– UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX

优时比（UCB），一家全球生物制药公司，今天宣布了来自三期试验及其开放标签扩展的新的三年数据，这些试验研究了BIMZELX。

▼(bimekizumab) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Bimekizumab, a dual inhibitor of IL-17A and IL-17F,

▼（比美珠单抗）用于治疗活动性银屑病关节炎（PsA）和轴向脊柱关节炎（axSpA）的成人患者。比美珠单抗是一种IL-17A和IL-17F的双重抑制剂，

showed sustained control of inflammation and deep efficacy in patients living with PsA and axSpA

在患有银屑病关节炎和轴向脊柱关节炎的患者中显示出持续的炎症控制和深度疗效

chronic inflammatory diseases with considerable impact on physical and emotional wellbeing.

对身心健康有相当大影响的慢性炎症性疾病。

Sustained symptom relief in patients with active psoriatic arthritis

活动性银屑病关节炎患者的持续症状缓解

“A primary treatment goal in psoriatic arthritis is sustained control of inflammation to help prevent long-term, irreversible structural damage and to improve quality of life,” said Professor Laure Gossec,

“银屑病关节炎的主要治疗目标是持续控制炎症，以帮助预防长期不可逆的结构性损伤，并改善生活质量，”Laure Gossec教授说道，

from the Sorbonne University Hospital, Paris, France. “These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients, with elimination of swollen joints in nearly sixty percent of patients and approximately half reaching minimal disease activity (MDA) at three years – both strong clinical responses that suggest real control of inflammation in PsA.”.

来自法国巴黎索邦大学医院。“这些比美珠单抗数据在初治和经治患者中表现出显著的一致性，近百分之六十的患者关节肿胀消失，约一半患者在三年内达到最小疾病活动度（MDA）——这两大强劲的临床反应表明对PsA炎症实现了真正的控制。”

#In patients with active PsA, regardless of prior treatment experience, results from BE OPTIMAL, BE COMPLETE and their open-label extension, BE VITAL, showed that bimekizumab delivered sustained efficacy across multiple stringent clinical endpoints for up to three years.

在患有活动性PsA的患者中，无论既往治疗经历如何，BE OPTIMAL、BE COMPLETE及其开放标签扩展试验BE VITAL的结果显示，bimekizumab在多个严格的临床终点上持续展现出长达三年的疗效。

At three years, 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints (SJC=0).

在三年时，分别为59.5%和59.1%的bDMARD初治患者和TNFi无应答患者实现了肿胀关节的消除（SJC=0）。

Complete skin clearance, measured by Psoriasis Area and Severity Index [PASI]100 was maintained to three years by 61.9% and 67.5% of bDMARD-naïve and TNFi-IR patients, respectively.

通过银屑病面积和严重程度指数 [PASI] 100 测量的完全皮肤清除率在三年内分别由 61.9% 的 bDMARD 初治患者和 67.5% 的 TNFi-IR 患者维持。

Minimal disease activity (MDA), a comprehensive and clinically meaningful endpoint, was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively.

最低疾病活动度（MDA）是一个综合且具有临床意义的终点，分别有52.9%和48.8%的bDMARD初治患者和TNFi无反应患者维持了三年。

Improvements in physical function across the full spectrum of patients with axial spondyloarthritis

改善轴向脊柱关节炎患者全病程的躯体功能

“Long-term data, showing that patients living with axSpA can maintain high levels of clinical response, are invaluable for informed treatment decisions. It’s particularly compelling to see sustained responses with bimekizumab treatment at three years with stringent outcome measures like ASAS40 and low disease activity,” said Professor Xenofon Baraliakos,.

“长期数据显示，患有axSpA的患者能够维持较高的临床反应水平，这对做出明智的治疗决策具有不可估量的价值。特别令人信服的是，在使用像ASAS40和低疾病活动度这样严格的指标衡量下，比美吉珠单抗治疗三年后仍能看到持续的疗效，” Xenofon Baraliakos教授说道。

from the Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany. “These endpoints are key indicators of durable inflammation control in axSpA and achieving this level of sustained disease management is likely to have a profound impact on patients’ daily lives.”

来自德国波鸿鲁尔大学赫恩鲁尔风湿病中心。“这些终点是axSpA中持久炎症控制的关键指标，达到这种持续的疾病管理水平可能会对患者的日常生活产生深远的影响。”

#Across patients with nr-axSpA and r-axSpA, data from two Phase 3 studies, BE MOBILE 1 and 2, and their combined open-label extension, BE MOVING, bimekizumab treatment demonstrated sustained clinical responses up to three years.

