Spesolimab may offer hope for patients with generalized pustular psoriasis
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The humanized anti-interleukin-36 receptor monoclonal antibody spesolimab demonstrated strong efficacy results with an attractive safety profile in patients with generalized pustular psoriasis, according to a study.
“Generalized pustular psoriasis (GPP) is a life-threatening condition in which the entire body can be covered with sterile pustules,” Mark G. Lebwohl, MD, dean for clinical therapeutics and professor and chairman emeritus of the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview with Healio. “Consequently, many of the protective functions of the skin, including a barrier to infection, are lost. There are no approved treatments for GPP in the U.S.”
The researchers added that interleukin (IL)-36 signaling has implications in the pathogenesis of GPP. However, little is known about whether spesolimab (Boehringer Ingelheim) is safe and effective in managing GPP flares.
The phase 2 trial included 53 participants with GPP flares, with 35 patients receiving spesolimab and 18 receiving placebo. The drug was administered as a single 900 mg IV dose. Patients initially were followed for 1 week. As per study protocols, all patients could receive an open-label dose of the study drug on day 8, a rescue dose after day 8 or both. The long-term follow-up duration was 12 weeks.
A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 to 4 by the end of the first week served as the primary endpoint. A total GPPGA score of 0 or 1 at the end of week 1 served as the secondary endpoint. The researchers noted that higher scores indicate greater disease severity.
Baseline data showed that a GPPGA pustulation subscore of 3 was reported in 46% of participants in the spesolimab arm and 39% of those receiving placebo. A baseline score of 4 was reported by 37% of study drug patients and 33% of those in the placebo group.
Week 1 results showed that 54% of patients treated with spesolimab reached a GPPGA pustulation subscore of 0, compared with 6% in the placebo group (difference, 49 percentage points; P < .001).
Further data showed that 43% of patients in the study drug arm reached a GPPGA total score of 0 or 1, while just 11% reached this endpoint after receiving placebo (difference, 32 percentage points; P = .02).
Safety data showed that 17% of patients treated with spesolimab reported infections in the first week, while 47% had infections by week 12 of follow-up. Nearly half (46%) of patients administered spesolimab demonstrated evidence of antidrug antibodies.
“We finally have a systemic therapy which reverses GPP quickly with the majority of patients achieving dramatic improvement in the first days to a week,” Lebwohl said.
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