Introduction: Mepolizumab is a monoclonal antibody against IL-5 for the treatment of severe eosinophilic asthma. The aim of the current study was to present a predesigned interim analysis of the data of patients who have completed 1 year of therapy with mepolizumab. Methods: This study is a prospective multicenter, noninterventional 2-year observational study and aims to describe the clinical benefit and safety profile of mepolizumab in patients with severe eosinophilic asthma. Results: Compared to the year preceding the initiation of treatment, the annual rate of exacerbations decreased significantly, from 4.3 ± 2.3 to 1.3 ± 1.8; p #x3c; 0.0001. Forty-two patients received maintenance dose of oral corticosteroids (OCS) at baseline. From these patients at the end of 1 year of therapy with mepolizumab, 17 patients (40%) had achieved OCS discontinuation. A reduction in the median dose of OCS was also achieved. After 1 year of treatment with mepolizumab, the asthma control test score significantly increased from 16.3 ± 3.7 to 21.2 ± 3.8 (p #x3c; 0.0001). This marked clinical improvement was paralleled by a significant reduction of blood eosinophil count. All patients showed a considerable improvement of airflow limitation. In respect to adverse events of treatment with mepolizumab, 19 patients (27%) were recorded to have at least one such occurrence during their 1-year treatment. Conclusions: We have shown that in patients with severe eosinophilic asthma, 1 year of treatment with mepolizumab was safe, resulted in significant reduction of the annual exacerbation rate, reduction (or even discontinuation) of the needed dose of OCS, and improvements of asthma control and lung function.
Int Arch Allergy Immunol

中文翻译：

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严重嗜酸性粒细胞性哮喘中的美泊利珠单抗：希腊专科哮喘诊所为期2年的随访：中期分析。

简介：美泊利单抗是针对IL-5的单克隆抗体，可用于治疗严重的嗜酸性粒细胞性哮喘。本研究的目的是对已完成美泊珠单抗治疗1年的患者数据进行预先设计的中期分析。方法：本研究是一项前瞻性多中心，非干预性两年观察性研究，旨在描述美泊利珠单抗在严重嗜酸性粒细胞性哮喘患者中的临床获益和安全性。结果：与开始治疗的前一年相比，年恶化率从4.3±2.3降至1.3±1.8；p＃x3c; 0.0001。42名患者在基线时接受了维持剂量的口服皮质类固醇（OCS）。在这些用美泊利单抗治疗1年结束时的患者中，有17名患者（40％）实现了OCS停药。还降低了OCS的中位剂量。用美泊利单抗治疗1年后，哮喘控制测试得分从16.3±3.7显着提高到21.2±3.8（p＃x3c; 0.0001）。显着的临床改善与血液中嗜酸性粒细胞计数的显着减少同时出现。所有患者均显示出明显的气流受限改善。关于美泊利珠单抗治疗的不良事件，据记录有19名患者（27％）在1年治疗期间至少发生过一次此类事件。结论：我们已经表明，对于患有严重嗜酸性粒细胞性哮喘的患者，美泊珠单抗治疗1年是安全的，可导致年加重率显着降低，所需OCS剂量减少（甚至中断），并改善哮喘控制和肺功能。
Int Arch过敏免疫