#在患有nr-axSpA和r-axSpA的患者中，来自两项三期研究BE MOBILE 1和2及其联合开放标签扩展研究BE MOVING的数据表明，bimekizumab治疗在长达三年的时间内表现出持续的临床反应。

Achievement of ASAS40 was sustained to three years by 60.4% and 60.1% of nr-axSpA and r-axSpA patients, respectively, while 61.8% and 59.9% of nr-axSpA and r-axSpA patients, respectively, maintained Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (LDA <2.1) through three years..

分别有60.4%和60.1%的nr-axSpA和r-axSpA患者在三年内持续达到ASAS40，而分别有61.8%和59.9%的nr-axSpA和r-axSpA患者在三年内保持了轴向脊柱关节炎疾病活动评分（ASDAS）低疾病活动状态（LDA <2.1）。

The importance of long-term control of inflammation in patients with PsA and axSpA

银屑病关节炎和轴型脊柱关节炎患者长期控制炎症的重要性

“Psoriatic arthritis and axial spondyloarthritis are serious, chronic inflammatory diseases that can have a great impact in the daily lives of patients and their families. The data presented at EULAR reinforce the role of bimekizumab to deliver deep, consistent and sustained outcomes across a spectrum of PsA and axSpA,” said Donatello Crocetta, Chief Medical Officer, UCB.

“银屑病关节炎和轴向脊柱关节炎是严重的、慢性的炎症性疾病，它们会对患者及其家人的日常生活产生重大影响。在EULAR上公布的数据进一步证实了bimekizumab在PsA和axSpA的广泛症状中实现深度、一致且持续结果的作用，”UCB首席医疗官Donatello Crocetta表示。

“These data, alongside our other EULAR data presentations of dapirolizumab pegol§ in systemic lupus erythematosus and romosozumab in osteoporosis, reflect UCB’s commitment to offering differentiated, science-driven solutions that meet the diverse and evolving needs of people living with rheumatic diseases.”.

“这些数据，连同我们在系统性红斑狼疮中关于dapirolizumab pegol§和在骨质疏松症中关于romosozumab的其他EULAR数据报告，反映了UCB致力于提供差异化、科学驱动的解决方案，以满足风湿病患者多样化且不断变化的需求。”

Across the three-year efficacy and safety data for PsA and axSpA, bimekizumab was generally well tolerated and no new safety signals were observed.

三年的PsA和axSpA疗效和安全性数据显示，bimekizumab总体耐受性良好，未发现新的安全性信号。

The most common treatment-emergent adverse events (TEAEs) over three years for both PsA and axSpA in these studies were SARS-CoV-2 (COVID-19) infection, nasopharyngitis and upper respiratory tract infection.

在这两项研究中，PsA和axSpA患者三年内最常见的治疗相关不良事件（TEAE）是SARS-CoV-2（COVID-19）感染、鼻咽炎和上呼吸道感染。

UCB will present 14 abstracts on PsA and axSpA at EULAR 2025 in Barcelona, Spain, 11–14 June, and will complement other presentations from UCB in systemic lupus erythematosus and osteoporosis. These data, together with a dedication to advancing clinical research – including the ongoing head-to-head Phase 3 BE BOLD trial in psoriatic arthritis – underscore UCB’s ambition to be a leader in rheumatology, commitment to advancing innovation and focus on providing meaningful solutions across the spectrum of rheumatic diseases. .

优时比（UCB）将在2025年6月11日至14日于西班牙巴塞罗那举行的欧洲风湿病学大会（EULAR 2025）上展示关于银屑病关节炎（PsA）和轴性脊柱关节炎（axSpA）的14篇摘要，并将补充其在系统性红斑狼疮和骨质疏松症领域的其他报告。这些数据，加上对推进临床研究的承诺——包括正在进行的针对银屑病关节炎的头对头III期BE BOLD试验——彰显了优时比在风湿病学领域的领导雄心、推动创新的决心，以及专注于为各类风湿性疾病提供有意义解决方案的目标。

PsA data reported from BE COMPLETE, BE OPTIMAL and their open-label extension (OLE), BE VITAL, for patients in the BKZ Total group (PBO/BKZ patients and BKZ-randomized patients). BE OPTIMAL (bDMARD-naïve) Week 52 and BE COMPLETE (TNFi-IR) Week 16 completers were eligible for the BE VITAL open-label extension..

来自BE COMPLETE、BE OPTIMAL及其开放标签扩展（OLE）BE VITAL的PsA数据，针对BKZ总体组患者（PBO/BKZ患者和BKZ随机分组患者）。BE OPTIMAL（bDMARD初治）第52周和BE COMPLETE（TNFi不耐受）第16周的完成者有资格参与BE VITAL开放标签扩展。

*mNRI: modified non-responder imputation (binary). All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response, other reasons for missing data were calculated using multiple imputation (MI).

