美泊利珠单抗在重度难治性嗜酸性粒细胞性哮喘合并多种并发症患者中的实际疗效。
Real-life effectiveness of mepolizumab in patients with severe refractory eosinophilic asthma and multiple comorbidities.
作者信息
Crimi Claudia, Campisi Raffaele, Cacopardo Giulia, Intravaia Rossella, Nolasco Santi, Porto Morena, Pelaia Corrado, Crimi Nunzio
机构信息
Respiratory Medicine Unit, A.O.U. "Policlinico-Vittorio Emanuele", Catania, Italy.
Respiratory Medicine Unit, A.O.U. "Policlinico-Vittorio Emanuele", Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
出版信息
World Allergy Organ J. 2020 Sep 18;13(9):100462. doi: 10.1016/j.waojou.2020.100462. eCollection 2020 Sep.
BACKGROUND
Data on mepolizumab in patients with severe eosinophilic asthma (EA) and comorbidities are needed to assess whether randomized controlled trial results are applicable in the real world.
OBJECTIVE
To evaluate real-life effectiveness and the presence/absence of predictors of treatment response in patients with one or more comorbidities (nasal polyps, allergic rhinitis, gastro-esophageal reflux disease, nonallergic rhinitis with eosinophilia syndrome, obesity, bronchiectasis) who received mepolizumab (MEPO) for the treatment of severe EA.
METHODS
We performed a single-center retrospective study in patients with severe asthma and presence of comorbidities treated with mepolizumab at the respiratory outpatient clinic, Policlinico-Vittorio Emanuele, Catania, Italy. Health records of 31 severe asthmatic patients were retrieved and analyzed. Asthma control test (ACT) score, blood eosinophil count, forced expiratory volume in 1 s (FEV), FEV% of predicted and FEV/FVC (Forced Vital Capacity) ratio, oral corticosteroid (OCS) dosage, and exacerbations were recorded at baseline (T0), after 3 (T1), 6 (T3), 9 (T6), and 12 months (T12). Clinical response was defined when 3 of these 4 criteria were fulfilled: i) 30% exacerbation decrease; ii) 80% blood eosinophilia reduction; iii) 3 point ACT increase; iv) FEV increase ≥200 mL.
RESULTS
83.87% of patients were classified as responsive to MEPO treatment. Substantial depletion of the blood eosinophils (>80%) was found in 87.1% of patients, FEV > 200 mL was seen in 54.84% of patients, a 3-point ACT improvement from baseline was recorded in 80.65% 25 of patients and a 30% reduction of exacerbations rates was seen in 96.77% of patients. Moreover, the majority 38.71% of patients met 3/4 parameters after 12 months. Neither the comorbidities nor other characteristics (sex, BMI, age, smoking) influenced treatment response.
CONCLUSIONS
MEPO in patients with severe EA is effective regardless of the presence of comorbidities.
背景
需要有关美泊利珠单抗治疗重度嗜酸性粒细胞性哮喘（EA）及合并症患者的数据，以评估随机对照试验结果是否适用于现实世界。
目的
评估接受美泊利珠单抗（MEPO）治疗重度EA的合并一种或多种合并症（鼻息肉、过敏性鼻炎、胃食管反流病、嗜酸性粒细胞增多综合征性非过敏性鼻炎、肥胖、支气管扩张）患者的实际疗效及治疗反应预测因素的有无。
方法
我们在意大利卡塔尼亚市维托里奥·埃马努埃莱综合医院呼吸门诊对接受美泊利珠单抗治疗的重度哮喘合并合并症患者进行了一项单中心回顾性研究。检索并分析了31例重度哮喘患者的健康记录。在基线（T0）、3个月（T1）、6个月（T3）、9个月（T6）和12个月（T12）时记录哮喘控制测试（ACT）评分、血嗜酸性粒细胞计数、第1秒用力呼气容积（FEV）、预测FEV%和FEV/用力肺活量（FVC）比值、口服糖皮质激素（OCS）剂量及病情加重情况。当满足以下4项标准中的3项时定义为临床反应：i）病情加重减少30%；ii）血嗜酸性粒细胞减少80%；iii）ACT增加3分；iv）FEV增加≥200 mL。
结果
83.87%的患者被归类为对MEPO治疗有反应。87.1%的患者血嗜酸性粒细胞大量减少（>80%），54.84%的患者FEV>200 mL，80.65%的患者ACT较基线提高3分，96.77%的患者病情加重率降低30%。此外，大多数（38.71%）患者在12个月后满足3/4项参数。合并症及其他特征（性别、BMI、年龄、吸烟）均未影响治疗反应。
结论
重度EA患者使用MEPO治疗有效，无论是否存在合并症。
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