苯拉唑马布
医学
安慰剂
哮喘
糖皮质激素
恶化
随机化
内科学
不利影响
随机对照试验
胃肠病学
嗜酸性粒细胞
美波利祖马布
病理
替代医学
作者
Parameswaran Nair,Sally E. Wenzel,Klaus F. Rabe,Arnaud Bourdin,Njira Lugogo,Piotr Kuna,Peter Barker,Stephanie Sproule,Sandhia Ponnarambil,Mitchell Goldman
标识
DOI:10.1056/nejmoa1703501
摘要
BACKGROUND: Many patients with severe asthma rely on oral glucocorticoids to manage their disease. We investigated whether benralizumab, a monoclonal antibody directed against the alpha subunit of the interleukin-5 receptor that significantly reduces the incidence of asthma exacerbations, was also effective as an oral glucocorticoid-sparing therapy in patients relying on oral glucocorticoids to manage severe asthma associated with eosinophilia. METHODS: In a 28-week randomized, controlled trial, we assessed the effects of benralizumab (at a dose of 30 mg administered subcutaneously either every 4 weeks or every 8 weeks [with the first three doses administered every 4 weeks]) versus placebo on the reduction in the oral glucocorticoid dose while asthma control was maintained in adult patients with severe asthma. The primary end point was the percentage change in the oral glucocorticoid dose from baseline to week 28. Annual asthma exacerbation rates, lung function, symptoms, and safety were assessed. RESULTS: ), as compared with placebo. The effects on various measures of asthma symptoms were mixed, with some showing significant changes in favor of benralizumab and others not showing significant changes. Frequencies of adverse events were similar between each benralizumab group and the placebo group. CONCLUSIONS: . (Funded by AstraZeneca; ZONDA ClinicalTrials.gov number, NCT02075255 .).
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