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Updated: Sep 14, 2025

The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
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Paradoxical psoriasis in pediatric tumor necrosis factor-α inhibitor therapy database

Yurong Piao1, Xiaolin Xu1,2, Xingfeng Yao3

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

Pediatric Research
|July 23, 2025
PubMed

Insights

Paradoxical psoriasis (PP) is a rare adverse event in pediatric patients using tumor necrosis factor inhibitors (TNFi). This study found a safety signal for PP with etanercept, infliximab, adalimumab, and certolizumab in children.

Area of Science:

  • Pharmacovigilance
  • Pediatric Adverse Events
  • Immunology

Background:

  • Paradoxical psoriasis (PP) is an adverse event associated with tumor necrosis factor inhibitors (TNFi).
  • Real-world data is crucial for understanding TNFi safety profiles in pediatric populations.
  • Quantifying PP signals in children treated with TNFi is essential for patient safety.

Purpose of the Study:

  • To quantify the pharmacovigilance signals of paradoxical psoriasis (PP) in pediatric patients treated with TNFi.
  • To analyze the disproportionality of PP adverse events across five specific TNFi drugs.

Main Methods:

  • Utilized the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q1 2023.
  • Extracted pediatric PP cases linked to etanercept, infliximab, adalimumab, certolizumab, and golimumab.
  • Employed disproportionality analyses including ROR, PRR, BCPNN, and MGPS to assess safety signals.

Main Results:

  • Identified 563 pediatric PP cases, with females (66.31%) more affected than males (33.69%).
  • The average age of affected children was 14 years.
  • Four TNFi drugs showed disproportionate reporting of PP: etanercept (ROR=18.53), infliximab (ROR=17.19), adalimumab (ROR=10.23), and certolizumab (ROR=3.95).

Conclusions:

  • Real-world pharmacovigilance data confirms a safety signal for PP associated with TNFi in pediatric patients.
  • Etanercept, infliximab, adalimumab, and certolizumab are associated with a disproportionate reporting of PP in children.
  • These findings highlight the importance of monitoring for PP in pediatric patients receiving TNFi therapy.
Abstract

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