Clinical outcomes in psoriatic arthritis: A systematic literature review
Open Access
- 6 December 2011
- journal article
- review article
- Published by Wiley in Arthritis Care & Research
- Vol. 64 (3), 397-406
- https://doi.org/10.1002/acr.21552
Abstract
Objective Many outcomes have been proposed in the assessment of psoriatic arthritis (PsA). The Outcome Measures in Rheumatology (OMERACT) core set for PsA evaluation comprises 6 domains: joints, skin, function, pain, patient's global assessment, and quality of life. The objective of this work was to assess reporting of outcomes in PsA, including patient‐reported outcomes (PROs) in recent publications. Methods A systematic literature search of clinical trials related to PsA and reporting at least 1 clinical outcome between 2006 and 2010 was performed in PubMed, i.e., just before to just after publication of the OMERACT core set. All clinical outcomes were noted and subdivided into domains of health. Data analysis was descriptive. Results Fifty‐eight articles (12,405 patients) were included in the analysis: 17 (29%) were randomized clinical trials; the patients' mean ± SD age was 48.2 ± 5.4 years and the mean ± SD disease duration was 9.0 ± 3.1 years. Eighty‐four different outcomes were reported, with a mean ± SD of 6.9 ± 4.3 per study. Patients were mainly assessed using the 6 core set domains, reported in 37.9% (quality of life) to 55.2% (skin) of articles; however, the core set was rarely completely reported since only 10.3% of the studies reported all 6 core domains. PROs were heterogeneous and in particular there was no consensus regarding the number of joints to assess and instruments for dactylitis and enthesitis. PROs were assessed in more than 75% of publications using 28 different instruments. Conclusion There is great heterogeneity in PsA assessment, even since publication of the OMERACT core set. Better consensus on instruments to assess each domain of health and better insight into which outcomes are important for patients is needed.Keywords
This publication has 79 references indexed in Scilit:
- Improvements in quality of life and functional status in patients with psoriatic arthritis receiving anti-tumor necrosis factor therapiesArthritis Care & Research, 2010
- The use of patient-reported outcomes instruments in registered clinical trials: Evidence from ClinicalTrials.govContemporary Clinical Trials, 2009
- Health care utilization in patients with spondyloarthropathiesRheumatology, 2008
- The psoriatic arthritis cost evaluation study: a cost-of-illness study on tumour necrosis factor inhibitors in psoriatic arthritis patients with inadequate response to conventional therapyRheumatology, 2008
- Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)Annals Of The Rheumatic Diseases, 2008
- A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissueAnnals Of The Rheumatic Diseases, 2008
- Incorporating the Patient's Perspective into Drug Development and Communication: An Ad Hoc Task Force Report of the Patient-Reported Outcomes (PRO) Harmonization Group Meeting at the Food and Drug Administration, February 16, 2001Value in Health, 2003
- Development and validation of the european league against rheumatism response criteria for rheumatoid arthritis: Comparison with the preliminary american college of rheumatology and the world health organization/international league against rheumatism criteriaArthritis & Rheumatism, 1996
- Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritisArthritis & Rheumatism, 1995
- Development and evaluation of a scale to measure perceived self‐efficacy in people with arthritisArthritis & Rheumatism, 1989