Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: 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 effects on GPP body surface area (BSA) over time in patients diagnosed <5 vs ≥5 years prior to enrollment when treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Within the FDA approved regimen spesolimab group, average BSA for patients diagnosed with GPP for <5 years (N=13) was 14.7 at baseline, 15.0 at Week 4, then decreasing to 11.7 at Week 16, and then to 5.0 at Week 48. For patients diagnosed with GPP for ≥ 5 years (N=17) the values were 12.3 at baseline, decreasing to 7.0 at Week 4, increasing slightly to 7.6 at Week 16, and decreasing to 4.1 at Week 48. Total BSA involvement decreased over the 48 weeks of the trial in spesolimab-treated patients regardless of whether they were early (< 5 years) or late (≥ 5 years) in their disease course. This finding demonstrates the efficacy of spesolimab in controlling GPP consistently for patients with various lengths of disease history.