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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.

DOI:10.1177/19160216241278659
PMID:39345032
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11450752/
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/11450752/31c64315c071/10.1177_19160216241278659-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/a08db27f873c/10.1177_19160216241278659-img2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/889f2c0a0996/10.1177_19160216241278659-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/31c64315c071/10.1177_19160216241278659-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/a08db27f873c/10.1177_19160216241278659-img2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/889f2c0a0996/10.1177_19160216241278659-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15ae/11450752/31c64315c071/10.1177_19160216241278659-fig2.jpg

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本文引用的文献

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Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.度普利尤单抗治疗中重度哮喘患者的长期安全性:TRAVERSE 延续研究。
J Allergy Clin Immunol Pract. 2024 Apr;12(4):991-997.e6. doi: 10.1016/j.jaip.2023.12.043. Epub 2023 Dec 30.
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Real-world evidence for the effectiveness and safety of dupilumab in patients with CRSwNP after 1 year of therapy.度普利尤单抗治疗1年后对慢性鼻-鼻窦炎伴鼻息肉患者有效性和安全性的真实世界证据。
World Allergy Organ J. 2023 May 18;16(5):100780. doi: 10.1016/j.waojou.2023.100780. eCollection 2023 May.
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Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL).
度普利尤单抗治疗伴有鼻息肉的重度难治性慢性鼻-鼻窦炎(CRSwNP):一项多中心观察性 IV 期真实世界研究(DUPIREAL)。
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Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial.SINUS-24试验中重度慢性鼻-鼻窦炎伴鼻息肉患者的健康相关生活质量损害
J Asthma Allergy. 2023 Mar 29;16:323-332. doi: 10.2147/JAA.S372598. eCollection 2023.
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Clinical outcomes of dupilumab therapy in chronic rhinosinusitis with nasal polyps in a Canadian tertiary care rhinology practice.在加拿大一家三级医疗鼻科学诊所中,度普利尤单抗治疗慢性鼻-鼻窦炎伴鼻息肉的临床疗效。
Allergy Asthma Clin Immunol. 2023 Mar 30;19(1):26. doi: 10.1186/s13223-023-00782-7.
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