Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels A Randomized Phase 3 Study
Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels A Randomized Phase 3 Study
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DOI：
10.1016/j.chest.2016.03.032
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发表时间：
2016-10-01
期刊：
影响因子：
9.6
通讯作者：
Germinaro, Matthew
中科院分区：
文献类型：
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作者：
Bjermer, Leif;Lemiere, Catherine;Germinaro, Matthew
背景技术背景：该3期研究进一步表征了瑞利珠单抗（一种人源化抗IL-5单克隆抗体）在年龄12至75岁的哮喘患者中的疗效和安全性，所述患者通过至少中等剂量的吸入性皮质类固醇控制不充分，并且血液嗜酸性粒细胞计数>= 400个细胞/μ L。患者随机接受瑞利珠单抗0.3或3.0 mg/kg或安慰剂，每4周一次给药，共16周，共4个剂量。主要终点是16周内使用支气管扩张剂前FEV1较基线的变化。次要终点包括FVC，用力呼气流量为FVC的25%-75%，患者报告的哮喘症状控制，短效β-激动剂SABA的使用，血嗜酸性粒细胞水平和安全性。P =.0237]和160 mL [95% CI，60 - 259; P =.0018]）。瑞利珠单抗3.0 mg/kg组观察到FVC（130 mL）和FEF（25%-75%，233 mL/s）出现具有临床意义的增加。与安慰剂相比，瑞利珠单抗改善了哮喘控制问卷（ACQ）和哮喘生活质量问卷（AQLQ）的评分，3.0 mg/kg组的效果更好; P
BACKGROUND: This phase 3 study further characterizes the efficacy and safety of reslizumab a humanized anti-IL-5 monoclonal antibody) in patients aged 12 to 75 years with asthma inadequately controlled by at least a medium-dose inhaled corticosteroid and with a blood eosinophil count >= 400 cells/mu L.METHODS: Patients were randomized to receive reslizumab 0.3 or 3.0 mg/kg or placebo administered once every 4 weeks for 16 weeks total four doses). The primary end point was change from baseline in pre-bronchodilator FEV1 over 16 weeks. Secondary end points included FVC, forced expiratory flow at 25% to 75% of FVC FEF25%-75%), patient-reported control of asthma symptoms, short-acting beta-agonist SABA) use, blood eosinophil levels, and safety.RESULTS: Reslizumab significantly improved FEV1 difference vs placebo [reslizumab 0.3 and 3.0 mg/kg], 115 mL [95% CI, 16-215; P =.0237] and 160 mL [95% CI, 60-259; P =.0018]). Clinically meaningful increases in FVC 130 mL) and FEF25%-75% 233 mL/s) were observed with reslizumab 3.0 mg/kg. Reslizumab improved scores on the Asthma Control Questionnaire ACQ) and Asthma Quality of Life Questionnaire AQLQ) vs placebo greater effects seen with 3.0 mg/kg; P