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加拿大真实世界研究:使用度普利尤单抗治疗伴有鼻息肉的慢性鼻-鼻窦炎的长期临床结果。

Canadian Real-World Study Long-Term Clinical Results Using Dupilumab for Chronic Rhinosinusitis With Polyps.

机构信息

Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, ON, Canada.

Ottawa Hospital Research Institute, Ottawa, ON, Canada.

出版信息

J Otolaryngol Head Neck Surg. 2024 Jan-Dec;53:19160216241278659. doi: 10.1177/19160216241278659.

Abstract

BACKGROUND

Dupilumab, an anti-IL4 receptor-α monoclonal antibody, was the first biologic to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). In phase III clinical trials, it has demonstrated to be effective in reducing nasal polyp size and the severity of symptoms, improve disease-specific quality of life, and to have an acceptable safety profile. This study aims to present long-term follow-up data on disease-specific sinonasal outcomes of patients with CRSwNP who have been treated with dupilumab for up to 3 years in a real-world setting.

METHODS

Retrospective review of electronic medical records of a single Canadian rhinology center evaluating disease-specific sinonasal outcomes that are routinely collected for clinical care. This study included all patients who received dupilumab for the treatment of CRSwNP and who had completed at least one follow-up visit. The Sino-Nasal Outcome Test (SNOT)-22 was used to evaluate treatment symptom improvement.

RESULTS

Ninety-nine patients started dupilumab therapy during the study period. The mean SNOT-22 at the start of therapy was 61.1 (±22.91) At the time of the review, 65 patients had completed 1 year of therapy, 40 had completed 2 years of therapy, and 18 had completed 3 years of therapy. The mean SNOT-22 score at these timepoints was 16.75 (±13.86), 15.02 (±14.40), and 10.22 (±11.56), respectively.

CONCLUSION

This real-world study shows that in patients with CRSwNP treated with dupilumab, improvement in disease-specific quality of life seen after 1 year continues and can be maintained at 3 years of treatment.

摘要

背景

度普利尤单抗是一种抗白细胞介素 4 受体-α单克隆抗体,是加拿大首个获批用于治疗慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)的生物制剂。在 III 期临床试验中,它已被证明能有效缩小鼻息肉的大小和减轻症状的严重程度,改善疾病特异性生活质量,且具有可接受的安全性。本研究旨在报告在真实世界环境中,接受度普利尤单抗治疗长达 3 年的 CRSwNP 患者的疾病特异性鼻-鼻窦结局的长期随访数据。

方法

回顾性分析加拿大单一鼻科中心的电子病历,评估常规收集的用于临床护理的疾病特异性鼻-鼻窦结局。本研究纳入了所有接受度普利尤单抗治疗 CRSwNP 且至少完成一次随访的患者。使用鼻-鼻窦炎结局测试 22 项(SNOT-22)评估治疗症状改善情况。

结果

在研究期间,99 例患者开始接受度普利尤单抗治疗。治疗开始时的平均 SNOT-22 为 61.1(±22.91)。在本回顾时,65 例患者完成了 1 年的治疗,40 例完成了 2 年的治疗,18 例完成了 3 年的治疗。这些时间点的平均 SNOT-22 评分分别为 16.75(±13.86)、15.02(±14.40)和 10.22(±11.56)。

结论

本真实世界研究表明,在接受度普利尤单抗治疗的 CRSwNP 患者中,1 年后观察到的疾病特异性生活质量改善持续存在,并可在 3 年的治疗中维持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/a08db27f873c/10.1177_19160216241278659-img2.jpg

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