*mNRI：改良的非应答者填补法（二分类）。因不良事件或疗效不足而中止治疗后的所有访视均被视为无应答，其他缺失数据的原因则通过多重填补法（MI）进行计算。

axSpA trials BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (r-axSpA) each comprised a 16-week, double-blind, placebo-controlled period and a 36-week maintenance period. All patients received subcutaneous BKZ 160 mg every 4 weeks (Q4W) from Week 16.

axSpA试验BE MOBILE 1（nr-axSpA）和BE MOBILE 2（r-axSpA）各自包括一个16周的双盲、安慰剂对照期和一个36周的维持期。从第16周开始，所有患者每4周接受一次皮下注射BKZ 160 mg（Q4W）。

At Week 52, eligible patients could enter the OLE, BE MOVING.

在第52周，符合条件的患者可以进入OLE，BE MOVING。

Of 586 randomized patients with axSpA (nr-axSpA: 254; r-axSpA: 332), 494 (84.3%) patients entered the OLE at Week 52.

在586名随机分配的axSpA患者中（nr-axSpA：254；r-axSpA：332），有494名（84.3%）患者在第52周进入了OLE。

Data presented include patients originally randomized to placebo; all patients were treated with BKZ 160 mg Q4W from Week 16.

提供的数据包括最初随机分配到安慰剂组的患者；从第16周开始，所有患者均接受了BKZ 160 mg Q4W的治疗。

Dapirolizumab pegol is an investigational drug and is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide.

Dapirolizumab pegol 是一种研究性药物，尚未获得任何全球监管机构批准用于系统性红斑狼疮的治疗。

Notes to Editors:

编辑须知：

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)..

ACR50：根据美国风湿病学会反应标准，从基线水平改善50%或更多，包括压痛和肿胀关节数量至少改善50%，以及另外三项指标（医生整体评估、患者整体评估、患者疼痛、功能和C反应蛋白/红细胞沉降率）也改善50%。

This represents a stringent efficacy outcome in PsA

这代表了银屑病关节炎中一个严格的疗效结果

ASAS40: Assessment of SpondyloArthritis international Society 40%, a composite endpoint covering a core set of domains that should be assessed in axSpA patients. This core set of domains includes physical function, morning stiffness, patient global assessment, and pain. In order to meet an ASAS40 response, three of the four domains should improve by at least 40% and a minimum of two units on a scale of one to ten.

ASAS40：国际脊柱关节炎评估协会40%标准，是一个综合终点，涵盖了一组应在轴向脊柱关节炎（axSpA）患者中评估的核心领域。这组核心领域包括身体功能、晨僵、患者总体评估和疼痛。为了达到ASAS40反应，四个领域中至少三个需要改善至少40%，并且在1到10的评分尺度上至少提高两个单位。

In the remaining domain, there should be no worsening at all.

在其余领域，应该完全没有恶化。

TNFi-inadequate response (TNFi-IR): Patients with PsA who experience prior inadequate response or intolerance to tumor necrosis factor inhibitors

TNFi反应不足（TNFi-IR）：既往对肿瘤坏死因子抑制剂反应不足或不耐受的PsA患者

bDMARD-naïve: Patients who had not previously taken a biologic disease-modifying antirheumatic drug (bDMARD)

bDMARD初治：既往未接受过生物类疾病修饰抗风湿药物（bDMARD）治疗的患者

About Psoriatic Arthritis

关于银屑病关节炎

Psoriatic arthritis 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.

银屑病关节炎是一种严重的、高度异质性的、慢性的、全身性炎症性疾病，影响关节和皮肤，患病率在总人口中为0.02%至0.25%。

Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.

银屑病关节炎影响大约30%的银屑病患者。

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).

它表现为关节疼痛和僵硬、皮肤斑块、脚趾和手指肿胀（指趾炎）以及肌腱或韧带附着于骨骼部位的炎症（附着点炎）。

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.6 In PsA, uncontrolled active disease can lead to long-term, irreversible structural damage.

PsA 患者除了身体不适外，其生活质量也受到影响，并伴有高血压、心血管疾病、焦虑和抑郁等合并症。在 PsA 中，未得到控制的活动性疾病可导致长期且不可逆的结构性损伤。

About BE OPTIMAL and BE COMPLETE

关于BE OPTIMAL和BE COMPLETE

BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of psoriatic arthritis.

BE OPTIMAL 和 BE COMPLETE 是两项评估 bimekizumab 治疗银屑病关节炎的有效性和安全性的 III 期研究。

The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16.

两项研究的主要终点是第16周时达到美国风湿病学会标准（ACR50）改善50%或以上的患者比例。

BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous bimekizumab 160 mg every four weeks (Q4W) in patients with PsA; both studies were placebo-controlled to Week 16, after which placebo patients switched to bimekizumab.

BE OPTIMAL（bDMARD初治）和BE COMPLETE（TNFi无应答）评估了每四周一次（Q4W）皮下注射160 mg bimekizumab在PsA患者中的效果；两项研究均在第16周前采用安慰剂对照，之后安慰剂组患者转为使用bimekizumab。

BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for BE VITAL open-label extension.

