WILMINGTON, Del.--(BUSINESS WIRE)--Positive results from the MANDARA Phase III trial for FASENRA® (benralizumab) in patients with EGPA were published in the New England Journal of Medicine today,1 as the first head-to-head trial of biologics in patients with EGPA,2 and the first to demonstrate that more than half of patients achieved remission with eosinophil-targeting biologic therapies.1 These findings were also presented today as a late-breaking poster at the American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting in Washington, DC, February 23-26.3.

特拉华州威尔明顿（商业新闻短讯）--FASENRA®（贝那利珠单抗）治疗EGPA患者的MANDARA III期临床试验的阳性结果发表在今天的《新英格兰医学杂志》上，1这是EGPA患者首次进行生物制剂的头对头试验，2，也是第一个证明超过一半的患者通过靶向嗜酸性粒细胞的生物疗法获得缓解的人。这些发现今天也作为最新的海报在华盛顿特区的美国过敏性哮喘与免疫学学会（AAAAI）年会上发表，2月23日至26日。

MANDARA compared benralizumab to mepolizumab in patients with EGPA receiving oral corticosteroids (OCS) with or without stable immunosuppressive therapy.2 Patients were randomized to receive either a single 30 mg subcutaneous injection of benralizumab, or three separate 100 mg subcutaneous injections of mepolizumab, once every four weeks.2 Full results showed that benralizumab met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab.1 The primary endpoint of adjusted rate of remission was 59% for benralizumab-treated patients at weeks 36 and 48, compared with 56% for mepolizumab (difference in rates: 3%; 95% CI:, –13,18).1 Remission in EGPA is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4 mg/day.2.

MANDARA比较了接受或不接受稳定免疫抑制治疗的口服皮质类固醇（OCS）的EGPA患者的贝那利珠单抗和美泊利珠单抗。2名患者随机接受单次30 mg皮下注射贝那利珠单抗或三次单独100 mg皮下注射美泊利珠单抗，每四周一次。2完整结果显示，贝那利珠单抗符合试验的主要终点，并且与mepolizumab相比，缓解率不低于mepolizumab。1贝那利珠单抗治疗的患者在第36周和第48周的调整缓解率主要终点为59%，而mepolizumab为56%（差异率：3%；95%置信区间：，–13,18）.1 EGPA的缓解定义为伯明翰血管炎活动评分（BVAS）=0，OCS剂量小于或等于4 mg/天。

A higher proportion of FASENRA-treated patients were able to fully taper off OCS during weeks 48 through 52 (41% in the benralizumab arm vs. 26% in the comparator arm (difference: 16%; 95% CI: 1,31).1 Additionally, 86% of benralizumab patients vs. 74% in the comparator arm (difference: 12%; 95% CI: −1, 25) had at least a 50% reduction in OCS dose during weeks 48 through 52.1.

在48至52周期间，接受FASENRA治疗的患者中有较高比例能够完全减少OC（贝那利珠单抗组为41%，对照组为26%（差异：16%；95%CI:1,31）。此外，在48至52.1周期间，86%的贝那利珠单抗患者与对照组的74%（差异：12%；95%CI:-1,25）的OC剂量至少减少了50%。

Dr. Michael Wechsler, Professor of Medicine and Director of The Asthma Institute at National Jewish Health, and International Coordinating Investigator of the MANDARA trial said: “Patients with EGPA typically rely on long-term, high-dose OCS, which can cause serious and lasting side effects, and often suffer recurrent relapses when attempting to taper off their treatment.

国家犹太卫生组织（National Jewish Health）医学教授、哮喘研究所所长、MANDARA试验国际协调研究员迈克尔·韦克斯勒（Michael Wechsler）博士说：“EGPA患者通常依赖长期高剂量的OCS，这可能会导致严重而持久的副作用，并且在试图逐渐减少治疗时经常会复发。

These findings are an exciting step forward as they affirm that eosinophil-targeting biologic treatments helped more patients achieve remission and taper off of steroid therapy.”.

