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Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without
Daniel J Lovell1, Hermine I Brunner2, Andreas O Reiff3,4
1Department of Pediatrics, Division of Rheumatology, University of Cincinnati, Cincinnati Children's Hospital Medical Center, PRCSG Coordinating Center, Cincinnati, Ohio, USA Daniel.lovell@cchmc.org.
Insights
Adalimumab treatment for juvenile idiopathic arthritis (JIA) over six years demonstrated good tolerability and significant clinical improvements, including remission, though long-term retention was low.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Clinical Pharmacology
Background:
- Juvenile idiopathic arthritis (JIA) is a chronic autoimmune disease affecting children.
- Long-term treatment options for JIA are crucial for managing disease activity and preventing long-term complications.
- Adalimumab is a biologic therapy used in JIA management.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of adalimumab in pediatric patients with JIA over a 6-year treatment period.
- To assess clinical response rates, including remission, and identify predictors of treatment success.
- To monitor adverse events associated with prolonged adalimumab therapy.
Main Methods:
- A phase III, randomized-withdrawal, double-blind, placebo-controlled trial was conducted.
- Patients aged 4-17 years with polyarticular JIA received adalimumab during an open-label lead-in, followed by a randomized withdrawal and a long-term extension phase.
- Efficacy was measured by JIA American College of Rheumatology (JIA ACR) responses and Juvenile Arthritis Disease Activity Score (JADAS27) for low disease activity (LDA) and inactive disease (ID).
Main Results:
- 62% of patients completed the 6-year study.
- Serious infections were reported in 11 patients.
- High rates of JIA ACR responses (66%-96%) and JADAS27 LDA were observed.
- 37% of patients achieved clinical remission (sustained JADAS27 ID).
- Early achievement of JIA ACR 50 or higher and JADAS27 LDA/ID predicted remission.
Conclusions:
- Adalimumab demonstrated good tolerability over 6 years in JIA patients.
- Significant clinical efficacy, including achievement of clinical remission, was observed.
- While effective, the long-term retention rate was relatively low, suggesting potential challenges in sustained treatment adherence or tolerability for some patients.
Objectives:
Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment.
Methods:
Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1).
Results:
Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis).
Conclusions:
Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.
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