BIMZELX[®](bimekizumab) demonstrates superior efficacy over SKYRIZI[®] (risankizumab) in psoriatic arthritis: BE BOLD Week 16 data

Brussels (Belgium), May 19, 2026 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced Week 16 data from the BE BOLD trial demonstrating superior ACR50 joint outcomes at Week 16 for BIMZELX^®(bimekizumab) versus SKYRIZI®(risankizumab) in adults living with active psoriatic arthritis (PsA). The results are being presented at the 2026 EULAR Annual Meeting in London, UK, June 3–6.¹

“Delivering high-level clinical responses is crucial for people with psoriatic arthritis. Achieving ACR50 level responses in clinical trials indicates joint improvements that correlate closely with clinically meaningful reductions in disease activity, inflammation control and consequent improvements in quality of life,” said Professor Iain McInnes, University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, UK. “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.”

“We are proud to announce results demonstrating the superiority of bimekizumab over risankizumab in improving joint outcomes, providing significant evidence that can inform the treatment landscape for psoriatic arthritis,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Evidence, UCB. “Head-to-head trials are the most rigorous approach to comparative clinical research. BE BOLD reflects UCB’s commitment to scientific excellence through generating high-quality evidence, that supports advancing care for people living with psoriatic disease.”

Bimekizumab is the first approved biologic therapy to demonstrate statistically significant superiority in ACR50 joint outcomes in any head-to-head trial for PsA. BE BOLD is also the first head-to-head trial in PsA to include an IL 23 inhibitor and is the fourth head-to-head study demonstrating superiority in the bimekizumab clinical trial program across psoriatic disease, with the previous studies comparing therapies in psoriasis.

The Week 16 results from BE BOLD will be presented at EULAR in an oral presentation at 12:00 BST on Saturday 6 June. These data from BE BOLD form part of UCB’s broader presence at the 2026 EULAR Annual Meeting, where a total of 27 abstracts will be presented across the UCB immunology portfolio assets in PsA, psoriasis, axial spondyloarthritis, rheumatoid arthritis, and systemic lupus erythematosus. 

BE BOLD Week 16 results 

• Bimekizumab met the primary endpoint for BE BOLD of superiority in ACR50 at Week 16, achieved by 49.1% receiving bimekizumab vs 38.4% receiving risankizumab, with statistical significance (p=0.0078).^1†
• The first ranked secondary endpoint, MDA at Week 16, was numerically higher in bimekizumab (43.0%) vs risankizumab (39.9%) at Week 16 but did not reach statistical significance within the prespecified testing hierarchy (p=0.4408).^1† Sequential testing stopped at this point due to the study design, and subsequent ranked secondary endpoints were descriptive only, with numerically higher proportions achieved with bimekizumab.¹
• Numerically higher proportions of those treated with bimekizumab vs risankizumab achieved the ranked secondary endpoint of simultaneous ACR50+PASI100 at Week 16 (33.5% vs 24.4%; nominal p=0.0800).^1†‡ The ranked secondary endpoint of ACR50 at Week 4 was considered nominally significant for bimekizumab over risankizumab (19.9% vs 7.2%; nominal p<0.0001); endpoints are considered ‘nominally significant’ if the statistical test for that endpoint meets its pre specified alpha level (i.e., p < 0.05 in this case) before accounting for multiplicity, hierarchy, or other adjustments required in a confirmatory analysis.^1,2,3†
• Of the exploratory endpoints: PASI100 at Week 16 was met by 53.4% treated with bimekizumab and 46.6% of those treated with risankizumab;^1‡ DAPSA LDA+REM, DAPSA score ≤14, at Week 16 was met by 65.3% treated with bimekizumab and 54.7% of those treated with risankizumab.^1† 
• No new safety signals were identified, and overall safety profiles were comparable between treatments, except for Candida infections which were more frequent for bimekizumab.1 All Candida infections were mild or moderate; none were serious, systemic or led to study discontinuation.¹ Rates of treatment-emergent adverse events (TEAEs) were 57.0% with bimekizumab and 52.0% with risankizumab.¹
• Serious TEAEs occurred in 5 (1.8%) bimekizumab-treated patients and 8 (2.9%) risankizumab-treated patients. Severe TEAEs in 5 (1.8%) bimekizumab-treated patients and 5 (1.8%) risankizumab-treated patients.¹
• Discontinuations due to TEAEs were low and identical between treatment arms.¹ There were no cases of suicidal ideation and behavior.¹ 

