对齐的患者治疗的患者减少口腔皮质类固醇（OCS）剂量的4倍以上的可能性比安慰剂的剂量
Benralizumab also reduced overall exacerbation rates by 70% and exacerbations requiring emergency room visits or hospitalisations by 93% in patients with severe, uncontrolled eosinophilic asthma
Trial results published simultaneously in New England Journal of Medicine
2017年5月22日
结果来自III阶段Zonda试验在美国胸部社会（ATS）2017年国际会议上表现出来，将北立人添加到护理标准允许患者依赖于ocs，在保持哮喘控制的同时显着减少或停止试用类固醇。Zonda研究的详细结果今天在线发布新英格兰医学杂志。
该试验达到了主要疗效终点，展示了与安慰剂相比的两种北中等动物剂量方案的日常维护OCs的统计显着和临床相关降低。用Benralizumab治疗的患者比降低ocs剂量的可能性超过安慰剂组的患者。对于用安慰剂对齐的患者，OCS剂量的中位数为75％，患者为25％的患者。
Zonda试验表明了次要终点的显着结果。对于8周给药方案的OCS减少：
- 66％的北半取生治疗的患者减少了OCS剂量≥50％，与37％接受安慰剂相比
- 37％的Benralizumab治疗患者的患者均可减少≥90％，与12％接受安慰剂相比
- 52％的北非人为治疗的患者有资格停止每次试验方案的OCS可以完全停止OCS使用，而19％接受安慰剂
在8周给药方案上对北大米马夫治疗患者急性哮喘事件的预防或减少分析：
- 与安慰剂相比，整体年度恶化率的70％降低
- 与安慰剂相比，需要急诊室访问或住院的93％的加剧。
麦克马斯大学汉默尔顿大学呼吸系统博士博士和试验的牵头调查员表示：“贝纳里姆巴可展示令人印象深刻的临床疗效，通过将加剧率降低至70％，同时使患者能够实现严重的患者哮喘显着降低它们的泼尼松剂量并保持肺功能。这可能是由于其抑制白细胞介素-5的受体的独特作用机制，潜在的耗尽血液和气道嗜酸性粒细胞。“
肖恩·Bohen执行副总统ident, Global Medicines Development and Chief Medical Officer, said: “One of the known clinical characteristics of the eosinophilic asthma phenotype is an over reliance on oral steroids to manage severe uncontrolled disease. What is exciting about the ZONDA trial is that we have shown benralizumab delivers a clinically meaningful OCS reduction alongside a substantial reduction in asthma exacerbation rate including emergency treatment or hospitalisations in this difficult-to-treat patient population.”
Zonda试验评估了Benralizumab 30mg在成年患者中使用8-或4周的给药方案给药（SC）在成年患者中患者的严重，不受控制的嗜酸性哮喘患者（ICS）/长 -具有或没有额外的哮喘控制器的Agons（Laba）和OCS具有良好的抗哮喘控制器，具有良好的耐受性，具有安慰剂的整体不良事件概况，并在先前的III期试验中观察到。在Zonda观察到的Zonda治疗的患者中最常见的不良事件（≥10％）是鼻咽炎，恶化的哮喘和支气管炎。
The data from the ZONDA trial, along with the pivotal Phase III SIROCCO and CALIMA trials, were included in regulatory submissions for benralizumab. Benralizumab is not approved anywhere in the world, but is under regulatory review in the US, EU, Japan and several other countries with a US PDUFA date during the fourth quarter of 2017.
编辑注释
关于严重的哮喘
哮喘影响全球3.15亿人，高达10％的哮喘患者具有严重的哮喘，尽管高剂量的护理哮喘控制器药物，可能需要使用慢性口服皮质类固醇（OCS）。
严重的不受控制的哮喘是衰弱和潜在的致命致命，患者经常发出恶劣和对肺功能和生活质量的显着限制。严重的，不受控制的哮喘具有比严重的哮喘更高的死亡风险八倍。
不受控制的哮喘可导致对OC的依赖性，具有全身类固醇暴露可能导致严重和不可逆的短期和长期不良影响，包括体重增加，糖尿病，骨质疏松症，青光眼，焦虑，抑郁，心血管疾病和免疫抑制。这些患者占哮喘相关成本的50％，也存在严重的哮喘的重要身体和社会经济负担。
关于Zonda试验
Zonda是一个28周，随机的双盲，并联，安慰剂控制的多期第III族试验，包括220名成年患者，其严重的不受控制的哮喘，需要用高剂量IC加上Laba和慢性ocss和血嗜酸性粒细胞治疗至少150个细胞/μl的计数[一世]The trial assessed the effects of benralizumab (30 mg every 4 weeks or every 8 weeks; first three doses every 4 weeks) versus placebo on OCS dose reduction while maintaining asthma control for adult patients with severe asthma. The primary endpoint was the percentage change in OCS dose from baseline to week 28.
患者在第0周进行随机化以接受Benralizumab或安慰剂，并进入4周的诱导阶段，在此期间维持优化的OCS剂量。在随后的还原阶段（周4-24）中，OCS剂量以4-5.0mg / d在4-每周间隔下减少2.5-5.0mg / d。只有优化基线OCS剂量≤12.5mg/ d的患者才有资格减少100％剂量。看看新英格兰医学杂志稿件今天发布在线，了解试验中OCS剂量协议的其他信息。
关于Benralizumab.
Benralizumab is an anti-eosinophil monoclonal antibody that induces direct, and near-complete depletion of eosinophils via antibody dependent cell-mediated cytotoxicity (ADCC). Depletion of circulating eosinophils is rapid, with an onset of action within 24 hours as confirmed in early phase I/II trials. In the pivotal Phase III trials, SIROCCO and CALIMA benralizumab demonstrated significant reduction in exacerbations and improved lung function and asthma symptoms in severe uncontrolled eosinophilic asthma patients. Eosinophils are the biological effector cells that drive inflammation and airway hyper-responsiveness in approximately 50% of asthma patients, leading to frequent exacerbations, impaired lung function and asthma symptoms. Benralizumab is not approved anywhere in the world, but is under regulatory review in the US, EU, Japan and several other countries.
波罗尼州开发的Astrazeneca的全球生物制剂研发武器由Medimmune开发欧洲杯微信买球，并获得BioWa，Inc。的授权，Kyowa Hakko Kirin Co.，Ltd。的全资子公司
关于Asta欧洲杯微信买球zeneca在呼吸系统疾病中
呼吸道disease is one of AstraZeneca’s main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2016. AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.
公司正在建立40年呼吸道疾病的遗产，Astazeneca吸入技术的能力跨越PMDIS和干粉吸入器，以及创新的共悬架欧洲杯微信买球TM值交付技术。The company’s biologics include benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan, tralokinumab (anti-IL-13), which is currently in Phase III, and tezepelumab (anti-TSLP), which successfully achieved its Phase IIb primary endpoint. AstraZeneca’s research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration。
关于Asta欧洲杯微信买球zeneca.
欧洲杯微信买球Astrazeneca是一家全球性的科学导向的生物制药公司，专注于处方药的发现，开发和商业化，主要用于治疗三个主要治疗区域的疾病 - 肿瘤，心血管和代谢疾病和呼吸道。该公司还在自身免疫，神经科学和感染方面有选择性地活跃。欧洲杯微信买球AstraZeneca在100多个国家运营，其创新的药物被全球数百万患者使用。有关更多信息，请访问www.欧洲杯微信买球astrazeneca.com.并在Twitter @astrazeneca上关注我欧洲杯微信买球们。
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