BE BOLD at 16 Weeks: Bimekizumab Outperforms Risankizumab for PsA

Key Takeaways

• In the head-to-head BE BOLD trial, bimekizumab achieved superior ACR50 responses versus risankizumab at week 16 in adults with active psoriatic arthritis.
• Almost half of patients treated with bimekizumab achieved the primary endpoint.
• Safety profiles were similar between treatments. Candida infections occurred more frequently with bimekizumab.

New data from the Phase 3 BE BOLD study show that bimekizumab (Bimzelx; UCB) achieved superior joint responses compared with risankizumab (Skyrizi; AbbVie) in adults with active psoriatic arthritis (PsA), according to news release from UCB.

The study enrolled 553 adults with active PsA who were biologic-naïve or had previously experienced an inadequate response or intolerance to one tumor necrosis factor inhibitor. Participants were randomized to receive either bimekizumab or risankizumab. 16-week results were presented at the 

At Week 16, 49.1% of patients treated with bimekizumab achieved the primary endpoint of a 50% improvement in American College of Rheumatology response criteria (ACR50), compared with 38.4% of patients receiving risankizumab (P = 0.0078). Investigators noted that bimekizumab is the first approved biologic therapy to demonstrate statistically significant superiority in ACR50 outcomes in a head-to-head PsA trial.

Early and Sustained Psoriatic Arthritis Responses

Minimal disease activity (MDA) at Week 16 (a secondary endpoint) numerically favored bimekizumab (43.0% vs 39.9%), but the difference did not reach statistical significance. Exploratory analyses showed complete skin clearance (PASI100) in 53.4% of bimekizumab-treated patients vs 46.6% of risankizumab-treated patients. Additionally, ACR50 responses emerged earlier with bimekizumab, with 19.9% of patients achieving the endpoint at Week 4 versus 7.2% in the risankizumab arm.

No new safety signals were identified. Overall adverse event rates were similar between groups, although Candida infections occurred more frequently among patients receiving bimekizumab. All reported Candida infections were mild or moderate and did not result in treatment discontinuation.

“The new BE BOLD data, showing bimekizumab achieved superiority vs risankizumab in ACR50 at Week 16 in a direct head-to-head trial design, can support clinicians in making early informed decisions for treating this chronic inflammatory disease,” said Professor Iain McInnes, University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, UK, in the press release.

Source

UCB press release.