重度哮喘患者对omalizumab、benralizumab和mepolizumab完全缓解者与非完全缓解者的临床特征:
2024/06/26
重度哮喘患者对omalizumab、benralizumab和mepolizumab完全缓解者与非完全缓解者的临床特征:一项长期回顾性分析
摘要
背景：一些重症哮喘患者可能会从生物制剂的治疗中获益，但大部分证据都是从随机对照试验（RCT）中收集的，而随机对照试验中患者的特征与现实世界中哮喘患者的特征有所不同。本研究旨在描述在日常诊疗中接受生物制剂长期治疗的重症哮喘患者中，完全应答者与非完全应答者的临床特征。
方法： 90名接受生物制剂（奥马珠单抗、苯拉利珠单抗和美泊利珠单抗）治疗至少12个月并随访至2022年3月的重症哮喘患者的队列数据。记录的数据包括基线时、12个月时和随访结束时的临床特征和治疗效果（病情加重、哮喘控制测试[ACT]评分、肺功能、维持性口服皮质类固醇 [mOCS]）、FeNO和血液嗜酸性粒细胞。如果除未出现病情加重或使用mOCS外，ACT评分大于20分，且FEV1预测值大于80%，则视为完全应答。
结果：经过12个月的治疗和平均55个月的随访，所有哮喘控制参数均有所改善。治疗12个月后，27.2% 的患者达到完全应答标准，在随访结束时，这一比例甚至上升到35.3%。美泊利珠单抗和奥马珠单抗治疗的长期完全应答与较好的肺功能有关，苯拉利珠单抗组的既往病情加重较少。未达到完全应答的主要原因是气流阻塞模式的持续存在。
结论；这项研究表明，奥马珠单抗、苯拉珠单抗和美泊利珠单抗改善了重症哮喘患者在门诊环境中的临床疗效，在长期随访中的效应大小与 RCT 相似。然而，气流阻塞是导致对生物制剂不完全反应的一个预测因素。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（Annals of Medicine 2024 Vol. 56 Issue 1 DOI: Artn 231735610.1080/07853890.2024.2317356）
（Annals of Medicine 2024 Vol. 56 Issue 1 DOI: Artn 231735610.1080/07853890.2024.2317356）
Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis
M. Basagaña, C. Martínez-Rivera, C. Padró, I. Garcia-Olivé, M. Martínez-Colls, J. Navarro, et al.
Abstract
BACKGROUND:Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.
METHODS: Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV1 >80% predicted.
RESULTS:An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.
CONCLUSIONS: This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.
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单次输注工程化的长寿命和多功能T细胞可使小鼠哮喘得到持久缓解
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哮喘治疗的精准医学：释放表观基因组和微生物组的潜力
