Spesolimab efficacious in generalized pustular psoriasis treatment
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BOSTON — Patients with generalized pustular psoriasis had a reduction in pustules and increased skin clearance with spesolimab, according to a poster presented at the American Academy of Dermatology Annual Meeting.
“[Generalized pustular psoriasis (GPP)] is an unpredictable, painful and potentially life-threatening rare skin disease,” Boni Elewski, MD, James Elder Professor and Chair of the Department of Dermatology at the University of Alabama School of Medicine, told Healio. “The findings presented at this year’s meeting are promising results for dermatologists and other clinicians as there are currently no approved treatment options available for patients living with GPP in the U.S. or Europe.”
This 12-week, multicenter, randomized, double blind, placebo-controlled Effisayil 1 trial included 53 patients who received a single intravenous dose of spesolimab (Boehringer Ingelheim) 900 mg or placebo.
An open label spesolimab dose was available for 12 patients in the treatment group and 15 patients in the placebo group at day 8 due to persistent symptoms.
Of the 53 patients in the initial treatment group, 61.8% achieved a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 at week 1, while 84.4% did so at week 12. A total GPPGA score of 0/1 (clear or almost clear) was recorded in 50% of patients at week 1 and 81.3% at week 12.
In the group that received placebo and then drug, a GPPGA pustulation subscore of 0 was recorded in 83.3% of patients at week 2 and 80% of patients at week 12. A total GPPGA score of 0/1 was achieved by 72.2% at week 2 and 93.3% at week 12.
Adverse events were recorded in 66% of the treatment group and 56% of the placebo group after the first week. Serious adverse events occurred in 6% of the treatment group at week 1.
“Spesolimab is associated with rapid pustular and skin clearance in patients experiencing a generalized pustular psoriasis flare, and has a favorable and well-tolerated safety profile,” Elewski said. “These findings provide further evidence of the rapid benefit that spesolimab could bring to patients living with GPP.”