Data from Boehringer Ingelheim’s phase 2b trial, Effisayil 2, reveal that spesolimab (Spevigo) significantly outperformed placebo in reducing the risk for generalized pustular psoriasis (GPP) flares.
Spesolimab is a novel, humanized antibody that works by blocking the activation of the interleukin-36 receptor (IL-36), a signaling pathway within the immune system involved in the pathogenesis of several autoinflammatory diseases, including GPP.
During the study, 123 patients were randomly assigned 1:1:1:1 to receive either placebo or one of three doses of spesolimab. The first, a low dose, which was 300 mg loading dose (LD) followed by 150 mg every 12 weeks. The second, a medium dose, which was 600 mg LD followed by 300 mg every 12 weeks. And the third, a high dose, which was 600 mg LD followed by 300 mg every four weeks.
Results of the study demonstrated that after 48 weeks of treatment, the risk for GPP flares was reduced by 84% in patients who were treated with spesolimab compared to those treated with placebo. Furthermore, the patients in the high-dose group did not experience any flares after four weeks.
The Effisayil 2 study builds on the previous Effisayil 1 study, which demonstrated that treatment with a single intravenous dose of spesolimab greatly improved signs and symptoms of GPP in patients experiencing a flare. Results from this initial trial supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.
Now that Effisayil 2 has demonstrated a reduction of 84% in GPP flares over a 48-week period, the program will move on to the next phase, Effisayil ON. This is an open-label extension study that will evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous trials.