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Ucb Announces Superior Efficacy of Bimzelx over Skyrizi in Psoriatic Arthritis
UCB, a global biopharmaceutical company, announced Week 16 data from the BE BOLD trial demonstrating superior ACR50 joint outcomes at Week 16 for BIMZELX (bimekizumab-bkzx) versus SKYRIZI (risankizumab-rzaa) in adults living with active psoriatic arthritis (PsA). BIMZELX is the first approved biologic therapy to demonstrate superior, head-to-head ACR50 joint outcomes in psoriatic arthritis: 49.1% of those receiving BIMZELX vs 38.4% receiving risankizumab achieved the stringent ACR50 primary endpoint at Week 16. Improvements in secondary endpoints: Numerically greater responses without statistical significance were observed for BIMZELX vs risankizumab across all secondary endpoints, with no new safety signals observed. Greater improvements in joint relief at Week 4: The secondary endpoint of ACR50 at Week 4 was 19.9% for those receiving BIMZELX vs 7.2% for those receiving risankizumab. Complete skin clearance: 53.4% of those receiving BIMZELX and 46.6% receiving risankizumab achieved the PASI100 exploratory endpoint at Week 16. BIMZELX is the first and only approved medicine 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. The Week 16 results from BE BOLD will be presented at EULAR in an oral presentation at 12:00 BST on Saturday, June 6. 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. BIMZELX met the primary endpoint for BE BOLD of superiority in ACR50 at Week 16, achieved by 49.1% receiving BIMZELX vs 38.4% receiving risankizumab, with statistical significance (p=0.0078). The first ranked secondary endpoint, MDA at Week 16, was numerically higher in BIMZELX (43.0%) vs risankizumab (39.9%) at Week 16 but did not reach statistical significance within the prespecified testing hierarchy (p=0.4408). 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 BIMZELX. Numerically higher proportions of those treated with BIMZELX vs risankizumab achieved the ranked secondary endpoint of simultaneous ACR50+PASI100 at Week 16 (33.5% vs 24.4%; nominal p=0.0800). The ranked secondary endpoint of ACR50 at Week 4 was considered nominally significant for BIMZELX over risankizumab (19.9% vs 7.2%; nominal pCandida infections were mild or moderate; none were serious, systemic, or led to study discontinuation. Rates of treatment-emergent adverse events (TEAEs) were 57.0% (158/277) with BIMZELX and 52.0% (143/275) with risankizumab. Serious TEAEs occurred in 5 (1.8%) BIMZELX-treated patients and 8 (2.9%) risankizumab-treated patients. Severe TEAEs were reported in 5 (1.8%) BIMZELX-treated patients and 5 (1.8%) risankizumab-treated patients. Discontinuations due to TEAEs were low and identical between treatment arms. BE BOLD was not statistically powered to compare safety outcomes between BIMZELX and risankizumab. 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 BIMZELX 160 mg every four weeks (Q4W) in those with no or mild psoriasis (n=248), and those receiving BIMZELX 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). 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). In a subgroup of people also living with psoriasis affecting at least 3% of body surface area at baseline. In this subgroup: BKZ Total, n=176 [BIMZELX 160 mg Q4W n=147; BIMZELX 320 mg Q4W/Q8W n=29]; risankizumab group, n=176. Differences between BIMZELX and risankizumab in ACR50+PASI100 at Week 16 and PASI100 at Week 16 were not statistically significant. 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). This represents a stringent efficacy outcome in psoriatic arthritis. 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. A participant in BE BOLD was considered as having MDA if five or more of the following seven criteria were fulfilled: 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. 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.