54203 VISIBLE: Clearance and Symptom Improvement With Guselkumab at Week 16 in Skin of Color Participants With Moderate-to-Severe Plaque Psoriasis
Recommended Citation
Stein-Gold L, Yeung J, Rodriguez AO, Vasquez J, Choi O, Rowland K, Alkousakis T, Jeyarajah J, Alonso-Llamazares J, Tyring S, Armstrong AW. 54203 VISIBLE: Clearance and Symptom Improvement With Guselkumab at Week 16 in Skin of Color Participants With Moderate-to-Severe Plaque Psoriasis. J Am Acad Dermatol 2024; 91(3):AB97.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Abstract
Objective: VISIBLE examines efficacy and safety of guselkumab in skin of color (SoC) participants with moderate-to-severe plaque psoriasis. Methods: Participants were randomized (3:1) to receive guselkumab 100mg or placebo. Week(W)16 Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA), and body surface area (BSA) results, along with participant health-related quality of life improvements as assessed by the Psoriasis Symptoms and Signs Diary (PSSD), are presented. Results: Co-primary endpoints of IGA 0/1 and PASI90 were achieved by significantly higher proportions of participants treated with guselkumab vs placebo (IGA0/1, 74.0% vs 0%; PASI90, 57.1% vs 3.8%; both p<0.001), as were IGA0 (32.5% vs 0%; p<0.001) and PASI100 (29.9% vs 0%; p<0.01). Proportions of guselkumab-treated participants achieving improvements in each PASI component (erythema, induration, scaling) were similar over time. In guselkumab and placebo groups, respectively, mean percent improvements from baseline were: BSA, 77.9% vs 0.9%; PASI, 84.5% vs 8.3% (both p<0.001). Mean changes from baseline in PSSD symptom score were: guselkumab -49.4 vs placebo -8.2 (p<0.001), with a change of ≥40 considered clinically meaningful. Mean changes from baseline in individual PSSD symptom scores for guselkumab vs placebo were: redness, -6.2 vs -1.4; dryness, -4.9 vs -0.9; scaling, -6.2 vs -1.2 (all p<0.001). Overall safety was consistent with the established guselkumab safety profile, no new safety signals were identified. Conclusions: After 3 doses of guselkumab, the majority of participants with moderate-to-severe plaque psoriasis achieved significantly clearer skin and reported clinically meaningful improvement in psoriasis symptoms.
Volume
91
Issue
3
First Page
AB97
