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Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic
Nicolino Ruperto1, Daniel J Lovell2, Alberto Berman3
1IRCCS Istituto G. Gaslini Clinica Pediatrica e Reumatologia, UOSID Centro Trial, PRINTO, Genova, Italy.
Insights
Subcutaneous abatacept improved patient-reported outcomes (PROs) in children with polyarticular-course juvenile idiopathic arthritis (pJIA). These improvements in pain and function were sustained over 24 months.
Area of Science:
- Pediatric Rheumatology
- Immunology
- Clinical Trials
Background:
- Polyarticular-course juvenile idiopathic arthritis (pJIA) significantly impacts children's quality of life.
- Patient-reported outcomes (PROs) are crucial for assessing treatment effectiveness in pediatric rheumatic diseases.
- Subcutaneous abatacept is an established therapy for various autoimmune conditions.
Purpose of the Study:
- To evaluate longitudinal changes in PROs in children with pJIA treated with subcutaneous abatacept.
- To assess the efficacy of abatacept in improving disability, pain, and overall well-being.
- To analyze clinical outcomes alongside PROs in a pediatric pJIA cohort.
Main Methods:
- Secondary analysis of a 24-month, open-label, single-arm study.
- Inclusion of pediatric patients aged 2-17 years with pJIA.
- Assessment of PROs including CHAQ-DI, PaGA, pain, and ALQ, alongside JIA ACR criteria, inactive disease, and JADAS.
Main Results:
- Significant improvements in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) observed in both age cohorts (6-17 and 2-5 years).
- Pain scores decreased below clinically relevant thresholds by month 1 and reached nadir by month 24.
- Parental global assessment (PaGA) and Activity Limitation Questionnaire (ALQ) scores showed marked improvement and sustained benefit.
Conclusions:
- Subcutaneous abatacept demonstrated early and sustained improvements in PROs for children with pJIA.
- The findings support the use of abatacept in managing pediatric patients with pJIA.
- PROs provide valuable insights into the comprehensive benefits of abatacept therapy in this population.
Objective:
To describe longitudinal changes in patient-reported outcomes (PROs) in children with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept.
Methods:
Secondary analysis of a single-arm, open-label 24-month study of patients ages 6-17 years and 2-5 years. PROs included Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), parent global assessment of child well-being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score.
Results:
For the 6- to 17-year-old (n = 173) and 2- to 5-year-old (n = 46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ-DI at months 4 and 24 were -0.3 (-0.8, 0.0) and -0.5 (-1.0, -0.1), and -0.4 (-0.8, 0.0) and -0.5 (-1.0--0.1). Median pain scores were below cutoff threshold for clinically relevant pain (<35 mm) by month 1 (6 to 17 years, 32.3 mm; 2 to 5 years, 25.7 mm), reaching a nadir at month 24 (6 to 17 years, 6.0 mm; 2 to 5 years, 2.0 mm). For the 6- to 17-year-old and 2- to 5-year-old cohorts, respectively, median PaGA scores were 47.8 (n = 172) and 42.1 (n = 46) at baseline and 6.3 (n = 107) and 2.0 (n = 37) at month 24. In both cohorts, ALQ components improved from baseline to month 4 and were largely maintained to month 24. Clinical outcomes improved through to month 24.
Conclusion:
Early and sustained PRO improvements were reported in this phase III, open-label trial of subcutaneous abatacept in patients with pJIA.
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