倍利珠单抗治疗重度嗜酸性粒细胞性哮喘和伴鼻息肉的慢性鼻-鼻窦炎：真实世界、多国RANS观察性研究
Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study.
作者信息
Le Tham T, Emmanuel Benjamin, Katial Rohit, Tran Trung N, Kwiatek Justin Joseph, Cohen David S, Daniel Shoshana R, Cao Yunhui, Shih Vivian H, Melcón Maria Gil, Devouassoux Gilles, Pelaia Girolamo
机构信息
BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
Center for Clinical Immunology, National Jewish Health & University of Colorado School of Medicine, Denver, CO, USA.
出版信息
J Asthma Allergy. 2024 Apr 5;17:313-324. doi: 10.2147/JAA.S437190. eCollection 2024.
PURPOSE
Real-world evidence of benralizumab effectiveness on nasal polyps (NP) and asthma outcomes in patients with severe eosinophilic asthma (SEA) and comorbid chronic rhinosinusitis with NP are limited. The objective of this study was to assess NP and asthma outcomes in benralizumab-treated patients with SEA and comorbid NP in a real-world setting.
PATIENTS AND METHODS
RANS was a retrospective, multi-country observational study (ClinicalTrials.gov: NCT05180357) using medical chart reviews of adults with SEA and comorbid NP. Total NP Score (NPS), SinoNasal Outcome Test-22 (SNOT-22) total score, annualized exacerbation rate (AER), and 6-item Asthma Control Questionnaire (ACQ-6) and Asthma Control Test (ACT) scores during the 12 months pre-index (baseline) and post-index (follow-up) were measured. Clinically meaningful improvement from baseline following treatment, in terms of total NPS (≥1-point reduction), SNOT-22 total (≥8.9-point reduction), ACQ-6 (≥0.5-point reduction) or ACT (≥3-point increase) scores, were reported.
RESULTS
A total of 233 patients were included. Baseline mean (standard deviation [SD]) NPS and SNOT-22 total scores were 3.8 (2.4) and 47.5 (22.6), respectively. The mean change (95% confidence interval [CI]) from baseline was -1.2 (-1.7, -0.6) for NPS, and -19.8 (-23.6, -15.9) for SNOT-22. The AER (95% CI) was 1.2 (0.96, 1.41) at baseline and 0.2 (0.13, 0.28) at follow-up. Mean (SD) ACQ-6 and ACT scores were 1.6 (1.3) and 15.0 (5.2) at baseline and 0.8 (1.0) and 22.0 (3.9) at follow-up, respectively. The proportion of patients who achieved clinically meaningful improvements in NPS, SNOT-22 total, ACQ-6, and ACT scores was 49.1%, 67.6%, 56.6%, and 81.1%, respectively.
CONCLUSION
In this real-world study, improvements in NP and asthma outcomes in patients with SEA and comorbid NP were observed during the 12 months following benralizumab initiation.
目的
关于倍利珠单抗对严重嗜酸性粒细胞性哮喘（SEA）合并慢性鼻-鼻窦炎伴鼻息肉（NP）患者的鼻息肉（NP）及哮喘相关结局有效性的真实世界证据有限。本研究的目的是在真实世界环境中评估接受倍利珠单抗治疗的SEA合并NP患者的NP及哮喘相关结局。
患者与方法
RANS是一项回顾性、多国家观察性研究（ClinicalTrials.gov：NCT05180357），通过对患有SEA合并NP的成人患者的病历进行回顾。测量了索引前（基线）和索引后（随访）12个月期间的总NP评分（NPS）、鼻-鼻窦结局测试-22（SNOT-22）总分、年化加重率（AER）以及6项哮喘控制问卷（ACQ-6）和哮喘控制测试（ACT）评分。报告了治疗后相对于基线在总NPS（降低≥1分）、SNOT-22总分（降低≥8.9分）、ACQ-6（降低≥0.5分）或ACT（升高≥3分）评分方面具有临床意义的改善情况。
结果
共纳入233例患者。基线时NPS和SNOT-22总分的平均值（标准差[SD]）分别为3.8（2.4）和47.5（22.6）。NPS相对于基线的平均变化（95%置信区间[CI]）为-1.2（-1.7，-0.6），SNOT-22为-19.8（-23.6，-15.9）。AER（95%CI）在基线时为1.2（0.96，1.41），随访时为0.2（0.13，0.28）。ACQ-6和ACT评分的平均值（SD）在基线时分别为1.6（1.3）和15.0（5.2），随访时分别为0.8（1.0）和22.0（3.9）。在NPS、SNOT-22总分、ACQ-6和ACT评分方面实现具有临床意义改善的患者比例分别为49.1%、67.6%、56.6%和81.1%。
结论
在这项真实世界研究中，观察到在开始使用倍利珠单抗后的12个月内，SEA合并NP患者的NP及哮喘相关结局有所改善。
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