Washington University School of Medicine, St. Louis, MO 63110, USA.
Am J Respir Crit Care Med. 2011 Nov 15;184(10):1125-32. doi: 10.1164/rccm.201103-0396OC. Epub 2011 Aug 18.
Eosinophilic asthma is a phenotype of asthma characterized by the persistence of eosinophils in the airways. IL-5 is involved in the activation and survival of eosinophils.
To evaluate the effect of the antibody to IL-5, reslizumab, in patients with eosinophilic asthma that is poorly controlled with high-dose inhaled corticosteroid.
Patients were randomly assigned to receive infusions of reslizumab at 3.0 mg/kg (n = 53) or placebo (n = 53) at baseline and at Weeks 4, 8, and 12, with stratification by baseline Asthma Control Questionnaire (ACQ) score less than or equal to 2 or greater than 2. The primary efficacy measure was the difference between the reslizumab and placebo groups in the change in ACQ score from baseline to end of therapy (Week 15 or early withdrawal).
Mean changes from baseline to end of therapy in ACQ score were -0.7 in the reslizumab group and -0.3 in the placebo group (P = 0.054) and in FEV(1) were 0.18 and -0.08 L, respectively (P = 0.002). In those patients with nasal polyps, the changes in ACQ score were -1.0 and -0.1, respectively (P = 0.012). Median percentage reductions from baseline in sputum eosinophils were 95.4 and 38.7%, respectively (P = 0.007). Eight percent of patients in the reslizumab group and 19% of patients in the placebo group had an asthma exacerbation (P = 0.083). The most common adverse events with reslizumab were nasopharyngitis, fatigue, and pharyngolaryngeal pain.
Patients receiving reslizumab showed significantly greater reductions in sputum eosinophils, improvements in airway function, and a trend toward greater asthma control than those receiving placebo. Reslizumab was generally well tolerated.
嗜酸性粒细胞性哮喘是一种以气道中嗜酸性粒细胞持续存在为特征的哮喘表型。IL-5 参与了嗜酸性粒细胞的激活和存活。
评估抗 IL-5 抗体 reslizumab 对高剂量吸入皮质类固醇治疗控制不佳的嗜酸性粒细胞性哮喘患者的疗效。
患者被随机分配至基线时和第 4、8、12 周接受 reslizumab（3.0mg/kg，n=53）或安慰剂（n=53）输注，分层依据基线哮喘控制问卷（ACQ）评分≤2 或＞2。主要疗效指标为 reslizumab 组与安慰剂组在治疗结束时（第 15 周或提前停药）ACQ 评分从基线到治疗结束的变化差异。
reslizumab 组和安慰剂组从基线到治疗结束时的 ACQ 评分变化分别为-0.7 和-0.3（P=0.054），FEV(1)变化分别为 0.18 和-0.08L（P=0.002）。在那些有鼻息肉的患者中，ACQ 评分的变化分别为-1.0 和-0.1（P=0.012）。从基线开始，痰中嗜酸性粒细胞的中位数百分比降低分别为 95.4%和 38.7%（P=0.007）。reslizumab 组 8%的患者和安慰剂组 19%的患者发生哮喘加重（P=0.083）。reslizumab 最常见的不良反应是鼻咽炎、疲劳和咽扁桃体疼痛。
与接受安慰剂的患者相比，接受 reslizumab 治疗的患者痰中嗜酸性粒细胞显著减少，气道功能改善，哮喘控制趋势增强。reslizumab 通常具有良好的耐受性。
