Background

Severe eosinophilic asthma is a high-burden disease. Mepolizumab has been effective in several randomized clinical trials. However, such success might not be applicable to patients treated in usual clinical practice. The objectives of this article are to evaluate the efficacy of mepolizumab in severe uncontrolled eosinophilic asthma under usual clinical practice, and to determine characteristics associated with the response to this treatment.

Methods

We have conducted a retrospective, multicentre study, including all adult patients with severe uncontrolled eosinophilic asthma in Galicia, Spain, on whom mepolizumab treatment was started before June 2020, at least 6 months before the time of inclusion, and had received at least one dose of the drug. Patient characteristics, clinical data, respiratory function and comorbidities were collected at baseline and at the 6-month-follow-up. Responders and super-responders were defined according to clinical response and requirement of systemic corticosteroids.

Results

122 patients (mean age 58 years old) were included. In the follow-up treatment 6 months later, 75.4% of the patients were well-controlled, displaying a significant reduction in blood eosinophil counts (p < 0.001), hospital admissions and disease exacerbations (p < 0.001), and had their systemic glucocorticosteroid dose significantly reduced (p < 0.001). The inhaled corticosteroid dose was also lowered (p < 0.01) after 6 months of treatment. Around two-thirds had a clinically significant increase in FEV1, 95% of the patients were considered responders and 43% super-responders.

Conclusion

In routine clinical practice, mepolizumab is effective in patients with severe eosinophilic asthma and it has a good safety profile.

中文翻译：

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美泊利单抗在常规临床实践中的疗效和反应者特征

背景

重度嗜酸性粒细胞哮喘是一种高负担疾病。美泊利单抗在多项随机临床试验中均有效。然而，这种成功可能不适用于在常规临床实践中接受治疗的患者。本文的目的是评估美泊利单抗在常规临床实践中对严重不受控制的嗜酸性粒细胞哮喘的疗效，并确定与该治疗反应相关的特征。

方法

我们进行了一项回顾性、多中心研究，包括西班牙加利西亚所有患有严重未控制的嗜酸性粒细胞性哮喘的成年患者，他们在 2020 年 6 月之前开始美泊利单抗治疗，至少在纳入前 6 个月，并且至少接受了一剂的药物。在基线和 6 个月的随访中收集患者特征、临床数据、呼吸功能和合并症。根据临床反应和全身性皮质类固醇的需求定义反应者和超反应者。

结果

包括 122 名患者（平均年龄 58 岁）。在 6 个月后的随访治疗中，75.4% 的患者控制良好，血液嗜酸性粒细胞计数（p < 0.001）、入院率和疾病恶化率（p < 0.001）显着降低，并且全身使用糖皮质激素剂量显着降低（p < 0.001）。治疗 6 个月后，吸入的皮质类固醇剂量也降低（p < 0.01）。大约三分之二的患者 FEV1 有临床显着增加，95% 的患者被认为是反应者，43% 是超级反应者。

结论

在常规临床实践中，美泊利单抗对重度嗜酸性哮喘患者有效，并且具有良好的安全性。