The US Food and Drug Administration (FDA) has approved spesolimab to treat adults with generalized pustular psoriasis (GPP) flares.
GPP is a rare skin disorder in which neutrophils accumulate in the skin that result in painful, sterile pustules. GPP flares can lead to serious complications, including heart failure, renal failure and sepsis. The unpredictability and severity of GPP flares can significantly a person’s quality of life.
Spesolimab blocks the activation of interleukin-36 receptor (IL-36R) which is involved in the pathogenesis of several autoinflammatory diseases, including GPP.
The approval is largely based on data from a 12-week Phase II clinical trial in which patients with a GPP flare (N=53), randomly assigned 2:1 to a single 900 mg intravenous dose of spesolimab or placebo. The primary end point was a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (range, 0 [no visible pustules] to 4 [severe pustulation]) at the end of week 1. The majority of patients in the trial had GPPGA pustulation subscore of 3 or 4 at the beginning of the trial. After one week, a total of 19 patients (54%) in the spesolimab group had a pustulation subscore of 0 compared to only 1 patient (6%) in the placebo group (P < .001). These results were published last year in the New England Journal of Medicine.
Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups respectively (at week one). Serious adverse events were reported in 6% of patients treated with spesolimab (at week one).
To stay up-to-date on the latest FDA approvals, go to checkrare.com/2022-pdufa-fda-approvals/