Spesolimab may control generalized pustular psoriasis flares within 24 hours

Spesolimab exhibited rapid control of generalized pustular psoriasis flare symptoms in as little as 24 hours and up to 12 weeks, according to a study.

Effisayil 1, a previously published randomized, placebo-controlled 12-week study, evaluated the effects of spesolimab (Spevigo, Boehringer Ingelheim), an investigational drug that targets the interleukin (IL)-36 pathway, in patients with generalized pustular psoriasis (GPP) flare. In this study, researchers expounded on the results showing that spesolimab can be effective as soon as 24-hours after administration.

“In Effisayil 1, in patients experiencing a GPP flare, a single infusion of the [anti-IL-36-receptor] antibody spesolimab led to rapid pustular clearance ... as early as 1 week after treatment,” Boni Elewski, MD, of the University of Alabama-Birmingham Heersink School of Medicine, and colleagues wrote. “Here, we show that some patients receiving spesolimab had complete pustular clearance within 24 hours and clear/almost clear skin within 48 hours.”

A total of 53 patients were randomly assigned 2:1 to receive a single intravenous dose of 900 mg spesolimab on day 1. On day 8, all patients were able to receive an optional open-label dose for persistent flare symptoms.

The primary endpoint was a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 at week 1, whereas the key secondary endpoint was a GPPGA total score of 0 or 1 in the same time frame.

Results showed that five (11.4%) spesolimab-treated patients achieved the primary endpoint by day 2 and 11 (31.4%) achieved it by day 3.

By week 1, 23 (65.7%) of those treated with a single dose of spesolimab achieved the primary endpoint and minimally clinically important difference compared with four (22.2%) patients in the placebo group. Similarly, 25 (71.4%) of those treated with spesolimab achieved the key secondary endpoint and minimally clinically important difference vs. seven (38.9%) of those in the placebo group.

By week 12, 12 (60%) patients in the spesolimab group achieved the primary and key secondary endpoint. Among the 15 patients who received open-label spesolimab after receiving placebo at baseline, 5.6% achieved the endpoints at day 8 which increased to 83.3% at week 2.

“Together with the Effisayil 1 primary analyses, these data indicate that spesolimab rapidly

blocks the action of the IL-36 signaling pathway ... and maintains this effect over time, further supporting its use as a therapeutic option for patients with a GPP flare,” Elewski and colleagues wrote.

According to the study, evaluations of long-term administration of spesolimab and use for flare prevention are ongoing in Effisayil ON and Effisayil 2, respectively.