severe thrombocytopenia. However, its safety profile in real-world populations remains unclear. The aim of study is provided a comprehensive profile of pacritinib's safety by evaluating the adverse events (AEs) using a real-world pharmacovigilance database.
Data from the FDA Adverse Event Reporting System (FAERS) database, spanning from the first quarter of 2022 to the second quarter of 2024, served as the basis for this analysis. To identify potential AE risk signals, several disproportionality analysis methods were applied, including the reporting odds ratio, the proportional reporting ratio, the multi-item gamma Poisson shrinker, and the Bayesian confidence propagation neural network.
A total of 4,304,335 AE reports were collected from the FAERS, with 1,940 reports identifying pacritinib as the primary suspect drug. Significant disproportionality was observed in the following system organ classes: gastrointestinal disorders, investigations, and surgical and medical procedures. Common preferred terms were identified, including diarrhea, fatigue, death, nausea, platelet count decreased, and hemoglobin decreased. Notably, 26 off--label AEs were also identified.
Our study would provide valuable insights for the post-marketing safety surveillance and assessment of pacritinib, and guide its clinical practice.
帕西替尼是一种选择性 Janus 激酶（JAK）抑制剂，已被批准用于治疗患有严重血小板减少症的成人骨髓纤维化。然而，其在现实世界人群中的安全性概况仍不清楚。本研究的目的是通过使用真实世界药物警戒数据库评估不良事件（AE），全面了解帕西替尼的安全性。
本分析的数据来自美国食品药品监督管理局不良事件报告系统（FAERS）数据库，时间跨度为 2022 年第一季度至 2024 年第二季度。为了识别潜在的 AE 风险信号，应用了几种不成比例分析方法，包括报告比值比、比例报告比、多项伽马泊松收缩器和贝叶斯置信传播神经网络。
从 FAERS 共收集了 4304335 份 AE 报告，其中 1940 份报告将帕西替尼列为主要可疑药物。在以下系统器官类别中观察到显著的不成比例：胃肠道疾病、检查以及手术和医疗程序。确定了常见的首选术语，包括腹泻疲劳、死亡、恶心、血小板计数减少和血红蛋白降低。值得注意的是，还识别出 26 种超说明书 AE。
我们的研究将为帕西替尼的上市后安全性监测和评估提供有价值的见解，并指导其临床实践。
