New two-year data presented at the American College of Rheumatology (ACR) Convergence 2024 highlights the sustained efficacy of bimekizumab-bkzx, an IL-17A and IL-17F inhibitor, in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The data reinforces bimekizumab's potential as an effective treatment for these chronic inflammatory diseases.
The findings come from Phase 3 studies BE OPTIMAL and BE COMPLETE (PsA), BE MOBILE 1 (nr-axSpA), BE MOBILE 2 (AS), and their open-label extensions BE VITAL and BE MOVING. Bimekizumab received FDA approval for PsA, nr-axSpA, and AS in September 2024.
Sustained Clinical Response in Psoriatic Arthritis
For patients with psoriatic arthritis, the new data demonstrated robust maintenance of clinical responses over two years. More than 7 in 10 Week 16 responders sustained a 50% improvement in ACR response criteria (ACR50) at two years. Complete skin clearance (PASI100) experienced at Week 16 was maintained to two years by 70.9% of bDMARD-naïve patients and 80.6% of TNFi-IR patients. Similar trends were observed for minimal disease activity (MDA) response, with approximately 75% of patients maintaining response to two years. Improvements in pain at one year were sustained up to two years, with approximately half of patients experiencing a ≥50% reduction in Pain Visual Analogue Scale (Pain VAS) at two years.
Efficacy in Axial Spondyloarthritis
In patients with nr-axSpA and AS, the two-year data demonstrated sustained, high levels of efficacy across all domains of axSpA, with long-term maintenance of low disease activity and remission. More than 8 in 10 patients who achieved ASAS40 at Week 16 sustained this response at two years. Of patients who reached ASDAS inactive disease (ASDAS <1.3) at Week 16, 76.0% maintained the response to two years.
Reduction in Inflammation and Structural Lesions
New one-year data demonstrated that a higher proportion of patients with nr-axSpA or AS treated with bimekizumab-bkzx achieved remission when defined by objective signs of inflammation (OSI) compared to ASDAS-Inactive Disease (ASDAS-ID). More than 50% of patients with nr-axSpA and AS treated with bimekizumab-bkzx achieved remission defined by the resolution of objective signs of inflammation (MRI of the sacroiliac joints and spine (SPARCC score <2), low C-reactive protein levels (≤5 mg/L) and a swollen joint count (SJC) of 0) at 52 weeks.
Safety Profile
A pooled safety analysis of six Phase 2b/3 studies and their open-label extensions in patients with active nr-axSpA, AS, and active PsA confirmed that the long-term safety profile was consistent with previous studies. The most frequently reported treatment-emergent adverse events after 2 years (≥6% of patients in both the axSpA and PsA pools) were SARS-CoV-2 (COVID-19) infection (20.9%), nasopharyngitis (15.7%), and upper respiratory tract infection (13.6%).
Expert Commentary
Dr. Fabian Proft, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Germany, noted, "The new results presented at ACR Convergence 2024 show that bimekizumab-bkzx met stringent clinical endpoints, with high levels of efficacy across multiple domains of axial spondyloarthritis and psoriatic arthritis, and were sustained for two years, demonstrating bimekizumab-bkzx’s ability to remain effective over the long term."
