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评估奥马珠单抗治疗的超应答者和非超应答者重症哮喘患者的临床特征和实验室数据:一项单中心真实世界研究。

Evaluation of the clinical features and laboratory data of patients with severe asthma classified as super-responder or non super-responder to omalizumab treatment: a single-center real-life study.

机构信息

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

出版信息

J Asthma. 2023 Oct;60(10):1862-1868. doi: 10.1080/02770903.2023.2196562. Epub 2023 Apr 21.

DOI:10.1080/02770903.2023.2196562
PMID:36971065
Abstract

INTRODUCTION

Omalizumab is used for the treatment of severe allergic asthma.

OBJECTIVE

The aim of this study was to evaluate the clinical features and laboratory data of patients with severe allergic asthma classified as super-responder or non super-responder to omalizumab.

METHODS

Comparisons were made of the laboratory data and clinical features of patients with severe allergic asthma. Patients who had no asthma exacerbation, no oral corticosteroid (OCS) use, asthma control test (ACT) score >20 and forced expiratory volume in 1 s (FEV1) >80% were considered super-responder after omalizumab.

RESULTS

A total of 90 patients were included in the study, comprising 19 (21.1%) males. The age at onset of asthma, allergic rhinitis rate, number of endoscopic sinus surgeries (ESS), intranasal corticosteroid (INS) use, baseline FEV 1 (%) and ACT score were significantly higher in the omalizumab super-responder group ( = 0.013,  = 0.015,  = 0.002,  = 0.001,  = 0.001 and  < 0.001, respectively). The duration of asthma, rate of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), regular use of OCS, baseline eosinophil count and eosinophil-to-lymphocyte ratio were significantly higher in the omalizumab non super-responder group ( = 0.015,  < 0.001,  = 0.004,  < 0.001 and  < 0.001, respectively). Blood eosinophil count (AUC: 0.187,  < 0.001), eosinophil-to-lymphocyte ratio (AUC: 0.150,  < 0.001) and FEV1 (%) (AUC:0.779,  = 0.001) were determined to have diagnostic value in predicting the treatment response to omalizumab of patients with severe allergic asthma.

CONCLUSION

High-blood eosinophil levels, CRSwNP and low pretreatment lung capacity may affect omalizumab treatment response in patients with severe allergic asthma. These results should be supported by further multicenter real-life studies.

摘要

介绍

奥马珠单抗用于治疗严重过敏性哮喘。

目的

本研究旨在评估根据奥马珠单抗治疗反应分为超应答者和非超应答者的严重过敏性哮喘患者的临床特征和实验室数据。

方法

比较严重过敏性哮喘患者的实验室数据和临床特征。奥马珠单抗治疗后,无哮喘加重、无口服皮质类固醇(OCS)使用、哮喘控制测试(ACT)评分>20 和用力呼气量 1 秒(FEV1)>80%的患者被认为是超应答者。

结果

本研究共纳入 90 例患者,其中男性 19 例(21.1%)。奥马珠单抗超应答组的哮喘发病年龄、变应性鼻炎发生率、内镜鼻窦手术次数(ESS)、鼻内皮质类固醇(INS)使用、基线 FEV1(%)和 ACT 评分显著较高(=0.013,=0.015,=0.002,=0.001,=0.001,<0.001)。奥马珠单抗无应答组的哮喘持续时间、慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)发生率、OCS 常规使用、基线嗜酸性粒细胞计数和嗜酸性粒细胞与淋巴细胞比值显著较高(=0.015,<0.001,=0.004,<0.001,<0.001)。血嗜酸性粒细胞计数(AUC:0.187,<0.001)、嗜酸性粒细胞与淋巴细胞比值(AUC:0.150,<0.001)和 FEV1(%)(AUC:0.779,=0.001)被确定为预测严重过敏性哮喘患者对奥马珠单抗治疗反应的有诊断价值。

结论

高血嗜酸性粒细胞水平、CRSwNP 和低预处理肺功能可能影响严重过敏性哮喘患者对奥马珠单抗的治疗反应。这些结果应得到进一步的多中心真实世界研究的支持。

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