Dupilumab与嗜酸性粒细胞水平升高持续哮喘。

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最终文策尔年代,福特L D,斯佩克特,谢尔L, Skobieranda F,王L, Kirkesseli年代,Rocklin R,烈性黑啤酒B,汉密尔顿J,明我,雷丁,斯塔尔N, Yancopoulos GD,格雷厄姆•N Pirozzi G

Dupilumab与嗜酸性粒细胞水平升高持续哮喘。

郑传经地中海J。2013年6月27日,368 (26):2455 - 66。doi: 10.1056 / NEJMoa1304048。2013年5月21日Epub。

PubMed ID

23688323 (在PubMed

]

文摘

背景:严重哮喘治疗仍然不佳。我们评估的有效性和安全性dupilumab (SAR231893 / REGN668),一个完整的人类单克隆抗体interleukin-4受体的α亚基,患者持续严重哮喘和嗜酸性粒细胞水平升高。方法:我们登记患者持续严重哮喘和血液嗜酸性粒细胞计数至少每微升300个细胞或痰嗜酸性粒细胞水平至少3%的人使用中等剂量大剂量吸入糖皮质激素加长效beta-agonists(腊八粥)。我们管理dupilumab(300毫克)或安慰剂皮下注射一次每周。病人被要求停止腊八粥在星期4和锥度和停止吸入糖皮质激素在周6到9。患者接受研究药物12周或protocol-defined哮喘恶化之前发生。主要终点是一个哮喘恶化的发生;次要终点包括哮喘控制的一系列措施。对各种影响2型辅助t细胞(Th2)相关的生物标志物和安全性和耐受性也评估。结果:共52例分配到dupilumab集团和52例分配给安慰剂组。 Baseline characteristics were similar in the two groups. Three patients had an asthma exacerbation with dupilumab (6%) versus 23 with placebo (44%), corresponding to an 87% reduction with dupilumab (odds ratio, 0.08; 95% confidence interval, 0.02 to 0.28; P<0.001). Significant improvements were observed for most measures of lung function and asthma control. Dupilumab reduced biomarkers associated with Th2-driven inflammation. Injection-site reactions, nasopharyngitis, nausea, and headache occurred more frequently with dupilumab than with placebo. CONCLUSIONS: In patients with persistent, moderate-to-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations when LABAs and inhaled glucocorticoids were withdrawn, with improved lung function and reduced levels of Th2-associated inflammatory markers. (Funded by Sanofi and Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT01312961.).

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药物

Dupilumab

药物靶点

药物	目标	类	生物	药理作用	行动
Dupilumab	Interleukin-4受体α亚基	蛋白质	人类	是的	抑制剂 抗体	细节