Enríquez-Rodríguez Ana Isabel, Hermida Valverde Tamara, Romero Álvarez Pedro, López-González Francisco Julián, Gullón Blanco Jose Antonio, Expósito Villegas Ana Rosa, Escobar Fernández María José, Beristáin Urquiza Ana María, Alonso Fernández Miguel Ángel, Gutiérrez Rodríguez Margarita, Castaño De Las Pozas Gema, Jiménez Pérez Jennifer, Fernández Mellado Roberto, García Clemente Marta María, Casan Clara Pere
Department of Pulmonary Medicine, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain.
Department of Pulmonary Medicine, Hospital Universitario de San Agustín, Avilés, Spain.
J Asthma. 2022 May;59(5):1005-1011. doi: 10.1080/02770903.2021.1897835. Epub 2021 Mar 27.
Add-on therapy with monoclonal antibodies is the recommended therapy for severe asthmatic patients refractory to maintenance treatment. In randomized control trials, mepolizumab reduced the number of exacerbations, the need of oral corticosteroids (OCS), increased asthma control, and lung function in a population of uncontrolled severe eosinophilic asthmatic patients. In this piece of work, we aimed to assess mepolizumab efficacy and safety in a cohort of patients with severe eosinophilic asthma in real-life conditions.
A retrospective study was carried out at eight hospitals from Asturias (Spain). The sample included patients treated with mepolizumab from 1 January 2016 to 31 March 2019. Demographic and clinical variables were collected, including OCS use, asthma control, lung function, and exacerbation rate.
Sixty-nine patients (72% women) with mean age 56 ± 13 years were included. Annual exacerbation rate decreased from 4.7 (SD 3.7) to 1.3 (SD 2.5) ( < 0.001). The number of patients requiring OCS treatment decreased from 25 patients (36%, mean prednisone dose = 18 mg/day) to 13 patients (19%, mean prednisone dose = 9 mg/day) ( < 0.001). Twelve patients (48%) stopped OCS treatment. Forced expired volume in one second (FEV1) as percentage increased from 68% (SD 20) to 76% (SD 21) ( < 0.001). Fifty-six patients (81%) were considered responders to mepolizumab. No serious adverse events were detected during the study period.
Overall, this study demonstrates mepolizumab efficacy and safety in a cohort of patients with uncontrolled severe eosinophilic asthma in routine clinical practice.
对于维持治疗无效的重度哮喘患者，推荐使用单克隆抗体进行附加治疗。在随机对照试验中，美泊利珠单抗减少了未控制的重度嗜酸性粒细胞性哮喘患者群体的急性加重次数、口服糖皮质激素（OCS）的使用需求，改善了哮喘控制情况及肺功能。在本研究中，我们旨在评估美泊利珠单抗在现实生活条件下对重度嗜酸性粒细胞性哮喘患者队列的疗效和安全性。
在西班牙阿斯图里亚斯的八家医院开展了一项回顾性研究。样本包括2016年1月1日至2019年3月31日接受美泊利珠单抗治疗的患者。收集了人口统计学和临床变量，包括OCS使用情况、哮喘控制情况、肺功能和急性加重率。
纳入了69例患者（72%为女性），平均年龄56±13岁。年急性加重率从4.7（标准差3.7）降至1.3（标准差2.5）（<0.001）。需要OCS治疗的患者人数从25例（36%，泼尼松平均剂量=18毫克/天）降至13例（19%，泼尼松平均剂量=9毫克/天）（<0.001）。12例患者（48%）停止了OCS治疗。一秒用力呼气容积（FEV1）百分比从68%（标准差20）增至76%（标准差21）（<0.001）。56例患者（81%）被认为对美泊利珠单抗有反应。在研究期间未检测到严重不良事件。
总体而言，本研究证明了美泊利珠单抗在常规临床实践中对未控制的重度嗜酸性粒细胞性哮喘患者队列的疗效和安全性。
