Treatment with bimekizumab was associated with clinically meaningful improvements in adult patients with moderate to severe hidradenitis suppurativa, according to topline results from two phase 3 studies.
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F). The BE HEARD I and BE HEARD II studies (ClinicalTrials.gov Identifier: NCT04242446 and NCT04242498, respectively) included more than 1000 adults with moderate to severe hidradenitis suppurativa (defined as a total of ≥5 inflammatory lesions) who had an inadequate response to a course of a systemic antibiotic.
Patients were randomly assigned to receive either bimekizumab or placebo. The primary endpoint was the percentage of patients who achieved clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50; defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count with no increase from baseline in abscess or draining tunnel count) at week 16.
Findings from both studies showed that a significantly greater proportion of patients treated with bimekizumab achieved HiSCR50 and HiSCR75 (a key secondary endpoint) at week 16, compared with placebo. The safety profile of bimekizumab was consistent with that observed in previous studies.
“We are excited to announce positive pivotal phase 3 outcomes in moderate to severe hidradenitis suppurativa which support our strong belief in bimekizumab and provide the first phase 3 evidence suggesting that targeting IL-17F in addition to IL-17A may be a promising treatment approach,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
UCB announces positive phase 3 studies for bimekizumab in hidradenitis suppurativa. News release. UCB. Accessed December 9, 2022. https://www.prnewswire.com/news-releases/ucb-announces-positive-phase-3-studies-for-bimekizumab-in-hidradenitis-suppurativa-301698971.html.