Performance of response criteria for assessing peripheral arthritis in patients with psoriatic arthritis: analysis of data from randomised controlled trials of two tumour necrosis factor inhibitors
- 1Department of Rheumatology, University Medical Centre St Radboud, Nijmegen, The Netherlands
- 2Department of Medicine III, Friedrich-Alexander University, Erlangen, Germany
- 3Seattle Rheumatology Associates, Swedish Medical Center, Seattle, Washington, USA
- 4Department of Medical Informatics, Friedrich-Alexander University, Erlanger, Germany
- 5Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, California, USA
- Correspondence to:
Department of Rheumatology, Radboud University Nijmegen Medical Centre, PO Box 9101, NL-6500HB Nijmegen, The Netherlands;
- Accepted 4 March 2006
- Published Online First 27 April 2006
Background: In recent clinical trials in patients with psoriatic arthritis (PsA), the response criteria and disease activity measures that have been used were those developed for rheumatoid arthritis. However, these have not yet been validated in PsA.
Objective: To compare the responsiveness and discriminative capacity of the psoriatic arthritis response criteria (PsARC), American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria and the Disease Activity Score (DAS) and core-set measures in patients with PsA and peripheral arthritis, using the data from two randomised placebo-controlled trials of tumour necrosis factor inhibitors.
Methods: In an infliximab trial, 104 patients with active PsA were randomised to receive placebo or infliximab for 16 weeks. In an etanercept trial, 60 patients with active PsA were randomised to receive placebo or etanercept for 12 weeks. Data from baseline and the end of the intervention phase were used from each study. Responsiveness was assessed using the standardised response mean and effect size. Capacity to discriminate between the active drug and placebo was assessed using t values or a χ2 test. Measures were ranked in order of their t value or χ2 value.
Results: The EULAR criteria performed better in discriminating the active drug from placebo than the ACR20 improvement criteria, which in turn performed better than the PsARC. It was also found that the pooled indices (DAS and DAS28) were generally more responsive, and performed better in discriminating active drug from placebo, than the single core-set measures.
Conclusion: Response criteria and pooled indices developed for rheumatoid arthritis are useful for the assessment of arthritis in PsA clinical trials.
- ACR, American College of Rheumatology
- DAS, Disease Activity Score
- DIP, distal interphalangeal
- EULAR, European League Against Rheumatism
- GST, global statistical test
- HAQ, Health Assessment Questionnaire
- IMPACT, Infliximab Multinational Psoriatic Arthritis Controlled Trial
- OMERACT, Outcome Measures in Rheumatoid Arthritis Clinical Trials
- PASI, Psoriasis Area and Severity Index
- PhGA, physician global assessment
- PsA, psoriatic arthritis
- PsARC, psoriatic arthritis response criteria
- PtGA, patient global assessment
- RAI, Ritchie Articular Index
- SJC, swollen joint count
- SRM, standardised response mean
- TJC, tender joint count
- TNF, tumour necrosis factor
- VAS, Visual Analogue Scale
Published Online First 27 April 2006
Competing interests: None declared.
CA is currently working at the Schering-Plough Research Institute, Kenilworth, New Jersey, USA.