Tezepelumab在阿司匹林加重性呼吸系统疾病中的有效性：一项真实世界多中心研究。
Tezepelumab effectiveness in Aspirin-Exacerbated Respiratory Disease: a real-world multicenter study.
文献信息
| PMID | 42778034 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | D Betancor |
| 作者单位 | Allergy Department, La Paz University Hospital, Madrid, Spain; Institute for Health Research, IdiPAZ, Madrid, Spain. |
| 期刊 | Respiratory medicine |
| SCI 分区 | Q2 |
| IF | 3.6 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景： 阿司匹林加重性呼吸系统疾病（AERD）是一种严重的哮喘表型，以伴鼻息肉的慢性鼻窦炎和对非甾体抗炎药的高敏性为特征，并与高疾病负担相关。关于tezepelumab在AERD中有效性的真实世界证据仍然有限。
目的： 评估tezepelumab在常规临床实践中对重度哮喘和AERD患者的有效性，并与无AERD患者的结果进行比较。
方法： 这项多中心回顾性真实世界研究纳入了接受tezepelumab 210 mg每4周一次治疗12个月的重度未控制哮喘患者。在基线、6个月和12个月时评估临床、功能和炎症参数。结局包括重度急性发作、急诊就诊、口服糖皮质激素（OCS）暴露、哮喘控制、肺功能和临床缓解。使用Firth惩罚逻辑回归进行敏感性分析，以考虑稀疏数据偏倚。
结果： 在157例患者中，23例（14.6%）患有AERD。12个月后，tezepelumab与AERD患者重度急性发作减少70%、急诊就诊减少76%和累积OCS暴露减少55%相关。与无AERD患者相比，AERD患者的重度急性发作率更低（发生率比[IRR] 0.74，95%置信区间[CI] 0.57-0.97；p=0.028），OCS暴露减少幅度更大（IRR 0.74，95% CI 0.71-0.77；p<0.001）。哮喘控制显著改善，而肺功能变化 modest 且未达到统计学显著性。敏感性分析得出了一致但不精确的估计值，置信区间较宽。
结论： Tezepelumab与重度哮喘和AERD患者的临床意义改善相关。尽管AERD患者显示出比无AERD患者更大的临床获益趋势，但敏感性分析无法就差异性治疗效应得出明确结论。这些发现支持进一步的前瞻性研究，以阐明AERD是否标识出对上游TSLP阻断反应增强的表型。
英文摘要
BACKGROUND: Aspirin-exacerbated respiratory disease (AERD) is a severe asthma phenotype characterized by chronic rhinosinusitis with nasal polyps and hypersensitivity to non-steroidal anti-inflammatory drugs, and is associated with a high disease burden. Real-world evidence on the effectiveness of tezepelumab in AERD remains limited.
OBJECTIVE: To evaluate the effectiveness of tezepelumab in patients with severe asthma and AERD in routine clinical practice and to compare outcomes with those of patients without AERD.
METHODS: This multicenter retrospective real-world study included patients with severe uncontrolled asthma treated with tezepelumab 210 mg every 4 weeks for 12 months. Clinical, functional, and inflammatory parameters were assessed at baseline, 6 months, and 12 months. Outcomes included severe exacerbations, emergency department visits, oral corticosteroid (OCS) exposure, asthma control, lung function, and clinical remission. Sensitivity analyses using Firth penalized logistic regression were performed to account for sparse-data bias.
RESULTS: Among 157 patients, 23 (14.6%) had AERD. After 12 months, tezepelumab was associated with a 70% reduction in severe exacerbations, a 76% reduction in emergency department visits, and a 55% reduction in cumulative OCS exposure in patients with AERD. Compared with patients without AERD, those with AERD had lower severe exacerbation rates (incidence rate ratio [IRR] 0.74, 95% confidence interval [CI] 0.57-0.97; p=0.028) and greater reductions in OCS exposure (IRR 0.74, 95% CI 0.71-0.77; p<0.001). Asthma control improved significantly, whereas lung function changes were modest and did not reach statistical significance. Sensitivity analyses yielded consistent but imprecise estimates with wide confidence intervals.
CONCLUSIONS: Tezepelumab was associated with clinically meaningful improvements in patients with severe asthma and AERD. Although patients with AERD showed a trend toward greater clinical benefit than those without AERD, the sensitivity analyses precluded definitive conclusions regarding a differential treatment effect. These findings support further prospective studies to clarify whether AERD identifies a phenotype with enhanced responsiveness to upstream TSLP blockade.