美泊利单抗对伴或不伴慢性鼻-鼻窦炎伴鼻息肉的重症哮喘患者的疗效：真实世界汇总分析
2025/08/01
摘要
背景：重症嗜酸性粒细胞表型哮喘（SAEP）和慢性鼻-窦炎伴鼻息肉（CRSwNP）是以2型炎症为主的疾病，以嗜酸性粒细胞炎症和显著的疾病负担为特征。美泊利单抗（Mepolizumab）是一种靶向白细胞介素-5（IL-5，2型炎症的关键细胞因子）的人源化单克隆抗体，已被批准用于SAEP和CRSwNP的有效治疗。
目的：本研究旨在分析美泊利单抗对合并SAEP和CRSwNP患者的真实世界疗效证据。
方法：本研究汇总了5项现有的以欧洲为主的队列数据，以评估美泊利单抗对无合并CRSwNP的SAEP（SAEP[-]CRSwNP）和合并CRSwNP的SAEP（SAEP[+]CRSwNP）患者的临床显著急性加重（CSEs）发生率及其他结局的影响。
结果：共纳入1037例患者，两组基线特征相似。美泊利单抗治疗12个月后，无论基线血嗜酸性粒细胞计数（BEC）如何，两组患者的年CSEs发生率均显著降低（SAEP[-]CRSwNP：72.7%；SAEP[+]CRSwNP：79.7%）。与SAEP[-]CRSwNP患者相比，SAEP[+]CRSwNP患者CSEs减少的额外获益达30.0%。治疗12个月后，两组患者的口服糖皮质激素使用量、BEC均下降，肺功能和哮喘控制测试（ACT）评分改善；分别有47.2%和52.3%的患者达到≥3项临床缓解标准。
结论：本研究进一步明确了美泊利单抗的有效性，结果显示无论基线BEC水平或是否合并CRSwNP，患者的哮喘结局均显著改善。合并CRSwNP的SAEP患者可能从美泊利单抗治疗中获益更显著。
Mepolizumab Effectiveness in Severe Asthma With/Without Chronic Rhinosinusitis With Nasal Polyps: Real-World Pooled Analysis
F. Schleich, S. Loukides, R. Chaudhuri, J. D. Leuppi, E. Heffler, C. Domingo, et al.
Abstract
BACKGROUND:
Severe asthma with an eosinophilic phenotype (SAEP) and chronic rhinosinusitis with nasal polyps (CRSwNP) are predominantly type 2-driven diseases, characterised by eosinophilic inflammation and substantial disease burden. Mepolizumab, a humanised monoclonal antibody that targets interleukin-5, a key cytokine in type 2 inflammation, is an effective, approved treatment both in SAEP and CRSwNP.
OBJECTIVE:
We aimed to analyse real-world evidence of mepolizumab effectiveness in patients with comorbid SAEP and CRSwNP.
METHODS:
This study pooled five existing, predominantly European cohorts to describe the impact of mepolizumab on the rate of clinically significant exacerbations (CSEs) and other outcomes in adults with SAEP without and with comorbid CRSwNP (SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively).
RESULTS:
Overall, 1037 patients were included. Baseline characteristics were similar in both cohorts. Mepolizumab was associated with a reduction from baseline in the annual rate of CSEs at 12-months post-initiation (SAEP[-]CRSwNP: 72.7%; SAEP[+]CRSwNP: 79.7%), irrespective of baseline blood eosinophil count (BEC). When patients with SAEP[+]CRSwNP were compared with patients with SAEP[-]CRSwNP, a 30.0% incremental benefit in the reduction of CSEs was observed. At 12-months post-initiation, mepolizumab was also associated with a reduction in oral corticosteroid use and BEC, and an improvement in lung function and Asthma Control Test (ACT) scores in both cohorts. Post-mepolizumab initiation, >= 3 clinical remission criteria were fulfilled by 47.2% and 52.3% of patients with SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively.
CONCLUSION:
The results provide a greater understanding of mepolizumab's effectiveness, demonstrating a substantial improvement in asthma outcomes, irrespective of baseline BEC and the presence of comorbid CRSwNP.
