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

Pediatric Research (2025)Cite this article

Abstract

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.

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Fig. 1: Year-wise reporting odds ratio of PP with TNFi.

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Data availability

All the data generated or analyzed during this study are included in this published article and its supplementary files. TNFi reports are available and can be retrieved form the FAERS Publish Dashboard (https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard).

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Acknowledgements

We thank the investigators and institutions involved in this study. This work was supported in part by the National Key R&D Program of China (2021YFC2702005, 2022YFC2703100, 2023YFC2706101), Beijing Hospitals Authority’s Ascent Plan (DFL20221001), Beijing Municipal Hospital Scientific Research and Cultivation Program (PX2023043), and Tianchi Talent Program of Xinjiang Uygur Autonomous Region.

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Author notes

  1. These authors contributed equally: Yurong Piao, Xiaolin Xu, Xingfeng Yao.

Authors and Affiliations

  1. Department of Immunology, Beijing Children’s Hospital, National Center for Children’s Health, Capital Medical University, Beijing, China

    Yurong Piao, Xiaolin Xu, Yan Li, Tongxin Han & Huawei Mao

  2. Department of Pharmacy, Beijing Children’s Hospital, National Center for Children’s Health, Capital Medical University, Beijing, China

    Xiaolin Xu, Yixin Sun & Xiaoling Wang

  3. Department of Pathology, Beijing Children’s Hospital, National Center for Children’s Health, Capital Medical University, Beijing, China

    Xingfeng Yao

  4. Ministry of Education Key Laboratory of Major Diseases in Children, Beijing Key Laboratory for Genetics of Birth Defects, Beijing, China

    Huawei Mao

  5. Department of Nephrology & Rheumatology, Xinjiang Hospital of Beijing Children’s Hospital, Children’s Hospital of Xinjiang Uygur Autonomous Region, Xinjiang, China

    Huawei Mao

Authors
  1. Yurong Piao
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  2. Xiaolin Xu
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  4. Yan Li
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  8. Huawei Mao
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Contributions

Y.P. and X.X. performed the study and analyzed the data. X.X. wrote the manuscript. X.Y. carried out the collection of resources. Y.L. surveyed the relevant literature. Y.S. performed methodological support. X.W. and T.H. were responsible for issuing and collecting scales. H.M. conceived and guided the study and critically revised the manuscript. All authors contributed to the article and approved the final manuscript.

Corresponding author

Correspondence to Huawei Mao.

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Competing interests

The authors declare no competing interests.

Ethics approval

Since the FAERS database is accessible to the public and patient records are anonymized and deidentified, ethical clearance and informed consent are not required for this study.

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Piao, Y., Xu, X., Yao, X. et al. Paradoxical psoriasis in pediatric tumor necrosis factor-α inhibitor therapy database. Pediatr Res (2025). https://doi.org/10.1038/s41390-025-04305-5

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