1176: VISIBLE Post-Inflammatory Pigmentation Journeys: Exploring the Impact of Pigmentation

Background/Purpose: Post-inflammatory pigment alteration (PIPA) following resolution of psoriasis plaques is an important, neglected problem that disproportionately impacts people of color.^1-3 VISIBLE, an ongoing Phase 3b study evaluating guselkumab for moderate-to-severe psoriasis across all skin tones, is designed to collect PIPA data.

Methods: Total 211 participants were randomized (3:1) to receive guselkumab or placebo with placebo crossover to guselkumab at Weeks 16, 20, and every 8 weeks (q8w) thereafter. Through Week 48, clinician-reported Psoriasis Area Severity Index (PASI) responses and patient-reported outcomes (Skin Discoloration Impact Evaluation Questionnaire [SDIEQ], Dermatology Life Quality Index [DLQI], and Patient-Reported Outcomes Measurement Information System-29 [PROMIS-29]) were collected. Standard and cross-polarized photographs were obtained and analyzed for skin tone evenness.

Results: Mean PASI improvement was ~95% at Week 48 for the guselkumab randomized groups. Correlation coefficients were higher for SDIEQ and DLQI versus SDIEQ and PASI at Week 48, indicating high impact of skin discoloration on quality of life (QoL). SDIEQ had moderate (r=0.4116) and weak (r=0.3204) correlations with PROMIS-29 anxiety and depression measures, respectively, whereas Week 48 PASI did not correlate with either PROMIS-29 outcome.

Conclusion: Impact of PIPA on QoL is much greater than skin clearance as measured by PASI. Awareness of patient concerns about PIPA will enable clinicians to better counsel patients starting psoriasis treatment. The study is limited by variations in photograph quality. PIPA due to psoriasis highly impacts QoL in people of color. Discussing PIPA before starting treatment is imperative and its effect should be explicitly measured. While there are objective ways to quantify PIPA, further planned analyses of mechanistic changes will help identify factors predictive of PIPA outcomes.

References

1. Amico S, et al. J Am Acad Dermatol. 2020;83:1188-1191.


2. Kauffman BP, et al. Am J Clin Dermatol. 2018;19:405-423.


3. Chiu HY, et al. J Am Acad Dermatol. 2022;86:642-645.