UCB, a global biopharmaceutical company, announced new long-term data from the BIMZELX Phase 2b study BE AGILE and its open-label extension (OLE) revealing that patients with ankylosing spondylitis (AS) treated with BIMZELX showed sustained improvements in signs and symptoms, disease activity, physical function, and health-related quality of life for up to five years, with a consistent safety profile. These findings were presented at the American College of Rheumatology Convergence 2023 conference in San Diego and mark the first report of ASAS40 five-year data in patients with ankylosing spondylitis to use a conservative non-responder imputation analysis method. This data showed that at least half of the patients treated with bimekizumab achieved sustained improvements through five years of treatment.
The dose-ranging BE AGILE study consisted of a 12-week double-blind, placebo-controlled period, followed by a period where patients received BIMZELX. 84.2% of patients who entered the open-label extension at Week 48 received at least one BIMZELX dose, and 79.2% of them completed the study. In terms of ASAS40 response, 51.7% of patients achieved ASAS40 at the entry visit, increasing to 59.0% at five years according to non-responder imputation. Meanwhile, quality of life measured by the Ankylosing Spondylitis Quality of Life questionnaire improved over five years, with a low incidence of treatment-related adverse events, indicating the safety and efficacy of BIMZELX.
These results are significant as they demonstrate that BIMZELX offers sustained improvements in the health of patients suffering from AS. This data is essential for providing better treatment options for patients who do not achieve long-term disease control with current therapies. Therefore, UCB is continuing its research and presentations to further inform and benefit those living with AS. This study fills a gap in the treatment of ankylosing spondylitis, raising hopes for future advancements in care for these patients.
