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July 15, 2026

Pharmacokinetics, effectiveness and safety of certolizumab pegol in children and adolescents with active juvenile idiopathic arthritis: 9+‐year results from a multicenter, open‐label study

HBHermine I. BrunnerCincinnati Children's Hospital Medical Center GLGrebenkina LaTogliatti State University INIrina NikishinaVA Nasonova Scientific Research Institute of Rheumatology

Key Points

This study evaluates the pharmacokinetics, effectiveness, and safety of certolizumab pegol in children and adolescents with active juvenile idiopathic arthritis.
Multicenter, open-label study with a median follow-up of 3.45 years.
Enrolled patients aged 2-17 with active juvenile idiopathic arthritis and inadequate response to disease-modifying anti-rheumatic drugs.
Primary outcomes included plasma certolizumab concentrations and treatment-emergent adverse events at Weeks 16 and 48.
At Week 16, 78.2% of patients achieved ACR50 criteria with any certolizumab dosage.
JADAS-71 median score decreased from 23.5 at baseline to 4.0 at Week 16.
Serious treatment-emergent adverse events occurred in 23.8% of patients, with chronic anti-certolizumab antibodies common but not affecting treatment response.

Abstract

OBJECTIVE: To assess the pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (CZP) in polyarticular-course juvenile idiopathic arthritis (pcJIA). METHODS: Pediatric Arthritis Study of Certolizumab Pegol (NCT01550003), a multicenter, open-label study, enrolled patients 2-17 years with active pcJIA and inadequate response/intolerance to ≥1 disease-modifying anti-rheumatic drug. Original CZP doses, based on pharmacokinetic model simulations, included loading, then 50/100/200 mg once every two weeks maintenance doses for patients 10-79.0% by Wk12) and associated with lower CZP concentrations, but maintained response to CZP. CONCLUSION: Open-label CZP treatment demonstrated rapid, long-term clinical improvements, an acceptable safety profile, and tolerability in patients with pcJIA; no new safety signals were identified.

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