Measuring Psoriatic Arthritis Symptoms, A Core Domain in Psoriasis Clinical Trials.

The International Dermatology Outcome Measures (IDEOM) established a set of core domains to be measured in all psoriasis trials. This set indicates that symptoms of psoriatic arthritis (PsA) should be measured in all psoriasis studies. To identify the approach to PsA screening, and the most appropriate outcome measure for capturing PsA symptoms. Following the COSMIN-COMET and OMERACT guidelines, we conducted a consensus-building study including patients, physicians, industry partners and patient association representatives. The process consisted of: (1) literature review and quality appraisal of measures for PsA symptoms, (2) pre-Delphi exercise, (3) Delphi survey, and (4) consensus meeting. Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative. Only IDEOM members participated in the consensus meeting. The overwhelming majority of expert stakeholders agreed that all psoriasis trial subjects should be screened for PsA with subsequent measurement of PsA symptoms with use of the PsAID9 (with the RAPID3 as an acceptable alternative measure)