重症嗜酸粒细胞性哮喘患者血嗜酸粒细胞计数变化及动力学研究
2020/05/14
摘要
背景：血嗜酸性粒细胞计数是一种无创、相对可靠的嗜酸性气道炎症替代指标。外周血嗜酸性粒细胞计数≥150个细胞/μL的可预测严重嗜酸性粒细胞哮喘患者对抗嗜酸性粒细胞治疗的反应。
目的：描述在两个大的随机对照临床试验中，接受安慰剂治疗的重度哮喘患者的血嗜酸性粒细胞计数随时间的变化。
方法：我们的分析包括在SIROCCO和CALIMA III期benralizumab研究中随机接受安慰剂的成年患者。将患者分为基线血嗜酸性粒细胞计数<150细胞/μL、>150-<300细胞/μL和≥300细胞/μL组。在治疗第4、8、24和40周及治疗结束时评估从基线到不同组的初始转移时间。基线特征，包括OCS的使用，根据是否存在血嗜酸性粒细胞计数移位来描述。
结果：在734名可评价的患者中，65%（n=474）的患者在研究期间改变了血嗜酸性粒细胞计数组，大多数（86%[n=410]）在第24周改变。<150个细胞/μL组开始的患者倾向于提前转移组，第4周转移59%，而其他组同期转移38-55%。改变血嗜酸性粒细胞计数组的患者与不改变血嗜酸性粒细胞计数组的患者相比，更倾向于降低血嗜酸性粒细胞计数，更多地使用OCS，鼻息肉/过去息肉切除的发生率更低。
结论：单次血嗜酸性粒细胞计数测定，特别是低值时，可能不足以帮助建立严重嗜酸性粒细胞哮喘的表型。
Blood Eosinophil Count Group Shifts and Kinetics in Severe, Eosinophilic Asthma.
Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ.
Abstract
BACKGROUND: Blood eosinophil count measurements are a noninvasive, relatively reliable surrogate marker for eosinophilic airway inflammation. Single measurements of peripheral blood eosinophil counts ≥150 cells/μL predict response to anti-eosinophil therapies for patients with characteristics of severe eosinophilic asthma.
OBJECTIVE: To describe how blood eosinophil counts shift over time for patients with severe, uncontrolled asthma receiving placebo in two large randomized, placebocontrolled clinical trials of benralizumab (SIROCCO and CALIMA).
METHODS: Our analysis included adult patients randomized to placebo in the SIROCCO and CALIMA Phase III benralizumab studies. Patients were categorized into baseline blood eosinophil count groups of <150 cells/μL, ≥150-<300 cells/μL, and ≥300 cells/μL. Timing of initial shift from baseline to a different group was evaluated at Weeks 4, 8, 24, and 40 and at end of treatment. Baseline characteristics, including OCS use, were described based on the presence or absence of a blood eosinophil count group shift.
RESULTS: Of 734 evaluable patients, 65% (n=474) shifted blood eosinophil count groups during the study, and the majority (86% [n=410]) shifted by Week 24. Patients who started in the <150 cells/μL group tended to shift groups earlier, with 59% shifting by Week 4 compared with 38-55% for the same time frame in other groups. Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
CONCLUSION: A single blood eosinophil count measurement, particularly when low, may be inadequate to help establish a phenotype of severe eosinophilic asthma.
背景：血嗜酸性粒细胞计数是一种无创、相对可靠的嗜酸性气道炎症替代指标。外周血嗜酸性粒细胞计数≥150个细胞/μL的可预测严重嗜酸性粒细胞哮喘患者对抗嗜酸性粒细胞治疗的反应。
目的：描述在两个大的随机对照临床试验中，接受安慰剂治疗的重度哮喘患者的血嗜酸性粒细胞计数随时间的变化。
方法：我们的分析包括在SIROCCO和CALIMA III期benralizumab研究中随机接受安慰剂的成年患者。将患者分为基线血嗜酸性粒细胞计数<150细胞/μL、>150-<300细胞/μL和≥300细胞/μL组。在治疗第4、8、24和40周及治疗结束时评估从基线到不同组的初始转移时间。基线特征，包括OCS的使用，根据是否存在血嗜酸性粒细胞计数移位来描述。
结果：在734名可评价的患者中，65%（n=474）的患者在研究期间改变了血嗜酸性粒细胞计数组，大多数（86%[n=410]）在第24周改变。<150个细胞/μL组开始的患者倾向于提前转移组，第4周转移59%，而其他组同期转移38-55%。改变血嗜酸性粒细胞计数组的患者与不改变血嗜酸性粒细胞计数组的患者相比，更倾向于降低血嗜酸性粒细胞计数，更多地使用OCS，鼻息肉/过去息肉切除的发生率更低。
结论：单次血嗜酸性粒细胞计数测定，特别是低值时，可能不足以帮助建立严重嗜酸性粒细胞哮喘的表型。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(Ann Allergy Asthma Immunol. 2020 Apr 22. pii: S1081-1206(20)30239-8. doi: 10.1016/j.anai.2020.04.011.)
(Ann Allergy Asthma Immunol. 2020 Apr 22. pii: S1081-1206(20)30239-8. doi: 10.1016/j.anai.2020.04.011.)
Blood Eosinophil Count Group Shifts and Kinetics in Severe, Eosinophilic Asthma.
Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ.
Abstract
BACKGROUND: Blood eosinophil count measurements are a noninvasive, relatively reliable surrogate marker for eosinophilic airway inflammation. Single measurements of peripheral blood eosinophil counts ≥150 cells/μL predict response to anti-eosinophil therapies for patients with characteristics of severe eosinophilic asthma.
OBJECTIVE: To describe how blood eosinophil counts shift over time for patients with severe, uncontrolled asthma receiving placebo in two large randomized, placebocontrolled clinical trials of benralizumab (SIROCCO and CALIMA).
METHODS: Our analysis included adult patients randomized to placebo in the SIROCCO and CALIMA Phase III benralizumab studies. Patients were categorized into baseline blood eosinophil count groups of <150 cells/μL, ≥150-<300 cells/μL, and ≥300 cells/μL. Timing of initial shift from baseline to a different group was evaluated at Weeks 4, 8, 24, and 40 and at end of treatment. Baseline characteristics, including OCS use, were described based on the presence or absence of a blood eosinophil count group shift.
RESULTS: Of 734 evaluable patients, 65% (n=474) shifted blood eosinophil count groups during the study, and the majority (86% [n=410]) shifted by Week 24. Patients who started in the <150 cells/μL group tended to shift groups earlier, with 59% shifting by Week 4 compared with 38-55% for the same time frame in other groups. Patients who shifted blood eosinophil count groups vs. those who did not tended to have lower blood eosinophil counts, more OCS use, and less incidence of nasal polyps/past polypectomy.
CONCLUSION: A single blood eosinophil count measurement, particularly when low, may be inadequate to help establish a phenotype of severe eosinophilic asthma.
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重症哮喘患者生物标记物的前瞻性、单臂、纵向研究
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痰微生物组分鉴定出12-18个月时相对稳定的重症哮喘表型
