{"title":"与Janus激酶抑制剂相关的感染风险调查:使用美国食品和药物管理局不良事件报告系统数据库的药物警戒分析。","authors":"Cansu Altınöz Güney, Huriye Aybüke Koç","doi":"10.1093/ced/llaf427","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The use of JAK inhibitors (JAKis) is growing in dermatology with approvals for atopic dermatitis, alopecia areata, plaque psoriasis, and psoriatic arthritis. This study aimed to evaluate infectious adverse events (iAEs) associated with abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, and upadacitinib.</p><p><strong>Methods: </strong>Data were retrieved from the FDA Adverse Event Reporting System (FAERS) via the open-source AERSMine platform (version:2025-04-16; Cincinnati Children's Hospital Medical Center, USA). Reports from 2004Q1 to 2024Q2 were screened under the MedDRA System Organ Class \"Infections and Infestations\". The analysis encompassed all indications, not only dermatologic use. Disproportionality metrics including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) were calculated.</p><p><strong>Results: </strong>Tofacitinib had the highest number of iAE reports (n=68,669), followed by upadacitinib (n=17,822). Most reports involved females and those aged 25-65, except baricitinib, which was more frequent in ≥66. Disproportionality analysis revealed sex- and age-related differences in iAE risk, with male sex generally associated with lower risk. Pediatric patients (0-14 years) had an elevated iAE risk with abrocitinib and upadacitinib, while older adults (≥66) showed increased risk with baricitinib and tofacitinib. Commonly reported iAEs included COVID-19, herpes zoster, nasopharyngitis, influenza, urinary tract infection, pneumonia, and sinusitis. Each JAKi was associated with distinct high-signal iAEs.</p><p><strong>Conclusion: </strong>This is the most comprehensive real-world analysis of iAEs linked to oral JAKis. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of post-marketing surveillance in ensuring safe JAKi use.</p>","PeriodicalId":10324,"journal":{"name":"Clinical and Experimental Dermatology","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Investigation of Infection Risk Associated with Janus Kinase Inhibitors: A Pharmacovigilance Analysis Using the Food and Drug Administration's Adverse Event Reporting System Database.\",\"authors\":\"Cansu Altınöz Güney, Huriye Aybüke Koç\",\"doi\":\"10.1093/ced/llaf427\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The use of JAK inhibitors (JAKis) is growing in dermatology with approvals for atopic dermatitis, alopecia areata, plaque psoriasis, and psoriatic arthritis. This study aimed to evaluate infectious adverse events (iAEs) associated with abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, and upadacitinib.</p><p><strong>Methods: </strong>Data were retrieved from the FDA Adverse Event Reporting System (FAERS) via the open-source AERSMine platform (version:2025-04-16; Cincinnati Children's Hospital Medical Center, USA). Reports from 2004Q1 to 2024Q2 were screened under the MedDRA System Organ Class \\\"Infections and Infestations\\\". The analysis encompassed all indications, not only dermatologic use. Disproportionality metrics including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) were calculated.</p><p><strong>Results: </strong>Tofacitinib had the highest number of iAE reports (n=68,669), followed by upadacitinib (n=17,822). Most reports involved females and those aged 25-65, except baricitinib, which was more frequent in ≥66. Disproportionality analysis revealed sex- and age-related differences in iAE risk, with male sex generally associated with lower risk. Pediatric patients (0-14 years) had an elevated iAE risk with abrocitinib and upadacitinib, while older adults (≥66) showed increased risk with baricitinib and tofacitinib. Commonly reported iAEs included COVID-19, herpes zoster, nasopharyngitis, influenza, urinary tract infection, pneumonia, and sinusitis. Each JAKi was associated with distinct high-signal iAEs.</p><p><strong>Conclusion: </strong>This is the most comprehensive real-world analysis of iAEs linked to oral JAKis. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of post-marketing surveillance in ensuring safe JAKi use.</p>\",\"PeriodicalId\":10324,\"journal\":{\"name\":\"Clinical and Experimental Dermatology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ced/llaf427\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ced/llaf427","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:随着特应性皮炎、斑秃、斑块型银屑病和银屑病关节炎的批准,JAK抑制剂(JAKis)在皮肤科的应用越来越广泛。本研究旨在评估与阿布替尼、巴西替尼、德克拉伐替尼、利来替尼、托法替尼和更新阿达替尼相关的感染不良事件(iae)。方法:通过开源的AERSMine平台(版本:2025-04-16;Cincinnati Children’s Hospital Medical Center, USA)从FDA不良事件报告系统(FAERS)中检索数据。2004年第一季度至2024年第二季度的报告在MedDRA系统器官类别“感染和侵扰”下进行筛选。分析包括所有适应症,而不仅仅是皮肤科的使用。计算歧化指标,包括报告优势比(ROR)、比例报告比(PRR)和信息成分(IC)。结果:Tofacitinib的iAE报告数量最多(n=68,669),其次是upadacitinib (n=17,822)。大多数报告涉及女性和25-65岁的患者,除了baricitinib,在≥66岁的患者中更常见。歧化分析揭示了iAE风险的性别和年龄相关差异,男性通常与较低的风险相关。儿童患者(0-14岁)使用阿布替尼和upadacitinib会增加iAE的风险,而老年人(≥66岁)使用巴西替尼和托法替尼会增加iAE的风险。常见的iae包括COVID-19、带状疱疹、鼻咽炎、流感、尿路感染、肺炎和鼻窦炎。每个JAKi都与不同的高信号iae相关。结论:这是与口腔JAKis相关的iae最全面的现实分析。虽然感染风险因病原体而异,但发现了常见和罕见但严重的事件。研究结果强调了个性化监测和预防策略的重要性,并强调了上市后监测在确保JAKi安全使用中的价值。
Investigation of Infection Risk Associated with Janus Kinase Inhibitors: A Pharmacovigilance Analysis Using the Food and Drug Administration's Adverse Event Reporting System Database.
Background: The use of JAK inhibitors (JAKis) is growing in dermatology with approvals for atopic dermatitis, alopecia areata, plaque psoriasis, and psoriatic arthritis. This study aimed to evaluate infectious adverse events (iAEs) associated with abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, and upadacitinib.
Methods: Data were retrieved from the FDA Adverse Event Reporting System (FAERS) via the open-source AERSMine platform (version:2025-04-16; Cincinnati Children's Hospital Medical Center, USA). Reports from 2004Q1 to 2024Q2 were screened under the MedDRA System Organ Class "Infections and Infestations". The analysis encompassed all indications, not only dermatologic use. Disproportionality metrics including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) were calculated.
Results: Tofacitinib had the highest number of iAE reports (n=68,669), followed by upadacitinib (n=17,822). Most reports involved females and those aged 25-65, except baricitinib, which was more frequent in ≥66. Disproportionality analysis revealed sex- and age-related differences in iAE risk, with male sex generally associated with lower risk. Pediatric patients (0-14 years) had an elevated iAE risk with abrocitinib and upadacitinib, while older adults (≥66) showed increased risk with baricitinib and tofacitinib. Commonly reported iAEs included COVID-19, herpes zoster, nasopharyngitis, influenza, urinary tract infection, pneumonia, and sinusitis. Each JAKi was associated with distinct high-signal iAEs.
Conclusion: This is the most comprehensive real-world analysis of iAEs linked to oral JAKis. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of post-marketing surveillance in ensuring safe JAKi use.
期刊介绍:
Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.