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

Brunner, HI; Grebenkina, L; Nikishina, I; Alexeeva, E; Chasnyk, V; Abud-Mendoza, C; Rubio-Pérez, N; Schmeling, H; Del Rocio Maldonado-Velázquez, M; Brown, D; Zeft, A; Morgan, E; Rabinovich, CE; Kingsbury, D; Bukulmez, H; Gottlieb, B; Griffin, T; Imundo, L; Tarvin, S; Silverman, E; Shaughnessy, L; Shimizu, S; Williams, P; Lledó-García, R; Utturkar, G; Ufuktepe, B; Martini, A; Lovell, DJ; Ruperto, N; Paediatric Rheumatology International Trials Organisation (PRINTO); the Pediatric Rheumatology Collaborative Study Group (PRCSG)

doi:10.1002/art.70274

Pediatric rheumatology

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

Arthritis RheumatolPublished 13 Jul 2026Open-label study

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Authors' 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.

Study context

Population: Patients aged 2 to 17 years with active polyarticular-course juvenile idiopathic arthritis (pcJIA) and inadequate response or intolerance to at least one DMARDmedian follow-up 3.45 years
Participants: 193 patients

Comparison: Certolizumab pegol at original vs reduced doses
Outcome: Plasma CZP concentrations, TEAEs and anti-CZP antibodies (ADAb)
Follow-up: Wk16 and Wk48

Methodological detailsmulticenter, prespecified interim analyses

Multicenter
Prespecified interim analyses

Main finding

As reported in the abstract

Mean plasma CZP concentration (steady state at Wk12)

Reduced dose8.4mean · 95% CI 6.2–11.4 · μg/mL

Original dose33.4mean · 95% CI 27.4–40.7 · μg/mL

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

Further findings

Outcome	Values
JIA ACR Pediatric 50 response at any CZP dosage · Wk16	CZP 78.2%

JIA ACR Pediatric 50 response at any CZP dosage: 151 of 193 patients

Median 71-joint Juvenile Arthritis Disease Activity Score · Wk16

Median score decreased from baseline to Wk16: 23.5 to 4.0

Safety

Serious treatment-emergent adverse events (TEAEs)

Serious TEAEs occurred in 46 of 193 patients: 23.8%

Chronic anti-CZP antibody positivity · by Wk12

Chronic ADAb positivity common, associated with lower CZP concentrations but maintained response: >79.0%

Reference

Authors: Brunner HI, Grebenkina L, Nikishina I, Alexeeva E, Chasnyk V, Abud-Mendoza C, et al.
All 30 authors
Brunner HI, Grebenkina L, Nikishina I, Alexeeva E, Chasnyk V, Abud-Mendoza C, Rubio-Pérez N, Schmeling H, Del Rocio Maldonado-Velázquez M, Brown D, Zeft A, Morgan E, Rabinovich CE, Kingsbury D, Bukulmez H, Gottlieb B, Griffin T, Imundo L, Tarvin S, Silverman E, Shaughnessy L, Shimizu S, Williams P, Lledó-García R, Utturkar G, Ufuktepe B, Martini A, Lovell DJ, Ruperto N, Paediatric Rheumatology International Trials Organisation (PRINTO); the Pediatric Rheumatology Collaborative Study Group (PRCSG)
Journal: Arthritis & Rheumatology
Published: 13 Jul 2026
DOI: 10.1002/art.70274
PubMed: 42439289
Registration: NCT01550003

Topic: Pediatric rheumatology

Group definitions

Original dose: loading then 50, 100 or 200 mg maintenance every two weeks for 10 to <20, 20 to <40 or ≥40 kg
Reduced dose: loading or maintenance doses reduced by 50% after interim analyses

Original publication

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. Arthritis Rheumatol. Published 13 July 2026. doi:10.1002/art.70274

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