Department of Medical and Surgical Sciences, Section of Respiratory Diseases, University "Magna Græcia" of Catanzaro, Italy.
Department of Health Science, University "Magna Græcia" of Catanzaro, Italy.
Pulm Pharmacol Ther. 2018 Dec;53:1-5. doi: 10.1016/j.pupt.2018.09.006. Epub 2018 Sep 11.
Mepolizumab is a humanized monoclonal antibody which targets interleukin-5 (IL-5) and is nowadays available in many countries for add-on biological therapy of severe eosinophilic asthma. Although the approval of mepolizumab use in clinical practice has been made possible by several successful pre-marketing controlled trials, so far only a very few studies have been performed in a real-life setting. Within such a context, our present observational investigation refers to 14 patients with refractory eosinophilic asthma, currently treated with mepolizumab at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy, whose anti-IL-5 treatment began between June 2017 and January 2018. These patients experienced a significant increase in asthma control test (ACT) score, that was evaluated at baseline (13.64 ± 3.00), as well as after 4 weeks (18.86 ± 3.15; p < 0.0001) and 24 weeks (20.07 ± 1.94; p < 0.0001) of add-on therapy with mepolizumab. This relevant improvement in symptom control was paralleled by a dramatic fall of blood eosinophil numbers, counted at baseline (647.1 ± 274.7 cells/μl), and at the 4th (147.8 ± 66.5 cells/μl; p < 0.0001) and 24th week (98.6 ± 40.3 cells/μl; p < 0.0001) after starting add-on treatment with mepolizumab. These changes were associated with significant and stable increases in FEV, which was recorded at baseline (1389 ± 454.3 mL), as well as after 4 weeks (1711 ± 482.3 mL; p < 0.001) and 24 weeks (1701 ± 456.0 mL; p < 0.01). Moreover, in comparison to the 6 months preceding the beginning of treatment with mepolizumab, after 24 weeks of anti-IL-5 therapy significant decreases were detected with regard to exacerbation numbers (from 3.64 ± 1.86 to 1.0 ± 0.78; p < 0.001) and oral intake of prednisone (from 24.11 ± 10.36 mg/day to 1.78 ± 3.82 mg/day). Therefore, these preliminary data referring to our single-centre observational study corroborate, in a real-life environment, the efficacy of mepolizumab for treatment of patients with exacerbation-prone, corticosteroid-refractory, severe eosinophilic asthma.
美泊利珠单抗是一种针对白细胞介素-5（IL-5）的人源化单克隆抗体，目前在许多国家已被批准用于严重嗜酸性粒细胞性哮喘的附加生物治疗。尽管几项成功的上市前对照试验使美泊利珠单抗在临床实践中的应用成为可能，但迄今为止，仅在真实环境中进行了极少数研究。在这种情况下，我们目前的观察性研究涉及意大利卡坦扎罗的“Magna Græcia”大学医院呼吸科的 14 名接受美泊利珠单抗治疗的难治性嗜酸性粒细胞性哮喘患者，他们的抗 IL-5 治疗开始于 2017 年 6 月至 2018 年 1 月之间。这些患者的哮喘控制测试（ACT）评分显著增加，基线评分为 13.64±3.00，在添加美泊利珠单抗治疗 4 周（18.86±3.15；p<0.0001）和 24 周（20.07±1.94；p<0.0001）后也有显著增加。这种症状控制的显著改善与血液嗜酸性粒细胞数量的显著下降相平行，基线计数为 647.1±274.7 个/μl，在添加美泊利珠单抗治疗第 4 周（147.8±66.5 个/μl；p<0.0001）和第 24 周（98.6±40.3 个/μl；p<0.0001）时也有显著下降。这些变化与 FEV 的显著和稳定增加有关，FEV 在基线时为 1389±454.3 mL，在添加美泊利珠单抗治疗 4 周（1711±482.3 mL；p<0.001）和 24 周（1701±456.0 mL；p<0.01）后也有增加。此外，与开始接受美泊利珠单抗治疗前的 6 个月相比，在接受抗 IL-5 治疗 24 周后，哮喘加重次数（从 3.64±1.86 降至 1.0±0.78；p<0.001）和泼尼松口服剂量（从 24.11±10.36 mg/天降至 1.78±3.82 mg/天）均显著减少。因此，这些来自我们单中心观察性研究的初步数据在真实环境中证实了美泊利珠单抗治疗易加重、皮质类固醇难治性严重嗜酸性粒细胞性哮喘患者的疗效。
