Bimekizumab

Brussels (Belgium), October 25, 2025 – 16:00 (CEST) 布鲁塞尔（比利时），2025年10月25日 – 16:00（欧洲中部夏令时间）– 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，今天宣布了来自三项为期三年的3期试验及其开放标签扩展的新数据，这些试验研究了BIMZELX。® ®(bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) (non-radiographic [nr-]axSpA and radiographic [r-]axSpA). Bimekizumab-bkzx, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), (bimekizumab-bkzx) 用于治疗活动性银屑病关节炎 (PsA) 和轴向脊柱关节炎 (axSpA)（非放射学 [nr-]axSpA 和放射学 [r-]axSpA）的成人患者。Bimekizumab-bkzx 是首个也是唯一获得批准的可选择性抑制白细胞介素 17A (IL-17A) 和白细胞介素 17F (IL-17F) 的药物，1 1continued to demonstrate sustained control of inflammation and deep efficacy in patients living with PsA and axSpA. 持续展现出对PsA和axSpA患者炎症的长期控制和显著疗效。2,3,4,5,6 2,3,4,5,6Sustained improvements across stringent measures of disease in patients with PsA 在PsA患者中，疾病严格指标的持续改善2 2“The diverse, multi-faceted nature of PsA can make it challenging to treat, as therapy should ideally address multiple disease domains,” said Professor Laura Coates, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford, United Kingdom. “These compelling data show sustained improvements over three years across key PsA disease domains. “PsA（银屑病关节炎）的多样性和多方面特性使其治疗具有挑战性，因为理想的治疗应针对多个疾病领域，”英国牛津大学纽菲尔德骨科、风湿病学和肌肉骨骼疾病系的劳拉·科茨教授说道。“这些令人信服的数据表明，在关键的PsA疾病领域中，三年内持续有所改善。”This demonstrates that bimekizumab-bkzx has potential to benefit a broad range of patients, and may improve long-term inflammation control and prevent structural damage.”. 这表明 bimekizumab-bkzx 有可能使广泛的患者受益，并可能改善长期炎症控制并预防结构性损伤。"In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis. 在PsA患者中，以下GRAPPA领域的一年改善持续到三年：*外周关节炎、指趾炎、附着点炎、皮肤银屑病和指甲银屑病。2 2 Individual domain responses were consistent between bDMARD‑naïve and TNFi-IR patients. 个体领域反应在bDMARD初治和TNFi无应答患者之间是一致的。2 2Further, exposure-adjusted incidence rates per 100 patient years for uveitis and definite or probable adjudicated Inflammatory Bowel Disease (IBD) to Week 156 were 0.2 (95% confidence interval 0.1, 0.6) and 0.3 (0.1, 0.7) in BE OPTIMAL and 0 and 0.1 (0.0, 0.6) in BE COMPLETE, respectively. 进一步地，调整暴露后的发生率（每100患者年）在第156周时，BE OPTIMAL中葡萄膜炎和确诊或可能的裁定炎症性肠病（IBD）分别为0.2（95%置信区间0.1, 0.6）和0.3（0.1, 0.7），而在BE COMPLETE中分别为0和0.1（0.0, 0.6）。2 2(See Appendix for further details). （详见附录）。Sustained clinical response to highly stringent endpoints in half of patients with axial spondyloarthritis 一半的轴向脊柱关节炎患者对高度严格的终点表现出持续的临床反应4 4“In clinical practice, ASDAS LDA is an important treatment target for disease control for people living with axSpA, as it is a highly stringent measure of low disease activity,” said Professor Fabian Proft, MD from Universitätsmedizin Berlin, Germany. “It is therefore meaningful that in this study of bimekizumab bkzx, half of the patients never lost their ASDAS LDA response at any assessed visit over three years, while over three quarters of patients maintained this response over three years. “在临床实践中，ASDAS LDA 是轴向脊柱关节炎患者疾病控制的重要治疗目标，因为它是低疾病活动度的严格衡量标准，”德国柏林大学医学中心的Fabian Proft教授表示。“因此，在这项针对bimekizumab bkzx的研究中，有意义的是，一半的患者在三年内的任何评估访视中从未失去ASDAS LDA反应，而超过四分之三的患者在三年内保持了这一反应。”