Abstract
INTRODUCTION: Post-inflammatory pigment alteration (PIPA) in skin previously affected by psoriasis is an important, often neglected problem. PIPA has a disproportionate negative impact in people with skin of color. The phase 3b VISIBLE study evaluated guselkumab efficacy and safety in participants with skin of color and moderate-to-severe plaque psoriasis (cohort A) or moderate-to-severe scalp psoriasis (cohort B). Here we report results from exploratory assessments of the quality-of-life impact of pigmentation changes as psoriasis lesions resolve and long-term skin clearance is achieved and of correlations between dyspigmentation and clinical and patient-reported outcomes. METHODS: Randomized (3:1) participants received guselkumab 100 mg or placebo with crossover to guselkumab at week 16. Patient-reported impact of dyspigmentation on quality of life was assessed via Skin Discoloration Impact Evaluation Questionnaire (SDIEQ). Correlations between SDIEQ, Psoriasis Area and Severity Index (PASI), and Dermatology Life Quality Index (DLQI) were assessed. Pigmentation journeys were tracked using standard and cross-polarized photographs evaluated for erythema, pigmentation, and skin tone evenness. RESULTS: Across treatment and Fitzpatrick skin type groups (N = 205), mean SDIEQ scores decreased from 8.4-9.5 (moderate impact) at baseline to 1.3-1.9 (mild impact) at week 48. Photographic improvements in pigmentation were also observed. The majority of guselkumab-treated participants achieved clear or almost clear skin at week 48. In cohort A, mean percent PASI improvement from baseline was 94.9%; in cohort B mean percent Psoriasis Scalp Severity Index improvement was 94.6%. At week 48, correlation between SDIEQ and DLQI (r = 0.7456; p < 0.001) was stronger than between PASI and DLQI (r = 0.3345; p < 0.001). CONCLUSION: Following treatment with guselkumab, most participants achieved clear or almost clear skin and substantial improvements in skin discoloration. Exploratory analyses showed SDIEQ improvements impacted quality of life more than PASI improvements, suggesting greater attention to PIPA is warranted in comprehensive psoriasis management, especially for patients with skin of color. GOV IDENTIFIER: NCT05272150.