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美泊利珠单抗在真实临床环境中的有效性综合评估。

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting.

作者信息

Cameli Paolo, Bergantini Laura, d'Alessandro Miriana, Perruzza Marco, Cekorja Behar, Perillo Felice, Massa Evaluna, Ruzza Annamaria, Fossi Antonella, Beltrami Valerio, Sestini Piersante, Bargagli Elena

机构信息

Department of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy,

Department of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.

出版信息

Int Arch Allergy Immunol. 2020;181(8):606-612. doi: 10.1159/000507996. Epub 2020 Jun 9.

Abstract

INTRODUCTION

Interleukin-5 (IL-5) is the principal cytokine regulating eosinophil growth, differentiation, activation, and expression. It is a specific target of mepolizumab, an anti-IL-5 monoclonal antibody used in the treatment of severe eosinophilic asthma. This new drug can improve symptoms, reduce asthma exacerbations and steroid use. Few data are available on its efficacy for nasal symptoms.

OBJECTIVE

To describe the all-round clinical impact of mepolizumab in a real-life setting, evaluating the efficacy and safety of the drug in severe eosinophilic asthma patients.

POPULATION AND METHODS

We retrospectively collected the clinical and functional data on 27 patients (16 males) affected with severe eosinophilic asthma, diagnosed at the Siena Regional Referral Centre and monitored for 6 months. Clinical, immunological, and functional data at baseline and follow-up were entered in a database together with comorbidities, number of exacerbations, steroid treatment, multiple-flow exhaled nitric oxide, and validated questionnaires.

RESULTS

A significant reduction in asthma exacerbations was observed in all patients after 6 months of the biological therapy (p = 0.0009), and 4/6 patients discontinued chronic oral steroids. A significant improvement in ACT, FEV1, SNOT22, and alveolar nitric oxide was observed after 1 month of mepolizumab (p = 0.003, p = 0.007, p = 0.047, and p = 0.019, respectively) and maintained after 6 months of treatment. After 6 months, FeNO 50 was reduced as well (p = 0.030). Mepolizumab was very well tolerated, and no major side effects were observed.

CONCLUSIONS

Our study suggests that mepolizumab is effective in improving control of asthma, lung function parameters, exhaled biomarkers, and nasal symptoms in patients with severe eosinophilic asthma.

摘要

引言

白细胞介素-5(IL-5)是调节嗜酸性粒细胞生长、分化、激活和表达的主要细胞因子。它是美泊利珠单抗的特异性靶点,美泊利珠单抗是一种用于治疗重度嗜酸性粒细胞性哮喘的抗IL-5单克隆抗体。这种新药可以改善症状、减少哮喘发作次数以及减少类固醇的使用。关于其对鼻部症状疗效的数据较少。

目的

描述美泊利珠单抗在实际临床环境中的全面临床影响,评估该药物在重度嗜酸性粒细胞性哮喘患者中的疗效和安全性。

研究对象与方法

我们回顾性收集了在锡耶纳地区转诊中心确诊的27例重度嗜酸性粒细胞性哮喘患者(16例男性)的临床和功能数据,并对其进行了6个月的监测。将基线和随访时的临床、免疫学和功能数据以及合并症、发作次数、类固醇治疗、多次呼气一氧化氮和经过验证的问卷录入数据库。

结果

生物治疗6个月后,所有患者的哮喘发作次数均显著减少(p = 0.0009),6例患者中有4例停用了慢性口服类固醇药物。使用美泊利珠单抗1个月后,哮喘控制测试(ACT)、第1秒用力呼气容积(FEV1)、鼻窦鼻息肉结局测试22项问卷(SNOT22)评分和肺泡一氧化氮水平均有显著改善(分别为p = 0.003、p = 0.007、p = 0.047和p = 0.019),治疗6个月后仍保持改善。6个月后,50 Hz时的呼出一氧化氮(FeNO 50)也有所降低(p = 0.030)。美泊利珠单抗耐受性良好,未观察到重大副作用。

结论

我们的研究表明,美泊利珠单抗可有效改善重度嗜酸性粒细胞性哮喘患者的哮喘控制、肺功能参数、呼出生物标志物和鼻部症状。

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