This suggests long-term disease control, which is paramount in treating both nr-axSpA and r-axSpA.”. 这表明长期疾病控制至关重要，这对治疗nr-axSpA和r-axSpA都是如此。A high proportion of bimekizumab-bkzx-randomized patients who achieved clinical responses at Week 16 maintained these to Week 164 across the full disease spectrum of axSpA, including nr-axSpA and r-axSpA. 在第16周达到临床反应的高比例bimekizumab-bkzx随机患者，在整个axSpA疾病谱（包括nr-axSpA和r-axSpA）中，这些反应维持到了第164周。4 4From Week 16 through to Week 164, 50% of patients never lost their ASDAS LDA (<2.1) status at any assessed visit (MI), with a further 22.4% only losing their ASDAS LDA status at one visit, and 6.1% at two visits, respectively (MI). 从第16周到第164周，50%的患者在任何评估访视中从未失去ASDAS LDA（<2.1）状态（MI），另有22.4%的患者仅在一次访视中失去ASDAS LDA状态，6.1%的患者在两次访视中失去该状态（MI）。4 4Of the 152 patients (43.6%; NRI) who achieved ASDAS LDA at Week 16, 78.8% still achieved ASDAS LDA at Week 164 (MI). 在第16周达到ASDAS LDA的152名患者（43.6%；NRI）中，78.8%在第164周（MI）时仍保持ASDAS LDA。4 4(Proportion of patients who achieved ASDAS LDA at Week 16 and Week 164 in patients randomized to bimekizumab-bkzx 160 mg Q4W at baseline). （在基线时随机分配至bimekizumab-bkzx 160 mg Q4W的患者中，第16周和第164周达到ASDAS LDA的患者比例）。4 4Real-world findings demonstrate rapid HRQoL improvements in patients with PsA and axSpA 现实世界的研究结果表明，PsA和axSpA患者的生活质量迅速改善。5,6 5,6Interim, post-hoc data analysis (observed case, OC) of patient-reported outcomes from the SPEAK study in routine clinical practice showed that: SPEAK研究在常规临床实践中对患者报告结果的中期、事后数据分析（观察病例，OC）显示：5,6 5，6For 为了bimekizumab-bkzx-treated PsA patients 比美珠单抗-bkzx治疗的银屑病关节炎患者, improvements in PsAID-12 total score were observed to 24 weeks, with mean (SD) change from baseline (CfB) at Week 24 of −1.9 (2.0). 在24周内观察到PsAID-12总分的改善，第24周时基线平均（标准差）变化（CfB）为−1.9（2.0）。5 5SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +4.6 [7.9]), as did PGADA scores (Mean [SD] CfB: −17.5 [23.8]). SF-36 PCS 评分改善至第 24 周（平均值 [SD] CfB：+4.6 [7.9]），PGADA 评分亦是如此（平均值 [SD] CfB：−17.5 [23.8]）。5 5At Week 2, mean (SD) change from baseline (CfB) in PsAID-12 total score and PGADA score were -0.8 (1.6) and -7.1 (19.3), respectively. 在第2周，PsAID-12总分和PGADA评分与基线相比的平均（标准差）变化分别为-0.8（1.6）和-7.1（19.3）。5 5For 为了bimekizumab-bkzx-treated nr-axSpA and r-axSpA patients bimekizumab-bkzx治疗的nr-axSpA和r-axSpA患者, improvements in ASAS HI score were observed to 24 weeks, with mean (SD) CfB at Week 24 of –1.6 (3.0). ASAS HI评分的改善持续到24周，第24周的平均（标准差）CfB为–1.6（3.0）。6 6SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB: –1.0 [2.5]. SF-36 PCS 评分改善至第 24 周（平均值 [标准差] CfB：+5.7 [7.3]），PGADA 评分亦是如此（平均值 [标准差] CfB：–1.0 [2.5]）。6 6At Week 2, mean (SD) change from baseline (CfB) in ASAS HI score and PGADA score were –0.7 (2.3) and –0.8 (2.1), respectively. 在第2周时，ASAS HI评分和PGADA评分的平均值（标准差）较基线的变化分别为-0.7（2.3）和-0.8（2.1）。6 6“This data presented at ACR shows that bimekizumab-bkzx continues to demonstrate long-term improvement in inflammation control and deep efficacy in patients living with PsA and axSpA, and emphasizes that this effect is consistent across a spectrum of patients with these psoriatic diseases,” said Donatello Crocetta, Chief Medical Officer, UCB. “ACR上展示的这些数据显示，bimekizumab-bkzx 在控制 PsA 和 axSpA 患者的炎症方面持续表现出长期改善和深度疗效，并强调了这种效果在这些银屑病患者群体中是一致的，”UCB 首席医学官 Donatello Crocetta 表示。