BE OPTIMAL 第52周和 BE COMPLETE 第16周的完成者有资格参与 BE VITAL 开放标签扩展研究。

About Axial Spondyloarthritis

关于轴向脊柱关节炎

Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.

轴向脊柱关节炎 (axSpA)，包括非放射学轴向脊柱关节炎 (nr-axSpA) 和强直性脊柱炎 (AS)，是一种慢性、免疫介导的炎症性疾病。

nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.

nr-axSpA 在临床上的定义是骶髂关节没有明确的结构性损伤的X光证据。

axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).

axSpA是一种主要影响脊柱以及连接骨盆和下脊柱（骶髂关节）的关节的疼痛性疾病。

The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.

大多数患者的 axSpA 主要症状是炎症性背痛，这种疼痛通过运动可以缓解，但休息无法改善。

Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis.

其他常见的临床特征还包括前葡萄膜炎、附着点炎、外周关节炎、牛皮癣、炎症性肠病和指趾炎。

The overall prevalence of axSpA is 0.3 percent to 1.4 percent of adults.

axSpA 的总体患病率为 0.3% 至 1.4% 的成年人。

Approximately half of all patients with axSpA are patients with nr-axSpA.7 axSpA onset usually occurs before the age of 45.7 Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.

大约一半的axSpA患者为nr-axSpA患者。axSpA的发病通常发生在45岁之前。大约10%到40%的nr-axSpA患者在2到10年内进展为强直性脊柱炎。

About BE MOBILE 1 and BE MOBILE 2

关于BE MOBILE 1和BE MOBILE 2

BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of nr-axSpA and r-axSpA, respectively.

BE MOBILE 1 和 BE MOBILE 2 是两项 III 期研究，分别评估了 bimekizumab 在治疗 nr-axSpA 和 r-axSpA 中的有效性和安全性。

The primary endpoint in both studies was the Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at Week 16.

两项研究的主要终点是第16周时的国际脊柱关节炎评估协会40％（ASAS40）反应。

BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.

BE MOBILE 1 和 BE MOBILE 2 包含一个为期16周的双盲治疗期，随后是为期36周的维持期。

In BE MOBILE 1 and BE MOBILE 2, patients were randomized to bimekizumab (160 mg Q4W; N=128 for BE MOBILE 1 and N=221 for BE MOBILE 2) or to placebo (N=126 for BE MOBILE 1 and N=111 for BE MOBILE 2).

在BE MOBILE 1和BE MOBILE 2研究中，患者被随机分配接受bimekizumab（每4周160 mg；BE MOBILE 1中N=128，BE MOBILE 2中N=221）或安慰剂（BE MOBILE 1中N=126，BE MOBILE 2中N=111）。

Patients initially randomized to placebo were switched to bimekizumab (160 mg Q4W) at Week 16.

最初随机分配到安慰剂组的患者在第16周转为接受bimekizumab（160 mg 每4周一次）。

About BIMZELX

关于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.

是一种人源化的单克隆IgG1抗体，旨在选择性抑制白细胞介素17A（IL-17A）和白细胞介素17F（IL-17F），这两种关键的细胞因子会驱动炎症过程。

About BIMZELX

关于BIMZELX

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

比美珠单抗▼在欧盟的获批适应症为：

Plaque psoriasis

斑块状银屑病

: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Bimekizumab 适用于系统治疗的中度至重度斑块型银屑病成人患者。

Psoriatic arthritis

银屑病关节炎

: 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)

比美珠单抗，单独使用或与甲氨蝶呤联合使用，适用于治疗对一种或多种疾病修饰抗风湿药物（DMARDs）反应不足或不耐受的活动性银屑病关节炎成年患者。

Axial spondyloarthritis

轴向脊柱关节炎

: 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.

Bimekizumab 适用于治疗具有客观炎症迹象（如C反应蛋白（CRP）升高和/或磁共振成像（MRI）所示）的活动性非放射学中轴型脊柱关节炎成年患者，这些患者对非甾体抗炎药（NSAIDs）反应不足或不耐受；以及用于治疗对常规疗法反应不足或不耐受的活动性强直性脊柱炎成年患者。

Hidradenitis suppurativa

化脓性汗腺炎

: 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

Bimekizumab 适用于治疗对传统系统性 HS 疗法反应不足的成人中度至重度活动性化脓性汗腺炎（HS；反向痤疮）。

The label information may differ in other countries where approved. Please check local prescribing information.

标签信息在其他已批准的国家可能会有所不同。请查阅当地的处方信息。

About UCB

关于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 €6.1 billion in 2024.

优时比公司（UCB），位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物及解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有约9,000名员工，并在2024年创造了61亿欧元的收入。