Pharmacokinetics, effectiveness and safety of certolizumab pegol in children and adolescents with active…

StudyArthritis & rheumatology (Hoboken, N.J.)· Jul 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.

Hermine I Brunner, Lyudmila Grebenkina, Irina Nikishina … Nicolino Ruperto

Pediatric RheumatologyStudyTreatmentQ1IF 6.7

78% of children with juvenile idiopathic arthritis achieved major improvement by week 16.

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.

Hermine I Brunner … Nicolino Ruperto

Arthritis & rheumatology (Hoboken, N.J.) · Jul 2026

Purpose

To assess the pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (certolizumab pegol) 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.

n = 193 patients

78.2%

Results

78.2%

most children reached major improvement in disease activity by week 16

n = 193 patients

More results

Mean plasma certolizumab pegol concentrations (95% confidence interval) reached steady state at Wk12 and were lower with reduced dose than original dose (reduced dose: 8.4 [6.2, 11.4] μg/mL; original dose: 33.4 [27.4, 40.7] μg/mL).

Serious treatment-emergent adverse events occurred in 23.8% (46/193) of patients.

More results

Chronic ADAb positivity was common (>79.0% by Wk12) and associated with lower certolizumab pegol concentrations, but maintained response to certolizumab pegol.

“

Conclusion

Open-label certolizumab pegol treatment demonstrated rapid, long-term clinical improvements, an acceptable safety profile, and tolerability in patients with pcJIA; no new safety signals were identified.

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.

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.

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