“This underlines the robust potential of bimekizumab-bkzx to help prevent long-term, irreversible structural damage and improve quality of life for many patients living with these debilitating rheumatic conditions.” . “这突显了bimekizumab-bkzx在帮助预防长期不可逆的结构性损伤以及改善众多患有这些致残性风湿病的患者生活质量方面的强大潜力。”UCB will present 16 abstracts on bimekizumab-bkzx at ACR 2025 in Chicago, Illinois, 24–29 October, across axSpA, PsA, and psoriasis. These will complement seven other presentations from UCB across their rheumatology portfolio. This data underscores UCB’s ambition to be a leader in rheumatology, commitment to advancing clinical research and innovation, and focus on developing meaningful solutions across the spectrum of rheumatic diseases.. 优时比公司将在2025年10月24日至29日于美国伊利诺伊州芝加哥举行的美国风湿病学会年会上，展示16份关于bimekizumab-bkzx的摘要，涵盖轴向脊柱关节炎、银屑病关节炎和银屑病。这些摘要将补充优时比在其风湿病学产品组合中的另外七个报告。这些数据凸显了优时比成为风湿病学领域领导者的雄心，致力于推进临床研究与创新，并专注于开发针对风湿病全谱的有意义解决方案。*Core domains of PsA according to GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) recommendations. 根据GRAPPA（银屑病和银屑病关节炎研究与评估小组）建议的PsA核心领域。7 7Study methodology 研究方法论PsA abstract PsA 摘要: ：2 2Included patients who were randomized to subcutaneous bimekizumab-bkzx 160 mg or placebo every 4 weeks (Q4W) in BE OPTIMAL (biologic DMARD [bDMARD]‑naïve patients with PsA), BE COMPLETE (patients with PsA with inadequate response or intolerance to TNF inhibitors [TNFi‑IR]), BE MOBILE 1 (non‑radiographic axSpA) and BE MOBILE 2 (radiographic axSpA, i.e., AS).. 纳入的患者被随机分配至每4周（Q4W）接受皮下注射bimekizumab-bkzx 160 mg或安慰剂，这些患者来自BE OPTIMAL（生物制剂DMARD[bDMARD]初治的PsA患者）、BE COMPLETE（对TNF抑制剂[TNFi-IR]反应不足或不耐受的PsA患者）、BE MOBILE 1（非放射学axSpA）和BE MOBILE 2（放射学axSpA，即AS）研究。2 2From Week 16, all placebo-randomized patients received bimekizumab-bkzx 160 mg Q4W. 从第16周开始，所有接受安慰剂随机分配的患者均接受了每4周一次160毫克的bimekizumab-bkzx治疗。2 2Week 52/16 BE OPTIMAL/BE COMPLETE completers were eligible for BE VITAL open-label extension; BE MOBILE 1 and 2 Week 52 completers could enter BE MOVING. 第52周/16周 BE OPTIMAL/BE COMPLETE 完成者有资格参与 BE VITAL 开放标签扩展；BE MOBILE 1 和 2 的第52周完成者可进入 BE MOVING。2 2AxSpA abstract AxSpA 摘要: ：4 4BE MOBILE 1 (nr-axSpA) and 2 from Week 16, all patients received subcutaneous bimekizumab-bkzx 160 mg every 4 weeks. At Week 52, eligible patients could enroll in the OLE (BE MOVING). 从第16周开始，在BE MOBILE 1（nr-axSpA）和2中，所有患者每4周接受一次160 mg的皮下注射bimekizumab-bkzx。在第52周时，符合条件的患者可以进入OLE（BE MOVING）阶段。4 4Real-world study 真实世界研究: ：5,6 5,6SPEAK is an ongoing 52-week, multi-country, observational study in Belgium, Czechia, France, Germany, Greece, Spain and the United Kingdom. SPEAK 是一项在比利时、捷克、法国、德国、希腊、西班牙和英国进行的持续 52 周的多国观察性研究。5,6 5,6This planned interim analysis reports data to April 2, 2025 (approx. 50% enrollment). 该计划的中期分析报告截至2025年4月2日的数据（约50%的注册）。5,6 5,6Adult patients with active PsA or axSpA who initiated bimekizumab-bkzx in routine clinical practice could be included if receiving treatment per label (bimekizumab-bkzx 160 mg every 4 weeks). 