Hospital Costa del Sol, Autovía A-7 Km 187, Marbella, Málaga, 29603, Spain.
H. Virgen de la Victoria, Málaga, Spain.
Respir Res. 2023 Sep 28;24(1):235. doi: 10.1186/s12931-023-02539-7.
The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain.
ORBE II (NCT04648839) was an observational, retrospective cohort study in adult SEA patients who had been prescribed benralizumab. Demographic and clinical data of 204 SEA patients were collected 12 months prior to benralizumab initiation (baseline) and at follow-up. Exacerbation rate, asthma symptoms, maintenance oral corticosteroid (OCS) use and lung function were evaluated, among other variables.
A total of 204 SEA patients were evaluated. Mean (standard deviation, SD) age of the study population was 56.4 (12.4) years, 62.3% were women and mean (SD) duration of asthma was 15.1 (12.7) years. Median (Q1-Q3) follow-up duration was 19.5 (14.2-24.2) months. At baseline, 72.6% of the overall population (OP) presented blood eosinophil counts ≥ 300 cells/µL; 36.8% had comorbid chronic rhinosinusitis with nasal polyps (CRSwNP); 84.8% reported at least one severe exacerbation, and 29.1% were OCS-dependent. At 1 year of follow-up, patients receiving benralizumab treatment had a 85.6% mean reduction in exacerbations from baseline, and 81.4% of patients achieved zero exacerbations. We also found a clinically relevant mean (SD) increase in pre-bronchodilator (BD) FEV of 331 (413) mL, with 66.7% of patients achieving a pre-BD FEV increase ≥ 100 mL, and 46.3% of patients achieving a pre-BD FEV ≥ 80% of predicted. Regarding symptom control, 73.8% of the OP obtained an ACT score ≥ 20 points. After 1 year of follow-up, mean reduction in the daily OCS dose was 70.5%, and complete OCS withdrawal was achieved by 52.8% of the OCS-dependent patients. Almost half (43.7%) of the OP on benralizumab met all four criteria for clinical remission. Patients with concomitant CRSwNP obtained similar or enhanced outcomes.
These data support the real-world benefits of benralizumab in SEA patients, and particularly in those with concomitant CRSwNP.
NCT04648839.
ORBE II 研究旨在描述在西班牙真实环境中接受 benralizumab 治疗的重度嗜酸性粒细胞性哮喘（SEA）成年患者的特征和临床结局。
ORBE II（NCT04648839）是一项观察性、回顾性队列研究，纳入了接受 benralizumab 治疗的 SEA 成年患者。在开始 benralizumab 治疗前（基线）和随访时收集了 204 例 SEA 患者的人口统计学和临床数据。评估了哮喘加重率、哮喘症状、维持口服皮质类固醇（OCS）的使用和肺功能等变量。
共评估了 204 例 SEA 患者。研究人群的平均（标准差，SD）年龄为 56.4（12.4）岁，62.3%为女性，哮喘平均（SD）病程为 15.1（12.7）年。中位（四分位距 1-3 分位距）随访时间为 19.5（14.2-24.2）个月。基线时，总体人群（OP）中 72.6%的患者血液嗜酸性粒细胞计数≥300 个/µL；36.8%患有伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）；84.8%报告至少有一次重度加重，29.1%为 OCS 依赖者。在 1 年的随访中，接受 benralizumab 治疗的患者哮喘加重的平均（SD）次数从基线减少了 85.6%，81.4%的患者无哮喘加重。我们还发现，支气管扩张剂（BD）前用力肺活量（FEV）的平均（SD）有临床意义的增加，为 331（413）mL，66.7%的患者 BD 前 FEV 增加≥100 mL，46.3%的患者 BD 前 FEV 增加≥80%预测值。在症状控制方面，OP 中 73.8%的患者 ACT 评分≥20 分。在 1 年的随访后，每日 OCS 剂量的平均减少量为 70.5%，52.8%的 OCS 依赖患者完全停用了 OCS。OP 中近一半（43.7%）的患者符合所有四项临床缓解标准。同时患有 CRSwNP 的患者获得了相似或更好的结局。
这些数据支持了 benralizumab 在 SEA 患者中的真实世界获益，特别是在同时患有 CRSwNP 的患者中。
NCT04648839。
Zotero 插件
