UCB presented two-year data from its Phase 3 BE HEARD I and BE HEARD II studies at the 33rd European Academy of Dermatology and Venereology (EADV) Congress, demonstrating the sustained efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). The trials, involving 1,014 patients, showed significant improvements in clinical response, disease severity, and quality of life over the extended treatment period. These findings offer hope for patients with this challenging condition, addressing the need for long-term treatment options.
Sustained Clinical Improvements
The BE HEARD I and II trials initially demonstrated significant efficacy at the 1-year mark, and the newly presented data affirm that these benefits are not only sustained but also enhanced over the following year. By week 96, 85.4% of patients treated with bimekizumab achieved HiSCR50, indicating a substantial reduction in disease symptoms. More rigorous endpoints showed that 77.1% achieved HiSCR75, and 44.2% reached HiSCR100, highlighting the treatment's efficacy.
Patients also exhibited considerable improvements in disease severity, as measured by the International HS Severity Score System (IHS4). At the start of the study, the mean IHS4 score among participants was 35.6. The percent change from baseline in IHS4 score at Week 48 among bimekizumab patients was maintained through Week 96 (-70.3±39.6 and -79.8±28.1 at Week 48 and Week 96, respectively).
Enhanced Quality of Life
The studies revealed that bimekizumab treatment significantly improved health-related quality of life. By Week 96, approximately one-third of patients reported minimal or no impact of HS on their lives, with 33.9% achieving a Dermatology Life Quality Index score of 0/1. This indicates a transformation in patients’ overall well-being, further reinforcing the treatment's potential benefits.
Favorable Safety Profile
The safety profile of bimekizumab remained favorable throughout the 2-year period. Over 900 patients received at least 1 dose, with treatment-emergent adverse events (TEAEs) reported in 917 individuals. Serious TEAEs were noted in 122 patients, with the most commonly observed events being hidradenitis itself, coronavirus infections, and oral candidiasis. Importantly, no new safety signals emerged during the extended treatment period, suggesting that bimekizumab can be considered a safe long-term option for patients with HS.
Expert Commentary
Professor Christos C. Zouboulis, president of the European HS Foundation (EHSF) e.V., stated, “HS is a chronic, relapsing and painful inflammatory skin disease that significantly impacts patients’ quality of life. The bimekizumab data presented at EADV 2024 showed maintained improvements in clinical response, symptoms, severity and quality of life over 2 years. These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients.”
Fiona du Monceau, executive vice president, head of patient evidence, UCB, added, “In moderate to severe HS, healthcare professionals and patients value long-term data when they are making treatment decisions. We are proud to present, for the first time, the bimekizumab two-year results at EADV 2024. These longer-term data build on the 48-week results, demonstrating maintained response over 2 years, which is highly relevant for the HS community.”
These findings signify a promising advancement in the treatment landscape for HS, offering sustained improvements and a favorable safety profile, which may inform clinical practice and patient care strategies moving forward.
