一项T2-复合生物标志物策略调节严重哮喘皮质类固醇治疗的随机试验，按性别进行事后分析
2023/02/01
摘要
背景：大约5-10%的哮喘患者有严重的疾病，并始终以女性为主。目前的哮喘指南建议逐步治疗以实现症状控制，没有性别差异的治疗考虑。
目的：与标准治疗相比，使用复合T2-生物标志物评分来调整严重哮喘患者的皮质类固醇治疗时，患者性别是否会影响结果。
方法：一项48周、多中心、随机对照临床试验，比较了生物标志物定义的治疗算法与标准治疗，对患者结果按性别分层的事后分析。主要结果是减少皮质类固醇治疗(吸入(ICS)和口服(OCS)皮质类固醇治疗)的患者比例。次要结局包括加重率、入院率和肺功能。
结果：随机抽取301例患者;女性194例(64.5%)，男性107例(35.5%)。与标准治疗相比，生物标志物算法导致更大比例的女性接受较低的皮质类固醇剂量，这在男性中没有出现(影响评估女性:3.57,95% CI: 1.14, 11.18比男性0.54,95% CI: 0.16, 1.80)。在T2生物标志物低的女性中，减少皮质类固醇剂量与加重无关。女性在所有ACQ-7领域得分较高，但在调整BMI/焦虑和/或抑郁后没有差异。在两性中都注意到症状与T2生物标志物之间的分离，女性症状高/T2生物标志物低的比例更高(22.8% vs.15.6%;p=0.0002)，而男性症状低/T2生物标志物高(11.4% vs. 22.3%;p＜0.0001)。
结论：这项探索性的事后分析发现，与针对症状的治疗相比，女性从生物标志物定向的皮质类固醇优化中获得了更大的益处。
A randomised trial of a T2-composite-biomarker strategy adjusting corticosteroid treatment in severe asthma, a post- hoc analysis by sex
Eastwood MC, Busby J, Jackson DJ,et al.
Abstract
BACKGROUND:Approximately 5-10% of patients with asthma have severe disease with a consistent preponderance in females. Current asthma guidelines recommend stepwise treatment to achieve symptom control with no differential treatment considerations for either sex.
OBJECTIVES:To examine whether patient sex affects outcomes when using a composite T2-biomarker score to adjust corticosteroid treatment in patients with severe asthma compared to standard care.
METHODS: Post-hoc analysis stratifying patient outcomes by sex of a 48-week, multicentre, randomised controlled clinical trial comparing a biomarker-defined treatment algorithm with standard care. The primary outcome was the proportion of patients with a reduction in corticosteroid treatment (inhaled (ICS) and oral (OCS) corticosteroids). Secondary outcomes included exacerbation rates, hospital admissions and lung function.
RESULTS: Of 301 patients randomised; 194 (64.5%) were females and 107 (35.5%) were males. The biomarker algorithm led to a greater proportion of females being on a lower corticosteroid dose vs standard care which was not seen in males (effects estimate females: 3.57, 95% CI: 1.14, 11.18 vs. males 0.54, 95% CI: 0.16, 1.80). In T2-biomarker low females, reducing corticosteroid dose was not associated with increased exacerbations. Females scored higher in all ACQ-7 domains, but with no difference when adjusted for BMI/ anxiety and/or depression. Dissociation between symptoms and T2-biomarkers were noted in both sexes, with a higher proportion of females being symptom high/T2-biomarker low (22.8% vs. 15.6%; p=0.0002), whereas males were symptom low/T2-biomarker high (11.4% vs. 22.3%; p<0.0001).
CONCLUSIONS: This exploratory post-hoc analysis identified females achieved a greater benefit from biomarker-directed corticosteroid optimisation versus symptom-directed treatment.
背景：大约5-10%的哮喘患者有严重的疾病，并始终以女性为主。目前的哮喘指南建议逐步治疗以实现症状控制，没有性别差异的治疗考虑。
目的：与标准治疗相比，使用复合T2-生物标志物评分来调整严重哮喘患者的皮质类固醇治疗时，患者性别是否会影响结果。
方法：一项48周、多中心、随机对照临床试验，比较了生物标志物定义的治疗算法与标准治疗，对患者结果按性别分层的事后分析。主要结果是减少皮质类固醇治疗(吸入(ICS)和口服(OCS)皮质类固醇治疗)的患者比例。次要结局包括加重率、入院率和肺功能。
结果：随机抽取301例患者;女性194例(64.5%)，男性107例(35.5%)。与标准治疗相比，生物标志物算法导致更大比例的女性接受较低的皮质类固醇剂量，这在男性中没有出现(影响评估女性:3.57,95% CI: 1.14, 11.18比男性0.54,95% CI: 0.16, 1.80)。在T2生物标志物低的女性中，减少皮质类固醇剂量与加重无关。女性在所有ACQ-7领域得分较高，但在调整BMI/焦虑和/或抑郁后没有差异。在两性中都注意到症状与T2生物标志物之间的分离，女性症状高/T2生物标志物低的比例更高(22.8% vs.15.6%;p=0.0002)，而男性症状低/T2生物标志物高(11.4% vs. 22.3%;p＜0.0001)。
结论：这项探索性的事后分析发现，与针对症状的治疗相比，女性从生物标志物定向的皮质类固醇优化中获得了更大的益处。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract.2023 Jan5;S2213-2198(22)01332-0 DOI:10.1016/j.jaip.2022.12.019）
A randomised trial of a T2-composite-biomarker strategy adjusting corticosteroid treatment in severe asthma, a post- hoc analysis by sex
Eastwood MC, Busby J, Jackson DJ,et al.
Abstract
BACKGROUND:Approximately 5-10% of patients with asthma have severe disease with a consistent preponderance in females. Current asthma guidelines recommend stepwise treatment to achieve symptom control with no differential treatment considerations for either sex.
OBJECTIVES:To examine whether patient sex affects outcomes when using a composite T2-biomarker score to adjust corticosteroid treatment in patients with severe asthma compared to standard care.
METHODS: Post-hoc analysis stratifying patient outcomes by sex of a 48-week, multicentre, randomised controlled clinical trial comparing a biomarker-defined treatment algorithm with standard care. The primary outcome was the proportion of patients with a reduction in corticosteroid treatment (inhaled (ICS) and oral (OCS) corticosteroids). Secondary outcomes included exacerbation rates, hospital admissions and lung function.
RESULTS: Of 301 patients randomised; 194 (64.5%) were females and 107 (35.5%) were males. The biomarker algorithm led to a greater proportion of females being on a lower corticosteroid dose vs standard care which was not seen in males (effects estimate females: 3.57, 95% CI: 1.14, 11.18 vs. males 0.54, 95% CI: 0.16, 1.80). In T2-biomarker low females, reducing corticosteroid dose was not associated with increased exacerbations. Females scored higher in all ACQ-7 domains, but with no difference when adjusted for BMI/ anxiety and/or depression. Dissociation between symptoms and T2-biomarkers were noted in both sexes, with a higher proportion of females being symptom high/T2-biomarker low (22.8% vs. 15.6%; p=0.0002), whereas males were symptom low/T2-biomarker high (11.4% vs. 22.3%; p<0.0001).
CONCLUSIONS: This exploratory post-hoc analysis identified females achieved a greater benefit from biomarker-directed corticosteroid optimisation versus symptom-directed treatment.
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