Summary

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• This summary is based on the review of six randomized controlled trial(s). ^[1-6]
• In the Effisayil-1 study (NCT03782792), 54% (19/35) of patients in the spesolimab group achieved a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 at week 1, compared to 6% (1/18) in the placebo group. By week 12, 60% of spesolimab patients and 83.3% of placebo patients (after receiving open-label spesolimab) achieved a pustulation subscore of 0.
• For the GPPGA total score of 0 or 1, 43% (15/35) of spesolimab patients and 11% (2/18) of placebo patients reached this outcome at week 1. In the Asian subgroup, 50% (8/16) of spesolimab patients and 15.4% (2/13) of placebo patients achieved a total score of 0 or 1 at week 1.
• In patient-reported outcomes (PROs) from the Effisayil-1 study, there was improvement in the Pain Visual Analogue Scale (VAS) by -21.3, FACIT-Fatigue by 7.0, DLQI (Dermatology Life Quality Index) by -2.5, and PSS by -4.0. Similar improvements were noted in the placebo group after receiving open-label spesolimab.
• In the Effisayil-1 study, 66% (22/35) of patients in the spesolimab group and 56% (10/18) in the placebo group reported adverse events (AEs) during the first week. No deaths or hypersensitivity reactions leading to discontinuation were reported.
• In the Phase 2 trial, infections were reported in 47% (24/51) of patients in the spesolimab group by week 12. Antidrug antibodies were detected in 46% (23/50) of patients who received at least one dose of spesolimab.
• Asian patients in the Effisayil-1 study achieved similar effectiveness and safety outcomes compared to the overall population, with 62.5% achieving a pustulation subscore of 0 at week 1 and 68.8% experiencing at least one adverse event. There were no significant differences based on gender.