Vienna, Austria – Last month at the European League Against Rheumatism (EULAR) 2024 conference, UCB presented compelling two-year data from phase 3 trials of bimekizumab (Bimzelx) for the treatment of psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). The study’s findings, highlighted in late-breaking presentations, underscore bimekizumab’s potential for long-term efficacy and safety across these conditions.
Background
Currently approved in the United States for moderate-to-severe plaque psoriasis, bimekizumab’s effectiveness and safety for PsA, nr-axSpA, and AS are still under review. The latest data suggests promising long-term outcomes, particularly in axial spondyloarthritis, with a notable emphasis on AS.
Psoriatic Arthritis (PsA) Insights – Laura Coates, PhD
How do patient-reported outcomes with bimekizumab compare to clinical assessments like DAPSA?
Clinical assessments and patient-reported outcomes in this study were well-aligned. Patients’ self-reported symptom improvements corresponded closely with the clinical measures used by physicians.
Did patients who reached Disease Activity Index for Psoriatic Arthritis (DAPSA) low disease activity or remission also report better outcomes?
While the study did not specifically analyze the correlation between clinical and patient-reported outcomes, existing data indicates that patients who achieve high treatment targets like DAPSA low disease activity or remission report improved quality of life, less pain, and reduced disease impact compared to those not reaching these targets.
Were there differences in treatment responses between biologic-naïve patients and those with prior biologic exposure?
Treatment with bimekizumab demonstrated consistent efficacy in both biologic-naïve patients and those previously treated with biologics. Both groups maintained minimal disease activity (MDA) and DAPSA low disease activity or remission through two years.
Axial Spondyloarthritis (axSpA) Insights – Xenofon Baraliakos, MD, PhD
Which subgroups within the axSpA population showed the most significant benefits from bimekizumab?
The data revealed robust efficacy and safety across both nr-axSpA and AS subgroups. Approximately 50% of patients in both categories achieved and maintained ASAS40—a 40% or greater improvement in axSpA symptoms—over two years. Additionally, around 60% of patients achieved ASDAS low disease activity (ASDAS <2.1), and 30% reached a state of inactive disease (ASDAS <1.3). These results were consistent among new biologic users and those with previous inadequate responses to tumor necrosis factor inhibitors (TNFi-IR).
Were there any notable safety findings or unexpected outcomes from the BE MOBILE studies?
The safety profile of bimekizumab was consistent with previous reports, with no new safety concerns identified. Uveitis incidence remained low, with an exposure-adjusted incidence rate of 1.6 per 100 patient-years.
What did the post hoc analyses of BE MOBILE 1 and BE MOBILE 2 reveal?
The studies highlighted that bimekizumab significantly improved MRI-detected inflammation, reduced erosions, and promoted tissue repair in sacroiliac joints in patients with both nr-axSpA and AS. Notably, over 90% of AS patients showed no significant spinal radiographic progression over two years, as indicated by a modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline of less than 2.
The imaging data presented this year reinforce bimekizumab’s potential to not only address inflammation but also mitigate structural damage in axial spondyloarthritis.
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