UCB to Present Two-Year BIMZELX® Data in Axial Spondyloarthritis and Psoriatic Arthritis at EULAR 2024

Patients with non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) treated with BIMZELX have shown consistent and sustained clinical and patient-reported outcomes for up to two years. Recent data reveal that over 90% of AS patients on BIMZELX experienced no spinal radiographic progression over this period, as indicated by a modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline of less than 2. Additionally, psoriatic arthritis (PsA) patients new to biologics and those previously unresponsive or intolerant to tumor necrosis factor inhibitors (TNFi-IR) demonstrated sustained minimal disease activity (MDA) over two years when treated with BIMZELX.

On June 12, 2024, UCB, a global biopharmaceutical company, released the first two-year data from Phase 3 studies BE MOBILE 1, BE MOBILE 2, and their open-label extension BE MOVING, which evaluate BIMZELX in active non-radiographic axial spondyloarthritis and ankylosing spondylitis. This data, along with information from the BE OPTIMAL and BE COMPLETE studies for PsA, was presented at the European Congress of Rheumatology, EULAR 2024 in Vienna, Austria.

BIMZELX is currently approved in the U.S. for treating moderate-to-severe plaque psoriasis in adults eligible for systemic therapy or phototherapy. However, its efficacy and safety for PsA, nr-axSpA, and AS have not been established in the U.S., and these indications remain investigational.

Emmanuel Caeymaex, Executive Vice President at UCB, emphasized the significance of the new data, highlighting BIMZELX's potential to deliver long-term robust outcomes for patients with psoriatic arthritis and axial spondyloarthritis. Professor Xenofon Baraliakos from Ruhr-University Bochum noted that patients with both non-radiographic and radiographic axSpA maintained inflammation suppression and reported improvements in spinal pain, morning stiffness, and fatigue over two years. The data also showed minimal structural progression in AS patients on BIMZELX.

Laura Coates, Associate Professor at the University of Oxford, pointed out that achieving minimal disease activity and remission are crucial treatment goals in PsA. The two-year data showed that approximately 50% of PsA patients on BIMZELX reached sustained minimal disease activity and remission, with significant improvements in joint and skin outcomes.

Key highlights from the two-year BIMZELX data for axial spondyloarthritis included:
- At Week 104, around 50% of nr-axSpA and AS patients achieved a 40% or greater improvement in signs and symptoms (ASAS40).
- Approximately 60% of patients achieved low disease activity (ASDAS <2.1), and 30% reached a state of inactive disease (ASDAS <1.3).
- The majority of AS patients showed no spinal radiographic progression, with a high proportion of non-progressors.

In psoriatic arthritis, about 50% of biologic-naïve and TNFi-IR patients treated with BIMZELX achieved sustained minimal disease activity and remission over two years, as measured by the Disease Activity Index for Psoriatic Arthritis (DAPSA).

Safety data over the two years indicated that BIMZELX was well-tolerated with no new safety signals. The most frequent treatment-emergent adverse events included SARS-CoV-2 infection, nasopharyngitis, and upper respiratory tract infection.

This comprehensive data underscores BIMZELX's potential to offer substantial and sustained benefits for patients with axial spondyloarthritis and psoriatic arthritis, supporting its role in long-term disease management.