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Two-year data from the Phase III BE MOBILE 1, BE MOBILE 2, and the open-label extension BE MOVING trials demonstrated the efficacy of Bimzelx (bimekizumab-bkzx) treating active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS).1 The data from these trials will be presented at the European Congress of Rheumatology (EULAR) 2024 from June 12-15.
“The [Bimzelx] new two-year data in axial spondyloarthritis and psoriatic arthritis presented at EULAR 2024 reinforce our belief in [Bimzelx] to provide long-term robust and sustained outcomes for patients with psoriatic arthritis and for patients across the full spectrum of axial spondyloarthritis,” Emmanuel Caeymaex, executive vice president, head of Patient Impact, chief commercial officer, UCB, said in a press release. “We are particularly excited to share new late-breaking data that highlights our commitment to demonstrate the long-term benefit of [Bimzelx] on disease progression in radiographic axial spondyloarthritis.”1
The humanized monoclonal IgG1 antibody was developed to selectively inhibit interleukin (IL)-17A and IL-17F, two cytokines that affect inflammatory processes. In October 2023, Bimzelx received FDA approval to treat adults with moderate to severe plaque psoriasis who are eligible for systemic therapies or phototherapies, making it the first and only approved psoriasis treatment that selectively inhibits IL-17A and IL17F.2
Both BE MOBILE 1 and BE MOBILE 2 included a 16-week double-blind treatment period followed by a 36-week maintenance period to analyze the efficacy and safety of Bimzelx in the treatment of nr-axSpA and AS, respectively. For both trials, the primary endpoint was Assessment of SpondyloArthritis International Society 40 percent (ASAS40) response at week 16.
BE MOBILE 1 randomly assigned 128 patients to Bimzelx 160 mg Q4W and 126 patients to placebo, whereas BE MOBILE 2 randomly assigned 221 patients to Bimzelx 160 mg Q4W and 111 patients to placebo. Those randomly assigned to the placebo cohorts were switched over to the Bimzelx treatment cohorts at week 16. Those who completed 52 weeks of treatment in both studies and those who achieved eligibility criteria were enrolled in BE MOVING. Among 254 patients with nr-axSpA and 332 patients with AS enrolled in the BE MOBILE 1 and 2 trials, 494 patients were enrolled in BE MOVING, of whom 189 patients with axSpA and 267 patients with AS completed week 104.
Data show that at week 104, 49.2% of patients with nr-axSpA (n=254) and 53.9% (n=332) of patients with AS administered Bimzelx achieved ASAS40 and 61.2% of those with nr-axSpA (n=254) and 63.4% of those with AS (n=332) administered Bimzelx achieved low disease activity (ASDAS<2.1). Patient-reported outcomes among those in the Bimzelx cohort showed consistent and sustained improvements in areas such as spinal pain, morning stiffness, and fatigue across two years, according to the investigators.
“The [Bimzelx] data in axial spondyloarthritis presented at EULAR 2024 showed that non-radiographic and radiographic axSpA patients achieved sustained suppression of inflammation over two years, and reported sustained improvements in symptoms which have a substantial impact on daily living including spinal pain, morning stiffness and fatigue,” Xenofon Baraliakos, professor of Internal Medicine and Rheumatology, Ruhr-University Bochum, Bochum, Germany, said in the release. “One of the long-term treatment goals in axSpA is the prevention of structural progression. Late-breaking data also shared at the congress showed that the majority of radiographic axial spondyloarthritis patients treated with [Bimzelx] had no spinal radiographic progression over two years.”1
In terms of safety, the profile of Bimzelx among patients with axSpA across two years of treatment was consistent with prior trials and no new safety signals were reported. At week 104 among patients with axSpA administered Bimzelx, 89.5% (514/574) reported ≥1 treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs by exposure-adjusted incidence rate per 100 patient-years were SARS-CoV-2 infection (13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0).
“Minimal disease activity and remission are key treatment targets in the treatment of psoriatic arthritis,” Laura Coates, associate professor, Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK, said in the release. “New two-year data presented at EULAR 2024 showed that approximately 50% of patients treated with [Bimzelx] achieved sustained minimal disease activity and remission over two years. Improvements were observed across all patient-reported and most clinical components of minimal disease activity, with robust improvements in joint and skin outcomes.”1
References
1. UCB to share first presentations of BIMZELX® (bimekizumab-bkzx) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024. News release. June 12, 2024. Accessed June 12, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-to-share-first-presentations-of-bimzelxr-bimekizumab-bkzx-two-year-data-in-axial-spondyloarthritis-and-psoriatic-arthritis-at-EULAR-2024
2. BIMZELX Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis. UCB. News release. October 18, 2023. Accessed June 12, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis