Two-year data from multiple Phase III trials and their open-label extensions demonstrate the sustained efficacy and safety of Bimzelx (bimekizumab-bkzx) in treating active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). The data, presented at the ACR Convergence 2024, reinforce Bimzelx's potential as a long-term treatment option for these chronic inflammatory diseases.
Bimzelx, a humanized monoclonal IgG1 antibody, selectively inhibits interleukin (IL)-17A and IL-17F, key cytokines driving inflammatory processes. The FDA approved Bimzelx in September 2024 for treating adults with PsA, nr-axSpA, and AS, marking the first approval of a medication for these conditions that selectively inhibits IL-17A and IL-17F. It was also approved for moderate-to-severe plaque psoriasis in October 2023.
Long-Term Efficacy in Multiple Spondyloarthritis Conditions
The long-term data for Bimzelx were gathered from the Phase III trials BE OPTIMAL (PsA), BE COMPLETE (PsA), and their open-label extension BE VITAL; and the Phase III BE MOBILE 1 (nr-axSpA), BE MOBILE 2 (AS), and their open-label extension BE MOVING. These trials assessed the drug's efficacy and safety over a two-year period.
The results indicated strong maintenance of clinical responses, including complete skin clearance, minimal disease activity, improved joint pain, and positive patient-reported outcomes over two years. Among patients who responded at week 16, more than 70% sustained a 50% improvement in ACR response criteria over the two-year study period. These responses were consistent regardless of prior biologic disease-modifying anti-rheumatic drug use or intolerance to TNF inhibitors.
In patients with nr-axSpA and AS, the two-year data demonstrated that Bimzelx maintained high levels of efficacy across all domains of axSpA, with long-term maintenance of limited disease activity and remission. More than 80% of patients who achieved ASAS40 at week 16 maintained this response for two years.
Safety Profile
A pooled analysis of data from three Phase IIb/III trials and their open-label extensions in patients with active nr-axSpA, AS, and active PsA showed that the safety profile of Bimzelx remained consistent with previous findings, with no new safety signals identified.
In a prior trial in patients with axSpA, the most commonly reported treatment-emergent adverse events, adjusted for exposure, were SARS-CoV-2 infection (13.2 per 100 patient-years), nasopharyngitis (10.2 per 100 patient-years), and upper respiratory tract infection (6.0 per 100 patient-years).
Expert Commentary
Dr. Fabian Proft, from Charité Universitätsmedizin Berlin, commented on the significance of the findings: "The new results presented at ACR Convergence 2024 show that [Bimzelx] 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 [Bimzelx’s] ability to remain effective over the long term."
