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在重度嗜酸性粒细胞性哮喘和鼻息肉患者中,使用 benralizumab 治疗 2 年可诱导持续缓解。

Sustained remission induced by 2 years of treatment with benralizumab in patients with severe eosinophilic asthma and nasal polyposis.

机构信息

Department of Medical and Surgical Sciences, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.

Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.

出版信息

Respirology. 2024 Oct;29(10):869-879. doi: 10.1111/resp.14767. Epub 2024 Jun 7.

Abstract

BACKGROUND AND OBJECTIVE

Several randomized controlled trials (RCTs) have shown that benralizumab is characterized by a good profile of efficacy and safety, thereby being potentially able to elicit clinical remission on-treatment of severe eosinophilic asthma (SEA). The main goal of this multicentre observational study was to verify the effectiveness of benralizumab in inducing a sustained remission on-treatment of SEA in patients with or without comorbid chronic rhinosinusitis with nasal polyps (CRSwNP).

METHODS

Throughout 2 years of treatment with benralizumab, a four-component evaluation of sustained remission of SEA was performed, including the assessment of SEA exacerbations, use of oral corticosteroids (OCSs), symptom control and lung function.

RESULTS

The present study recruited 164 patients suffering from SEA. After 24 months of add-on biological therapy with benralizumab, 69 (42.1%) achieved the important target of sustained remission on-treatment (exacerbation rate = 0, OCS dose = 0, pre-bronchodilator FEV ≥80% pred., ACT score ≥ 20). During the same period, a persistent improvement of CRSwNP (SNOT-22 < 30, NP recurrence = 0) was observed in 33 (40.2%) out of 82 subjects with concomitant NP. The latter comorbidity and post-bronchodilator reversibility of airflow limitation were two independent predictors of sustained remission on-treatment (OR = 2.32, p < 0.05 and OR = 5.59, p < 0.01, respectively).

CONCLUSION

Taken together, the results of this real-life clinical investigation indicate that benralizumab can induce a sustained remission on-treatment of SEA, especially in those patients with comorbid CRSwNP and reversible airflow limitation.

摘要

背景和目的

几项随机对照试验(RCTs)表明,贝那鲁肽具有良好的疗效和安全性,因此有可能在重度嗜酸性粒细胞性哮喘(SEA)的治疗中引发临床缓解。本多中心观察性研究的主要目标是验证贝那鲁肽在伴有或不伴有鼻息肉(CRSwNP)的慢性鼻-鼻窦炎(CRSwNP)合并症的 SEA 患者中诱导持续缓解治疗的有效性。

方法

在贝那鲁肽治疗的 2 年内,对 SEA 的持续缓解进行了四部分评估,包括评估 SEA 加重、口服皮质类固醇(OCS)的使用、症状控制和肺功能。

结果

本研究共招募了 164 名 SEA 患者。在贝那鲁肽的附加生物治疗 24 个月后,69 名(42.1%)达到了治疗中持续缓解的重要目标(加重率=0,OCS 剂量=0,支气管扩张剂前 FEV1≥80%预计值,ACT 评分≥20)。在此期间,在 82 名伴有 NP 的患者中,有 33 名(40.2%)持续改善 CRSwNP(SNOT-22<30,NP 复发=0)。后者合并症和支气管扩张剂后气流受限的可逆性是治疗中持续缓解的两个独立预测因素(OR=2.32,p<0.05 和 OR=5.59,p<0.01)。

结论

综上所述,这项真实临床研究的结果表明,贝那鲁肽可以诱导 SEA 的持续缓解治疗,特别是在伴有 CRSwNP 和可逆转气流受限的患者中。

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