Laorden D, Hernández I, Domínguez-Ortega J, Romero D, Álvarez-Sala R, Quirce S
Department of Pneumology, Hospital La Paz, Universidad Autónoma de Madrid, IdiPAZ, and CIBER of Respiratory Diseases, Madrid, Spain.
Department of Allergy, Hospital La Paz, IdiPAZ, and CIBER of Respiratory Diseases, Madrid, Spain.
Eur Ann Allergy Clin Immunol. 2024 Jul;56(4):169-175. doi: 10.23822/EurAnnACI.1764-1489.289. Epub 2023 Mar 16.
Mepolizumab, a monoclonal antibody that interacts with IL-5, was the first anti-IL-5 approved for uncontrolled severe eosinophilic asthma. In several randomised, placebo-controlled trials, treatment with mepolizumab has shown a significant improvement in asthma symptoms and the need to use of oral corticosteroids (OCS). Several studies have correlated blood levels of eosinophil cationic protein (ECP) with the degree of eosinophilic inflammation, which could make it an indirect marker of eosinophilic activity. This was a single-centre retrospective study that included all patients diagnosed with severe eosinophilic asthma under treatment with mepolizumab. We recorded the number of exacerbations, daily prednisone intake, asthma control test scores and forced expiratory volume in the first second. We followed 22 patients, 14 of whom were OCS-dependent with a mean daily dose of 15.85 ± 15.62 mg prednisone. After 12 months, only five continued taking OCS and the mean daily dose was reduced by up to 2.50 ± 3.84 mg (p less than 0.007). The exacerbation rate at baseline was 2.91 ± 2.27 and decreased to 0.82 ± 1.14 in the following year (p less than 0.001). ACT scores increased significantly from 16.00 ± 5.85 to 20.71 ± 4.45 after six months (p = 0.003). We also observed a decrease in ECP from 81.46 ± 43.99 µg/L to 19.12 ± 18.80 µg/L (p > 0.001). These real-life results are consistent with previous clinical trials demonstrating the efficacy and safety of mepolizumab in routine clinical practice for severe uncontrolled eosinophilic asthma. We observed a significant decrease in blood eosinophil counts and in ECP levels, suggesting a reduction in eosinophil activity following mepolizumab treatment.
美泊利珠单抗是一种与白细胞介素-5相互作用的单克隆抗体，是首个被批准用于治疗无法控制的重度嗜酸性粒细胞性哮喘的抗白细胞介素-5药物。在多项随机、安慰剂对照试验中，使用美泊利珠单抗治疗已显示出哮喘症状有显著改善，且减少了口服糖皮质激素（OCS）的使用需求。多项研究已将嗜酸性粒细胞阳离子蛋白（ECP）的血液水平与嗜酸性粒细胞炎症程度相关联，这可能使其成为嗜酸性粒细胞活性的间接标志物。这是一项单中心回顾性研究，纳入了所有接受美泊利珠单抗治疗的重度嗜酸性粒细胞性哮喘患者。我们记录了急性加重次数、每日泼尼松摄入量、哮喘控制测试分数以及第一秒用力呼气量。我们对22例患者进行了随访，其中14例依赖OCS，泼尼松平均每日剂量为15.85±15.62mg。12个月后，只有5例继续服用OCS，平均每日剂量减少至2.50±3.84mg（p小于0.007）。基线时的急性加重率为2.91±2.27，次年降至0.82±1.14（p小于0.001）。6个月后，哮喘控制测试分数从16.00±5.85显著提高至20.71±4.45（p = 0.003）。我们还观察到ECP从81.46±43.99μg/L降至19.12±18.80μg/L（p>0.001）。这些实际临床结果与先前的临床试验一致，证明了美泊利珠单抗在重度无法控制的嗜酸性粒细胞性哮喘的常规临床实践中的疗效和安全性。我们观察到血液嗜酸性粒细胞计数和ECP水平显著降低，表明美泊利珠单抗治疗后嗜酸性粒细胞活性降低。
