度普利尤单抗减量治疗两年的数据显示，其对伴有非甾体抗炎药加重的呼吸系统疾病的慢性鼻-鼻窦炎伴鼻息肉具有高效性。

Two-Year Data of Tapered Dupilumab Shows High Effectiveness in Chronic Rhinosinusitis with Nasal Polyps With Nonsteroidal Anti-inflammatory Drug-Exacerbated Respiratory Disease.

作者信息

Elzinga H B E, Otten J J, Cornet M E, Rinia A B, Van Der Lans R J L, Fokkens W J, Reitsma S

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Department of Otorhinolaryngology, