UCB Reveals 2-Year BIMZELX® Data for Severe Hidradenitis Suppurativa at EADV 2024

UCB, a global biopharmaceutical company, has unveiled two-year data from their Phase 3 studies, BE HEARD I and BE HEARD II, and the subsequent open-label extension. The studies focus on the efficacy and safety of BIMZELX® (bimekizumab-bkzx), an inhibitor of interleukin (IL)-17A and IL-17F, in treating adults with moderate-to-severe hidradenitis suppurativa (HS). This information was presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

The data reveal that the improvements seen after one year of BIMZELX treatment continued to be significant over a two-year period. By Week 96, 85.4% of the patients achieved HS Clinical Response 50 (HiSCR50). More stringent endpoints such as HiSCR75 and HiSCR100 were reached by 77.1% and 44.2% of the patients, respectively. Additionally, reductions in disease severity, draining tunnel count, and improvements in health-related quality of life were maintained over the two years. BIMZELX was found to be generally well-tolerated without new safety concerns.

Hidradenitis suppurativa is a chronic and painful inflammatory skin condition that greatly affects patients' quality of life. Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, emphasized the significance of this data, noting the pressing need for treatments that offer long-term relief. He highlighted the sustained improvements in clinical response, symptoms, and quality of life over the two-year period as particularly encouraging.

Fiona du Monceau, Executive Vice President and Head of Patient Evidence at UCB, echoed the importance of long-term data for treatment decisions in moderate to severe hidradenitis suppurativa. The two-year results, presented for the first time at EADV 2024, build on previous 48-week findings, showcasing a maintained response over a longer period.

Key data from the two-year study include:
- HiSCR50 was achieved by 79.9% of patients at Week 48 and 85.4% at Week 96.
- HiSCR75 was achieved by 64.0% of patients at Week 48 and 77.1% at Week 96.
- HiSCR90 was achieved by 42.3% at Week 48 and 57.6% at Week 96.
- HiSCR100 was achieved by 30.2% at Week 48 and 44.2% at Week 96.

In terms of disease severity, patients saw a decrease in HS symptoms as measured by the International HS Severity Score System (IHS4), with mean IHS4 scores improving from baseline through Week 96. The reduction in draining tunnel count was also noteworthy, improving significantly from baseline through Week 96. Additionally, health-related quality of life, measured by the Dermatology Life Quality Index (DLQI), showed that approximately one-third of patients reported minimal or no impact of the disease on their quality of life over the two years.

Over the two-year period, BIMZELX was well-tolerated with no new safety signals. Among the 995 patients who received at least one dose of BIMZELX, 917 experienced treatment-emergent adverse events (TEAEs), with 122 reporting serious TEAEs. The most common TEAEs included hidradenitis, coronavirus infection, and oral candidiasis.

Hidradenitis suppurativa is a chronic, debilitating inflammatory skin disease characterized by nodules, abscesses, and draining tunnels, predominantly affecting the armpits, groin, and buttocks. The disease often leads to severe pain and has a major impact on quality of life. It typically develops in early adulthood and affects about 1% of the population in studied countries.

The Phase 3 BE HEARD I and BE HEARD II studies, along with the open-label extension, evaluated BIMZELX's efficacy and safety profile in adult patients with moderate-to-severe HS. These studies had a combined enrollment of 1,014 participants. Patients who completed Week 48 in these studies could join the open-label extension, where 446 patients completed Week 96. The primary endpoint for both trials was HiSCR50 at Week 16, with a key secondary endpoint being HiSCR75 at the same time point.

Bimekizumab, the active ingredient in BIMZELX, is a monoclonal antibody that inhibits both IL-17A and IL-17F, cytokines involved in inflammatory processes. In the U.S., BIMZELX is approved for treating moderate-to-severe plaque psoriasis in adults, as well as for other inflammatory conditions like psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. However, it is not approved for treating hidradenitis suppurativa in the U.S., and its efficacy and safety profile for HS have not been established.

These findings highlight the potential of BIMZELX as a long-term treatment option for patients with moderate-to-severe hidradenitis suppurativa, offering sustained clinical benefits and improved quality of life over an extended period.