UCB : BIMZELX 3-Year Results Confirm Sustained Efficacy In Psoriatic And Axial Spondyloarthritis

(RTTNews) - UCB (UCB) announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), which includes both non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and ankylosing spondylitits (AS).

BIMZELX, a dual inhibitor of IL-17A and IL-17F, demonstrated sustained control of inflammation and deep efficacy in patients living with psoriatic arthritis and active axial spondyloarthritis, chronic inflammatory diseases with considerable impact on physical and emotional wellbeing.

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 BIMZELX delivered sustained efficacy across multiple stringent clinical endpoints for up to three years. At three years, 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints (SJC=0).

The company noted that Complete skin clearance, measured by Psoriasis Area and Severity Index [PASI]100, was sustained to three 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.

In addition, the company announced that, 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 three years. Achievement of ASAS40 was sustained to three 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.

The company noted that, across the three-year clinical trial data for PsA and axSpA, BIMZELX was generally well-tolerated and no new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) over three years for both PsA and axSpA in these studies were SARS-CoV-2 (COVID-19) infection, nasopharyngitis, and upper respiratory tract infection.

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