2-Year Study Affirms Bimekizumab's Efficacy in Hidradenitis Suppurativa

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At the 33rd European Academy of Dermatology and Venereology (EADV) Congress held in Amsterdam from September 25 to 28, 2024, UCB announced groundbreaking 2-year data from its phase 3 studies, BE HEARD I and BE HEARD II, regarding the efficacy and safety of bimekizumab. Both studies targeted adults with moderate to severe hidradenitis suppurativa (HS).¹

Study Overview

The BE HEARD I and II trials involved a total of 1,014 patients randomized to receive either bimekizumab or a placebo. Those completing the initial 48-week treatment period had the option to enter an open-label extension study, receiving bimekizumab every 2 or 4 weeks based on their response. The studies' primary endpoint was HS Clinical Response 50 (HiSCR50) at week 16, with HiSCR75 as a key secondary endpoint.

Sustained Improvements Over 2 Years

The phase 3 trials initially demonstrated significant efficacy at the 1-year mark, and researchers found the newly presented data affirm that these benefits are not only sustained but also enhanced over the following year. By week 96, they reported 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.²

Furthermore, researchers found patients 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 company stated 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).

Quality of Life Enhancements

The studies showed that bimekizumab treatment significantly improved health-related quality of life as well. 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 indicated to researchers a transformation in patients’ overall well-being, further reinforcing the treatment's potential benefits.

Safety Profile

The safety profile of bimekizumab also 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. Researchers reported 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 Insights

The significance of these findings was underscored by Professor Christos C. Zouboulis, president of the European HS Foundation (EHSF) e.V., director of the departments of dermatology, venereology, allergology and immunology, StädtischesKlinikum Dessau, and founding professor of Dermatology and Venereology at the Brandenburg Medical School, Germany: “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.”

“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,” said Fiona du Monceau, executive vice president, head of patient evidence, UCB. “These longer-term data build on the 48-week results, demonstrating maintained response over 2 years, which is highly relevant for the HS community.”

Conclusion

The 2-year data presented by UCB at the EADV Congress signify a promising advancement in the treatment landscape for HS. With sustained improvements in clinical response, disease severity, and quality of life, bimekizumab offers hope for many patients suffering from this challenging condition. As the need for long-term treatment options becomes increasingly evident, the findings contribute valuable insights that may inform clinical practice and patient care strategies moving forward. UCB's commitment to addressing this unmet medical need marks a significant step toward improving the quality of life for individuals living with HS.

References

1. UCB announces late-breaking two-year data for BIMZELX[®](bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024. News Release. UCB. September 27, 2024. Accessed September 27, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-late-breaking-two-year-data-for-BIMZELXRVbimekizumab-in-moderate-to-severe-hidradenitis-suppurativa-at-EADV-2024 
2. Zouboulis C, Garg A, Sayed C, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. Abstract presented at EADV 2024. Amsterdam, Netherlands. September 25-28, 2024.