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All patients with GPP benefit from IL-36 inhibitor therapy

SPIN 2022
Phase 2, Effisayil 1
The IL-36 receptor antibody spesolimab showed to be effective in all patients with generalised pustular psoriasis (GPP), independent of age, sex, race, BMI, IL-36RN mutation status, and different physician global assessment scores. This was the result of a subgroup analysis of the phase 2 trial Effisayil 1.

In the 12-week randomised, placebo-controlled, phase 2 Effisayil 1 trial (NCT03782792), a single intravenous dose of the anti-IL-36 receptor antibody spesolimab led to a higher incidence of skin clearance compared with placebo: 54% of patients in the spesolimab group versus 6% in the placebo group achieved complete clearance of pustules, corresponding to a general pustular psoriasis global assessment (GPPGA) pustulation subscore of 0 (primary endpoint) [1]. The key secondary endpoints were a GPPGA total score of 0 or 1 (clear or almost clear skin).

At the SPIN meeting, a subgroup analysis of this trial assessed the treatment effects of spesolimab on the primary and key secondary endpoints in pre-specified patient groups according to age, sex, race, BMI, and different physician global assessment scores for pustular psoriasis [2].

Efficacy of spesolimab was consistent across all pre-specified subgroups for the duration of the study. Subgroup treatment effect estimates were generally comparable to those of the overall trial population. Interestingly, spesolimab efficacy was independent of IL-36RN mutation status; the proportion of IL3-6RN-negative patients achieving the primary endpoint was 9/21 patients (42.9%) with spesolimab and 0/11 patients with placebo; for IL-36RN-positive patients, 7/8 (87.5%) with spesolimab and 1/6 (16.7%) with placebo achieved the primary endpoint (interaction P=0.982).

The authors concluded that the efficacy of spesolimab was consistent across all pre-specified subgroups and was generally comparable with the overall trial population.

  1. Bachelez H, et al. New Engl J Med. 2021;385:2431-40.
  2. Burden D, et al. Efficacy of spesolimab for the treatment of GPP flares across prespecified patient subgroups in the EFFISAYIL 1 study. P087, SPIN 2022 Congress, 06–08 July, Paris, France.


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