Correlation of Physician-Assessed Psoriasis Area and Severity Index Scores With Patient-Reported Psoriasis Symptoms and Signs Diary Scores Among Patients With Moderate-to-Severe Psoriasis: Results From VOYAGE 1 and VOYAGE 2 Studies

Abstract

Background: Patient-reported and clinician-determined outcomes do not always correlate in clinical trials for psoriasis, even among those with clear skin. Objective: To compare clinical responses with patient-reported outcomes among patients with psoriasis enrolled in 2 phase 3, double-blind, controlled trials of guselkumab (VOYAGE 1 and VOYAGE 2). Methods: Overall, 1432 patients randomized to guselkumab, placebo, or adalimumab at baseline were included in the pooled patient population; measures were assessed at baseline and week 16. End points included proportions of patients achieving 100% improvement in their Psoriasis Area and Severity Index (PASI 100) score and summary scores = 0 on the Psoriasis Symptoms and Signs Diary (PSSD). Proportions of patients with PSSD symptom/sign summary scores = 0 and mean PSSD summary scores were summarized by PASI 100 status. Association between PASI and PSSD scores were evaluated using Pearson correlation coefficients. Results: Among week-16 PASI 100 responders, 46.8% and 34.1% reported PSSD symptom and sign summary scores = 0, respectively, and 30.9% and 49.0% reported minimal symptoms/signs (scores = 1 to <10), respectively; mean scores (scale 0-100) were 6.4 for symptoms and 5.8 for signs. Among PASI 100 nonresponders, only 11.1% (symptoms) and 7.5% (signs) reported PSSD summary scores = 0; mean scores were 25.7 and 26.7, respectively. Correlation coefficients between overall PASI response and PSSD scores were 0.63 (symptoms) and 0.68 (signs; both P < .0001). Conclusion: While PASI and PSSD scores were highly correlated and most PASI 100 responders reported no/minimal symptoms or signs at week 16, substantial discrepancies were found between complete clearance from the clinician’s view versus symptom/sign-free status from patients’ perspectives.

Association of Patient Mental Health Status With the Level of Agreement Between Patient and Physician Ratings of Psoriasis Severity

“…Two studies in trial settings similarly highlighted discordance between patient and physician assessments of psoriasis, but again did not explore the factors contributing to the discrepancy. 10,11 There are also reports of discordance between physicians and patients regarding their satisfaction with the level of psoriasis control achieved. Two surveys in the US showed patient-physician discordance in satisfaction with psoriasis control among 18% of patients, and this discordance was associated with higher disease severity and reduced quality of life.…”

“…Their retrospective study found that 45% of physician-patient pairs were in disagreement about psoriasis severity (assessed using a 5-point scale: clear, almost clear, mild, moderate, and severe) but did not examine reasons for the discordance. Two studies in trial settings similarly highlighted discordance between patient and physician assessments of psoriasis, but again did not explore the factors contributing to the discrepancy . There are also reports of discordance between physicians and patients regarding their satisfaction with the level of psoriasis control achieved.…”

“…Physician Global Assessment (GA) and Psoriasis Area Severity Index (PASI) are physician-rated disease activity measures commonly used in real-world practice and clinical trials and recommended in treatment guidelines . Although data are limited in psoriasis, studies have identified discordance between physician and patient measures of disease severity in chronic inflammatory diseases, for example, among one-third of patients with rheumatoid arthritis . Because this discordance is associated with patient dissatisfaction, lower treatment adherence, and poorer disease outcomes, an improved understanding of the underlying factors is important.…”