Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials.

BACKGROUND: The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies. OBJECTIVE: To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms. METHODS: Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting. RESULTS: 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. LIMITATIONS: Only International Dermatology Outcome Measures members participated in the consensus meeting. CONCLUSION: The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).

The impact of comorbidities on interleukin-17 inhibitor therapy in psoriatic arthritis: a Danish population-based cohort study.

Objective: To investigate the influence of comorbidities on treatment response, disease activity and persistence with first-line IL-17 inhibitor (IL-17i) treatment in patients with PsA. Methods: Patients were divided into three groups depending on the presence and/or severity of comorbidities using the Charlson Comorbidity Index (CCI). Groups were CCI 0: no comorbidities, CCI 1: one comorbidity and CCI ≥2: two or more comorbidities or one or more severe comorbidities. Outcomes in the groups were compared for treatment persistence, treatment response and disease activity. Results: A higher CCI score was associated to an elevation in baseline CRP, swollen joint count and frequency of depression and/or anxiety. The median drug persistence in the groups were CCI 0: 1.8 years, CCI 1: 1.9 years and CCI ≥2: 1.5 years, but was not statistically significant to the CCI score. There were no significant differences in clinical response rates between the groups. Conclusion: The presence of comorbidities was associated with increased baseline disease activity and frequency of depression and/or anxiety, but was not associated with shorter treatment persistence or lower clinical response rates in a cohort of 155 Danish patients with PsA treated with first-line IL-17i.

Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative.

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included "PsA Symptoms" as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for "PsA Symptoms" in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for "PsA Symptoms", we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. "PsA Symptoms" measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.