Efficacy
Wilson, death, pustulation, Psoriasis
PSORIASIS
The primary endpoint, a GPPGA pustulation subscore of 0 (no visible pustules) at Week 1, was achieved by 10 patients (62.5%) in the spesolimab group and one patient (7.7%) in the placebo group (risk difference 54.8, 95% confidence interval [CI] 17.3–79.8; Figure Proportion of Asian patients (a and b) and patients in the overall population of the Effisayil™ 1 study (c and d) with a GPPGA pustulation subscore of 0 (no visible pustules) and a GPPGA total score of 0 or 1 (clear or almost clear skin) at Week 1. Primary analysis: any values post death or any other medication for GPP represent nonresponse. *95% CIs calculated using the method of Wilson; Proportion of patients in the spesolimab group with a GPPGA pustulation subscore of 0 (no visible pustules) (a) and a GPPGA total score of 0 or 1 (clear or almost clear skin) (b) up to week 12. Data are shown for patients initially randomized to receive spesolimab who received up to two doses of spesolimab: Day 1 (Of the three patients with In patients randomized to spesolimab, the Japanese Dermatological Association Generalized Pustular Psoriasis Severity Index improved over time, with a median (interquartile range [IQR] Q1, Q3) absolute change from baseline of −1.50 (−3.0, 0.0) at Week 1, which further reduced up to Week 4 and was sustained up to Week 12 (Figure 