Department of Health Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
Clin Exp Allergy. 2020 Jul;50(7):780-788. doi: 10.1111/cea.13613. Epub 2020 May 13.
Anti-interleukin-5 (IL-5) monoclonal antibodies can be used as add-on biological therapies in allergic and non-allergic patients with severe eosinophilic asthma. However, within such a therapeutic context real-life investigations are lacking.
Therefore, the aim of the present observational study was to evaluate the effects of mepolizumab in allergic and non-allergic subjects with severe eosinophilic asthma.
Relevant clinical, functional, laboratory, and pharmacotherapeutic parameters were assessed in the above patient subgroups.
After one year of add-on biological treatment with mepolizumab, our 88 patients experienced a remarkable improvement of their severe asthma, documented by a better symptom control, expressed by a significant improvement in asthma control test (ACT) score. Indeed, the mean value (±standard deviation) of ACT score increased from 12.55 (±3.724) to 21.08 (±3.358). Moreover, significant improvements were also detected with regard to the median values (interquartile range) of forced expiratory volume in one second (FEV ), blood eosinophil numbers, annual rate of disease exacerbations, and daily intake of oral corticosteroids (OCS). In particular, FEV enhanced from 1640 mL (1110-2275) to 1920 mL (1525-2615), blood eosinophil count dropped from 711.0 cells/μL (500.0-1022) to 90.00 cells/μL (50.00-117.5), the annual rate of asthma exacerbations decreased from 3.000 (2.000-6.000) to 0.000 (0.000-1.000), and the daily prednisone intake fell from 6.250 mg (0.000-25.00) to 0.000 mg (0.000-0.000). After one year of mepolizumab treatment, the improvements in clinical, functional, and haematological parameters were quite similar in patient subgroups characterized by skin prick test (SPT) negativity or positivity, respectively. A significant correlation was observed between serum IgE levels and OCS intake decrease (r = -0.2257; P < .05).
Hence, our real-life data suggest that mepolizumab can represent a valid add-on therapeutic option for patients with severe eosinophilic asthma, irrespective of IgE serum concentrations, and allergic sensitization.
抗白细胞介素-5（IL-5）单克隆抗体可作为过敏和非过敏的严重嗜酸性粒细胞性哮喘患者的附加生物治疗药物。然而，在这种治疗环境下，缺乏真实世界的研究。
因此，本观察性研究的目的是评估美泊利珠单抗在过敏和非过敏的严重嗜酸性粒细胞性哮喘患者中的作用。
在上述患者亚组中评估了相关的临床、功能、实验室和药物治疗参数。
在接受美泊利珠单抗附加生物治疗一年后，我们的 88 名患者的严重哮喘得到了显著改善，这表现为哮喘控制测试（ACT）评分的显著改善。事实上，ACT 评分的平均值（±标准差）从 12.55（±3.724）增加到 21.08（±3.358）。此外，用力呼气量（FEV ）、血嗜酸性粒细胞数、疾病加重的年发生率和每日口服皮质类固醇（OCS）的中位数（四分位距）也有显著改善。特别是，FEV 从 1640mL（1110-2275）增加到 1920mL（1525-2615），血嗜酸性粒细胞计数从 711.0 细胞/μL（500.0-1022）降至 90.00 细胞/μL（50.00-117.5），哮喘加重的年发生率从 3.000（2.000-6.000）降至 0.000（0.000-1.000），每日泼尼松摄入量从 6.250mg（0.000-25.00）降至 0.000mg（0.000-0.000）。经过一年的美泊利珠单抗治疗，在分别由皮肤点刺试验（SPT）阴性或阳性特征的患者亚组中，临床、功能和血液参数的改善非常相似。血清 IgE 水平与 OCS 摄入量减少之间存在显著相关性（r=-0.2257；P<0.05）。
因此，我们的真实世界数据表明，美泊利珠单抗可作为严重嗜酸性粒细胞性哮喘患者的有效附加治疗选择，与血清 IgE 浓度和过敏致敏无关。
