Spesolimab Shows Significant Prevention of GPP Flares up to 48 Weeks

Boehringer Ingelheim’s spesolimab (Spevigo), an anti-interleukin (IL)-36 receptor antibody, met primary and secondary endpoints in the EFFISAYIL 2 (NCT04399837) trial showing significant prevention of generalized pustular psoriasis (GPP) flares in adolescents and adults for up to 48 weeks.¹ The positive study results from EFFISAYIL 2 build on data from the previous EFFISAYIL 1 trial (NCT03782792), which demonstrated rapid pustular and skin clearance in patients with GPP flares sustained over 12 weeks.

"GPP is a devastating disease and is a dermatologic emergency. Only recently do we now have the approval of spesolimab, a life-saving targeted treatment for GPP flares. The release of the spesolimab EFFISAYIL 2 trial is continued progress showing that the biologic is able to safely prevent GPP flares - this is no doubt that this firstline treatment will save or impact many lives," said Aaron Farberg, MD, FAAD, chief medical officer of Bare Dermatology in Aubrey, Texas.

During EFFISAYIL 2, 123 participants aged 12 to 67 years who had GPP flares in the past but whose skin was clear or almost at the start of the study were selected. Participants were given 3 different doses of spesolimab to test the efficacy of preventing GPP flares. Three groups were given varying doses of spesolimab, and the fourth group was given a placebo injection.

Carrine Brouillon, a member of the Board of the Managing Directors at Boehringer Ingelheim, noted that the positive EFFISAYIL 2 trial results demonstrate spesolimab’s potential to prevent GPP flares. Brouillon expects Boehringer Ingelheim to present more findings later this year.

Spesolimab was approved by the US Food and Drug Administration (FDA) in September 2022 for the treatment of GPP flares in adults as the first FDA-approved treatment to specifically target the IL-36 pathway. The primary endpoint of EFFISAYIL 1 was a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub score of 0, defined as no visible pustules. The key secondary endpoint was the percentage of patients who achieved a GPPGA total score of 0 or 1—clear or almost clear skin. According to the study, 54% of patients who were treated with spesolimab achieved the primary endpoint vs 6% of placebo. For the key secondary endpoint, 43% of patients treated with spesolimab achieved a GPPGA total score of 0 or 1 compared to 11% of the placebo group.

For more information on GPP and the efficacy of spesolimab, visit our Case-Based Partner Perspectives series featuring Mark Lebwohl, MD, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai in New York City and chairman emeritus of the Kimberly and Eric J. Waldman department of dermatology at Mount Sinai.

Reference

1. A study to test whether BI 655130 (spesolimab) prevents flare-ups in patients with generalized pustular psoriasis. ClinicalTrials.gov identifier: NCT04399837. Updated December 30, 2022. Accessed January 30, 2023. https://clinicaltrials.gov/ct2/show/NCT04399837?term=EFFISAYIL+2&draw=2&rank=1