符合以下条件的成年患者可纳入研究：在常规临床实践中开始使用比美珠单抗-bkzx治疗，且按照说明书接受每4周160 mg的剂量。5,6 5,6Notes to Editors 编辑须知 ASAS40 responder rate: Assessment in SpondyloArthritis international Society ≥40% improvement ASAS40应答率：国际脊柱关节炎评估协会≥40%改善标准4 4ASAS HI: Assessment of SpondyloArthritis international Society Health Index ASAS HI：国际脊柱关节炎评估协会健康指数6 6ASDAS LDA: axSpA Disease Activity Score (ASDAS) low disease activity (LDA; <2.1) ASDAS LDA：axSpA疾病活动评分（ASDAS）低疾病活动度（LDA；<2.1）4,8 4，8Dactylitis: Inflammation of a finger or toe 指（趾）炎：手指或脚趾的炎症9 九Enthesitis: Inflammation where the tendons and ligaments insert into bones 附着点炎：肌腱和韧带插入骨头处的炎症10 10GRAPPA domains: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-based treatment recommendations focus on six core domains and the PsA-related conditions, uveitis and IBD. The six core domains are: peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis. GRAPPA领域：基于银屑病和银屑病关节炎研究与评估小组（GRAPPA）的治疗建议重点关注六个核心领域及与PsA相关的疾病，如葡萄膜炎和IBD。这六个核心领域包括：外周关节炎、轴向疾病、附着点炎、指趾炎、皮肤银屑病和指甲银屑病。2 2IBD: Inflammatory Bowel Disease IBD：炎症性肠病MI: Multiple imputation MI：多重插补2 2mNAPSI: Modified nail psoriasis severity index mNAPSI：改良指甲银屑病严重程度指数2 2mNRI: Modified NRI mNRI：改进的NRI2 2NRI: Non-responder imputation NRI：无应答者填补2 2PASI 100: 100% improvement from baseline in Psoriasis Area and Severity Index PASI 100：银屑病面积和严重程度指数较基线改善100%2 2PGADA: Patient Global Assessment of Disease Activity PGADA：患者对疾病活动的总体评估5,6 5,6PsAID-12: 12-item PsA Impact of Disease questionnaire PsAID-12：12项银屑病关节炎疾病影响问卷5 5SF-36 PCS: Short Form 36-item Health Survey Physical Component Summary SF-36 PCS：简表36项健康调查生理成分总结5,6 5,6SJC: Swollen joint count SJC：肿胀关节计数2 2TNFi-IR: Inadequate response or intolerance to tumor necrosis factor inhibitors TNFi-IR：对肿瘤坏死因子抑制剂反应不足或不耐受2 2Uveitis: Inflammation of the middle layer of the eyeball called the uvea 葡萄膜炎：眼球中间层称为葡萄膜的部分发生炎症11 11Appendix 附录Further detail from 3-year PsA data across GRAPPA domains 来自GRAPPA领域3年PsA数据的更多细节 2 2For the majority of GRAPPA domains, 1-year improvements were sustained to 3 years across all studies. 对于大多数GRAPPA领域，所有研究中1年的改善都持续到了3年。2 2These include stringent measures of disease within the disease domains, for example, complete resolution of the following: 这些措施包括在疾病领域内严格的疾病评估标准，例如，以下症状的完全缓解：2 2Adapted from Merola J. ACR. #2129566. 改编自梅罗拉 J. ACR。#2129566。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、系统性炎症性疾病，影响关节和皮肤，患病率在人口中为0.02%至0.25%。12 十二Psoriatic arthritis affects approximately 30 percent of people living with psoriasis. 银屑病关节炎影响着大约30%的银屑病患者。13 13It 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的部位发炎（附着点炎）。14 14The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression. PsA患者除了身体不适外，生活质量也受到影响，伴随的疾病包括高血压、心血管疾病、焦虑和抑郁。15 15In PsA, uncontrolled active disease can lead to long-term, irreversible structural damage. 在银屑病关节炎（PsA）中，未控制的活动性疾病可导致长期、不可逆的结构性损伤。16 16About BE OPTIMAL and BE COMPLETE 关于BE OPTIMAL和BE COMPLETEBE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of bimekizumab-bkzx in the treatment of psoriatic arthritis. BE OPTIMAL 和 BE COMPLETE 是两项评估 bimekizumab-bkzx 治疗银屑病关节炎的有效性和安全性的 III 期研究。