Reslizumab控制哮喘与血液嗜酸性粒细胞升高水平不足:随机第三阶段的研究。

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Bjermer L, C Lemiere, Maspero J,维斯年代,Zangrilli J, Germinaro M

Reslizumab控制哮喘与血液嗜酸性粒细胞升高水平不足:随机第三阶段的研究。

胸部。2016年10月,150 (4):789 - 798。doi: 10.1016 / j.chest.2016.03.032。Epub 2016年4月4。

PubMed ID

27056586 (在PubMed

]

文摘

背景:这个阶段3进一步研究特征的有效性和安全性reslizumab(人性化anti-IL-5单克隆抗体)与哮喘患者年龄在12到75年至少中等剂量吸入激素控制的不足,血液嗜酸性粒细胞计数> / = 400个细胞/ muL。方法:患者随机接受reslizumab 0.3或3.0毫克/公斤或安慰剂注射每隔4周16周(共四个剂量)。主要终点是改变从基线pre-bronchodilator FEV1 / 16周。次要终点包括FVC、用力呼气流量在25%到75%的FVC (fef25% - 75%), patient-reported控制哮喘症状,短效beta-agonist(沙巴)使用,血液嗜酸性粒细胞水平,和安全。结果:Reslizumab显著提高残(区别与安慰剂(Reslizumab 0.3和3.0毫克/公斤),115毫升(95%可信区间,16 - 215;P = .0237]和160毫升[95% CI, 60 - 259;P = .0018])。临床上有意义的增加FVC(130毫升)和fef25% - 75%(233毫升/秒)观察reslizumab 3.0毫克/公斤。Reslizumab改善哮喘控制问卷得分(ACQ)和哮喘生活质量问卷(AQLQ)和安慰剂(3.0毫克/公斤,大的负面影响P < . 05)。 The minimally important difference was reached for the AQLQ (reslizumab 3.0 mg/kg) but not on the ACQ. Scores on the Asthma Symptom Utility Index and SABA use were improved with reslizumab. The most common adverse events were worsening of asthma, headache, and nasopharyngitis; most events were mild to moderate in severity. CONCLUSIONS: Reslizumab improved lung function, asthma control and symptoms, and quality of life. It was well tolerated in patients with inadequately controlled asthma (despite standard therapy) and elevated blood eosinophil levels. Overall, the 3.0-mg/kg dose of reslizumab provided greater improvements in asthma outcomes vs the 0.3-mg/kg dose, with comparable safety. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01270464; URL: www.clinicaltrials.gov.

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Reslizumab