Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful,… – Press Release


  • Patients treated with investigational bimekizumab, an IL-17A and IL-17F inhibitor, achieved statistically significant and clinically meaningful improvements over placebo in signs and symptoms of hidradenitis suppurativa at week 16, as measured by HiSCR50
  • Bimekizumab demonstrated deep levels of clinical response over placebo at week 16, as measured by HiSCR75, a key secondary endpoint
  • Patients treated with bimekizumab experienced improved health-related quality of life over placebo at week 16, a key secondary endpoint
  • Clinical responses were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75, at week 48±

BRUSSELS and ATLANTA, March 18, 2023 /PRNewswire/ — UCB, a global biopharmaceutical company, today announced detailed positive results from two Phase 3 studies (BE HEARD I and BE HEARD II) evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48.1,± Clinical responses with bimekizumab were observed from the first dose with some patients achieving HiSCR50 at week four.1 These new data were presented today at a late-breaking platform presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, March 17-22.

“Hidradenitis suppurativa is a chronic, debilitating inflammatory skin disease for which only one approved treatment is available today,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston. “Treating moderate to severe cases with bimekizumab has shown promising results in Phase 3 patient trials, with sustained improvement…