17,18 17,18The 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。17,18 17，18BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous bimekizumab-bkzx 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-bkzx. BE OPTIMAL（bDMARD初治）和BE COMPLETE（TNFi无应答）研究评估了每四周一次（Q4W）皮下注射160 mg的bimekizumab-bkzx在PsA患者中的疗效；两项研究均在第16周前为安慰剂对照，之后安慰剂组患者转为使用bimekizumab-bkzx。17,18 17，18BE 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。17,18 17，18About 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。19 19nr-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。19 19axSpA 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。19 19The 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 主要症状是炎性背痛，运动后可缓解，但休息后无法缓解。19 19Other 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。19 19The 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。 20,21 20，21Approximately half of all patients with axSpA are patients with nr-axSpA.15 axSpA onset usually occurs before the age of 45.19 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。19 19About BE MOBILE 1 and BE MOBILE 2 关于BE MOBILE 1和BE MOBILE 2BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of bimekizumab-bkzx in the treatment of nr-axSpA and r-axSpA, respectively. BE MOBILE 1 和 BE MOBILE 2 是两项三期研究，分别评估了 bimekizumab-bkzx 治疗 nr-axSpA 和 r-axSpA 的有效性和安全性。22 22The 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。22 22BE 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。22 22In BE MOBILE 1 and BE MOBILE 2, patients were randomized to bimekizumab-bkzx (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-bkzx（160 mg 每4周一次；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）。22 22Patients initially randomized to placebo were switched to bimekizumab-bkzx (160 mg Q4W) at Week 16. 最初随机分配到安慰剂组的患者在第16周时改用比美珠单抗-bkzx（160 mg 每4周一次）。22 22About BIMZELX® (bimekizumab-bkzx) in the U.S. 关于美国的BIMZELX®（bimekizumab-bkzx）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.1 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.1 BIMZELX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。1 在病灶性银屑病皮肤中发现IL-17A和IL-17F水平升高。1The approved indications for BIMZELX in the U.S. are: 美国批准的BIMZELX适应症为：1 1Plaque psoriasis 银屑病斑块: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy BIMZELX 获批用于治疗适合接受系统治疗或光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: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis BIMZELX 适用于治疗患有活动性银屑病关节炎的成年患者。Non-radiographic axial spondyloarthritis 非放射学中轴脊柱关节炎: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation BIMZELX 适用于治疗具有客观炎症迹象的活动性非放射学中轴型脊柱关节炎成年患者。Ankylosing spondylitis 强直性脊柱炎: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis BIMZELX 适用于治疗患有活动性强直性脊柱炎的成年患者。Hidradenitis suppurativa 化脓性汗腺炎: BIMZELX is indicated for the treatment of adults with moderate-to-severe hidradenitis suppurativa BIMZELX 适用于治疗中度至重度化脓性汗腺炎的成人患者。BIMZELX U.S. IMPORTANT SAFETY INFORMATION BIMZELX 美国重要安全信息 IMPORTANT SAFETY INFORMATION 重要安全信息Suicidal Ideation and Behavior 自杀意念与行为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. BIMZELX（比美珠单抗-bkzx）可能会增加自杀意念和行为（SI/B）的风险。