Pediatric research · 2025
Paradoxical psoriasis in pediatric tumor necrosis factor-α inhibitor therapy database.
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Piao Yurong, Xu Xiaolin, Yao Xingfeng, Li Yan, Sun Yixin, Han Tongxin, Wang Xiaoling, Mao Huawei
Аннотация
BACKGROUND: Paradoxical psoriasis (PP) is a class of adverse events associated with tumor necrosis factor α 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.
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.