UCB公布Bimekizumab-bkzx 在BE BOLD试验中的第24周数据

Brussels (Belgium), November 9, 2026 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced Week 24 data for bimekizumab-bkzx from BE BOLD, building on the study's previously reported Week 16 results, which demonstrated statistically significant superiority in ACR50 joint outcomes versus risankizumab at Week 16 in psoriatic arthritis (PsA).1 Numerically greater rates of ACR50 were sustained through Week 24.1 The full Week 24 findings are being presented at the 2026 ACR Convergence in Orlando, Florida, USA, November 6–11.1 Data reported in this press release are based on the dataset included in the ACR abstract.1

“ACR50 is the new standard in PsA, reflecting considerable joint improvements and is known to be associated with clinically meaningful reductions in disease activity and subsequent improvements in quality of life,” said Joseph F. Merola, MD MMSc, Rheumatologist, Dermatologist, President of the Psoriasis and Psoriatic Arthritis Multicenter Advancement Network, Co-President of the Group for Research in Psoriasis and Psoriatic Arthritis and President of the Rheumatologic Dermatology Society. “In the BE BOLD head-to-head trial, bimekizumab demonstrated rapid and greater ACR50 responses that were sustained to six months, in addition to delivering high rates of complete skin clearance, both of which are especially important for those living with psoriatic arthritis.”

Overall safety treatment-emergent adverse events (TEAEs) were comparable between treatments in BE BOLD, with the exception of increased rates of mild to moderate localized Candida infections in the bimekizumab-bkzx arm.1 BE BOLD was not powered to compare safety.1

“Head-to-head trials designed to mirror clinical practice are the gold standard for comparative clinical research. The BE BOLD results help redefine treatment expectations for people living with psoriatic arthritis, reinforcing our belief that patients and clinicians can aim higher when setting treatment goals,” said Donatello Crocetta, Chief Medical Officer, UCB. “This data is part of UCB’s wider evidence portfolio at ACR, showing treatment with bimekizumab enables rapid and sustained clinically meaningful improvements in this chronic inflammatory disease.”

The full Week 24 results from BE BOLD will be presented at ACR in an oral presentation at 10:15 ET on Tuesday 10 November. The data from BE BOLD form part of UCB’s broader presence at the 2026 ACR Convergence, where a total of 18 abstracts will be presented across the UCB immunology portfolio assets in PsA, axial spondyloarthritis, rheumatoid arthritis, and systemic lupus erythematosus.

BE BOLD Week 24 results

• Week 16 data for BE BOLD, assessing bimekizumab-bkzx, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),2,3  versus the interleukin 23 inhibitor risankizumab4 in adults living with active PsA, was first presented at the EULAR 2026 annual congress.5 Bimekizumab met the primary endpoint for BE BOLD of superiority in ACR50 at Week 16, achieved by 49.1% receiving bimekizumab-bkzx vs 38.0% receiving risankizumab (a difference of 11.1%), with statistical significance (p=0.0058)1†

• At Week 24, ACR50 was achieved in 54.9% of those receiving bimekizumab-bkzx and 43.8% receiving risankizumab.1*† Higher ACR50 responses were observed with bimekizumab-bkzx at every study point, and as early as Week 4 (nominal p<0.0001)1*†

• The first ranked secondary endpoint (MDA at Week 16) was 3.4 percentage points higher with bimekizumab-bkzx (p=0.3921; sequential testing stopped at this point, and subsequent ranked secondary endpoints were descriptive only), with higher rates sustained to Week 241†

• Numerically greater responses without statistical significance observed for bimekizumab-bkzx across secondary endpoints, encompassing joint, skin‡ and overall disease activity, sustained to Week 241†

• At Week 4, PASI100 was achieved in 12.5% of those receiving bimekizumab-bkzx and 3.4% receiving risankizumab (nominal p<0.01).1*†‡ At Week 16, PASI100 was achieved in 53.4% of those receiving bimekizumab-bkzx and 46.6% receiving risankizumab, without nominal significance.1*†‡ Rates of PASI100 for bimekizumab-bkzx and risankizumab were comparable at Week 20 and Week 24 (59.7% and 59.1%, without nominal significance, at Week 24)*†‡

• Including all data to the cut-off, 161/277 (58.1%) bimekizumab-bkzx-treated and 152/275 (55.3%) risankizumab-treated patients had ≥1 TEAE1

• No new safety signals were identified in the study at Week 24.1 Discontinuation rates due to TEAEs and serious/severe TEAEs were low in both treatment groups.1 Fewer patients reported serious TEAEs on bimekizumab-bkzx (5 [1.8%]) than on risankizumab (9 [3.3%]).1 One death occurred in a risankizumab-treated patient, deemed unrelated to treatment by the investigator1

• Candida infections were more frequent in bimekizumab-bkzx-treated patients (2.9%) than in risankizumab-treated patients (0.7%), as anticipated by the mechanism of action; all were mild or moderate, none were serious, systemic, or led to study discontinuation1

* Exploratory endpoint: nominally significant1

† 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-bkzx Total group (BKZ Total), which includes those receiving bimekizumab-bkzx (n=277) 160 mg every four weeks (Q4W) in those with no or mild psoriasis (n=248), and those receiving bimekizumab-bkzx 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-bkzx 160 mg Q4W n=147; bimekizumab-bkzx 320mg Q4W/Q8W n=29]; risankizumab group, n=176.1 At baseline, 10.5% in the bimekizumab-bkzx group and 11.2% in the risankizumab group had moderate-to-severe psoriasis, in addition to PsA.1

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% or greater improvement in three of five additional criteria (physician global, patient global, patient pain, function, and C-reactive protein (CRP)/erythrocyte sedimentation rate).6 This represents a stringent efficacy outcome in psoriatic arthritis7,8

• 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 of the seven indicates MDA.9 A participant in BE BOLD was considered as having MDA if five or more of the following seven criteria were fulfilled:10

  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 clearance11

References

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17. UCB. Data on file.