尚未明确确立使用BIMZELX治疗与SI/B风险增加之间的因果关系。在有严重抑郁或SI/B病史的患者中使用BIMZELX之前，处方者应权衡潜在的风险和益处。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. . 建议监测抑郁、自杀意念或其他情绪变化的出现或恶化。如果发生此类变化，应指示患者立即寻求医疗关注，酌情转诊给心理健康专业人士，并重新评估继续治疗的风险和益处。Infections 感染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. BIMZELX可能会增加感染风险，包括严重感染。在任何有临床重要性活动性感染的患者中，感染未解决或未得到适当治疗之前，请勿开始使用BIMZELX治疗。对于患有慢性感染或有反复感染史的患者，在开BIMZELX处方前应权衡风险和益处。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.. 如果出现提示有临床重要感染的体征或症状，应指导患者寻求医疗建议。如果患者发生此类感染或对标准治疗无反应，应密切监测患者，并在感染解决之前不要给予BIMZELX。 Tuberculosis 结核病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. 在开始使用BIMZELX治疗前，评估患者是否存在结核病（TB）感染。避免在活动性结核病感染患者中使用BIMZELX。在给予BIMZELX之前，启动对潜伏性结核的治疗。对于有潜伏性或活动性结核病史且无法确认已接受充分治疗的患者，在开始使用BIMZELX前考虑进行抗结核治疗。Closely monitor patients for signs and symptoms of active TB during and after treatment.. 在治疗期间和治疗后密切监测患者是否有活动性结核病的体征和症状。Liver Biochemical Abnormalities 肝生化异常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. 在BIMZELX的临床试验中报告了血清转氨酶升高。在使用BIMZELX治疗前、治疗期间定期以及根据常规患者管理，检测肝酶、碱性磷酸酶和胆红素。如果出现与治疗相关的肝酶升高并怀疑药物引起的肝损伤，应中断BIMZELX治疗，直至排除肝损伤的诊断。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. . 对于转氨酶和胆红素同时升高的患者，永久停止使用BIMZELX。避免在急性肝病或肝硬化患者中使用BIMZELX。Inflammatory Bowel Disease 炎症性肠病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. 使用包括BIMZELX在内的IL-17抑制剂治疗的患者中已有炎症性肠病（IBD）病例报告。避免在活动性IBD患者中使用BIMZELX。在BIMZELX治疗期间，应监测患者是否出现IBD的体征和症状，如果出现新发或恶化的体征和症状，则应停止治疗。. 。Immunizations 免疫接种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. 在开始使用BIMZELX治疗之前，根据现行免疫指南完成所有适龄疫苗接种。避免在使用BIMZELX治疗的患者中使用活疫苗。Most Common Adverse Reactions 最常见的不良反应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 斑块状银屑病和化脓性汗腺炎中最常见（≥1%）的不良反应包括上呼吸道感染、口腔念珠菌病、头痛、注射部位反应、癣感染、胃肠炎、单纯疱疹感染、痤疮、毛囊炎等。candida 白色念珠菌infections, and fatigue. 感染、疲劳。Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. 最常见的（≥2%）银屑病关节炎不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻和尿路感染。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. 非放射学中轴型脊柱关节炎最常见的（≥2%）不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻、咳嗽、疲劳、肌肉骨骼疼痛、肌痛、扁桃体炎、转氨酶升高和尿路感染。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. 最常见的（≥2%）强直性脊柱炎不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻、注射部位疼痛、皮疹和外阴阴道真菌感染。Please see Important Safety Information below and full U.S. Prescribing Information at 请参阅下面的重要安全信息，并在美国处方信息中查看完整内容。www.UCB-USA.com/Innovation/Products/BIMZELX www.UCB-USA.com/创新/产品/BIMZELX. 。About BIMZELX 关于BIMZELX® ®▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA) ▼（bimekizumab）在欧盟 (EU)/欧洲经济区 (EEA)BIMZELX 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。23 23About BIMZELX®▼(bimekizumab) EU/EEA* 关于BIMZELX®▼（bimekizumab）欧盟/欧洲经济区*The approved indications for bimekizumab▼ in the European Union are: 欧盟批准的比美珠单抗▼适应症为：23 23Plaque psoriasis 银屑病斑块: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy 比美珠单抗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人患者。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的活动性非放射学中轴型脊柱关节炎成人患者，这些迹象表现为C反应蛋白（CRP）升高和/或磁共振成像（MRI）异常，且对非甾体抗炎药（NSAIDs）反应不足或不耐受的患者；同时也适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人患者。