BIMZELX®▼(bimekizumab) superior to SKYRIZI® (risankizumab) in BE BOLD: first head-to-head study in active psoriatic arthritis (PsA) to demonstrate superiority in ACR50
- Primary endpoint showing superiority met: Bimekizumab achieved statistically significant superiority over risankizumab in reducing disease activity, as measured by the stringent ACR50 endpoint, at Week 16 in adults living with active psoriatic arthritis
- Landmark psoriatic arthritis (PsA) study: Bimekizumab is the first licensed biologic therapy to demonstrate superiority in psoriatic arthritis over an IL-23 inhibitor
- Fourth bimekizumab study showing superiority: BE BOLD is the fourth head-to-head study demonstrating superiority in the bimekizumab clinical trial program across psoriatic disease, and the first conducted in PsA
ATLANTA, March 11, 2026 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced positive topline data from the BE BOLD trial assessing BIMZELX® (bimekizumab) versus SKYRIZI® (risankizumab) in adults with active psoriatic arthritis (PsA). Bimekizumab, the first and only approved medicine to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), demonstrated statistically significant superiority in the ACR50 primary efficacy endpoint at Week 16. Treatment with bimekizumab was generally well tolerated, with no new safety signals observed to Week 16.
"Our landmark BE BOLD study provides the first head-to-head evidence of superiority versus an IL-23 inhibitor in psoriatic arthritis. These topline results reinforce bimekizumab's potential to deliver clinically meaningful improvements using the stringent ACR50 measure of disease activity, indicating more complete control of joint inflammation," said Emmanuel Caeymaex, Executive Vice President, Head of Patient Evidence, UCB. "BE BOLD represents the fourth head-to-head study demonstrating bimekizumab superiority, supporting physicians to make informed treatment decisions and advancing our ambitions to raise the standard of care for people living with psoriatic disease."
The results of BE BOLD add to the breadth of data for bimekizumab across a range of immune-mediated inflammatory diseases. UCB plans to submit the full BE BOLD results to a forthcoming international congress.
Notes to Editors
- ACR50: A 50% or greater improvement from baseline in American College of Rheumatology response criteria, including at least a 50% improvement in tender and swollen joint counts as well as 50% improvement in three additional criteria (physician global, patient global, patient pain, function, and CRP/erythrocyte sedimentation rate).1 This represents a stringent efficacy outcome in psoriatic arthritis.2,3
About psoriatic arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.4 Of people living with psoriasis, approximately 30% progress to also develop psoriatic arthritis.5 It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).6 The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression.7 In PsA, uncontrolled active disease can lead to long-term structural damage.8
About the BE BOLD trial
BE BOLD is a multicenter, randomized, double-blind, risankizumab-controlled, parallel-group study designed to evaluate the efficacy and safety of bimekizumab in adult study participants (n=553) with active psoriatic arthritis (PsA).9 The study includes adults with active PsA who are naïve to biologic treatments or who had previous exposure to one tumor necrosis factor-inhibitor (TNFi) with an inadequate or intolerant response.9
The primary endpoint in BE BOLD is ACR50 at Week 16.9 The study has a double-blinded methodology until Week 24.10 In the study, participants were randomized 1:1 to receive either bimekizumab or risankizumab.10
For details about BE BOLD: https://clinicaltrials.gov/study/NCT06624228.
About BIMZELX®▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA)
BIMZELX® is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.11
About BIMZELX®▼(bimekizumab) EU/EEA*
The approved indications for bimekizumab▼ in the European Union are:11
- Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
- Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs)
- Axial spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy
- Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy
The label information may differ in other countries where approved. Please check local Prescribing Information.
BIMZELX®▼(bimekizumab) EU/EEA* Important Safety Information The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to
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