重症嗜酸性粒细胞性哮喘生物学标记物
2018/01/05
摘要
过去的10年中，针对重症哮喘特异性不同表型的数种新药获得批准应用。本文介绍美泊利单抗临床研发过程，研究提示相较于痰液或组织嗜酸性粒细胞计数，外周血嗜酸性粒细胞计数可以作为一种药代动力学和预测性生物学标志物勇于评价重症嗜酸性粒细胞哮喘患者接受美泊利单抗治疗的疗效。在现有的循证医学和临床共识下，基线外周血嗜酸性粒细胞计数≥150/μL或既往血嗜酸性粒细胞计数≥300/μL这些重症哮喘患者可以通过美泊利单抗治疗显著减少急性发作的次数。
Biomarkers for severe eosinophilic asthma.
J Allergy Clin Immunol.2017Dec;140(6):1509-1518.doi:10.1016/j.jaci.2017.10.005.
Yancey SW, Keene ON, Albers FC, Ortega H4, Bates S, Bleecker ER, Pavord I.
Abstract
The last decade has seen the approval of several new biologics for the treatment of severe asthma-targeting specific endotypes and phenotypes. This review will examine how evidence generated from the mepolizumab clinical development program showed that blood eosinophil counts, rather than sputum or tissue eosinophil counts, evolved as a pharmacodynamic and predictive biomarker for the efficacy of treatment with mepolizumab in patients with severe eosinophilic asthma. Based on the available evidence and combined with clinical judgement, a baseline blood eosinophil threshold of 150 cells/μL or greater or a historical blood eosinophil threshold of 300 cells/μL or greater will allow selection of patients with severe eosinophilic asthma who are most likely to achieve clinically significant reductions in the rate of exacerbations with mepolizumab treatment.
过去的10年中，针对重症哮喘特异性不同表型的数种新药获得批准应用。本文介绍美泊利单抗临床研发过程，研究提示相较于痰液或组织嗜酸性粒细胞计数，外周血嗜酸性粒细胞计数可以作为一种药代动力学和预测性生物学标志物勇于评价重症嗜酸性粒细胞哮喘患者接受美泊利单抗治疗的疗效。在现有的循证医学和临床共识下，基线外周血嗜酸性粒细胞计数≥150/μL或既往血嗜酸性粒细胞计数≥300/μL这些重症哮喘患者可以通过美泊利单抗治疗显著减少急性发作的次数。
（上海交通大学医学院附属瑞金医院呼吸与危重症医学科 周剑平 万欢英 摘译）
（J Allergy Clin Immunol. 2017 Dec;140(6):1509-1518. doi: 10.1016/j.jaci.2017.10.005.）
Biomarkers for severe eosinophilic asthma.
J Allergy Clin Immunol.2017Dec;140(6):1509-1518.doi:10.1016/j.jaci.2017.10.005.
Yancey SW, Keene ON, Albers FC, Ortega H4, Bates S, Bleecker ER, Pavord I.
Abstract
The last decade has seen the approval of several new biologics for the treatment of severe asthma-targeting specific endotypes and phenotypes. This review will examine how evidence generated from the mepolizumab clinical development program showed that blood eosinophil counts, rather than sputum or tissue eosinophil counts, evolved as a pharmacodynamic and predictive biomarker for the efficacy of treatment with mepolizumab in patients with severe eosinophilic asthma. Based on the available evidence and combined with clinical judgement, a baseline blood eosinophil threshold of 150 cells/μL or greater or a historical blood eosinophil threshold of 300 cells/μL or greater will allow selection of patients with severe eosinophilic asthma who are most likely to achieve clinically significant reductions in the rate of exacerbations with mepolizumab treatment.
