Spesolimab may control generalized pustular psoriasis flares within 24 hours
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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.
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