背景：重症嗜酸性粒细胞表型哮喘（SAEP）和慢性鼻-窦炎伴鼻息肉（CRSwNP）是以2型炎症为主的疾病，以嗜酸性粒细胞炎症和显著的疾病负担为特征。美泊利单抗（Mepolizumab）是一种靶向白细胞介素-5（IL-5，2型炎症的关键细胞因子）的人源化单克隆抗体，已被批准用于SAEP和CRSwNP的有效治疗。
目的：本研究旨在分析美泊利单抗对合并SAEP和CRSwNP患者的真实世界疗效证据。
方法：本研究汇总了5项现有的以欧洲为主的队列数据，以评估美泊利单抗对无合并CRSwNP的SAEP（SAEP[-]CRSwNP）和合并CRSwNP的SAEP（SAEP[+]CRSwNP）患者的临床显著急性加重（CSEs）发生率及其他结局的影响。
结果：共纳入1037例患者，两组基线特征相似。美泊利单抗治疗12个月后，无论基线血嗜酸性粒细胞计数（BEC）如何，两组患者的年CSEs发生率均显著降低（SAEP[-]CRSwNP：72.7%；SAEP[+]CRSwNP：79.7%）。与SAEP[-]CRSwNP患者相比，SAEP[+]CRSwNP患者CSEs减少的额外获益达30.0%。治疗12个月后，两组患者的口服糖皮质激素使用量、BEC均下降，肺功能和哮喘控制测试（ACT）评分改善；分别有47.2%和52.3%的患者达到≥3项临床缓解标准。
结论：本研究进一步明确了美泊利单抗的有效性，结果显示无论基线BEC水平或是否合并CRSwNP，患者的哮喘结局均显著改善。合并CRSwNP的SAEP患者可能从美泊利单抗治疗中获益更显著。
（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）
（Allergy 2025 DOI: 10.1111/all.16618）
Mepolizumab Effectiveness in Severe Asthma With/Without Chronic Rhinosinusitis With Nasal Polyps: Real-World Pooled Analysis
F. Schleich, S. Loukides, R. Chaudhuri, J. D. Leuppi, E. Heffler, C. Domingo, et al.
Abstract
BACKGROUND:
Severe asthma with an eosinophilic phenotype (SAEP) and chronic rhinosinusitis with nasal polyps (CRSwNP) are predominantly type 2-driven diseases, characterised by eosinophilic inflammation and substantial disease burden. Mepolizumab, a humanised monoclonal antibody that targets interleukin-5, a key cytokine in type 2 inflammation, is an effective, approved treatment both in SAEP and CRSwNP.
OBJECTIVE:
We aimed to analyse real-world evidence of mepolizumab effectiveness in patients with comorbid SAEP and CRSwNP.
METHODS:
This study pooled five existing, predominantly European cohorts to describe the impact of mepolizumab on the rate of clinically significant exacerbations (CSEs) and other outcomes in adults with SAEP without and with comorbid CRSwNP (SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively).
RESULTS:
Overall, 1037 patients were included. Baseline characteristics were similar in both cohorts. Mepolizumab was associated with a reduction from baseline in the annual rate of CSEs at 12-months post-initiation (SAEP[-]CRSwNP: 72.7%; SAEP[+]CRSwNP: 79.7%), irrespective of baseline blood eosinophil count (BEC). When patients with SAEP[+]CRSwNP were compared with patients with SAEP[-]CRSwNP, a 30.0% incremental benefit in the reduction of CSEs was observed. At 12-months post-initiation, mepolizumab was also associated with a reduction in oral corticosteroid use and BEC, and an improvement in lung function and Asthma Control Test (ACT) scores in both cohorts. Post-mepolizumab initiation, >= 3 clinical remission criteria were fulfilled by 47.2% and 52.3% of patients with SAEP[-]CRSwNP and SAEP[+]CRSwNP, respectively.
CONCLUSION:
The results provide a greater understanding of mepolizumab's effectiveness, demonstrating a substantial improvement in asthma outcomes, irrespective of baseline BEC and the presence of comorbid CRSwNP.
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