Brussels (Belgium), 23 May, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that The Lancet has published results from the Phase 3 BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 This article represents the primary publication of bimekizumab data from the two pivotal Phase 3 HS studies.

布鲁塞尔（比利时），2024年5月23日–07:00（CET）-全球生物制药公司UCB今天宣布，《柳叶刀》发表了评估IL-17A和IL-17F抑制剂bimekizumab治疗成人中度至重度化脓性汗腺炎（HS）的疗效和安全性的3期BE HEARD I和BE HEARD II试验的结果。本文代表了来自两个关键的3期HS研究的bimekizumab数据的主要出版物。

HS is one of the most burdensome, chronic, systemic, inflammatory skin diseases that can have a profound impact on patients’ health-related quality of life.2,3,4.

HS是最沉重的慢性全身性炎症性皮肤病之一，可对患者的健康相关生活质量产生深远影响[2,3,4]。

“Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for bimekizumab in this chronic inflammatory skin disease,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. .

“在世界领先的医学杂志《柳叶刀》上发表的BE HEARD I和II试验结果反映了这些数据对皮肤病学界的重要性。化脓性汗腺炎患者面临着很高的未满足的医疗需求。这些试验的积极结果支持了针对这种慢性炎症性皮肤病的bimekizumab的全球监管提交，”UCB执行副总裁，患者影响主管，首席商务官Emmanuel Caeymaex说。。

“The Phase 3 studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold endpoint, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease.

“bimekizumab的3期研究代表了化脓性汗腺炎社区的一个重要里程碑，其中包括HiSCR75，一个高阈值终点，作为一个关键的排名次要结果。在这些研究中，bimekizumab始终证明了中重度疾病患者的临床和患者报告结果的持续改善。

These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S..

这些发现为靶向IL-17A和IL-17F作为未来一种新的有前途的治疗方法提供了强有力的支持，”首席研究者Alexa B.Kimball说，Alexa B.Kimball，医学博士，公共卫生硕士，贝斯以色列女执事医学中心，美国马萨诸塞州波士顿哈佛医学院皮肤病学教授。。

In April 2024, UCB announced that the European Commission granted marketing authorization for bimekizumab for the treatment of active moderate to severe HS in adults with an inadequate response to conventional systemic HS therapy. In April 2024, UCB also announced that the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for bimekizumab-bkzx for the treatment of adults with moderate to severe HS.

2024年4月，UCB宣布，欧盟委员会批准了bimekizumab的上市许可，用于治疗对常规全身性HS治疗反应不足的成人活动性中度至重度HS。2024年4月，UCB还宣布，美国食品和药物管理局接受了bimekizumab bkzx用于治疗中度至重度HS成人的补充生物制剂许可证申请。

Other regulatory submissions for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa are underway around the world. .

bimekizumab治疗中度至重度化脓性汗腺炎的其他监管提交正在世界各地进行。。

Notes to editors:

编辑须知：

About BE HEARD I and BE HEARD II

关于被倾听我和被倾听II

BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 3 trials designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS).1 The two trials had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS.1 The primary endpoint in both trials was HiSCR50 at Week 16.1 A key secondary endpoint was HiSCR75 at Week 16.1 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule count or draining tunnel count.1.

BE HEARD I和BE HEARD II是一项随机、双盲、安慰剂对照、平行组、多中心的3期临床试验，旨在评估bimekizumab在成人中度至重度化脓性汗腺炎（HS）中的疗效和安全性。1这两项试验共纳入1014名诊断为中度至重度HS的参与者。1两项试验的主要终点是第16周的HiSCR50。1关键的次要终点是第16周的HiSCR75。HiSCR50和HiSCR75被定义为总脓肿和炎性结节计数比基线至少减少50%或75%，脓肿和炎性结节比基线没有增加e计数或排水隧道计数。1。

Results from BE HEARD I and BE HEARD II showed that a significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16.

BE HEARD I和BE HEARD II的结果显示，与安慰剂相比，接受bimekizumab治疗的患者在第16周时HS体征和症状改善了50%或更多，这是两项试验的主要终点。Bimekizumab治疗还导致排名关键次要终点HiSCR75与安慰剂在第16周的临床意义改善。

Responses were maintained to Week 48.1 The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.1 .

反应维持到第48周。bimekizumab的安全性与之前试验中观察到的安全性数据一致，没有新的观察到的安全性信号。

About hidradenitis suppurativa (HS)

关于化脓性汗腺炎（HS）

Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease, that is associated with systemic manifestations.2,3 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin) which typically occur in the armpits, groin, and buttocks.2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2,3 HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.2,3 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.2,3 The symptoms of pain, discharge and scarring are not only a physical burden.

