重度难治性慢性鼻-鼻窦炎伴鼻息肉患者生物制剂治疗的应答者：一项多中心观察性真实世界研究

Responders to biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: a multicentric observational real-life study.

作者信息

Mortuaire G, Bequignon E, Daveau C, Papon J-F, Lecanu J-P, Favier V, de Gabory L, Vandersteen C, Castillo L, Saroul N, Verillaud B, Carsuzaa F, Rumeau C, Jankowski R, Michel J, de Bonnecaze G, Escabasse V, Coste A, Lefevre G, Malard O

机构信息

Otorhinolaryngology, Head and neck Department - Huriez Hospital, CHU Lille, Lille, France; Univ. Lille, Inserm, CHU Lille, U1286 - INFINITE - Institute for Translational Research in Inflammation, Lille, France.

Otorhinolaryngology, Head and neck Department, Creteil, France. CNRS EMR 7000, Creteil, France. INSERM, IMRB, Univ Paris Est Creteil, Creteil, France.

出版信息

Rhinology. 2025 Feb 1;63(1):22-31. doi: 10.4193/Rhin24.284.

DOI:10.4193/Rhin24.284

PMID:39660730

Abstract

BACKGROUND

Clinical trials have demonstrated the effectiveness of biologics in treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, real-world evidence regarding patient outcomes and predictors of clinical response remains limited.

METHODOLOGY

In this multicentric 18-month follow-up study, 326 adult patients who initiated biologic therapy for severe uncontrolled CRSwNP were included. Patient characteristics, including clinical and inflammatory markers, and comorbidities were collected at baseline and at 3, 6, 12, and 18 months of follow-up. We examined success rates based on current guidelines and identified potential factors associated to clinical response at 6 months.

RESULTS

We observed a significant decrease of Sino-Nasal Outcomes Test-22 (SNOT-22) from a median score (interquartile range) of 60.5 (47-74) at baseline to 26.0 (11-41) at 3 months. A significant decrease of nasal symptoms and endoscopic nasal polyp score was observed at 3 months. After 6 months of biologic treatment, 59% of patients were classified as excellent responders according to the EUFOREA-EPOS 2023 criteria. Multivariate analysis revealed a suggestive association between baseline eosinophil blood count, type of biologic and an excellent response at 6 months.

CONCLUSIONS

This real-world study confirms the effectiveness of biologics as an add-on therapy in patients with severe uncontrolled CRSwNP. Biologics lead to rapid and sustained improvement in clinical symptoms. A significant proportion of patients exhibit an excellent response, with no need for systemic corticosteroids.

摘要

背景

临床试验已证明生物制剂在治疗伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）方面的有效性。然而，关于患者预后和临床反应预测因素的真实世界证据仍然有限。

方法

在这项为期18个月的多中心随访研究中，纳入了326例开始接受生物制剂治疗严重难治性CRSwNP的成年患者。在基线以及随访的3、6、12和18个月时收集患者特征，包括临床和炎症标志物以及合并症。我们根据当前指南检查成功率，并确定与6个月时临床反应相关的潜在因素。

结果

我们观察到鼻窦鼻结局测试-22（SNOT-22）从基线时的中位数评分（四分位间距）60.5（47-74）显著下降至3个月时的26.0（11-41）。在3个月时观察到鼻部症状和内镜下鼻息肉评分显著下降。生物制剂治疗6个月后，根据EUFOREA-EPOS 2023标准，59%的患者被归类为优秀反应者。多变量分析显示基线嗜酸性粒细胞计数、生物制剂类型与6个月时的优秀反应之间存在提示性关联。