广西医学2025，Vol.47Issue(2)：263-268,6.DOI:10.11675/j.issn.0253-4304.2025.02.16
基于FAERS数据库的JAK抑制剂相关皮肤癌信号挖掘与分析
Signal mining and analysis of skin cancer associated with JAK inhibitors based on FAERS database
摘要
Abstract
Objective To perform the signal mining and analysis of skin cancer associated with Janus kinase(JAK)inhibitors based on the United States Food and Drug Administration Adverse Event Reporting System(FAERS)database.Methods JAK inhibitors(ruxolitinib,tofacitinib,baritinib,upadacitinib,abxicitinib)related skin cancer reported from the fourth quarter of 2011 to the fourth quarter of 2023 were retrieved from the FAERS database.Adverse events were standardized with the use of preferred terms from the Medical Dictionary for Regulatory Activities,version 26.1.The reported odds ratio(ROR)method was adopted to detect JAK inhibitors related skin cancer risk signals.The Weibull distribution was employed to analyze the onset time of JAK inhibitors related skin cancer.Results A total of 1053 patients with JAK inhibitors related skin cancer were retrieved.Ruxolitinib involved 12 preferred terms such as recurrent cutaneous squamous cell carcinoma and cutaneous metastasis.Tofacitinib involved 5 preferred terms such as cutaneous neuroendocrine carcinoma and vulvar cancer.Baritinib had been implicated in cutaneous malignant melanoma.Upadacitinib involved 9 preferred terms such as cutaneous squamous cell carcinoma and malignant melanoma in situ.Abxitinib had been implicated in cutaneous T-cell lymphoma and cutaneous squamous cell carcinoma.Compared with females,males had a higher potential risk of suffering from skin cancer by using JAK inhibitos(ROR=1.83,95%CI:1.56,2.15).Compared with patients aged 20-59 years,patients aged≥60 years had a higher potential occurrence risk of skin cancer when using JAK inhibitors(ROR=2.50,95%CI:2.06,3.04).The median onset time of skin cancer induced by ruxolitinib,tofacitinib,and baritinib was 699 days,625 days,and 338 days,respectively.The Weibull distribution suggested that the onset time of skin cancer induced by these three JAK inhibitors belonged to wear failure type.Conclusion Five categories of JAK inhibitors are associated with the occurrence risk of skin cancer.It is necessary to be alert to the occurrence of skin cancer when JAK inhibitors are used for a long time in clinical practice.关键词
Janus激酶抑制剂/药物不良事件/皮肤肿瘤/数据挖掘/药物警戒性Key words
Janus kinase inhibitor/Drug adverse events/Skin cancer/Data mining/Pharmacovigilance分类
医药卫生引用本文复制引用
谭皓文,陈颖,欧璇..基于FAERS数据库的JAK抑制剂相关皮肤癌信号挖掘与分析[J].广西医学,2025,47(2):263-268,6.基金项目
广西壮族自治区卫生健康委西医类自筹经费科研课题(Z-D20231663) （Z-D20231663）
梧州医学高等专科学校2023年度校级科研项目(23WYKY08) （23WYKY08）