化脓性汗腺炎（HS）是一种慢性、反复发作、疼痛和衰弱的炎症性皮肤病，与全身表现有关。2,3主要症状是结节、脓肿和脓液排出瘘管（通向皮肤的通道），通常发生在腋窝、腹股沟和臀部。2,3 HS患者会出现疾病发作和剧烈疼痛，这可能对生活质量产生重大影响。2,3 HS最常见于成年早期，影响大多数研究国家约1%的人口。2,3大约三分之一的HS患者有HS家族史和生活方式因素例如吸烟和肥胖也可能在HS的临床过程中起关键作用。2,3疼痛，放电和疤痕的症状不仅是身体负担。

People with HS also experience stigma: worrying about, or directly experiencing, negative attitudes and reactions from society in response to their symptoms.4 These feelings can lead to embarrassment, social isolation, low self-esteem and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.5  .

HS患者也会经历耻辱感：担心或直接经历社会对其症状的负面态度和反应。4这些感觉会导致尴尬，社会孤立，自尊低下和性生活障碍，并影响生活的各个领域，包括人际关系，教育和工作。

About bimekizumab

关于Bimekizumab

BIMZELX® (bimekizumab) is a humanized monoclonal IgG1 antibody designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.6

BIMZELX®（bimekizumab）是一种人源化单克隆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），这是驱动炎症过程的两种关键细胞因子

The therapeutic indications in the EU are7:

欧盟的治疗适应症为7：

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

斑块状银屑病：Bimekizumab适用于治疗全身治疗候选人的成人中度至重度斑块状银屑病。

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).

银屑病关节炎：Bimekizumab单独或与甲氨蝶呤联合用于治疗反应不足或对一种或多种缓解疾病的抗风湿药物（DMARDs）不耐受的成年人的活动性银屑病关节炎。

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. .

轴性脊柱关节炎：Bimekizumab适用于治疗活动性非放射性轴性脊柱关节炎的成年人，其具有客观的炎症迹象，如C反应蛋白（CRP）升高和/或磁共振成像（MRI）反应不足或不耐受非甾体抗炎药（NSAIDs），以及治疗对常规治疗反应不足或不耐受的活动性强直性脊柱炎成年人。。

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.

化脓性汗腺炎：Bimekizumab适用于治疗对常规全身HS治疗反应不足的成人活动性中度至重度化脓性汗腺炎（HS；痤疮反转）。

BIMZELX® ▼ (bimekizumab) EU/EEA* Important Safety Information7

BIMZELX® （bimekizumab）欧盟/欧洲经济区*重要安全信息7

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).

bimekizumab最常报告的不良反应是上呼吸道感染（斑块型银屑病，银屑病关节炎，轴性脊柱关节炎（axSpA）和化脓性汗腺炎分别为14.5%，14.6%，16.3%，8.8%）和口腔念珠菌病（PSO，PsA，axSpA和HS分别为7.3%，2.3%，3.7%，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, fatigue.

常见不良反应（≥1/100至<1/10）为口腔念珠菌病、癣感染、耳部感染、单纯疱疹感染、口咽念珠菌病、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、疲劳。

Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab..

使用bimekizumab时，老年人可能更容易出现某些不良反应，例如口腔念珠菌病，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).

Bimekizumab禁用于对活性物质或任何赋形剂过敏的患者以及具有临床重要活动性感染（例如活动性结核病）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.

Bimekizumab可能会增加感染风险。对于任何临床上重要的活动性感染患者，不得开始使用bimekizumab治疗。如果出现提示感染的体征或症状，应指示接受bimekizumab治疗的患者寻求医疗建议。如果患者发生感染，应仔细监测患者。

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效，应停止治疗，直到感染消退。在开始使用bimekizumab治疗之前，应评估患者的结核病（TB）感染。活动性结核病患者不应服用Bimekizumab。

Patients receiving bimekizumab should be monitored for signs and symptoms of active TB..

接受bimekizumab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..

bimekizumab报道了炎症性肠病新发或恶化的病例。Bimekizumab不推荐用于炎症性肠病患者。如果患者出现炎症性肠病的体征和症状或经历先前存在的炎症性肠病的恶化，则应停止使用bimekizumab，并应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.

用IL-17抑制剂观察到严重的超敏反应，包括过敏反应。如果发生严重的超敏反应，应立即停止服用bimekizumab并开始适当的治疗。

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

接受bimekizumab治疗的患者不应接种活疫苗。

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 €5.3 billion in 2023.

比利时布鲁塞尔UCB（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和解决方案，以改变患有严重免疫系统或中枢神经系统疾病的人的生活。该公司在大约40个国家拥有约9000名员工，2023年实现收入53亿欧元。