FDA Approves Novel Treatment for Rare Type of Psoriasis Flare

The FDA has approved Boehringer Ingelheim’s Spevigo (spesolimab-sbzo) injection, the first treatment option for adults with generalized pustular psoriasis (GPP) flares. Spevigo is a novel antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of generalized pustular psoriasis.

Generalized pustular psoriasis is different from plaque psoriasis. It is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares. In the United States, it is estimated that one out of every 10,000 people has generalized pustular psoriasis.

“GPP flares can greatly impact a patient’s life and lead to serious, life-threatening complications,” Mark Lebwohl, M.D., lead investigator and publication author, and dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, said in a press release. “We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares.”

In the 12-week pivotal Effisayil 1 clinical trial, 53 patients experiencing a generalized pustular psoriasis flare were treated with Spevigo or placebo. After one week, 54% of patients treated with Spevigo showed no visible pustules compared with 6% in the placebo in the placebo arm. The most common adverse reactions in patients who received Spevigo were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.