Rojo-Tolosa Susana, González-Gutiérrez María Victoria, Sánchez-Martínez José Antonio, Jiménez-Gálvez Gonzalo, Pineda-Lancheros Laura Elena, Gálvez-Navas José María, Jiménez-Morales Alberto, Pérez-Ramírez Cristina, Morales-García Concepción
Respiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, Spain.
Pharmacy Service, Pharmacogenetics Unit, University Hospital Virgen de las Nieves, 18014 Granada, Spain.
Pharmaceutics. 2023 Feb 4;15(2):523. doi: 10.3390/pharmaceutics15020523.
Most patients with asthma can control their symptoms with a basic standard of medical care and with maintenance and rescue medication. However, between 5% and 10% of asthmatics worldwide do not achieve control of their symptoms and have recurrent exacerbations and respiratory difficulties. The objective of the study was the real-life evaluation of the clinical improvement of patients with severe eosinophilic asthma treated with omalizumab, together with the search for biomarkers associated with the response. An observational retrospective cohort study was conducted that included patients with severe uncontrolled allergic asthma being treated with omalizumab. Three types of response were evaluated: lower use of oral corticosteroids, improvement in lung function, and reduction in exacerbations. A total of 110 patients under treatment with omalizumab were included, with a mean age of 48 ± 16 years. After 12 months had elapsed, significant reductions were found in the number of exacerbations, use of oral cortico-steroids and doses of inhaled corticosteroids ( < 0.001). Lung function and asthma control improved significantly ( < 0.001; = 0.004) and eosinophil levels were significantly reduced ( = 0.004). Low scores in the Asthma Control Test were associated with the oral corticosteroid-saving effect; lower previous FEV1 levels and absence of chronic obstructive pulmonary disease (COPD) were related to improvement in lung function, and prior FEV1 values higher than 80% and absence of gastroesophageal reflux disease (GERD) with a reduction in exacerbations. The results of this study confirm the clinical benefit obtained after the introduction of omalizumab and the possible predictive biomarkers of response to the treatment.
大多数哮喘患者通过基本的标准医疗护理以及维持和急救药物治疗，能够控制症状。然而，全球5%至10%的哮喘患者无法控制症状，反复出现病情加重和呼吸困难。本研究的目的是对接受奥马珠单抗治疗的重度嗜酸性粒细胞性哮喘患者的临床改善情况进行实际评估，并寻找与治疗反应相关的生物标志物。开展了一项观察性回顾性队列研究，纳入接受奥马珠单抗治疗的重度未控制过敏性哮喘患者。评估了三种治疗反应类型：口服糖皮质激素使用减少、肺功能改善以及病情加重次数减少。总共纳入110例接受奥马珠单抗治疗的患者，平均年龄为48±16岁。12个月后，病情加重次数、口服糖皮质激素的使用以及吸入性糖皮质激素的剂量均显著减少（<0.001）。肺功能和哮喘控制情况显著改善（<0.001；=0.004），嗜酸性粒细胞水平显著降低（=0.004）。哮喘控制测试得分低与口服糖皮质激素节省效应相关；既往较低的第一秒用力呼气容积（FEV1）水平以及无慢性阻塞性肺疾病（COPD）与肺功能改善相关，而既往FEV1值高于80%以及无胃食管反流病（GERD）与病情加重次数减少相关。本研究结果证实了引入奥马珠单抗后获得的临床益处以及对该治疗反应的可能预测性生物标志物。
