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评估接受美泊利珠单抗治疗的重症嗜酸粒细胞性哮喘患者中超级应答者、部分应答者和无应答者的临床特征和实验室数据:一项真实世界研究。

Evaluation of the Clinical Features and Laboratory Data of Patients with Severe Eosinophilic Asthma Classified as Super-Responders, Partial Responders, or Nonresponders to Mepolizumab Treatment: A Real-Life Study.

机构信息

Department of Allergy and Clinical Immunology, Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey.

出版信息

Int Arch Allergy Immunol. 2023;184(8):736-743. doi: 10.1159/000529760. Epub 2023 Mar 30.

DOI:10.1159/000529760
PMID:36996772
Abstract

INTRODUCTION

Mepolizumab is a treatment option in patients with severe eosinophilic asthma, which inhibits interleukin-5. The aim of this study was to evaluate the clinical features and laboratory data of patients with severe eosinophilic asthma who were classified as super-responders, partial responders, or nonresponders to mepolizumab treatment.

METHODS

In this retrospective real-life study, the clinical features and laboratory data were compared between groups of patients with severe eosinophilic asthma who were classified as super-responders, partial responders, or nonresponders to mepolizumab treatment.

RESULTS

Evaluation was made of a total of 55 patients, comprising 17 (30.9%) males and 38 (69.1%) females with a mean age of 51.28 ± 14.32 years. All the patients were receiving mepolizumab treatment for severe eosinophilic asthma, with 17 (30.9%) patients evaluated as super-responders, 26 (47.3%) as partial responders, and 12 (21.8%) as nonresponders. After mepolizumab treatment, there was a statistically significant decrease in asthma exacerbations, the number of oral corticosteroids (OCSs) used, the rate of hospitalization due to asthma attacks, and the eosinophil count (cells/µL) (p < 0.001, p < 0.001, p < 0.001, and <0.001, respectively). A statistically significant increase was determined in the forced expiratory volume in 1 s (FEV1) value (p = 0.010) and asthma control test (ACT) score (p < 0.001) after mepolizumab treatment. The baseline eosinophil count, eosinophil/lymphocyte ratio and FEV1 (%) values were significantly higher in the super-responder and partial responder groups (p < 0.001, p = 0.002, and p = 0.002, respectively). The baseline ACT score and the rate of chronic sinusitis with nasal polyps were significantly higher in the partial responder group (p = 0.004, p = 0.015, respectively). The rate of regular OCS use before mepolizumab treatment was significantly higher in the nonresponder group (p = 0.049). As a result of the receiver operating characteristics curve analysis, the blood eosinophil count (area under the curve [AUC]: 0.967, p < 0.001), eosinophil/lymphocyte ratio (AUC: 0.921, p < 0.001), and FEV1 (%) (AUC: 0.828, p = 0.002) were found to have diagnostic value in predicting the response to mepolizumab treatment in patients with severe eosinophilic asthma.

CONCLUSION

Baseline eosinophil count, eosinophil/lymphocyte ratio, and FEV1 (%) were found to be important predictors of response to mepolizumab treatment. Further studies are needed to define the characterization of mepolizumab responders in the real world.

摘要

简介

美泊利珠单抗是一种治疗严重嗜酸性粒细胞性哮喘的方法,它能抑制白细胞介素-5。本研究的目的是评估被分类为美泊利珠单抗治疗的超级应答者、部分应答者或无应答者的严重嗜酸性粒细胞性哮喘患者的临床特征和实验室数据。

方法

在这项回顾性真实世界研究中,比较了被分类为美泊利珠单抗治疗的严重嗜酸性粒细胞性哮喘的超级应答者、部分应答者或无应答者的患者之间的临床特征和实验室数据。

结果

共评估了 55 例患者,其中男性 17 例(30.9%),女性 38 例(69.1%),平均年龄为 51.28±14.32 岁。所有患者均接受美泊利珠单抗治疗严重嗜酸性粒细胞性哮喘,17 例(30.9%)患者被评估为超级应答者,26 例(47.3%)为部分应答者,12 例(21.8%)为无应答者。美泊利珠单抗治疗后,哮喘恶化、口服皮质类固醇(OCS)使用数量、因哮喘发作而住院的比率和嗜酸性粒细胞计数(细胞/µL)均有显著下降(p<0.001,p<0.001,p<0.001 和 <0.001,分别)。美泊利珠单抗治疗后用力呼气量 1 秒(FEV1)值(p=0.010)和哮喘控制测试(ACT)评分(p<0.001)有显著升高。超级应答者和部分应答者组的基线嗜酸性粒细胞计数、嗜酸性粒细胞/淋巴细胞比值和 FEV1(%)值显著更高(p<0.001,p=0.002 和 p=0.002,分别)。部分应答者组的基线 ACT 评分和慢性鼻-鼻窦炎伴鼻息肉的发生率更高(p=0.004,p=0.015,分别)。美泊利珠单抗治疗前,无应答者组定期使用 OCS 的比例显著更高(p=0.049)。通过接受者操作特征曲线分析,发现血液嗜酸性粒细胞计数(曲线下面积[AUC]:0.967,p<0.001)、嗜酸性粒细胞/淋巴细胞比值(AUC:0.921,p<0.001)和 FEV1(%)(AUC:0.828,p=0.002)对预测严重嗜酸性粒细胞性哮喘患者对美泊利珠单抗治疗的反应具有诊断价值。

结论

基线嗜酸性粒细胞计数、嗜酸性粒细胞/淋巴细胞比值和 FEV1(%)是预测美泊利珠单抗治疗反应的重要指标。需要进一步的研究来确定美泊利珠单抗应答者在真实世界中的特征。

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