这些发现是向前迈出的令人兴奋的一步，因为他们证实嗜酸性粒细胞靶向生物治疗有助于更多患者缓解并逐渐减少类固醇治疗。”。

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said, “The results from this trial are an important step forward for the EGPA community, as this is the first trial to demonstrate that remission from EGPA with an eosinophil-targeting biologic is achievable for the majority of patients.

阿斯利康生物制药研发执行副总裁莎伦·巴尔（SharonBarr）表示：“这项试验的结果是EGPA社区向前迈出的重要一步，因为这是第一项证明EGPA缓解嗜酸性粒细胞靶向生物制剂对大多数患者是可实现的。

This is a significant advancement and shows that benralizumab helped patients achieve remission and reduce chronic OCS usage, in a convenient, single, monthly subcutaneous injection, and could alleviate some of the impact of this debilitating disease.”.

这是一项重大进步，表明贝那利珠单抗可以通过方便的单次每月皮下注射帮助患者缓解并减少慢性OCS的使用，并且可以减轻这种使人衰弱的疾病的一些影响。”。

Elevated levels of eosinophils play a central role in EGPA disease pathophysiology.4 All patients with EGPA have very high levels of eosinophils at some point in their disease, both in peripheral blood and in affected tissues or organs.5,6 Approximately half of patients with EGPA have concomitant, adult-onset severe eosinophilic asthma, and often have sinus and nasal symptoms.5,7.

嗜酸性粒细胞水平升高在EGPA疾病的病理生理学中起着重要作用[4]。所有EGPA患者在疾病的某个阶段，外周血和受影响的组织或器官中都有非常高水平的嗜酸性粒细胞[5,6]。大约一半的EGPA患者伴有成人发作的严重嗜酸性粒细胞哮喘，并且经常有鼻窦和鼻腔症状[5,7]。

FASENRA has a unique mode of action that leads to near complete depletion of eosinophils.8,9 Treatment with benralizumab was associated with a greater reduction of blood eosinophil counts from week 1 compared to mepolizumab and maintained at all timepoints.1 At week 1 mean blood eosinophil count ratio to baseline was 0.15 vs.

FASENRA具有独特的作用模式，可导致嗜酸性粒细胞接近完全耗竭[8,9]。与mepolizumab相比，贝那利珠单抗治疗与第1周血液嗜酸性粒细胞计数的减少相关，并在所有时间点维持[1]。第1周平均血液嗜酸性粒细胞计数与基线的比率为0.15 vs。

0.39 respectively (adjusted geometric mean ratio: 0.38; 95% CI: 0.29, 0.49) and 0.10 vs. 0.26 at week 52 (adjusted geometric mean ratio: 0.36; 95% CI: 0.27, 0.49).1 Benralizumab was well tolerated with no new safety signals, which is consistent with the known profile of the medicine.1.

第52周分别为0.39（校正几何平均比：0.38；95%CI:0.29,0.49）和0.10比0.26（校正几何平均比：0.36；95%CI:0.27,0.49）。1贝那利珠单抗耐受性良好，没有新的安全信号，这与已知的药物特征一致。

FASENRA is currently approved as an add-on maintenance treatment for SEA in 80 countries including the US, Japan and in the EU, and is approved for self-administration in the US, EU and other countries.10-13

FASENRA目前在美国、日本和欧盟等80个国家被批准作为SEA的附加维护治疗，并被批准在美国、欧盟和其他国家进行自我管理。10-13

AstraZeneca has been working with regulatory authorities around the world in order to bring benralizumab to EGPA patients as quickly as possible.

阿斯利康一直在与世界各地的监管机构合作，以便尽快将贝那利珠单抗带给EGPA患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

Known hypersensitivity to benralizumab or excipients.

已知对贝那利珠单抗或赋形剂过敏。

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity Reactions

超敏反应

Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

服用FASENRA后发生超敏反应（例如过敏反应，血管性水肿，荨麻疹，皮疹）。这些反应通常在给药后数小时内发生，但在某些情况下会延迟发作（即数天）。如果出现超敏反应，请停止使用。

Acute Asthma Symptoms or Deteriorating Disease

急性哮喘症状或疾病恶化

FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

FASENRA不应用于治疗急性哮喘症状，急性加重或急性支气管痉挛。

Reduction of Corticosteroid Dosage

减少皮质类固醇剂量

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy..

