Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Department of Respiratory Medicine, Ghent University Hospital and Ghent University, Ghent, Belgium.
Drugs. 2017 May;77(7):777-784. doi: 10.1007/s40265-017-0740-2.
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.
雷西珠单抗(Cinqaero;Cinqair)是一种针对白细胞介素-5(IL-5)的人源化单克隆抗体,白细胞介素-5 是嗜酸性粒细胞气道炎症的细胞因子介质。雷西珠单抗基于 III 期 BREATH 临床试验计划的数据,被批准用于治疗成人重度嗜酸性粒细胞性哮喘,作为附加疗法。在为期 52 周的三项双盲 BREATH 研究中,将静脉注射雷西珠单抗(3mg/kg,每 4 周一次)添加到当前哮喘疗法中,治疗未能充分控制吸入性皮质类固醇的嗜酸性粒细胞性哮喘患者(年龄 12-75 岁),与添加安慰剂相比,可显著降低临床哮喘加重的频率,并显著改善肺功能、哮喘控制和健康相关生活质量。两项 52 周研究的汇总数据表明,雷西珠单抗在各种患者亚组中均具有相似的益处,包括重度嗜酸性粒细胞性哮喘患者。雷西珠单抗总体耐受性良好,极少数患者出现严重或严重的治疗相关不良事件。此外,在一项开放标签扩展研究中,继续使用雷西珠单抗长达 2 年与持久的肺功能获益相关,没有出现新的耐受性问题。因此,静脉注射雷西珠单抗为未能充分控制标准疗法的重度嗜酸性粒细胞性哮喘成人提供了有价值的附加治疗选择。