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Adverse events of biological agents in pediatric rheumatologic diseases

Merve Cansu Polat1, Saniye Mertek2, Zeynep Birsin Özçakar3

  • 1Department of Pediatric Rheumatology, University of Health Sciences, Ankara City Hospital, Cankaya, Turkey.

Postgraduate Medicine
|February 28, 2024
PubMed

Insights

Pediatric patients on biologic agents (BAs) for rheumatic diseases experienced adverse events, including increased risk of latent tuberculosis (TB) with longer use. Physicians should monitor for TB and skin reactions, especially with anti-IL1 therapies.

Area of Science:

  • Pediatric Rheumatology
  • Immunology
  • Pharmacovigilance

Background:

  • Biologic agents (BAs) are increasingly used for pediatric rheumatologic diseases.
  • Understanding the safety profile of BAs in this population is crucial for optimal patient care.

Purpose of the Study:

  • To evaluate adverse events (AEs) in pediatric patients with rheumatic diseases treated with approved or off-label biologic agents.
  • To identify specific risks associated with different classes of BAs.

Main Methods:

  • Observational, retrospective, multicenter study (2010-2022).
  • Included pediatric patients (<18 years) receiving interleukin-1 antibodies (Anti-IL1), interleukin-6 antibodies (Anti-IL6), or tumor necrosis factor alpha inhibitors (anti-TNF).
  • Collected data on efficacy, AEs, and timing of AEs from electronic medical records.

Main Results:

  • Fifty AEs occurred in 44 of 237 patients (18.6%) treated with 315 BAs.
  • Latent tuberculosis (TB) and herpes infections were associated with anti-TNF therapy.
  • Recurrent upper respiratory tract infections and local skin reactions were more common with Anti-IL1.
  • BA use for ≥23.5 months increased the risk of latent TB 5.94-fold.
  • Severe skin reactions like DRESS and anaphylaxis were reported.

Conclusions:

  • Physicians should maintain vigilance for latent TB in patients on BAs for over two years.
  • Local skin reactions are more common with Anti-IL1, but severe reactions like DRESS can occur.
  • No malignancies or deaths were observed in the study cohort.
Abstract

Keywords:
Adverse eventsbiological agentsoptic neuritispediatric rheumatologic diseasetuberculosis

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