* nominally significant^1
† All results are assessed with non-responder imputation (NRI): All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response. Results are reported from the Bimekizumab Total group (BKZ Total), which includes those receiving bimekizumab 160 mg every four weeks (Q4W) in those with no or mild psoriasis (n=248), and those receiving bimekizumab 320 mg every four weeks to Week 16 and then every eight weeks thereafter (Q4W/Q8W) in those with moderate or severe psoriasis (n=29).¹ Those in the risankizumab group (n=276) received risankizumab 150 mg at baseline, Week 4, and Week 16 regardless of whether the recipient had no or mild psoriasis (n=245), or moderate or severe psoriasis (n=31)^1
‡ In a subgroup of people also living with psoriasis affecting at least 3% of body surface area at baseline.¹ In this subgroup: BKZ Total, n=176 [bimekizumab 160 mg Q4W n=147; bimekizumab 320mg Q4W/Q8W n=29]; risankizumab group, n=176.¹ Differences between bimekizumab and risankizumab in ACR50+PASI100 at Week 16 and PASI100 at Week 16 were not statistically significant¹

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).⁴ This represents a stringent efficacy outcome in psoriatic arthritis.^5,6
• MDA: Minimal Disease Activity (MDA), a dichotomous endpoint (i.e., either it is reached or it is not) demonstrating minimum inflammatory disease. The MDA score comprises seven relevant disease-related domains (tender/swollen joint count, skin, physical function, pain, enthesis, general patient-based evaluation), such that achieving five or more of the seven indicates MDA.⁷ A participant in BE BOLD was considered as having MDA if five or more of the following seven criteria were fulfilled:⁸
  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA ≤3 (less than or equal to 3% body surface area affected)
  • PtAAP VAS ≤15 (Patient's Assessment of Arthritis Pain score ≤15: 0=no pain;100=most severe pain)
  • PGA-PsA VAS ≤20 (Physician's Global Assessment in Psoriatic Arthritis score ≤20: 0=very good, asymptomatic, no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities)
  • HAQ-DI ≤0.5 (Health Assessment Questionnaire-Disability Index score ≤0.5: degree of difficulty experienced in eight domains of daily living activities [20 questions], total score [0–3] computed from item scores, with lower scores meaning less disability)
  • Tender enthesial points ≤1
• PASI100: 100% improvement from baseline in Psoriasis Area and Severity Index (PASI), indicating complete skin clearance.⁹
• DAPSA LDA+REM: Disease Activity Index for Psoriatic Arthritis (DAPSA) low disease activity (LDA)+remission(REM). DAPSA is a continuous scale incorporating tender/swollen joint counts, Patient Global Assessment (PtGA) of PsA activity, patient pain assessment and C-reactive protein (CRP) levels. DAPSA classifications validated for PsA include: ≤4 (REM), >4–≤14 (LDA), >14–≤28 (moderate disease activity) and >28 (high disease activity).^1,10 

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.¹¹ Of people living with psoriasis, approximately 30 percent progress to also develop psoriatic arthritis.¹² 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).¹³ 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.¹⁴ In PsA, uncontrolled active disease can lead to long-term structural damage.¹⁵

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).^1,8 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.⁸ 

The primary endpoint in BE BOLD is ACR50 at Week 16.⁸ The study has a double-blinded methodology until Week 24.¹⁶ In the study, participants were randomized 1:1 to receive either bimekizumab or risankizumab.¹⁶

For details about BE BOLD: https://clinicaltrials.gov/study/NCT06624228.

About BIMZELX^®(bimekizumab) EU/EEA

The approved indications for bimekizumab in the European Union are:¹⁷ 

• 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 <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions (injection site erythema, reaction, edema, pain, swelling, hematoma), fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the Summary of Product Characteristics in relation to other side effects, full safety and prescribing information.

European SmPC date of revision: 30 April 2026. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf  

*EU/EEA means European Union/European Economic Area.

Last accessed: May 2026.

About BIMZELX^® (bimekizumab-bkzx) in the U.S.

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.  Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.¹⁸
The approved indications for BIMZELX in the U.S. are:¹⁸

• Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
• Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
• Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
• Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
• Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adults with moderate to severe hidradenitis suppurativa

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior
BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections
BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. 

Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

Most Common Adverse Reactions
Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.

Please full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.

For further information, contact UCB: 

Investor Relations
Yvonne Naughton 
T +44.175.344.7521 
yvonne.naughton@ucb.com

Sahar Yazdian
T +32.2.559.91.37 
email sahar.yazdian@ucb.com

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@ucb.com

Brand Communications
Amy Cheshire
T +44 7786 743 577
email amy.cheshire@ucb.com

About UCB 
UCB, Brussels, Belgium (www.ucb.com), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB).

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