Reslizumab for Poorly Controlled, Eosinophilic Asthma A Randomized, Placebo-controlled Study
Reslizumab for Poorly Controlled, Eosinophilic Asthma A Randomized, Placebo-controlled Study
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DOI：
10.1164/rccm.201103-0396oc
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发表时间：
2011-11-15
影响因子：
24.7
通讯作者：
Nair, Parameswaran
中科院分区：
文献类型：
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作者：
Castro, Mario;Mathur, Sameer;Nair, Parameswaran
原理：嗜酸粒细胞性哮喘是一种哮喘表型，其特征是气道中嗜酸粒细胞持续存在。白细胞介素 - 5（IL - 5）参与嗜酸粒细胞的活化和存活。
目的：评估抗IL - 5抗体瑞利珠单抗（reslizumab）在高剂量吸入性糖皮质激素控制不佳的嗜酸粒细胞性哮喘患者中的疗效。
方法：患者被随机分配在基线以及第4、8和12周接受3.0 mg/kg的瑞利珠单抗输注（n = 53）或安慰剂（n = 53），并根据基线哮喘控制问卷（ACQ）评分≤2或＞2进行分层。主要疗效指标是从基线到治疗结束（第15周或提前退出）ACQ评分变化在瑞利珠单抗组和安慰剂组之间的差异。
测量和主要结果：从基线到治疗结束ACQ评分的平均变化在瑞利珠单抗组为 - 0.7，在安慰剂组为 - 0.3（P = 0.054），第1秒用力呼气容积（FEV₁）分别为0.18 L和 - 0.08 L（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）。痰液嗜酸粒细胞从基线的中位数百分比减少分别为95.4%和38.7%（P = 0.007）。瑞利珠单抗组8%的患者和安慰剂组19%的患者出现哮喘加重（P = 0.083）。瑞利珠单抗最常见的不良事件是鼻咽炎、疲劳和咽喉疼痛。
结论：与接受安慰剂的患者相比，接受瑞利珠单抗的患者痰液嗜酸粒细胞减少更显著，气道功能改善更明显，并且在哮喘控制方面有更好的趋势。瑞利珠单抗通常耐受性良好。
Rationale: 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.Objectives: 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.Methods: 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).Measurements and Main Results: 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 FEV1 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.Conclusions: 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.