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度普利尤单抗对慢性鼻-鼻窦炎伴鼻息肉患者嗅觉、鼻息肉评分及生活质量的一年疗效:巴西一项真实世界多中心研究

One-year efficacy of Dupilumab in sense of smell, nasal polyp score and quality of life in CRSwNP patients: A real-world multicenter study in Brazil.

作者信息

Mieli Otávio Marana, Valera Fabiana Cardoso Pereira, Dinarte Vanessa Ramos Pires, de Lima Clara Mônica Figueiredo, Nakanishi Marcio, Zanetti Maria Eduarda Trocoli, Pires Felipe Oliveira, Garcia Denny Marcos, Murashima Adriana de Andrade Batista, Arruda Luisa Karla de Paula, Romano Fabrizio Ricci, Lemos José Eduardo Seneda, Kosugi Eduardo Macoto, Sakano Eulalia, Tepedino Miguel Soares, Tamashiro Edwin, Anselmo-Lima Wilma Terezinha

机构信息

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, São Paulo, SP, Brazil.

Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, São Paulo, SP, Brazil.

出版信息

Braz J Otorhinolaryngol. 2025 Sep 6;91(6):101704. doi: 10.1016/j.bjorl.2025.101704.

Abstract

INTRODUCTION

Chronic rhinosinusitis with nasal polyp (CRSwNP) is a predominant type 2 inflammatory disease, affecting the sense of smell and quality of life. Loss of smell compromises physical and emotional health, creating negative impacts and its treatment in CRSwNP is challenging.

AIM

To present the outcomes of dupilumab in olfactory function, Nasal Polyp Score (NPS) and quality of life in Brazilian patients with severe CRSwNP.

MATERIAL & METHODS: We selected severe type 2 CRSwNP patients from different Brazilian centers. Dupilumab was indicated after failure of optimized medical and surgical treatment. Patients were evaluated with endoscopic Nasal Polyps Score (NPS), Connecticut smell test (CCCRC) and quality of life questionnaire (SNOT-22), at baseline (T0) and at one year (T1) after dupilumab was initiated. The clinical response was classified as good or non-responsive, according to the degree of improvement at T1. Regarding disease control, patients were classified as controlled, partially controlled or uncontrolled.

RESULTS

53 patients completed one year of treatment (19-76 years-old); 51 individuals (96.2%) had asthma and 33 had Aspirin-Exacerbated Respiratory Disease (AERD) (62.3%). Dupilumab decreased mean SNOT-22 scores from 61.9 to 16.7 points (paired t-test, t = 13.4, p < 0.0001). The median CCCRC scores improved from anosmia (0-points) to mild hyposmia (5.5-points) (Wilcoxon signed rank test, p < 0.0001). Regarding NPS, we observed a decrease from a median of 6 in T0 to 1 at T1. AERD patients showed similar responses to those with only asthma as comorbid disease. Overall, most of the patients (86.8%) showed improvement in the disease control (Bowker's Test, p < 0.0001).

CONCLUSIONS

Real-world data show that dupilumab improved NPS, smell function, and SNOT-22 scores in the Brazilian CRSwNP population. These results support the benefits of dupilumab in treating severe cases of CRSwNP.

LEVEL OF EVIDENCE

Level 3.

摘要

引言

伴鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种主要的2型炎症性疾病,会影响嗅觉和生活质量。嗅觉丧失会损害身心健康,产生负面影响,且其在CRSwNP中的治疗具有挑战性。

目的

介绍度普利尤单抗对巴西重度CRSwNP患者嗅觉功能、鼻息肉评分(NPS)和生活质量的治疗效果。

材料与方法

我们从巴西不同中心选取了重度2型CRSwNP患者。在优化的药物和手术治疗失败后使用度普利尤单抗。在基线期(T0)和开始使用度普利尤单抗一年后(T1),使用内镜鼻息肉评分(NPS)、康涅狄格嗅觉测试(CCCRC)和生活质量问卷(SNOT-22)对患者进行评估。根据T1期的改善程度,将临床反应分为良好或无反应。在疾病控制方面,将患者分为控制、部分控制或未控制。

结果

53例患者完成了一年的治疗(年龄19 - 76岁);51例患者(96.2%)患有哮喘,33例患有阿司匹林加重的呼吸系统疾病(AERD)(62.3%)。度普利尤单抗使SNOT-22平均评分从61.9分降至16.7分(配对t检验,t = 13.4,p < 0.0001)。CCCRC评分中位数从嗅觉丧失(0分)改善至轻度嗅觉减退(5.5分)(Wilcoxon符号秩检验,p < 0.0001)。关于NPS,我们观察到中位数从T0期的6降至T1期的1。AERD患者与仅合并哮喘的患者表现出相似的反应。总体而言,大多数患者(86.8%)的疾病控制情况有所改善(Bowker检验,p < 0.0001)。

结论

真实世界数据表明,度普利尤单抗改善了巴西CRSwNP患者的NPS、嗅觉功能和SNOT-22评分。这些结果支持度普利尤单抗治疗重度CRSwNP病例的益处。

证据水平

3级。

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