The FDA has approved spesolimab-sbzo as the first treatment for generalized pustular psoriasis (GPP) flares in adults. The agent is a novel, selective antibody infusion that blocks the activation of the interleukin-36 receptor, part of an immune system signaling pathway thought to be involved in the cause of GPP. The approval was based on a 12-week trial in which 53 patients with a GPP flare were treated with spesolimab-sbzo or placebo. After 1 week, more patients treated with spesolimab-sbzo showed no visible pustules than those treated with placebo (54% vs 6%). The most common adverse reactions (≥5%) reported in patients taking spesolimab-sbzo were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection. “GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” Mark Lebwohl, MD, lead investigator for the trial, said in a statement. “The approval… is a turning point for dermatologists and clinicians.”
