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

IF 4.8 2区医学 Q1 OTORHINOLARYNGOLOGY Rhinology Pub Date : 2025-02-01 DOI:10.4193/Rhin24.284

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

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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.

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严重不受控制的慢性鼻窦炎伴鼻息肉患者对生物制剂的反应：一项多中心观察性现实研究。

背景：临床试验已经证明了生物制剂治疗慢性鼻窦炎伴鼻息肉（CRSwNP）的有效性。然而，关于患者结局和临床反应预测因素的真实证据仍然有限。方法：在这项为期18个月的多中心随访研究中，纳入了326名因严重不受控制的CRSwNP而开始生物治疗的成年患者。在基线和随访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。我们根据现行指南检查了成功率，并确定了6个月时与临床反应相关的潜在因素。结果：我们观察到鼻腔结局测试-22 （SNOT-22）的中位评分（四分位数范围）从基线时的60.5分（47-74分）显著下降到3个月时的26.0分（11-41分）。3个月时观察到鼻症状和鼻息肉内窥镜评分显著降低。经过6个月的生物治疗，根据EUFOREA-EPOS 2023标准，59%的患者被分类为优秀应答者。多变量分析显示，基线嗜酸性粒细胞计数、生物制剂类型和6个月时的良好反应之间存在暗示关联。结论：这项现实世界的研究证实了生物制剂作为严重不受控制的CRSwNP患者的附加治疗的有效性。生物制剂可迅速和持续地改善临床症状。相当比例的患者表现出良好的反应，不需要全身皮质类固醇。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Rhinology 医学-耳鼻喉科学

CiteScore

15.80

自引率

9.70%

发文量

135

审稿时长

6-12 weeks

期刊介绍： Rhinology serves as the official Journal of the International Rhinologic Society and is recognized as one of the journals of the European Rhinologic Society. It offers a prominent platform for disseminating rhinologic research, reviews, position papers, task force reports, and guidelines to an international scientific audience. The journal also boasts the prestigious European Position Paper in Rhinosinusitis (EPOS), a highly influential publication first released in 2005 and subsequently updated in 2007, 2012, and most recently in 2020. Employing a double-blind peer review system, Rhinology welcomes original articles, review articles, and letters to the editor.