利用美国食品和药物管理局临床不良事件报告系统分析Janus激酶抑制剂与恶性皮肤肿瘤的关联。
Analysis of the association between Janus kinase inhibitors and malignant skin tumors using the Food and Drug Administration Adverse Event Reporting System.
发表日期：2023 Aug 22
作者：
Tianqi Liu, Ruonan Gao, Li Li, Bin Wu, Fengbo Wu
来源：
Food & Function
摘要：
恶性皮肤肿瘤是关于Janus激酶（JAK）抑制剂的不良事件的关注点。本研究旨在评估JAK抑制剂与恶性皮肤肿瘤不良事件之间的关联，并对主要特征进行描述。通过使用美国食品药品监督管理局不良事件报告系统（FAERS）收集了2012-2021年的数据，具体提取了以JAK抑制剂为主要疑似药物的不良事件案例用于进一步分析。不均衡分析通过估计报告比值比（ROR）和信息组分（IC）及其95%置信区间（95% CI）来评估JAK抑制剂与恶性皮肤肿瘤事件之间的关联。共收集了142,673个以JAK抑制剂为主要疑似药物的病例，其中包括1400个恶性皮肤肿瘤事件。不均衡分析中包括了鲁索利替尼、乌帕达替尼、托法替尼和巴瑞替尼。三种JAK抑制剂与恶性皮肤肿瘤事件有关，分别是鲁索利替尼（ROR 5.40，95% CI 5.03-5.81；IC 2.39，95% CI 2.14-2.62）、乌帕达替尼（ROR 4.79，95% CI 4.03-5.71；IC 2.24，95% CI 1.62-2.77）和托法替尼（ROR 1.67，95% CI 1.53-1.83；IC 0.73，95% CI 0.43-1.02）。发病时间的中位数为378.5天。我们发现鲁索利替尼、乌帕达替尼和托法替尼与恶性皮肤肿瘤存在关联。在临床实践中，开处方给予JAK抑制剂时应更加注意此类事件。© 2023. 作者，独家授权给Springer Nature Switzerland AG。
Malignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.This study aimed to evaluate the association between JAK inhibitors and adverse events of malignant skin tumors, and to characterize the main features.Data (2012-2021) were collected using the US Food and Drug Administration Adverse Event Reporting System (FAERS). Adverse event cases of JAK inhibitors as the primary suspected drug were extracted for further analysis. Disproportionality analysis evaluated the association between JAK inhibitors and malignant skin tumor events by estimating the reporting odds ratio (ROR) and the information component (IC) with 95% confidence intervals (95% CI).A total of 142,673 cases with JAK inhibitors as a primary suspected drug were collected, including 1400 malignant skin tumor events. Ruxolitinib, upadacitinib, tofacitinib, and baricitinib were included in the disproportionality analysis. Three JAK inhibitors were associated with malignant skin tumor events, namely ruxolitinib (ROR 5.40, 95% CI 5.03-5.81; IC 2.39, 95% CI 2.14-2.62), upadacitinib (ROR 4.79, 95% CI 4.03-5.71; IC 2.24, 95% CI 1.62-2.77), and tofacitinib (ROR 1.67, 95% CI 1.53-1.83; IC 0.73, 95% CI 0.43-1.02). The median time to onset time was 378.5 days.We found association between malignant skin tumors and ruxolitinib, upadacitinib, and tofacitinib. More attention should be paid to these events when prescribing JAK inhibitors in clinical practice.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.