A new consensus statement by members of the International Dermatology Outcome Measures (IDOM) suggests that clinical trials for psoriasis should consistently use validated screening tools for psoriatic arthritis (PsA). Members of the IDOM agreed that the Psoriatic Arthritis Impact of Disease-9 (PsAID9) and Routine Assessment Patient Index Data-3 (RAPID3) should be considered for measuring PsA symptoms in these trials. The findings from the consensus were published in the Journal of the American Academy of Dermatology.
Guidelines from the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and Core Outcome Measures in Effectiveness Trials (COMET) initiative were used to form a consensus-building study comprising patients, physicians, representatives from patient associations, and industry partners. A literature review and quality appraisal of PsA symptom measures were performed. A pre-Delphi exercise, which consisted of an online survey and consensus meeting, was also conducted. A Delphi survey was then conducted, which involved voting on the role of PsA screening of patients with psoriasis in clinical trials and on measurement properties of instruments that assess PsA symptoms, and ranking candidate ‘PsA Symptoms’ instruments. Following the survey, a consensus meeting was held, consisting of a pre-meeting patient session, breakout group discussions, and plenary voting.
The majority of participants who completed the first phase agreed that patients in psoriasis trials should be asked about a PsA diagnosis made by a rheumatologist (91.2%). In addition, most participants (87.5%) agreed that all patients who enter a psoriasis trial should be screened for PsA. The PsAID9 was voted as the instrument possessing the highest quality for measuring PsA symptoms. The first and second choices for measuring PsA symptoms were the PSAID9 and RAPID3, respectively. In the consensus meeting following the Delphi survey, approximately 77% of participants agreed that PsA screening should be incorporated into psoriasis trials. Approximately 76% of consensus attendees voted PsAID9 as the best measure for assessing PsA symptoms in clinical trials.
A limitation of the study was the inclusion of only members of the IDOM, limiting the representation of clinicians outside of the organization.
Based on their consensus, members of the IDOM “call for researchers, industry and other relevant stakeholders to implement and disseminate these recommendations.”
The authors report conflicts of interest with Abbvie; Allergan; Beiersdorf; BM;, Celgene; Dermira, Dr. Reddy, Incyte Corporation, Janssen Ortho Inc., Lilly ICOS LLC, Novartis, Sun Pharmaceutical Industries, UCB, Valeant Pharmaceutical International, Valeant Pharmaceutical North America LLC, and XBiotech.
Perez-Chada LM, Gottlieb AB, Cohen J, et al. Measuring Psoriatic Arthritis Symptoms, A Core Domain in Psoriasis Clinical Trials [published online June 1, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.05.075