Recent advancements in hidradenitis suppurativa treatment have shown promising results, with bimekizumab demonstrating significant improvement in nearly half of the patients within a 16-week period. This novel therapeutic option outperformed current biological agents, such as adalimumab and secukinumab, offering hope for better management of this debilitating condition and improved patient outcomes.
The BE HEARD I and II trials, published in The Lancet, assessed the efficacy and safety of bimekizumab in 1,014 patients with moderate-to-severe hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody that inhibits both IL-17A and IL-17F, received EU approval for the treatment of HS in April 2024, extending its indications beyond plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
In these randomized, double-blind, placebo-controlled phase 3 trials, patients were administered bimekizumab 320 mg biweekly or monthly, or a placebo for 16 weeks, followed by a maintenance phase up to week 48. The primary endpoint, HS Clinical Response at week 16 (HiSCR50), was achieved by 48% and 52% of patients in the biweekly bimekizumab group in BE HEARD I and II, respectively, compared to 29% and 32% in the placebo groups (BE HEARD I: odds ratio [OR] 2.23, 97.5% CI 1.16–4.31; P = .0060; BE HEARD II: OR 2.29, 97.5% CI 1.22–4.29; P = .0032). Monthly administration was effective only in BE HEARD II (54% vs 32%, OR 2.42, 97.5% CI 1.22–4.80; P = .0038).
Exploratory endpoints, including HiSCR75, HiSCR90, and HiSCR100, provided further evidence of bimekizumab's efficacy. Notably, HiSCR100 was reported for the first time in the BE HEARD studies, with 16% of patients in the bimekizumab group achieving this endpoint at week 16 compared to 6% in the placebo group. Quality of life and skin pain also showed significant improvement.
Adverse events were consistent with IL-17 inhibitor profiles, with fungal infections observed in 23.7% of patients. Serious treatment-emergent adverse events occurred in 6.4% of patients, and 6.7% discontinued treatment due to adverse effects. Bimekizumab did not significantly alter the frequency of HS flares.
The study included 193 patients (19%) who had received previous biological therapy with anti-TNF-α or anti-IL-17 agents, although specific efficacy data for this subgroup were not provided.
The dual inhibition of IL-17A and IL-17F by bimekizumab may offer advantages over single IL-17A inhibition, as both cytokines are involved in the pathogenesis of HS. However, head-to-head studies comparing bimekizumab with other IL-17 inhibitors are needed to confirm this hypothesis.
The authors concluded that bimekizumab is an efficacious and well-tolerated treatment for moderate-to-severe HS, with a favorable benefit-risk profile. They also noted that long-term data from the ongoing BE HEARD maintenance period and open-label extension study will provide further evidence on the durability of response and long-term safety of bimekizumab in HS.
Full disclosure statement can be found in the original study.