Bimekizumab appears to be an effective treatment for patients with hidradenitis suppurativa, according to the findings of a phase 3 trial.
Hidradenitis suppurativa (HS) is a chronic inflammatory disorder affecting intertriginous areas of skin. and affects around 1% of the population. Clinically, patients experience cutaneous inflamed nodules, abscesses and pus-discharging tunnels that develop in axillary, inguinal, gluteal and perianal body sites.
There is often a diagnostic delay and which leads to more severe disease. Bimekizumab is a humanised, monoclonal antibody that selectively inhibits both IL-17A and IL-17F. A phase 2 trial found use of the drug led to clinically meaningful improvement in patients with HS.
In the recent study, data from two phase 3, randomised, placebo-controlled trials in adult patients with moderate to severe HS. Both trials had a 16-week initial and 32-week maintenance treatment period.
Bimekizumab was used at a dose of 320 mg every two weeks and 320 mg every four weeks. The Hidradenitis Suppurativa Clinical Response (HiSCR50) served as the primary outcome measure. This is defined as a 50% decrease in the total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count.
Bimekizumab and HS outcomes
There were 1,014 patients in the two trials. In both trials at week 16, more patients using bimekizumab achieved the primary outcome compared to placebo. For example, 45.3% vs28.7%, p = 0.030 (BE HEARD 1) and 53.8% vs 32.2%, p = 0.004 ( BE HEARD II). These improvements were seen for both drug regimens. In addition, over 75% percent of patients using bimekizumab achieved HiSCR50 and over 55% a HiSCR75 at week 48.
The company will submit data for global regulatory approval of the drug in patients with moderate to severe HS later in 2023.