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奥马珠单抗治疗黑人和白人过敏性哮喘患者的反应。

Response to Omalizumab in Black and White Patients with Allergic Asthma.

机构信息

Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo.

Department of Microbiology & Immunology, Albert Einstein College of Medicine, Bronx, NY.

出版信息

J Allergy Clin Immunol Pract. 2021 Nov;9(11):4021-4028. doi: 10.1016/j.jaip.2021.07.013. Epub 2021 Jul 22.

Abstract

BACKGROUND

Higher asthma burden is more likely to be experienced by Black than White patients. In clinical research, underrepresentation of minority populations is observed.

OBJECTIVE

To estimate response to omalizumab in Black and White patients in North America with moderate to severe asthma.

METHODS

Data from placebo-controlled (EXTRA) and single-armed (PROSPERO) omalizumab studies were used for this post hoc analysis. We used a Poisson regression model to examine exacerbation rates. An analysis of covariance model was used to estimate placebo-corrected change in FEV and Asthma Quality of Life Questionnaire (AQLQ) by racial group.

RESULTS

This analysis included 631 White and 176 Black patients from EXTRA and 567 White and 130 Black patients from PROSPERO. In EXTRA, placebo-corrected exacerbation rate reductions (relative rate change [95% confidence interval], 22.6% [2.0-38.9%] vs 22.0% [-18.0% to 48.4%]) and FEV improvements were similar for White and Black patients. There was a trend toward greater AQLQ improvements for Black versus White patients (least squares mean treatment differences: 0.0 vs 0.3, 0.6 vs 0.4, and 0.6 vs 0.2 at weeks 16, 32, and 48, respectively) throughout the study. In PROSPERO, on-study exacerbation rates (0.76 [0.65-0.88] vs 0.77 [0.56-1.10]) and AQLQ improvements (least squares mean change from baseline: 1.2 vs 1.2 and 1.3 vs 1.2 at month 6 and end of study, respectively) were similar for White versus Black patients. A trend toward greater FEV improvement was observed in White versus Black patients throughout the study.

CONCLUSIONS

This analysis of EXTRA and PROSPERO suggests that Black and White patients with moderate to severe asthma experience similar improvements in exacerbations, FEV, and AQLQ with omalizumab.

摘要

背景

黑人患者比白人患者更有可能经历更高的哮喘负担。在临床研究中,观察到少数族裔人群代表性不足。

目的

评估奥马珠单抗在北美的中重度哮喘黑人和白人患者中的疗效。

方法

本事后分析使用了安慰剂对照(EXTRA)和单臂(PROSPERO)奥马珠单抗研究的数据。我们使用泊松回归模型检查加重率。使用协方差分析模型估计按种族分组的 FEV 和哮喘生活质量问卷(AQLQ)的安慰剂校正变化。

结果

这项分析包括来自 EXTRA 的 631 名白人和 176 名黑人和来自 PROSPERO 的 567 名白人和 130 名黑人患者。在 EXTRA 中,安慰剂校正后的加重率降低(相对率变化[95%置信区间],22.6%[2.0-38.9%]与 22.0%[-18.0%至 48.4%])和 FEV 改善在白人和黑人患者中相似。黑人患者的 AQLQ 改善趋势大于白人患者(在整个研究过程中,治疗差异的最小平方均值分别为 0.0 与 0.3、0.6 与 0.4 和 0.6 与 0.2,分别在第 16、32 和 48 周)。在 PROSPERO 中,在研期间的加重率(0.76[0.65-0.88]与 0.77[0.56-1.10])和 AQLQ 改善(自基线的最小平方均值变化:在第 6 个月和研究结束时分别为 1.2 与 1.2 和 1.3 与 1.2)在白人和黑人患者中相似。在整个研究过程中,观察到 FEV 改善趋势在白人患者中大于黑人患者。

结论

EXTRA 和 PROSPERO 的这项分析表明,中重度哮喘的黑人和白人患者接受奥马珠单抗治疗后,在加重、FEV 和 AQLQ 方面的改善相似。

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