0523: SPECTREM: Guselkumab Significantly Improves Patient Reported Outcomes at Week 16 in Participants with Low Body Surface Area, Moderate Psoriasis with Special Sites Involvement

Background/Purpose: Even low body surface area (BSA) psoriasis can be extremely bothersome to patients and can have a significant impact on their lives just as much as more extensive disease. SPECTREM is an ongoing, Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of guselkumab in participants with low BSA (2%-15%), moderate (Investigator’s Global Assessment [IGA]=3) psoriasis involving ≥1 special site (scalp, face, intertriginous, or genital).

Methods: A total of 338 participants were randomized 2:1 to receive guselkumab 100 mg (n=225) or placebo (n=113) at Week 0 and Week 4, then every 8 weeks. Patient-reported outcomes (PROs) assessed at Week 16 included change from baseline in Psoriasis Symptoms and Signs Diary (PSSD; range, 0-100), and Dermatology Life Quality Index (DLQI; range, 0-30).

Results: At baseline, participants had mean (standard deviation [SD]) BSA of 7.6% (3.7%); mean (SD) PSSD total symptoms score of 53.8 (23.2), mean (SD) PSSD itch score of 6.8 (2.2), and a mean (SD) DLQI of 11.5 (6.7). On average, participants had a disease duration of 17 years, and the majority of participants had never received systemic therapy (86.3%). At Week 16, guselkumab-treated participants achieved significantly greater mean change from baseline in the PSSD total symptoms score (guselkumab –36.08 vs placebo 0.37; p< 0.001). Among participants with PSSD itch score ≥4 at baseline, a significantly greater proportion of guselkumab-treated participants achieved ≥4-point reduction at Week 16 (guselkumab 62.7% vs placebo 12.5%; p< 0.001). A significant proportion of guselkumab-treated participants with PSSD symptom score >0 achieved a PSSD symptom score of 0 at Week 16 (21.9% vs placebo 2.7%; p< 0.001). Similarly, a significantly greater proportion of guselkumab-treated participants achieved DLQI 0/1 (guselkumab 48.9% vs placebo 3.5%; p< 0.001) and DLQI 0 (guselkumab 28.4% vs placebo 3.5% p< 0.001) at Week 16. No new safety signals were identified.

Conclusion: In this low BSA, moderate psoriasis population, quality of life impact significantly improved after just 3 doses of guselkumab.