Abstract Background: Patients with severe asthma often suffer from comorbidities whose impact on the course of biological therapy has not been elucidated yet. Objective: This study evaluated, for the first time, patients with one or more comorbidities who received mepolizumab (MEPO) for the treatment of severe eosinophilic asthma to assess its real-life effectiveness and to explore the presence/absence of predictors of treatment response. Methods: Health records of 31 patients prescribed with MEPO were retrospectively analysed. Asthma control test (ACT) score, blood eosinophil count, forced expiratory volume in 1 second (FEV1), FEV1% of predicted and FEV1/FVC (Forced Vital Capacity) ratio, oral corticosteroid (OCS) dosage and exacerbations were recorded at baseline (T0), after 3 (T1), 6 (T3), nine (T6) and 12 months (T12). A clinical response was defined as: i) 30% exacerbation decrease; ii) 80% blood eosinophilia reduction; iii) 3 point ACT increase; iv) FEV1 increase ≥ 200 mL. Results: At T12 blood eosinophil level decreased by 89.89% (p>0.0001), a minimally clinical important difference in ACT score (an improvement in ACT of 3 points from baseline) was recorded in 80.65% of patients (p>0.0001) and 96.77% of patients reduced by minimum 30% the number of exacerbations (p>0.0001). 84% of patients discontinued OCS (p>0.0001). FEV1 increased by 9% (p=0.0224) while FEV1/FVC was statistically significant only at T1. No significant differences were generally found among patients with a specific comorbidity. Patients without nasal polyps showed a greater blood eosinophilia reduction than patients with nasal polyps (p=0.0395), and patients with allergy, showed a greater ACT improvement than those without (p=0.048). The number of comorbidities did not influenced treatment with MEPO. Neither the comorbidities nor other characteristics of patients at baseline (sex, BMI, age, smoking, baseline eosinophil level) influenced MEPO therapy. Conclusions: These data indicate that MEPO effectiveness in patients with severe eosinophilic asthma, regardless the presence of one or more comorbidities.

中文翻译：

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美泊利珠单抗在重症难治性嗜酸性粒细胞性哮喘和多种合并症患者真实队列中的有效性

摘要背景：重症哮喘患者常合并症，其对生物治疗过程的影响尚未阐明。目的：本研究首次评估接受美泊利单抗（MEPO）治疗严重嗜酸性粒细胞性哮喘的一种或多种合并症患者，以评估其真实生活效果并探讨治疗反应预测因子的存在/不存在。方法：回顾性分析31例MEPO患者的健康记录。在基线时记录哮喘控制测试（ACT）得分，血液嗜酸性粒细胞计数，1秒内的呼气量（FEV1），预测的FEV1％和FEV1 / FVC（强制肺活量）比，口服皮质类固醇（OCS）剂量和加重情况（ T0），3（T1），6（T3），9（T6）和12个月（T12）之后。临床反应定义为：i）病情加重30％；ii）血液嗜酸性粒细胞减少80％；iii）ACT增加3点；iv）FEV1增加≥200 mL。结果：在T12血中嗜酸性粒细胞水平下降了89.89％（p> 0.0001），在80.65％的患者中记录了最低的ACT评分临床重要差异（ACT较基线提高了3分）（p> 0.0001）和96.77 ％的患者减少了至少30％的加重次数（p> 0.0001）。84％的患者停用OCS（p> 0.0001）。FEV1增加了9％（p = 0.0224），而FEV1 / FVC仅在T1时有统计学意义。通常在具有特定合并症的患者之间没有发现显着差异。没有鼻息肉的患者比具有鼻息肉的患者（p = 0.0395）和过敏患者的血嗜酸性粒细胞减少率更高。与没有（p = 0.048）的患者相比，ACT的改善更大。合并症的数量不影响MEPO的治疗。基线患者的合并症或其他特征（性别，BMI，年龄，吸烟，基线嗜酸性粒细胞水平）均不影响MEPO治疗。结论：这些数据表明，无论是否存在一种或多种合并症，MEPO在重度嗜酸性哮喘患者中的有效性。