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Juvenile Spondyloarthritis Disease Activity Index Validation in Enthesitis-Related Arthritis and Juvenile Psoriatic
Pamela F Weiss1, Nicolino Ruperto2, Erhard Quebe-Fehling3
1P.F. Weiss, MD, MSCE, Division of Rheumatology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; WEISSPA@chop.edu.
Insights
The Juvenile Spondyloarthritis Disease Activity Index (JSpADA) is a valid tool for measuring disease activity in children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (jPsA). This study confirms its utility in clinical trials.
Area of Science:
- Pediatric Rheumatology
- Clinical Trial Methodology
- Disease Activity Measurement
Background:
- Assessing disease activity in pediatric rheumatic conditions like enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (jPsA) is crucial for effective treatment.
- The Juvenile Spondyloarthritis Disease Activity Index (JSpADA) is a potential tool for this purpose.
Purpose of the Study:
- To validate the Juvenile Spondyloarthritis Disease Activity Index (JSpADA) in children diagnosed with ERA or jPsA.
- To assess JSpADA's convergent validity, discriminant validity, and responsiveness within a prospective clinical trial setting.
Main Methods:
- The JUNIPERA study (NCT03031782), a phase III trial, evaluated secukinumab in children with ERA and jPsA.
- JSpADA validity was assessed by correlating it with established measures (JADAS10, cJADAS10, PGA) and analyzing its performance in distinguishing active vs. inactive disease and its responsiveness to treatment changes.
Main Results:
- JSpADA demonstrated moderate to good convergent validity with JADAS10, cJADAS10, and PGA at week 12 (Spearman ρ > 0.4).
- JSpADA scores were significantly higher in patients with active disease compared to inactive disease (P < 0.001).
- JSpADA showed responsiveness to clinical disease activity changes from week 12 to week 52, with significant differences observed between improving, worsening, and stable disease groups (P < 0.001).
Conclusions:
- The Juvenile Spondyloarthritis Disease Activity Index (JSpADA) is validated as a reliable measure of disease activity for pediatric patients with ERA and jPsA.
- JSpADA's performance was consistent across both ERA and jPsA patient subgroups within the prospective clinical trial setting.
Objective:
To investigate the validity of the Juvenile Spondyloarthritis Disease Activity Index (JSpADA) in children with enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (jPsA) in a prospective clinical trial setting.
Methods:
JUNIPERA (ClinicalTrials.gov: NCT03031782) is a phase III, placebo-controlled withdrawal study investigating the safety and efficacy of secukinumab in children with ERA and jPsA. After 12 weeks of open-label treatment with secukinumab, patients were randomized 1:1 to secukinumab or placebo until disease flare or week 52. JSpADA validity was assessed using 3 criteria: convergent validity (Spearman correlation) at week 12 with the Juvenile Arthritis Disease Activity Score in 10 joints (JADAS10), clinical JADAS10 (cJADAS10), and physician global assessment of disease activity (PGA); discriminatory validity at week 12 among patients with active or inactive disease and juvenile idiopathic arthritis American College of Rheumatology response criteria; and responsiveness to change in clinical disease activity from weeks 12 to 52.
Results:
At week 12, mean (SD) JSpADA scores showed moderate to good correlation with JADAS10, cJADAS10, and PGA scores (all Spearman ρ > 0.4) and were higher among patients with active vs inactive disease (1.8 [1.3] vs 0.5 [0.8], P < 0.001). Patients with improved disease activity from weeks 12 to 52 had greater improvements in JSpADA than patients with worsening disease (-0.8 [1.1] vs 0.4 [1.0], P < 0.001); patients with stable disease had minimal change in JSpADA (-0.1 [0.5]). Validity results were similar for ERA and jPsA.
Conclusion:
These results validate JSpADA as a disease activity measure for children with ERA and jPsA in a prospective clinical trial setting.
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