Bimekizumab 3-Year Data Shows Lasting Efficacy, Control of Inflammation for PsA, axSpA

Bimekizumab (BIMZELX®) demonstrated sustained control of inflammation and deep efficacy in patients living with psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), according to new 3-year data from phase 3 trials and open-label extensions in adults with active PsA and active axSpA, which includes both non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and ankylosing spondylitits (AS).

“A primary treatment goal in psoriatic arthritis is sustained control of inflammation to help prevent long-term, irreversible structural damage and to improve quality of life,” Laure Gossec, MD, PhD, of the Sorbonne University Hospital in Paris, France, said in a press release from UCB. “These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients, with elimination of swollen joints in nearly sixty percent of patients and approximately half reaching minimal disease activity (MDA) at 3 years—both strong clinical responses that suggest real control of inflammation in PsA.”
In patients with active PsA, regardless of prior treatment experience, results from BE OPTIMAL, BE COMPLETE, and their open-label extension, BE VITAL, showed that bimekizumab delivered sustained efficacy across multiple stringent clinical endpoints for up to 3 years. At 3 years, 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints (SJC=0). Complete skin clearance, measured by Psoriasis Area and Severity Index (PASI) 100, was sustained to 3 years by 61.9% and 67.5% of bDMARD-naïve and TNFi-IR patients, respectively. MDA, a comprehensive and clinically meaningful endpoint, was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively.
“Long-term data, showing that patients living with axSpA can maintain high levels of clinical response, are invaluable for informed treatment decisions. It’s particularly compelling to see sustained responses with bimekizumab treatment at three years with stringent outcome measures like ASAS40 and low disease activity,” Xenofon Baraliakos, MD, PhD, from the Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, in Bochum, Germany, said in the press release. “These endpoints are key indicators of durable inflammation control in axSpA, and achieving this level of sustained disease management is likely to have a profound impact on patients’ daily lives.”
Across patients with nr-axSpA and AS, data from two Phase 3 studies, BE MOBILE 1 and 2, and their combined open-label extension, BE MOVING, BIMZELX treatment demonstrated sustained clinical responses up to 3 years. Achievement of ASAS40 was sustained to 3 years by 60.4% and 60.1% of nr-axSpA and AS patients, respectively, while 61.8% and 59.9% of nr-axSpA and AS patients, respectively, maintained Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (LDA <2.1) through three years.
“Psoriatic arthritis and axial spondyloarthritis are serious, chronic inflammatory diseases that can have a great impact in the daily lives of patients and their families. The data presented at EULAR reinforce the role of bimekizumab to deliver deep, consistent, and sustained outcomes across a spectrum of PsA and axSpA,” Donatello Crocetta, Chief Medical Officer for UCB, said in the release. “These data, alongside our other EULAR data presentations of dapirolizumab pegol in systemic lupus erythematosus and romosozumab in osteoporosis, reflect UCB’s commitment to offering differentiated, science-driven solutions that meet the diverse and evolving needs of people living with rheumatic diseases.”
Across the 3-year clinical trial data for PsA and axSpA, bimekizumab was generally well-tolerated and no new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) over 3 years for both PsA and axSpA in these studies were SARS-CoV-2 (COVID-19) infection, nasopharyngitis, and upper respiratory tract infection.
UCB will present 14 abstracts on PsA and axSpA at EULAR 2025 in Barcelona, Spain, on June 11-14, and will complement other presentations from UCB in systemic lupus erythematosus and osteoporosis. These data, together with a dedication to advancing clinical research—including the ongoing head-to-head Phase 3b BE BOLD trial in psoriatic arthritis—underscore UCB’s ambition to be a leader in rheumatology, commitment to advancing innovation, and focus on providing meaningful solutions across the spectrum of rheumatic diseases.