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In a randomized, placebo-controlled study, spesolimab (Spevigo) quickly and effectively controlled flares of generalized pustular psoriasis (GPP) over a 12-week period.

Approved by the FDA in September 2022, spesolimab is an IL-36 antagonist developed for the treatment of various immune disorders. The study paper appears in the .

On day 1 of the trial, patients (N=53) received either a single intravenous dose of 900 mg of spesolimab or placebo. Beginning on day 8, participating patients could receive open-label spesolimab if they were experiencing persistent flare symptoms.

The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) was used to evaluate patients in the study. By week 12, 60% of patients receiving spesolimab achieved both a GPPGA pustulation subscore of 0 and a total GPPGA score of 0 or 1. Among patients originally randomized to placebo but who subsequently switched to spesolimab, the proportion of a GPPGA pustulation subscore of 0 increased from 5.6% at day 8 to 83.3% at week 2.

First author, Boni Elewski, MD, is chair of the dermatology department and director of clinical research at the University of Alabama at Birmingham Heersink School of Medicine. She recently discussed the study and its implications with the Reading Room. The exchange has been edited for length and clarity.

What was the unanswered question your study was designed to address?

Elewski: Spesolimab, an anti-IL-36R monoclonal antibody, has been shown to be effective for GPP treatment. Studies have identified the IL-36 pathway as the key element in the pathogenesis of GPP.

We investigated the effects of spesolimab for treatment of GPP flares over the course of the 12-week study. We also determined the proportion of patients who achieved clinically significant improvements in GPPGA scores and compared the effects of single versus multiple doses of spesolimab.

How would you summarize your key findings?

Elewski: We showed that some patients receiving spesolimab had complete pustular clearance within 24 hours and clear or almost clear skin within 48 hours.

Improvements observed after 1 week were sustained through week 12.

Furthermore, patients initially randomized to placebo who received spesolimab at day 8 showed equally rapid and sustained pustular clearance and clear or almost clear skin.

Did anything surprise you about the study or its results?

Elewski: The time to resolution for pustules in this study was amazingly fast, and results were sustained over the 12-week study.

What do you see as the clinical takeaways for dermatologists?

Elewski: GPP is a life-threatening disease that needs to be diagnosed quickly at the bedside so patients can receive life-saving treatments. Spesolimab is a new, FDA-approved treatment, and it is safe and effective.

It is also noteworthy to point out that acute generalized exanthematous pustulosis (AGEP) is a common differential diagnosis with GPP. However, GPP pustules are generally larger, and the patient with GPP may be more toxic. AGEP pustules may be very tiny.