瑞利珠单抗在嗜酸性粒细胞哮喘中的应用
2017/11/20
摘要
瑞利珠单抗(Cinqaero®; Cinqair®)是一种针对白介素5（IL-5）的人源化单克隆抗体，白介素5是一种介导嗜酸性粒细胞气道炎症的细胞因子。基于BREATH第三阶段的临床试验研究数据，瑞利珠单抗可作为成人重度嗜酸性粒细胞哮喘的添加治疗。在三次长达52周的BREATH双盲研究中，对于应用吸入性糖皮质激素未能控制的嗜酸性粒细胞哮喘患者（12-75岁），在现有哮喘治疗的基础上，静脉应用瑞利珠单抗与应用安慰剂相对比，可显著减少哮喘急性发作的频率，显著改善肺功能、哮喘控制以及健康相关生活质量。在历时52周的两个实验中得到的合并数据显示，在不同的患者亚组中瑞利珠单抗有相似的益处，其中包括重度嗜酸性粒细胞哮喘患者。患者对瑞利珠单抗普遍耐受，极少数的试用者会经历严重的治疗相关性的不良反应。此外，在一个开放式扩展研究中，持续应用瑞利珠单抗长达2年与持久的肺功能受益相关，但没有任何新的耐受性的担忧。因此，对于应用常规治疗不能控制的成人重度嗜酸性粒细胞哮喘患者而言，静脉应用瑞利珠单抗不失为一种有价值的添加治疗。
Reslizumab in Eosinophilic Asthma: A Review
Deeks ED, Brusselle G.
Author information
Abstract
Reslizumab (Cinqaero®; Cinqair®) is a humanized monoclonal antibody against interleukin-5 (IL-5), a cytokine mediator of eosinophilic airway inflammation. Reslizumab is indicated as an add-on treatment for severe eosinophilic asthma in adults, on the basis of data from the BREATH phase III clinical trial programme. In three double-blind BREATH studies of up to 52 weeks' duration, adding intravenous reslizumab (3 mg/kg, once every 4 weeks) to the current asthma therapy of patients (aged 12-75 years) with eosinophilic asthma inadequately controlled with inhaled corticosteroids resulted in significant reductions in clinical asthma exacerbation frequency and significant improvements in lung function, asthma control and health-related quality of life relative to adding placebo. Pooled data from the two trials of 52 weeks' duration indicated similar benefits with reslizumab across various patient subgroups, including patients with severe eosinophilic asthma. Reslizumab was generally well tolerated, with very few recipients experiencing severe or serious treatment-related adverse events. Moreover, in an open-label extension study, continued use of reslizumab for up to 2 years was associated with durable lung function benefit, without any new tolerability concerns. Thus, intravenous reslizumab extends the valuable add-on treatment options for adults with severe eosinophilic asthma inadequately controlled with standard therapies.
瑞利珠单抗(Cinqaero®; Cinqair®)是一种针对白介素5（IL-5）的人源化单克隆抗体，白介素5是一种介导嗜酸性粒细胞气道炎症的细胞因子。基于BREATH第三阶段的临床试验研究数据，瑞利珠单抗可作为成人重度嗜酸性粒细胞哮喘的添加治疗。在三次长达52周的BREATH双盲研究中，对于应用吸入性糖皮质激素未能控制的嗜酸性粒细胞哮喘患者（12-75岁），在现有哮喘治疗的基础上，静脉应用瑞利珠单抗与应用安慰剂相对比，可显著减少哮喘急性发作的频率，显著改善肺功能、哮喘控制以及健康相关生活质量。在历时52周的两个实验中得到的合并数据显示，在不同的患者亚组中瑞利珠单抗有相似的益处，其中包括重度嗜酸性粒细胞哮喘患者。患者对瑞利珠单抗普遍耐受，极少数的试用者会经历严重的治疗相关性的不良反应。此外，在一个开放式扩展研究中，持续应用瑞利珠单抗长达2年与持久的肺功能受益相关，但没有任何新的耐受性的担忧。因此，对于应用常规治疗不能控制的成人重度嗜酸性粒细胞哮喘患者而言，静脉应用瑞利珠单抗不失为一种有价值的添加治疗。
（复旦大学附属中山医院呼吸内科 李蕾 摘译 杨冬 审校）
（Drugs. 2017;77(7):777-784.）
（Drugs. 2017;77(7):777-784.）
Reslizumab in Eosinophilic Asthma: A Review
Deeks ED, Brusselle G.
Author information
Abstract
Reslizumab (Cinqaero®; Cinqair®) is a humanized monoclonal antibody against interleukin-5 (IL-5), a cytokine mediator of eosinophilic airway inflammation. Reslizumab is indicated as an add-on treatment for severe eosinophilic asthma in adults, on the basis of data from the BREATH phase III clinical trial programme. In three double-blind BREATH studies of up to 52 weeks' duration, adding intravenous reslizumab (3 mg/kg, once every 4 weeks) to the current asthma therapy of patients (aged 12-75 years) with eosinophilic asthma inadequately controlled with inhaled corticosteroids resulted in significant reductions in clinical asthma exacerbation frequency and significant improvements in lung function, asthma control and health-related quality of life relative to adding placebo. Pooled data from the two trials of 52 weeks' duration indicated similar benefits with reslizumab across various patient subgroups, including patients with severe eosinophilic asthma. Reslizumab was generally well tolerated, with very few recipients experiencing severe or serious treatment-related adverse events. Moreover, in an open-label extension study, continued use of reslizumab for up to 2 years was associated with durable lung function benefit, without any new tolerability concerns. Thus, intravenous reslizumab extends the valuable add-on treatment options for adults with severe eosinophilic asthma inadequately controlled with standard therapies.
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支气管热成形术在哮喘中作用的新认识
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对重度嗜酸性粒细胞性哮喘患者使用mepolizumab：III期MENSA试验的经济学分析