在开始使用FASENRA治疗时，不要突然停止全身或吸入皮质类固醇。如果适当的话，皮质类固醇剂量的减少应该是逐渐的，并在医生的直接监督下进行。皮质类固醇剂量的减少可能与全身性戒断症状和/或先前被全身性皮质类固醇治疗抑制的掩盖状况有关。。

Parasitic (Helminth) Infection

寄生虫（蠕虫）感染

It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves..

目前尚不清楚FASENRA是否会影响患者对蠕虫感染的反应。在开始使用FASENRA治疗之前，先治疗已有蠕虫感染的患者。如果患者在接受FASENRA治疗时感染，并且对抗蠕虫治疗无反应，则停止FASENRA治疗，直到感染消退。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

最常见的不良反应（发生率≥5%）包括头痛和咽炎。

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

注射部位反应（例如疼痛，红斑，瘙痒，丘疹）在接受FASENRA治疗的患者中发生率为2.2%，而安慰剂治疗的患者发生率为1.9%。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

怀孕暴露登记处监测怀孕期间暴露于FASENRA的女性的妊娠结局。要注册，请致电1-877-311-8972或访问www.mothertobaby.org/fasenra。

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy..

来自临床试验的妊娠暴露数据不足以告知药物相关风险。单克隆抗体如贝那利珠单抗在妊娠晚期通过胎盘转运；因此，在妊娠晚期，对胎儿的潜在影响可能更大。。

INDICATION

指示

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

FASENRA适用于12岁及以上严重哮喘患者以及嗜酸性粒细胞表型的附加维持治疗。

FASENRA is not indicated for treatment of other eosinophilic conditions

FASENRA不适用于治疗其他嗜酸性粒细胞疾病

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

FASENRA不适用于缓解急性支气管痉挛或哮喘状态

Please read full Prescribing Information, including

请阅读完整的处方信息，包括

Patient Information and Instructions for Use.

患者信息和使用说明。

You may report side effects related to AstraZeneca products.

您可能会报告与阿斯利康产品有关的副作用。

Notes

注意事项

Eosinophilic granulomatosis with polyangiitis

嗜酸性肉芽肿伴多血管炎

EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated inflammatory disease that is caused by inflammation of small to medium-sized blood vessels.4,5 It is estimated that 118,000 people throughout the world live with EGPA.14

EGPA，以前称为Churg-Strauss综合征，是一种罕见的免疫介导的炎症性疾病，由中小型血管炎症引起[4,5]。据估计，全世界有118000人患有EGPA

EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.5 The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.5,6 Without treatment, the disease may be fatal.5,6 Almost half (47%) of patients do not achieve remission with current treatments.15.

EGPA可导致多个器官受损，包括肺、上呼吸道、皮肤、心脏、胃肠道和神经。5最常见的症状和体征包括极度疲劳、体重减轻、肌肉和关节疼痛、皮疹、神经痛、鼻窦和鼻腔症状以及呼吸急促。5,6如果不治疗，该疾病可能致命。5,6几乎一半（47%）目前的治疗没有达到缓解。

There are limited treatment options for EGPA. Patients are often treated with chronic high-dose OCS and experience recurrent relapses when attempting to taper off OCS.6,16 Mepolizumab is currently the only approved treatment for EGPA.17

EGPA的治疗选择有限。患者经常接受慢性高剂量OCS治疗，并且在尝试逐渐减少OCS时会复发[6,16]。Mepolizumab是目前唯一被批准用于EGPA的治疗方法

MANDARA

曼达拉

MANDARA was a randomized, double blind, double-dummy, active-controlled, parallel group, multicentre 52-week Phase III trial which compared the efficacy and safety of FASENRA to mepolizumab in adult patients with relapsing or refractory EGPA.2 In the blinded trial, 140 patients were randomized 1:1 (70 per treatment group) to receive either a single 30mg subcutaneous injection of FASENRA or three separate 100mg subcutaneous injections of mepolizumab once every four weeks.1.

