Spevigo reduces risk for generalized pustular psoriasis flares in new, late-breaking data
Click Here to Manage Email Alerts
Key takeaways:
- Spevigo (spesolimab) reduced the risk for generalized pustular psoriasis flares by 84% over 48 weeks.
- Spevigo’s safety profile was comparable to placebo.
Spevigo significantly outperformed placebo in reducing the risk for generalized pustular psoriasis flares, Boehringer Ingelheim announced in a press release after its late-breaker session at the 25th World Congress of Dermatology.
Boehringer Ingelheim presented new, late-breaking data from its phase 2b trial, Effisayil 2, which is the first and largest multinational randomized clinical trial evaluating a treatment for the prevention of generalized pustular psoriasis (GPP) flares, according to the press release.
Built upon the results from the Effisayil 1 trial, Effisayil 2 results demonstrated that Spevigo (spesolimab), an interleukin-36 inhibitor that is FDA-approved for the treatment of GPP, demonstrated the ability to significantly reduce the risk for GPP flares while maintaining a favorable safety profile.
“Through our comprehensive Effisayil clinical program we have already delivered spesolimab as a major advancement for flaring GPP patients,” Carinne Brouillon, PharmD, member of the board of managing directors and head of human pharma at Boehringer Ingelheim, said in the release. “The Effisayil 2 trial results build on this success, bringing us closer to achieving our ultimate goal of a flare-free future for everyone living with GPP.”
In the study, 123 patients were randomly assigned 1:1:1:1 to receive placebo or one of three doses of spesolimab: low dose, which was 300 mg loading dose [LD] followed by 150 mg every 12 weeks; medium dose, which was 600 mg LD followed by 300 mg every 12 weeks; or high dose, which was 600 mg LD followed by 300 mg every 4 weeks.
After 48 weeks of treatment, results showed that the risk for GPP flares was reduced by 84% in those treated with spesolimab compared with placebo.
None of the 30 patients in the high dose group experienced flares after 4 weeks. In fact, the high dose group particularly demonstrated statistically significant improvement over placebo on the primary endpoint, time-to-first GPP flare by week 48 (hazard ratio = 0.157; 95% CI, 0.05-0.54).
Spesolimab also maintained a favorable safety profile that was comparable to placebo and not dose-dependent.
With recent breakthrough therapy designations from the FDA and the Center for Drug Evaluation in China, spesolimab may be a promising investigational treatment for the prevention of GPP flares.
Reference:
Read more about
Click Here to Manage Email Alerts