In Phase 2b Trial, Spesolimab Meets Endpoints for Prevention of Generalized Pustular Psoriasis (GPP) Flares

Spesolimab (Boehringer Ingelheim), an anti-interleukin-36 receptor antibody, met its primary and key secondary endpoint, demonstrating it can prevent flares in patients with generalized pustular psoriasis (GPP) and provide sustained symptom management up to 48 weeks, according to results of the Phase 2b Effisayil 2 trial [1,2]. Safety data were in line with previously conducted clinical trials with spesolimab.

Results build on data from the Effisayil 1 trial, which demonstrated rapid and sustained pustular and skin clearance in flaring adult GPP patients treated with spesolimab, according to Boehringer Ingelheim. The Effisayil 1 trial results supported the recent approval of spesolimab (Spevigo) as the first specific treatment for GPP flares in adults in major markets including the US, Japan, Mainland China and the European Union.

“Painful GPP flares can occur suddenly, escalate quickly, and may require urgent hospital care leaving people anxious and uncertain about what the future might hold,” Carinne Brouillon, member of the board of managing directors responsible for Human Pharma, Boehringer Ingelheim, said in a company news release. “The Effisayil 2 results reinforce the potential of spesolimab to prevent GPP flares, giving patients the power to plan their lives, regardless of their disease. We look forward to presenting the data later this year and sharing the findings with regulatory authorities.”

GPP is a rare and unpredictable systemic skin disease that is distinct from plaque psoriasis in both its disease mechanism and severity. It is the first approved treatment to specifically target the IL-36 pathway for the treatment of GPP flares that has been evaluated in a statistically powered, randomized, placebo-controlled trial.

Further spesolimab data is expected later this year, including the final Effisayil 2 results investigating prevention of GPP flares. Spesolimab is also under investigation for the treatment of other IL-36 mediated skin diseases.[3]

References

1.  Morita A, Choon SE, Bachelez H et al. Design of EffisayilTM 2: A randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther (Heidelb) (2023) 13:347–359.

2.  A study to test whether BI 655130 (spesolimab) prevents flare-ups in patients with generalized pustular psoriasis.  www.clinicaltrials.gov/ct2/show/study/NCT04399837?term=Boehringer. Last accessed January 2023.

3.  A study to test whether spesolimab helps people with a skin disease called hidradenitis suppurativa. Available at: https://clinicaltrials.gov/ct2/show/NCT04762277.January 2023.