UCB Presents 4-Year Data on Bimekizumab for Plaque Psoriasis

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This week, UCB released promising 4-year data on bimekizumab (Bimzlex; UCB) for moderate to severe plaque psoriasis during the 33rd European Academy of Dermatology and Venereology (EADV) Congress held in Amsterdam. The findings focus on the long-term effectiveness of bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, in maintaining skin clearance and evaluating responses in patients who previously exhibited inadequate results from other treatments.¹

Key Findings on Treatment Response

The data presented emphasizes the durability of response in patients who achieved near complete or complete skin clearance after 1 year of bimekizumab treatment. "Given the chronic nature of psoriasis, it is critically important to evaluate long-term response of treatments. Achieving completely clear skin is a key goal for people living with moderate-to-severe plaque psoriasis, and results presented at EADV 2024 showed that over 7 out of 10 patients who achieved complete skin clearance after 1 year maintained this response at 4 years," Richard Warren, BSc, MBChB, MRCP, PhD, the Northern Care Alliance NHS Foundation Trust and professor at the University of Manchester, United Kingdom, said in a press release.

Fiona du Monceau, MSc, MBA, UCB’s executive vice president, underscored the importance of these results, noting that the data reflect not just the clinical efficacy of bimekizumab, but also its potential for providing lasting relief for patients battling this chronic condition: "The 4-year data presented at EADV 2024 demonstrate maintenance of complete skin clearance for patients continuing treatment with bimekizumab. We are also proud to share the design of BE UNIQUE, a phase 3b study investigating whether the durability of clinical response with bimekizumab is associated with molecular and cellular changes in skin, blood, and joints of patients with psoriatic disease."²

Comprehensive Data Analysis

The findings stem from extensive post-hoc analyses of previously conducted pivotal trials, specifically the 52-week BE VIVID and 56-week BE SURE and BE READY studies, alongside the open-label extension BE BRIGHT.³ From a cohort of 771 patients, the results were:

• Psoriasis Area and Severity Index (PASI) 90: 89.6% of patients responded positively at year 1.
• PASI100: 75.1% achieved complete skin clearance at year 1.
• Among the PASI90 responders, 87.9% maintained their status at year 4, and 74.2% of PASI100 responders did the same.

Insights from Patients Switching Treatments

The analysis also examined the responses of patients who switched to bimekizumab after showing inadequate results with other therapies, including adalimumab, ustekinumab, and secukinumab. The findings indicated significant improvements post-switch:

• Adalimumab: 41.9% of patients were not achieving PASI90 at the time they switched to bimekizumab, yet 92.2% achieved PASI90 and 74.4% achieved PASI100 after 176 weeks on bimekizumab.
• Ustekinumab: 33.3% were not at PASI90 at the time of switch, but 82.0% achieved PASI90 and 58.8% PASI100 after 144 weeks on bimekizumab.
• Secukinumab: 18.5% were not achieving PASI90 at the time of switch, but 71.7% achieved PASI90 and 39.8% achieved PASI100 after 96 weeks on bimekizumab.

The BE UNIQUE Study

Alongside these findings, UCB introduced the BE UNIQUE study, an exploratory phase 3b trial aimed at understanding the molecular and cellular responses to bimekizumab This study seeks to analyze changes in gene expression associated with bimekizumab's mechanism of action and its impact on psoriatic disease pathways. By focusing on these biological changes, UCB says it aims to deepen the understanding of treatment effectiveness and tailor approaches for psoriatic disease management.²

Safety Profile

In addition to the efficacy data, UCB shared long-term safety findings on bimekizumab, which revealed that treatment-emergent adverse events remained consistent with extended exposure and no new safety concerns arose, reinforcing the treatment's profile.

References

1. UCB presents new 4-year data for bimzelx (bimekizumab-bkzx) in moderate-to-severe plaque psoriasis at EADV 2024. News release. PR Newswire. September 25, 2024. Accessed September 26, 2024. https://www.prnewswire.com/news-releases/ucb-presents-new-4-year-data-for-bimzelx-bimekizumab-bkzx-in-moderate-to-severe-plaque-psoriasis-at-eadv-2024-302257850.html#:~:text=UCB%20previously%20shared%20four%2Dyear,with%20no%20new%20safety%20signals.
2. Gudjonsson J, Merola J, Warren R, et al. Bimekizumab: Exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease – Design and rationale behind the exploratory, multicentre, open-label phase 3b BE UNIQUE study. Abstract presented at EADV 2024, Amsterdam, Netherlands.
3. Gordon KB, Cather J, Pariser D, et al. Bimekizumab maintenance of response from the end of pivotal trials through 4 years: Results in patients with moderate to severe plaque psoriasis from BE BRIGHT. Abstract presented at EADV 2024, Amsterdam, Netherlands.