生物制剂在EGPA的首次面对面试验, comparing a single monthly injection of Fasenra to three injections per month of mepolizumab
Positive high-level results from the 曼达拉 Phase III trial showed 澳门葡京网赌游戏’s Fasenra (benralizumab)达到了试验的主要终点，并且与mepolizumab相比，在接受口服皮质类固醇(OCS)伴或不伴稳定免疫抑制治疗的嗜酸性肉芽肿病伴多血管炎(EGPA)患者中，缓解率不低于mepolizumab.
曼达拉是首个EGPA生物制剂的III期正面试验，比较了两种药物的有效性和安全性 Fasenra versus mepolizumab, the only currently approved treatment.1,2 在盲法试验中, patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg subcutaneous injections of mepolizumab once every four weeks.1,2
EGPA是一种罕见的, immune-mediated vasculitis that is caused by inflammation of small to medium-sized blood vessels.3,4 大约一半的EGPA患者伴有成人发病的严重嗜酸性哮喘(SEA)。.5 EGPA会对多个器官造成损害, 包括肺, 皮肤, 心, 胃肠道和神经, which accumulates over time and without treatment can be fatal.3,6
Michael Wechsler博士, 首席研究员说:“阳性的曼达拉试验结果令人兴奋，因为嗜酸性肉芽肿病合并多血管炎患者目前的治疗选择有限，但面临严重症状, 如果不治疗甚至可能致命. 这项试验表明，每月注射一次生物药物可以帮助患者达到与目前标准治疗相当的缓解率, 增加了benralizumab作为嗜酸性肉芽肿病合并多血管炎的潜在治疗选择的重要性.”
Sharon Barr, Executive Vice President, 澳门葡京赌博游戏 R&D, 澳门葡京网赌游戏, said: “The positive results from 曼达拉 demonstrate that Fasenra, which has a unique mechanism of action and directly targets eosinophils, 是否可以通过更方便的每月单次皮下注射来帮助患者缓解这种炎症性疾病的衰弱影响.”
安全性和耐受性概况 Fasenra in the trial was consistent with the known profile of the medicine.
曼达拉的全部结果将在即将召开的医学会议上公布，数据将与世界各地的卫生当局共享.
Fasenra 是一种单克隆抗体，直接结合嗜酸性粒细胞上的IL-5受体α，并吸引自然杀伤细胞，通过细胞凋亡(程序性细胞死亡)诱导大多数患者血液和组织嗜酸性粒细胞的快速和近乎完全消耗。.7,8
Fasenra is currently approved as an add-on maintenance treatment for SEA in the US, EU, 日本和其他国家, and is approved for self-administration in the US, 欧盟和其他国家.9,10 FDA批准了孤儿药认定 Fasenra for EGPA in 2018 and 澳门葡京网赌游戏 continues to explore Fasenra的 除严重哮喘外的潜能, as a treatment across many diseases where eosinophils are expected to play a role.11-14
笔记
EGPA
EGPA, 以前被称为丘格-施特劳斯综合症, 是罕见的, 由中小血管炎症引起的免疫介导的炎症性疾病.3,4 It is estimated that 118,000 people throughout the world live with EGPA.15
EGPA会对多个器官造成损害, 包括肺, 皮肤, 心, 胃肠道和神经.3 The most common symptoms and signs include extreme fatigue, 减肥, 肌肉和关节疼痛, 皮疹, 神经疼痛, 鼻窦和鼻腔症状, 还有呼吸短促.3,6 如果不治疗，这种疾病可能是致命的.3,6
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.3,6 Approximately half of patients with EGPA have concomitant adult-onset SEA, 并且经常有鼻窦和鼻腔症状.3,5
EGPA的治疗选择有限. 患者通常接受慢性高剂量OCS治疗，当试图逐渐减少OCS时，可能会出现复发.6,16 Mepolizumab is currently the only approved treatment for EGPA.2
曼达拉
曼达拉是随机的, 双盲, double-dummy, active-控制, 平行组, 多中心 52-week Phase III trial which compared the efficacy and safety of Fasenra to mepolizumab in adult patients with relapsing or refractory EGPA.1 在盲法试验中, 140例患者按1:1随机分组(每个治疗组70例)，接受单次皮下注射30mg Fasenra or three separate 100mg subcutaneous injections of mepolizumab once every four weeks.1
The primary endpoint was the proportion of patients who were in remission at both weeks 36 and 48.1 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4mg/天.1 Fasenra remission was compared to the historical placebo rate from mepolizumab’s Phase III trial, MIRRA.17 The primary statistical analysis was to demonstrate non-inferiority of Fasenra 与mepolizumab相比基于主要终点.
所有完成52周双盲治疗期的患者可能有资格继续进入开放tags延长(OLE)期, intended to allow each patient at least one year of treatment with 非盲 Fasenra.1
Mepolizumab is a humanized IL-5 antagonist monoclonal antibody.2
Fasenra
Fasenra (benralizumab) is currently approved as an add-on maintenance treatment for SEA in the US, EU, 日本和其他国家, and is approved for self-administration in the US, 欧盟和其他国家.9,10 Fasenra has been studied in almost 4,000 patients in global clinical trials.18-22
Fasenra is in 发展 for other eosinophilic diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.12-14
Fasenra was developed by 澳门葡京网赌游戏 and is in-licensed from BioWa, Inc.是协和麒麟株式会社的全资子公司.有限公司.,日本.
呼吸 & 免疫学
呼吸 & 免疫学, 澳门葡京网赌游戏澳门葡京赌博游戏公司的一部分, is a key disease area and growth driver to the Company.
澳门葡京网赌游戏是呼吸系统护理领域的领导者，拥有50年的历史，并在免疫介导疾病方面拥有不断增长的药物组合. The Company is committed to addressing the vast unmet needs of these chronic, 常常使人衰弱的, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. 澳门葡京赌博游戏的目标是提供改变生活的药物，帮助消除COPD这一主要死亡原因, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, 发展, and commercialisation of prescription medicines in 肿瘤学, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. 请访问 澳门葡京网赌游戏.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.
参考文献
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