超越嗜酸性粒细胞清除：贝那利珠单抗在重度嗜酸性哮喘合并CRSwNP患者中的长期临床轨迹与应答持久性：一项为期18个月的真实世界研究（BANDOR研究）
Beyond eosinophil depletion: long-term clinical trajectory and durability of response to benralizumab in patients with severe eosinophilic asthma and CRSwNP: an 18-month real-world study (the BANDOR study).
文献信息
| PMID | 42973484 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Emanuele Bizzi |
| 作者单位 | Internal Medicine, Vita-Salute San Raffaele University, Milan, Italy. |
| 期刊 | Frontiers in immunology |
| SCI 分区 | Q1 |
| IF | 7.4 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景： 重度嗜酸性哮喘合并慢性鼻窦炎伴鼻息肉患者的管理需要能够诱导稳定缓解的治疗。虽然贝那利珠单抗是重度哮喘的既定治疗，但鼻息肉病的随机对照试验未能达到主要临床终点或显示不一致的结果。因此，缺乏关于其在临床实践中表现的证据。本研究的主要目的是在真实世界环境中评估重度嗜酸性哮喘合并慢性鼻窦炎伴鼻息肉患者不同症状领域应答的动力学，并确定临床改善的预测因素。
方法： 这项回顾性观察研究分析了一个具有联合气道疾病表型的患者队列，这些患者连续接受贝那利珠单抗治疗18个月。我们绘制了特定SNOT-22子领域和肺功能的纵向轨迹。根据临床改善的时间将患者分为早期和晚期应答者，以确定快速与逐渐应答的基线预测因素。
结果： 分析显示SNOT-22子领域表现出不同的恢复模式。尽管先前临床试验报告的成功有限，鼻部和躯体症状在治疗最初几个月内显示出显著改善。相比之下，功能和情感领域需要更长的治疗时间才能达到稳定平台。与晚期应答者相比，早期应答者的特征是具有显著更高的基线嗜酸性粒细胞计数（中位数885 vs 530个细胞/微升）和基线时更严重的支气管阻塞。FEV1的功能稳定性和口服糖皮质激素使用的减少在整个观察期间得以维持。
结论： BANDOR研究表明，贝那利珠单抗可以在维持治疗依从性的特定患者亚群中诱导持久的临床缓解。应答速度具有领域特异性，躯体症状先于情感和功能症状改善。高初始嗜酸性粒细胞负荷是快速应答的主要决定因素。这些发现表明，虽然随机试验显示疗效有限，但真实世界数据识别出一种高疾病负担表型，该表型从受体靶向嗜酸性粒细胞清除中获得显著的长期获益。
英文摘要
BACKGROUND: The management of patients with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps requires therapies capable of inducing stable remission. While benralizumab is an established treatment for severe asthma, randomized controlled trials in nasal polyposis have failed to reach primary clinical endpoints or showed inconsistent results. Consequently, there is a lack of evidence regarding its performance in clinical practice. The primary objective of this study was to evaluate the kinetics of response across different symptom domains and to identify predictors of clinical improvement in a Real-World setting in patients affected by severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps.
METHODS: This retrospective observational study analyzed a cohort of patients with a United Airways Disease phenotype treated with benralizumab for a continuous period of 18 months. We mapped the longitudinal trajectory of specific SNOT 22 subdomains and lung function. Patients were stratified into early and late responders based on the timing of clinical improvement to identify baseline predictors of rapid versus gradual response.
RESULTS: Analysis revealed that SNOT 22 subdomains exhibit distinct recovery patterns. Nasal and physical symptoms showed a significant improvement within the first months of therapy despite the limited success reported in previous clinical trials. In contrast, functional and emotional domains required a longer period of treatment to reach a stable plateau. Early responders were characterized by a significantly higher baseline eosinophil count (median 885 vs 530 cells per microliter) and greater bronchial obstruction at baseline compared to late responders. Functional stability in FEV1 and a reduction in oral corticosteroid use were maintained throughout the observation.
CONCLUSIONS: The BANDOR study demonstrates that benralizumab can induce durable clinical remission in a specific subset of patients who maintain treatment adherence. The speed of response is domain specific, with physical symptoms improving before emotional and functional ones. A high initial eosinophilic burden is the primary determinant of a rapid response. These findings suggest that while randomized trials showed limited efficacy, Real-World data identifies a high disease burden phenotype that derives significant long term benefit from receptor targeted eosinophil depletion.