Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial

Abstract

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the percentage of patients achieving clear skin (Physician’s Global Assessment for GPP [GPPGA]=0)1 over time from patients who were treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Measurements were completed for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). The data were analyzed as observed. Proportion of patients with GPPGA total score of 0 increased over time under spesolimab treatment (10.0% (N=3/30) at baseline, 27.6% (N=8/29) at Week 4, 48.1% (N=13/27) at Week 16, and 52.2% (N=12/23) at Week 48). Continuous treatment with spesolimab SC improved skin symptoms in GPP, with 50% of patients achieving clear skin at Week 48. These findings suggest a role of spesolimab in complete resolution of GPP skin symptoms.