| アブストラクト | BACKGROUND: Paradoxical psoriasis (PP) is a class of adverse events associated with tumor necrosis factor alpha inhibitor (TNFi) that are realistically observed in the real world. We aim to quantify the signals of PP with TNFis in pediatric patients based on a pharmacovigilance study. METHODS: Data on pediatric PP cases linked to five TNFi drugs-etanercept, infliximab, adalimumab, certolizumab, and golimumab-were extracted from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2023). PP event reports were assessed using ROR, PRR, BCPNN, MGPS, and logistic regression to conduct a disproportionality analysis and identify signal disparities. RESULTS: The FAERS database noted 563 pediatric PP cases, with 33.69% male and 66.31% female, representing 0.58% of all pediatric TNFi adverse event reports. The average age was 14 years. Among the five TNFis, four showed disproportionate reporting of PP: etanercept [ROR = 18.53], infliximab [ROR = 17.19], adalimumab [ROR = 10.23], and certolizumab [ROR = 3.95]. CONCLUSIONS: The real-world FAERS pharmacovigilance data showed the safety signal for PP associated with TNFi in pediatric patients. Etanercept, infliximab, adalimumab, and certolizumab showed disproportionate reporting. IMPACT: This study collected and analysed the data of paradoxical psoriasis (PP) associated with TNFis in pediatric patients from a worldwide pharmacovigilance database. Reports of PP adverse events accounted for 0.58% of the overall TNFi adverse event reports in pediatric patients. Among the five TNFis, we found disproportionate reporting of PP with etanercept, infliximab, adalimumab, and certolizumab in pediatric patients. |
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| ジャーナル名 | Pediatric research |
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| Pubmed追加日 | 2025/7/24 |
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| 投稿者 | Piao, Yurong; Xu, Xiaolin; Yao, Xingfeng; Li, Yan; Sun, Yixin; Han, Tongxin; Wang, Xiaoling; Mao, Huawei |
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| 組織名 | Department of Immunology, Beijing Children's Hospital, National Center for;Children's Health, Capital Medical University, Beijing, China.;Department of Pharmacy, Beijing Children's Hospital, National Center for;Department of Pathology, Beijing Children's Hospital, National Center for;Children's Health, Capital Medical University, Beijing, China. maohwei@qq.com.;Ministry of Education Key Laboratory of Major Diseases in Children, Beijing Key;Laboratory for Genetics of Birth Defects, Beijing, China. maohwei@qq.com.;Department of Nephrology & Rheumatology, Xinjiang Hospital of Beijing Children's;Hospital, Children's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang,;China. maohwei@qq.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40702205/ |
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