GSK哮喘药物Nucala显著提高嗜酸性粒细胞哮喘患者生活质量

2017-03-10 生物谷 生物谷

英国制药巨头葛兰素史克(GSK)近日公布了哮喘药物Nucala IIIb期临床研究MUSCA的新数据,数据显示,Nucala治疗嗜酸性粒细胞哮喘使患者生活质量和肺功能得到显著提高。根据在美国过敏哮喘及免疫学会年会上公布的结果,该研究成功地达到了主要和全部次要终点:当添加至标准护理时,与安慰剂相比,Nucala使患者健康相关生活质

英国制药巨头葛兰素史克(GSK)近日公布了哮喘药物Nucala IIIb期临床研究MUSCA的新数据,数据显示,Nucala治疗嗜酸性粒细胞哮喘使患者生活质量和肺功能得到显著提高。

根据在美国过敏哮喘及免疫学会年会上公布的结果,该研究成功地达到了主要和全部次要终点:当添加至标准护理时,与安慰剂相比,Nucala使患者健康相关生活质量和肺功能实现临床意义和统计学意义的显著提高。

具体数据包括:(1)经过24周治疗后,与安慰剂组相比,Nucala治疗组圣乔治呼吸问卷(SGRQ,评估患者生活质量的一种工具)评分从基线提高7.7个单位,达到了主要终点;(2)与安慰剂组相比,Nucala治疗组支气管扩张剂用药前第1秒用力呼气量(FEV1,评估患者肺功能的一种工具)提高120毫升,达到了首个次要终点;(3)与安慰剂组相比,Nucala治疗组哮喘控制(ACQ-5,评估患者哮喘病情控制的一种工具)也得到显著改善,达到了额外次要终点;(4)与安慰剂组相比,Nucala治疗组哮喘急性发作年发生率降低58%、需要急救或住院的急性发作次数降低68%,达到了2个探索性终点。

哮喘是一种慢性呼吸道疾病;据估计,重症哮喘约占全部哮喘病例的5%-10%,患者需要服用多种药物来控制日常症状,减少严重哮喘发作的风险和频率。在重症哮喘中,有一类是由于嗜酸性粒细胞过量产生导致的肺部炎症引起,导致呼吸困难和哮喘急性发作风险升高,即所谓的嗜酸性粒细胞哮喘,这是重症哮喘中最难以治疗的一类。

Nucala是葛兰素史克推出的全球首个靶向白细胞介素-5(IL-5)的生物疗法,于2015年底获美国和欧盟批准治疗重度嗜酸性粒细胞哮喘。IL-5是一种细胞因子,调控嗜酸性粒细胞的生长、活化、存活及迁移。通过靶向结合IL-5,Nucala能够抑制IL-5与嗜酸性粒细胞表面受体的结合作用,降低血液、组织、痰液中嗜酸性粒细胞水平,从而减少嗜酸性粒细胞所介导的炎症,缓解哮喘病情。

在线量表:哮喘控制问卷(ACQ-5/ACQ-7)

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    2017-04-30 huangdf
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    2017-03-12 tastas

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