James Q. Del Rosso, DO, gives a comprehensive overview of Bimzelx for HS, including dosing, clinical trial results, safety, and more.

UCB has announced the FDA approval of Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). Bimzelx, the first and only approved therapy specifically designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), offers a novel mechanism of action for addressing this chronic and often debilitating condition.

Clinical trial insights

The approval of Bimzelx is based on positive results from two Phase 3 clinical trials, BE HEARD I and BE HEARD II, which assessed its efficacy and safety in adult patients with moderate-to-severe HS.

Key findings include:

• A higher proportion of patients treated with Bimzelx achieved a 50% or greater improvement in HS signs and symptoms (HiSCR50) at Week 16 compared to placebo, meeting the trials' primary endpoint
• Clinically meaningful improvements in HiSCR75 were also observed at Week 16 as a secondary endpoint
• Clinical responses were sustained through Week 48

The trials enrolled a combined total of 1014 patients and employed a randomized, double-blind, placebo-controlled, parallel-group, multicenter design. The primary endpoint for both studies, HiSCR50, was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscesses or draining tunnels. Secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16.

Safety profile

In the trials, Bimzelx demonstrated a safety profile consistent with previous trials across indications, with no new safety signals identified.

Common (≥1%) adverse reactions in plaque psoriasis and HS include upper respiratory tract infections, oral candidiasis, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

Expanding therapeutic indications

The approval for HS expands Bimzelx’s therapeutic footprint. Initially approved in October 2023 for moderate-to-severe plaque psoriasis in adults, Bimzelx has since gained approval for psoriatic arthritis, nonradiographic axial spondyloarthritis with objective signs of inflammation, and ankylosing spondylitis.

This latest indication reinforces UCB’s commitment to addressing unmet needs in dermatology and immunology by providing innovative solutions for complex conditions. Dermatologists now have a promising new option to improve the lives of patients with moderate-to-severe HS.