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Safety of biological agents in paediatric rheumatic diseases: A real-life multicenter retrospective study using the

Natalia Cabrera1, Jean-Christophe Lega2, Behrouz Kassai3

  • 1UMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, 69376 Lyon cedex 08, France; Inserm U1111, National Referral Centre for rare Juvenile Rheumatological and Auto-immune Diseases (RAISE), Department of Paediatric Rheumatology, Lyon University Hospital, University of Lyon, 69677 Bron cedex, France.

Joint Bone Spine
|September 12, 2018
PubMed

Insights

Biologic agents are generally safe for children with inflammatory rheumatic diseases. However, combining them with immunosuppressive drugs increases the risk of adverse events, particularly for juvenile idiopathic arthritis patients.

Area of Science:

  • Pediatric Rheumatology
  • Pharmacovigilance
  • Immunology

Background:

  • Biological agents are increasingly used for pediatric inflammatory diseases.
  • Real-world data on the safety of these agents in children is crucial.
  • Understanding adverse event profiles informs clinical practice.

Purpose of the Study:

  • To determine the incidence of side effects of biologic agents in pediatric patients with inflammatory diseases.
  • To identify risk factors for adverse events in this population.

Main Methods:

  • International, observational, retrospective, multicenter study.
  • Data from the Juvenile Inflammatory Rheumatism (JIR) cohort.
  • Kaplan-Meier and Cox regression analyses were used.

Main Results:

  • 813 patients with 3439 patient-years of follow-up.
  • 27.3% of patients experienced adverse events (12.2 per 100 PY).
  • Serious adverse events occurred at 3.9 per 100 PY; concomitant immunosuppressants increased risk.

Conclusions:

  • Biologic agents demonstrate acceptable safety in pediatric inflammatory rheumatic diseases.
  • Concomitant use of immunosuppressive drugs with biologics significantly elevates adverse event risk.
  • Specific agents like tocilizumab, infliximab, and canakinumab showed associations with adverse events.
Abstract

Keywords:
Adverse eventsBiological agentsJIRcohorteJuvenile idiopathic arthritisPaediatric rheumatologySerious adverse events

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