Pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (CZP) in 193 children and adolescents (ages 2–17) with polyarticular-course juvenile idiopathic arthritis (pcJIA) who had inadequate response or intolerance to ≥1 DMARD; followed for a median of 3.45 years (up to ~11.4 years) in a multicenter, open-label trial.
At Week 16, 78.2% (151/193) achieved JIA ACR50; median JADAS-71 dropped from 23.5 at baseline to 4.0. Serious treatment-emergent adverse events occurred in 23.8% (46/193). Chronic anti-drug antibody positivity exceeded 79% by Week 12 and was linked to lower CZP levels but did not block clinical response.
Open-label, single-arm design with no placebo or active comparator, limiting causal inference. Dose was adjusted mid-study after interim analyses, creating heterogeneous exposure groups. High immunogenicity rates (>79%) raise questions about long-term drug-level adequacy that cannot be fully answered without a controlled arm.
CZP produced rapid and durable disease control in pediatric pcJIA across weight-based dosing tiers, with no new safety signals over 9+ years — a reassuring long-term profile for clinicians considering this agent in children who have failed DMARDs. Monitor for high rates of anti-drug antibody formation, though clinical response appears preserved despite lower drug levels.
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