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Background <p>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.</p> Methods <p>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.</p> Results <p>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].</p> Conclusions <p>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.</p> Impact <p><UnorderedList Mark="Bullet"> <ItemContent> <p>This study collected and analysed the data of paradoxical psoriasis (PP) associated with TNFis in pediatric patients from a worldwide pharmacovigilance database.</p> </ItemContent> <ItemContent> <p>Reports of PP adverse events accounted for 0.58% of the overall TNFi adverse event reports in pediatric patients.</p> </ItemContent> <ItemContent> <p>Among the five TNFis, we found disproportionate reporting of PP with etanercept, infliximab, adalimumab, and certolizumab in pediatric patients.</p> </ItemContent> </UnorderedList></p>

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Paradoxical psoriasis in pediatric tumor necrosis factor-α inhibitor therapy database

  • 期刊论文

  • 发表日期：

    2025年7月23日

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  • Yurong Piao,
  • Xiaolin Xu,
  • Xingfeng Yao,
  • Yan Li,
  • Yixin Sun,
  • Tongxin Han,
  • Xiaoling Wang,
  • Huawei Mao

摘要

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.