Brusselle Guy, Canvin Janice, Weiss Sivan, Sun Shawn X, Buhl Roland
Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Depts of Respiratory Medicine and Epidemiology, Erasmus Medical Center, Rotterdam, the Netherlands.
ERJ Open Res. 2017 Aug 17;3(3). doi: 10.1183/23120541.00004-2017. eCollection 2017 Jul.
Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies. This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines. Pooled data from duplicate, Phase III, reslizumab placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in 1 s (FEV) and patient-reported outcomes. Of 953 patients, 69% (n=657) and 11% (n=106) were receiving Step 4 and Step 5 therapy, respectively. Compared with placebo, reslizumab reduced exacerbation rates by 53% (95% CI 0.36-0.62) and 72% (95% CI 0.15-0.52), in Step 4 and Step 5 groups respectively. By study end, reslizumab increased FEV in Step 4 and Step 5 groups by 103 mL (95% CI 52-154 mL) and 237 mL (95% CI 68-407 mL), respectively. Reslizumab also improved patient-reported outcomes compared with placebo in both groups. Reslizumab reduces exacerbation rates and improves lung function and patient-reported outcomes in patients with eosinophilic asthma receiving therapy per Steps 4 and 5 of the GINA guidelines.
如III期研究所示，抗白细胞介素-5单克隆抗体瑞利珠单抗可显著降低重度嗜酸性粒细胞性哮喘成人患者的急性加重频率，并改善其肺功能、哮喘控制情况及生活质量。这项二次分析评估了瑞利珠单抗在按照全球哮喘防治创议（GINA）第4步和第5步指南接受基线治疗的患者中的疗效。来自重度嗜酸性粒细胞性哮喘（血液嗜酸性粒细胞≥400个·µL）患者的两项重复III期瑞利珠单抗安慰剂对照研究的汇总数据，根据基线治疗进行了分层。疗效评估指标为急性加重率以及1秒用力呼气容积（FEV）相对于基线的变化和患者报告的结局。在953例患者中，分别有69%（n = 657）和11%（n = 106）接受第4步和第5步治疗。与安慰剂相比，瑞利珠单抗在第4步和第5步治疗组中分别将急性加重率降低了53%（95%CI 0.36 - 0.62）和72%（95%CI 0.15 - 0.52）。到研究结束时，瑞利珠单抗在第4步和第5步治疗组中分别使FEV增加了103 mL（95%CI 52 - 154 mL）和237 mL（95%CI 68 - 407 mL）。与安慰剂相比，瑞利珠单抗在两组中还改善了患者报告的结局。对于按照GINA指南第4步和第5步接受治疗的嗜酸性粒细胞性哮喘患者，瑞利珠单抗可降低急性加重率，并改善肺功能和患者报告的结局。