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 适用于治疗对传统全身性 HS 疗法反应不佳的成人中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。BIMZELX BIMZELX® ®▼(bimekizumab) EU/EEA* Important Safety Information ▼(bimekizumab) 欧盟/欧洲经济区* 重要安全信息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). 比美莫单抗最常见的不良反应是上呼吸道感染（在斑块型银屑病、银屑病关节炎、轴向脊柱关节炎 (axSpA) 和化脓性汗腺炎中的发生率分别为 14.5%、14.6%、16.3% 和 8.8%）以及口腔念珠菌病（在银屑病、银屑病关节炎、轴向脊柱关节炎和化脓性汗腺炎中的发生率分别为 7.3%、2.3%、3.7% 和 5.6%）。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. 常见的不良反应（≥1/100 至 <1/10）包括口腔念珠菌病、癣感染、耳部感染、单纯疱疹感染、口咽部念珠菌病、胃肠炎、毛囊炎、外阴阴道真菌感染（包括外阴阴道念珠菌病）、头痛、皮疹、皮炎和湿疹、痤疮、注射部位反应（注射部位红斑、反应、水肿、疼痛、肿胀、血肿）、疲劳。Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.. 老年人在使用bimekizumab时可能更容易出现某些不良反应，如口腔念珠菌病、皮炎和湿疹。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). 比美珠单抗禁用于对活性物质或任何辅料过敏的患者，以及患有临床重要活动性感染（如活动性结核病）的患者。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. 比美珠单抗可能会增加感染的风险。任何有临床重要活动性感染的患者都不应开始使用比美珠单抗治疗。接受比美珠单抗治疗的患者应被指导在出现提示感染的体征或症状时寻求医疗建议。如果患者发生感染，应对患者进行仔细监测。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. 如果感染变得严重或对标准治疗无反应，应停止治疗直至感染消退。在开始使用比美珠单抗治疗前，应对患者进行结核病（TB）感染评估。比美珠单抗不应给予患有活动性结核病的患者。Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.. 接受比美珠单抗治疗的患者应监测活动性结核病的体征和症状。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.. 使用Bimekizumab已报告出现新的或加重的炎症性肠病病例。不建议炎症性肠病患者使用Bimekizumab。如果患者出现炎症性肠病的症状和体征，或原有的炎症性肠病加重，应停止使用Bimekizumab并开始适当的医疗管理。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. 使用IL-17抑制剂已观察到严重的超敏反应，包括过敏性反应。如果发生严重的超敏反应，应立即停止使用bimekizumab，并启动适当的治疗。 Live vaccines should not be given in patients treated with bimekizumab. 接受比美珠单抗治疗的患者不应接种活疫苗。Please consult the Summary of Product Characteristics in relation to other side effects, full safety and prescribing information. 请查阅产品特性摘要以了解其他副作用、完整安全性和处方信息。European SmPC date of revision: April 2025. 欧洲药品说明书修订日期：2025年4月。https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf*EU/EEA means European Union/European Economic Area. *欧盟/欧洲经济区是指欧洲联盟/欧洲经济区。Last accessed: October 2025. 最后访问时间：2025年10月。▼ ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 该药品受到额外的监测。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。For further information, contact UCB: 如需更多信息，请联系UCB：Investor Relations 投资者关系Sahar Yazdian 萨哈尔·亚兹迪安 T +32.2.559.91.37 电话：+32.2.559.91.37email Sahar.YAZDIAN@ucb.com 电子邮件 Sahar.YAZDIAN@ucb.comCorporate Communications 企业传播Laurent Schots 劳伦特·肖茨T +32.2.559.92.64 T +32.2.559.92.64email laurent.schots@ucb.com 电子邮件：laurent.schots@ucb.comBrand Communications 品牌传播Adriaan Snauwaert 阿德里安·斯瑙沃特T +32.4.977.02.346 电话：+32 4 977 02 346email adriaan.snauwaert@ucb.com 电子邮件 adriaan.snauwaert@ucb.comAbout UCB 关于UCBUCB, 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。该公司拥有约9,000名员工，遍布约40个国家，2024年实现收入61亿欧元。UCB is listed on Euronext Brussels (symbol: UCB).. UCB在布鲁塞尔泛欧交易所上市（股票代码：UCB）。Forward looking statements 前瞻性声明This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. 本文件包含前瞻性陈述，包括但不限于含有“潜在”、“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表达的陈述。这些前瞻性陈述基于管理层当前的计划、估计和信念。All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. 