MANDARA是一项随机、双盲、双模拟、主动对照、平行组、多中心、为期52周的III期临床试验，比较了FASENRA和mepolizumab在复发或难治性EGPA成年患者中的疗效和安全性。2在盲法试验中，140名患者被随机分为1:1（每个治疗组70名）每四周接受一次30mg皮下注射FASENRA或三次100mg皮下注射mepolizumab。

The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.2 Remission is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less than or equal to 4 mg/day.2 FASENRA remission was compared to the historical placebo rate from mepolizumab’s Phase III trial, MIRRA.18 The primary statistical analysis was to demonstrate non-inferiority of FASENRA versus mepolizumab based on the primary endpoint.1.

主要终点是在第36周和第48周缓解的患者比例。2缓解定义为伯明翰血管炎活动评分（BVAS）=0，OCS剂量小于或等于4 mg/天。2将FASENRA缓解与mepolizumab III期试验的历史安慰剂率进行比较，MIRRA.18主要统计分析是基于主要终点证明FASENRA与mepolizumab的非劣效性。

All patients who complete the 52-week double-blind treatment period were eligible to continue into an ongoing open label extension (OLE) period, intended to allow each patient at least one year of treatment with open-label FASENRA.2

所有完成52周双盲治疗期的患者都有资格继续进入持续的开放标签延长（OLE）期，旨在使每位患者至少接受一年的开放标签FASENRA治疗

Mepolizumab is a humanized IL-5 antagonist monoclonal antibody.3

Mepolizumab是一种人源化IL-5拮抗剂单克隆抗体

FASENRA

发票

FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).8,9

FASENRA是一种单克隆抗体，可直接与嗜酸性粒细胞上的IL-5受体α结合，并通过细胞凋亡（程序性细胞死亡）吸引自然杀伤细胞诱导大多数患者血液和组织嗜酸性粒细胞快速和接近完全耗竭。8,9

FASENRA (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan, and is approved for self-administration in the US, EU and other countries.10-13 FASENRA has been prescribed to over 120,000 patients globally.19

FASENRA（benralizumab）目前已在包括美国，欧盟，日本在内的80多个国家获得批准，并在美国，欧盟和其他国家被批准用于自我管理.10-13 FASENRA已被全球超过120000名患者处方.19

FASENRA is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.20-22

FASENRA正在开发其他疾病，包括慢性阻塞性肺病，慢性鼻-鼻窦炎伴鼻息肉和嗜酸性粒细胞增多综合征.20-22

FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

FASENRA由阿斯利康开发，由日本协和麒麟株式会社的全资子公司BioWa，Inc.授权。

Respiratory & Immunology

呼吸与免疫学

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

呼吸与免疫学是阿斯利康生物制药的一部分，是该公司的关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康是呼吸系统护理领域的公认领导者，拥有50年的历史，并且在免疫介导疾病方面的药物组合不断增加。该公司致力于通过吸入药物、生物制剂和针对以前无法达到的生物目标的新模式的管道和组合，解决这些慢性病（通常使人衰弱）的巨大未满足需求。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物，帮助消除COPD作为主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq:AZN）是一家全球科学领先的生物制药公司，专注于肿瘤学，罕见病和生物制药（包括心血管，肾脏和代谢以及呼吸和免疫学）中处方药的发现，开发和商业化。

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca..

阿斯利康总部位于英国剑桥，在100多个国家运营，其创新药物被全球数百万患者使用。请访问www.astrazeneca-us.com并在社交媒体@astrazeneca上关注公司。。

References

参考文献

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6.Baldini C等人。Churg-Strauss综合征的临床表现和治疗。大黄Dis Clin N Am。2010；36:527-543。

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Veeva ID: Z4-61457   Date of Preparation: Feb 2024

Veeva ID:Z4-61457编制日期：2024年2月