P54 VISIBLE cohort B: guselkumab demonstrates significant scalp clearance at Week 16 in participants with moderate-to-severe scalp psoriasis across all skin tones

Abstract The ongoing first-of-its-kind, large-scale, prospective, Phase 3b, randomized, double-blind, placebo-controlled VISIBLE study is evaluating the efficacy and safety of guselkumab in participants with moderate-to-severe body or scalp psoriasis across all skin tones. Scalp psoriasis causes physical and social distress (daily life interference) and is often associated with intense pruritus and scaling, and sometimes alopecia. This analysis presents the efficacy and safety of guselkumab vs. placebo from the VISIBLE moderate-to-severe scalp psoriasis cohort at Week (W)16. VISIBLE Cohort B participants (N = 108) received (3:1) guselkumab 100 mg or placebo at W0, W4, then every 8W. Co-primary endpoints: proportions of participants achieving scalp-specific Investigator Global Assessment (ss-IGA) response of absence of disease (0)/very mild disease (1) and Psoriasis Scalp Severity Index (PSSI) 90 response at W16. Major secondary endpoints: proportions of participants achieving complete scalp clearance (ss-IGA 0 and PSSI 100), median time to PSSI 90 response, and mean per cent improvements in PSSI and scalp surface area (SSA). Efficacy analysis included participants correctly randomized to Cohort B (n = 102); safety analysis included all randomized participants (n = 108). Participants were largely male (56.9%) with a median age of 43.5 years and mean baseline weight of 88.1 kg. Despite participants having extensive moderate-to-severe scalp disease (mean SSA: 59.8%, mean PSSI: 34.3; ss-IGA 3: 82.4%; ss-IGA 4: 17.6%), <20% of participants had received prior systemic therapies (11.8%, phototherapy; 17.6%, non-biologic systemics; and 12.7%, biologics). Significantly greater proportions of guselkumab-treated participants achieved the co-primary endpoints vs. placebo: ss-IGA 0/1 (68.4 vs. 11.5%) and PSSI 90 (65.8 vs. 3.8%; both P < 0.001). Median time to PSSI 90 response was 11.6W for the guselkumab group (vs. not achieved by placebo). Significantly greater proportions of guselkumab-treated participants achieved complete scalp clearance vs. placebo (ss-IGA 0: 57.9 vs. 3.8%; PSSI 100: 59.2 vs. 3.8%; both P < 0.001). Significantly greater mean per cent improvements in PSSI (87.6 vs. 37.8%) and SSA (86.6 vs. 33.4%) from baseline were reported with guselkumab vs. placebo groups (both P < 0.001). There were no new safety signals, and safety findings were consistent with the established guselkumab safety profile. After just 3 doses of guselkumab, the majority of participants achieved rapid and significant scalp clearance across all measures evaluated, with nearly 6 of 10 achieving complete scalp clearance at W16. These results highlight that guselkumab is a highly effective treatment for extensive moderate-to-severe scalp psoriasis and will enable evidence-based shared decision-making for people with scalp psoriasis across diverse populations and the full range of skin tones.