所有声明，除历史事实声明外，均可能被视为前瞻性声明，包括收入、营业利润率、资本支出、现金、其他财务信息、预期的法律、仲裁、政治、监管或临床结果或实践以及其他此类估计和结果。By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. . 此类前瞻性声明因其性质，并不保证未来的表现，且受已知和未知的风险、不确定性及假设的影响，这可能导致UCB的实际结果、财务状况、业绩或成就，或行业结果，与本文件中包含的此类前瞻性声明所明示或暗示的任何未来结果、业绩或成就存在重大差异。Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. 可能导致此类差异的重要因素包括但不限于：战争、疫情和恐怖主义的全球蔓延及影响、总体地缘政治环境、气候变化、总体经济、商业和竞争状况的变化、无法获得必要的监管批准或无法在可接受的条件或预期时间内获得批准、与研发相关的成本、UCB在研产品或开发中产品的前景变化、未来司法裁决或政府调查的影响、安全性、质量、数据完整性或生产问题、供应链中断和业务连续性风险；潜在或实际的数据安全和隐私泄露，或UCB信息技术系统的中断、产品责任索赔、对产品或候选产品专利保护的挑战、来自其他产品（包括生物类似药或颠覆性技术/商业模式）的竞争、法律法规的变化、汇率波动、与税收和关税相关法律及规则及其执行方面的变化或不确定性，以及员工的招聘、留用和合规问题。There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. 不能保证在研发管线中会发现或识别出新的产品候选者，也不能保证现有产品的新的适应症会被开发和批准。从概念到商业产品的推进是不确定的；临床前结果并不能保证产品候选者在人体中的安全性和有效性。So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has. 到目前为止，人体的复杂性无法在计算机模型、细胞培养系统或动物模型中重现。完成临床试验和获得产品上市监管批准的时间长度已经。Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. 鉴于这些不确定性，公众被提醒不要对这些前瞻性陈述给予任何过度依赖。这些前瞻性陈述仅在本文档发布之日作出，除非另有说明，否则并未反映上述不断演变的事件或风险以及任何其他不利因素的潜在影响。The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.. 公司继续认真跟进发展，评估这些事件对UCB的财务影响，视情况而定。UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.. UCB明确表示，除非适用法律法规要求，否则不承担更新本文件中任何前瞻性陈述的义务，无论这些陈述是为了确认实际结果，还是为了报告或反映与其相关的任何变化，或任何基于该等陈述的事件、条件或情况的变化。References 参考文献BIMZELX BIMZELX® ®(bimekizumab) U.S. PI. （比美珠单抗）美国产品说明书。https://www.ucb-usa.com/Innovation/Products/BIMZELX https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: October 2025. 最后访问时间：2025年10月。Merola J. Sustained Efficacy up to 3 Years with Bimekizumab Treatment Across GRAPPA Core Domains in Patients with Psoriatic Arthritis: Long-Term Results from Two Phase 3 Trials. 2025 [abstract]. ACR. #2129566. Merola J. Bimekizumab治疗在银屑病关节炎患者中GRAPPA核心领域持续3年的疗效：两项三期试验的长期结果。2025 [摘要]. ACR. #2129566.Rudwaleit M. Long-Term Uveitis Rates with Bimekizumab Treatment Across Pooled Phase 2b and Phase 3 Studies in Patients with Axial Spondyloarthritis or Psoriatic Arthritis: 3-Year Update [abstract]. ACR 2025. #2129301. Rudwaleit M. 比美莫单抗治疗轴向脊柱关节炎或银屑病关节炎患者的长期葡萄膜炎发生率：2b期和3期研究的汇总分析，3年更新 [摘要]. ACR 2025. #2129301.Proft F. 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2025年10月22日，诺华（Novartis）公布IL-17A单抗药物司库奇尤单抗（secukinumab）在成人多发性肌痛风湿（Polymyalgia Rheumatica，PMR）Ⅲ期临床数据：药物成功达到主要终点及全部次要终点，在第52周实现了相较安慰剂具有统计学及临床意义的持续缓解。 司库奇尤单抗是一种靶向白介素-17A（IL-17A）的全人源单克隆IgG1抗体，通过直接抑制IL-17A信号通路，阻断其在多种免疫介导炎症性疾病中的关键致炎作用。该药物由诺华自主研发，是全球首批IL-17A抑制剂之一，已在全球100多个国家获批，用于治疗银屑病、银屑病关节炎、强直性脊柱炎、非放射学轴性脊柱关节炎及化脓性汗腺炎等免疫性疾病。 在本次全球Ⅲ期随机、双盲、安慰剂对照研究中，Cosentyx联合24周激素递减方案在第52周实现显著且持久的疾病缓解。研究同时显示，患者在使用Cosentyx治疗期间的糖皮质激素累积剂量显著低于安慰剂组，且药物耐受性良好，其安全性与既往已知的药物特征一致。诺华计划在2026年上半年向监管机构提交该适应症的上市申请。 PMR是一种常见于50岁及以上人群的炎性风湿性疾病，主要表现为颈、肩、髋部双侧疼痛、晨僵及疲乏。目前的标准治疗仍以长期糖皮质激素为主，但复发率高、长期使用风险显著，包括骨质疏松和糖尿病等并发症，治疗选择极为有限。 目前已获批的 IL-17A单抗药物，还有礼来的Ixekizumab（依奇珠单抗），用于中重度斑块型银屑病、银屑病关节炎、强直性脊柱炎；Bimekizumab获批用于治疗银屑病。 在研的 IL-17A单抗药物中，进展较快的包括康方生物的古莫奇单抗（AK111）、君实生物的JS005、丽珠医药（Livzon）的LZM012（XKH004）灯光。 新浪医药综合 ...... 加入读者交流群： —精彩回顾— 我国启动全球最大规模尿液HPV筛查研究 针对红斑狼疮！阿斯利康首创生物制剂 III 期成功 恒瑞乙肝「突破性疗法」来袭 ADC之后，ABC来了 全球首例！中国医生体内CAR-T成功治疗狼疮 商  务  合  作  ：  杨小雨 15210041717