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Background: People of color may face additional challenges to the physical and psychological effects imposed by psoriasis, such as misdiagnoses and barriers to optimal care, often due to underrepresentation in clinical studies and lack of data. To help address these health inequities, a phase 3b, first-of-its-kind, large-scale, randomized, double-blind, placebo-controlled clinical trial (VISIBLE) has been initiated in people of color with moderate-to-severe plaque psoriasis. Objectives: VISIBLE (NCT05272150) examines the efficacy and safety of guselkumab in skin of color participants with moderate-to-severe plaque psoriasis. Methods: Participants were randomized (3:1) to receive guselkumab 100 mg or placebo. Week 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 (IGA 0/1, 74.0% vs 0%; PASI90, 57.1% vs 3.8%; both pConclusion: 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. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: Olivia Choi Employee of Janssen Scientific Affairs, LLC, and may own stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary, Linda Stein Gold Investigator/advisor and/or speaker for Abbvie, Amgen, Arctis, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Jensen Yeung Served as a speaker, consultant and/or investigator for Abbvie, Amgen, Arcutis, BMS, Coval Biopharma, Eli Lilly, Dermavant, Janssen, KoBio Labs, Leo Pharma, National Psoriasis Foundation, Novartis, Pfizer, Regeneron, Sanofi, and UCB, Adrian O. Rodriguez Served as an advisor and/or speaker for Arcutis, Dermavant, Eli Lilly, EPI Health, Janssen, Leo Pharma, Novartis, Sciton, Sun, and UCB, owns stock in Strathspey Crown, Jessica Vasquez Employee of Janssen Scientific Affairs, LLC, and may own stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary, Saakshi Khattri Received grant/research support from and is an investigator for Eli Lilly and Company, Katelyn Rowland Employee of Janssen Scientific Affairs, LLC, and may own stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary, Theodore Alkousakis Employee of Janssen Scientific Affairs, LLC, and may own stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary, Jenny Jeyarajah Employee of Janssen Research & Development, LLC, and may own stock/stock options in Johnson & Johnson, of which Janssen is a subsidiary, Javier Alonso-Llamazares Speaker for Arcutis, Eli Lilly, Incyte, UCB, advisor for Arcutis, Leo, investigator for Amgen, Eli Lilly, Janssen, and Takeda, Stephen Tyring Served as an investigator and/or speaker for Abbott, AiCuris, Epiphany, Galderma, GSK, Inhibitex, Leo Pharma, Merck, Novartis, and Pfizer, received a research grant and honoraria from Amgen, for whom he has served as a consultant, investigator, and speaker, April W. Armstrong Served as a research investigator and/or consultant to AbbVie, Bristol Myers, Squibb Dermavant, Dermira, Eli Lilly, Janssen, KHK, Leo, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma, and UCB.
Choi et al. (Sat,) studied this question.