Efficacy and Safety of Bimekizumab in Treating Hidradenitis Suppurativa Demonstrated in Phase 3 Trials
USA: Bimekizumab, a novel monoclonal antibody, has shown promising results in treating moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The findings emerged from two pivotal phase 3 trials, BE HEARD I and BE HEARD II, randomized, double-blind, placebo-controlled studies spanning 48 weeks and conducted across multiple centers.
The study published in The Lancet revealed that bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses, maintained for up to 48 weeks.
"Data from these two trials support the bimekizumab use for treating patients with moderate-to-severe hidradenitis suppurativa," the researchers wrote.
Hidradenitis suppurativa patients have substantial unmet clinical needs and scarce therapeutic options. Prof Alexa B Kimball, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA, and colleagues aimed to assess the safety and efficacy of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with moderate-to-severe HS.
BE HEARD I and II were two identically designed, 48-week randomized, placebo-controlled, double-blind, multicentre phase 3 trials. It included patients aged 18 years or older with moderate-to-severe hidradenitis suppurativa. They were randomly assigned 2:2:2:1 to receive subcutaneous bimekizumab 320 mg every two weeks; bimekizumab 320 mg every two weeks to week 16, then every four weeks to week 48; bimekizumab 320 mg every four weeks to week 48; or placebo to week 16, then bimekizumab 320 mg every two weeks.
The primary outcome was an HS clinical response of at least 50%, defined as a reduction in total abscess and inflammatory nodule count of at least 50% from baseline with no rise in abscess or draining tunnel count (HiSCR50) at week 16. Efficacy analyses included all randomly assigned study patients (intention-to-treat population). Safety analyses included patients who received at least one full or partial dose of study treatment in the safety set and bimekizumab in the active medication set.
The researchers reported the following findings:
· Patients for BE HEARD I were recruited from 2020 to 2021, and 505 patients were enrolled and randomly assigned. Patients for BE HEARD II were recruited from 2020 to 2021, and 509 patients were enrolled and randomly assigned.
· The primary outcome at week 16 was met in the group who received bimekizumab every two weeks using modified non-responder imputation; higher responder rates were observed with bimekizumab versus placebo in both trials: 48% of 289 patients versus 29% of 72 patients in BE HEARD I (odds ratio [OR] 2·23) and 52% of 291 patients versus 32% of 74 patients in BE HEARD II (2·29).
· In BE HEARD II, HiSCR50 was also met in the group administered bimekizumab every four weeks (54% of 144 vs 32% of 74 with placebo; 2·42).
· Responses were maintained or increased to week 48. Serious treatment-emergent adverse events were in 8% of patients in BE HEARD I and 5% of patients in BE HEARD II treated with bimekizumab over 48 weeks.
· The most frequently reported treatment-emergent adverse events to week 48 were hidradenitis in both trials, coronavirus infection and diarrhea in BE HEARD I, and oral candidiasis and headache in BE HEARD II.
· Across the two trials, there was one death due to congestive heart failure in a patient with substantial cardiovascular history treated with bimekizumab every two weeks in BE HEARD I (considered unrelated to bimekizumab treatment by the investigator).
· No new safety signals were observed.
The results of BE HEARD I and BE HEARD II trials have been submitted to regulatory authorities for review, with hopes that bimekizumab soon become available as a treatment option for HS.
Reference:
Kimball AB, Jemec GBE, Sayed CJ, Kirby JS, Prens E, Ingram JR, Garg A, Gottlieb AB, Szepietowski JC, Bechara FG, Giamarellos-Bourboulis EJ, Fujita H, Rolleri R, Joshi P, Dokhe P, Muller E, Peterson L, Madden C, Bari M, Zouboulis CC. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024 May 22:S0140-6736(24)00101-6. doi: 10.1016/S0140-6736(24)00101-6. Epub ahead of print. PMID: 38795716.
