Trial of spesolimab for generalized pustular psoriasis
New England Journal of Medicine Jan 05, 2022
Bachelez H, Choon SE, Marrakchi S, et al. - In a phase 2 trial, treatment with spesolimab (interleukin-36 receptor inhibitor) led to a higher incidence of lesion clearance at 1 week than placebo but was linked with infections and systemic drug reactions in patients with generalized pustular psoriasis.
A total of 53 patients were randomly assigned to receive spesolimab (n=35) or placebo (n=18).
In the spesolimab and placebo groups, 46% and 39% had a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 3, respectively, at baseline; and 37% and 33%, respectively, had a pustulation subscore of 4.
A pustulation subscore of 0 at the end of week 1 was evident in 54% of the patients in the spesolimab group vs in 6% in the placebo group (difference, 49 percentage points; 95% confidence interval [CI], 21 to 67; P<0.001).
A GPPGA total score of 0 or 1 was found in 43% vs 11% in the spesolimab group vs placebo group (difference, 32 percentage points; 95% CI, 2 to 53; P=0.02).
Two patients who received spesolimab developed drug reactions, in 1 of them concurrent with a drug-induced hepatic injury.
Infections developed through the first week in 17% of the patients assigned to the spesolimab group; among those who received spesolimab at any time in the trial, infections had occurred in 47% at week 12.
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