Concise ReportPatient global assessment in psoriatic arthritis – what does it mean? An analysis of 223 patients from the Psoriatic arthritis impact of disease (PsAID) study
Introduction
Psoriatic arthritis (PsA) is a heterogeneous disease, which includes varying levels of peripheral joint involvement and skin manifestations. Evaluating its outcomes should reflect all these different aspects [1], [2], [3], [4], [5]. Outcome measures in rheumatology (OMERACT) and the Group of research and assessment of psoriasis and psoriatic arthritis (GRAPPA) have proposed six core domains to be measured in clinical trials and observational studies of PsA: peripheral joint activity, skin activity, pain, patient global assessment (PGA), physical function and health-related quality of life [1]. Furthermore, over the recent years, patient reported outcomes (PROs) have been increasingly recognized as important efficacy endpoints [6], [7]. PGA is one of the most widely used PROs in PsA [8], [9], however, we lack information on the concepts encompassed in PGA, from the patient's perspective. PGA may include physical aspects, e.g. of musculoskeletal disease, or skin or nail disease, or a composite of all these domains; but also psychological or social aspects [10].
Recently, the European league against rheumatism (EULAR) developed the Psoriatic arthritis impact of the disease (PsAID) questionnaire, a score reflecting the impact of PsA based on the patients’ perspective [11]. The PsAID questionnaire assesses 12 domains of health, ranging from pain or physical activity to anxiety or embarrassment. The PsAID composite score was found to correlate strongly with PGA [11]. However, the specific relationships between PsAID questions reflecting different domains of health and PGA were not assessed [11].
GRAPPA has also suggested using other PGA questions, specific to joints and skin: the joint and skin patient assessments [8]. In an initial study, PGA appeared to be related to both of these patient assessments [8]. Variations in wording of patient assessment are relevant, as has been shown in rheumatoid arthritis [12]. Thus, the new wordings proposed by GRAPPA [8] should be further assessed.
The objectives of the present study were to explore the notion of PGA in PsA from the patients’ perspective by describing its construct validity against the PsAID questions and other outcome measures in PsA. Furthermore, we explored the construct validity of the 2 specific (joint, skin) patient assessments proposed by GRAPPA [8].
Section snippets
Study design
This was a post-hoc analysis of the cross-sectional part of the PsAID study performed in 2011–2012 in 13 countries across Europe [11].
Patients
Adult patients with definite PsA according to the rheumatologist opinion were recruited to the cross-sectional part of the PsAID study in the participating secondary or tertiary care centres in 13 countries [11]. In the present study, of the 474 patients included, only patients with PsA fulfilling the Classification criteria for psoriatic arthritis (CASPAR)
Results
In all, 223 patients had analyzable data; 112 (51.1%) were females. Mean (SD) age was 51.0 (±13.3) years, with a mean disease duration of 9.9 (±10.1) years; 140 (66.0%) patients were currently taking a synthetic and 69 (35.2%) patients a biological disease modifying antirheumatic drug (Table 2). There were 186 (84.1%) patients currently presenting with skin psoriasis, most with limited skin involvement, but 62 (28.0%) patients had extensive or very extensive psoriasis on physical examination
Discussion
PGA is the most widely used patient-reported outcome in PsA studies, however we did not, until this study, have a clear idea about what is meant with this concept or what is actually measured by it.
In the present study, patient-perceived global assessment reflected both physical and psychological aspects of PsA, however skin related issues were only weakly associated to PGA. Skin patient assessment had a lower impact on PGA in multivariate analysis than joint patient assessment, potentially
Disclosure of interest
Sandra Tälli, Adrien Etcheto, Bruno Fautrel, Turid Heiberg, Mara Maccarone and Dora Niedermayer declare that they have no competing interest.
Andra Balanescu has received fees for speaking and/or consulting from AbbVie, BMS, Janssen, MSD, Pfizer/Wyeth, Roche and UCB.
Jurgen Braun has received honoraria for talks, advisory boards, paid consultancies and grants from studies from Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough),
Funding
Grants: ST was supported by a Kristjan Jaak Scolarship from the Archimedes Foundation in collaboration with the Ministry of Education and Research of the Republic of Estonia (http://archimedes.ee/stipendiumid/en/kristjan-jaak/).
The PsAID study was supported by the European League Against Rheumatism (EULAR).
References (30)
- et al.
The use of patient-reported outcomes instruments in registered clinical trials: evidence from ClinicalTrials.gov
Contemp Clin Trials
(2009) - et al.
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, 2001
Value Health
(2003) - et al.
Evaluating psoriasis with Psoriasis Area and Severity Index. Psoriasis Global Assessment, and Lattice System Physician's Global Assessment
J Am Acad Dermatol
(2004) - et al.
Impact of coping strategies on mental and physical well-being in patients with rheumatoid arthritis
Semin Arhtritis Rheum
(2012) - et al.
Consensus on a core set of domains for psoriatic arthritis
J Rheumatol
(2007) - et al.
The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project)
Ann Rheum Dis
(2013) - et al.
Comparison of composite measures of disease activity in psoriatic arthritis using data from an interventional study with Golimumab
Arthritis Care Res (Hoboken)
(2014) - et al.
Application of composite disease activity scores in psoriatic arthritis to the PRESTA dataset
Ann Rheum Dis
(2012) - et al.
Development of composite measures for psoriatic arthritis: a report from the GRAPPA 2010 annual meeting
J Rheumatol
(2012) - et al.
Patient global assessment in psoriatic arthritis: a multicenter GRAPPA and OMERACT study
J Rheumatol
(2011)