Lancet

Trial data support use of bimekizumab for hidradenitis suppurativa treatment

June 3, 2024

Among patients with hidradenitis suppurativa, bimekizumab was well tolerated and led to rapid and clinically meaningful responses that were maintained for up to 48 weeks.

For the identically designed, phase 3 BE HEARD I (N=505) and II (N=509) trials, patients ≥18 years with moderate-to-severe hidradenitis suppurativa were randomly assigned 2:2:2:1 to receive:

• SC bimekizumab 320 mg q2wks
• bimekizumab 320 mg q2wks to week 16, then q4wks to week 48
• bimekizumab 320 mg q4wks to week 48
• placebo to week 16, then bimekizumab 320 mg q2wks

Primary outcome was hidradenitis suppurativa clinical response of ≥50%, defined as a reduction in total abscess and inflammatory nodule count of ≥50% from baseline with no increase from baseline in abscess or draining tunnel count (HiSCR50) at week 16.

Using modified non-responder imputation, investigators determined that the primary outcome at week 16 was met in the group who received bimekizumab q2wks. Higher responder rates were seen with bimekizumab vs. placebo in both trials: 48% vs. 29% in BE HEARD I (odds ratio [OR], 2.23), and 52% vs. 32% in BE HEARD II (OR, 2.29). In BE HEARD II, HiSCR50 was met in the group given bimekizumab q4wks (54% vs. 32% with placebo; OR, 2.42). Responses were maintained or increased to week 48.

Rates of serious treatment-emergent adverse events among bimekizumab recipients were 8% in BE HEARD I and 5% in BE HEARD II. No new safety signals were observed.

Source:

Kimball AB, et al. (2024, May 22). Lancet. 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. https://pubmed.ncbi.nlm.nih.gov/38795716/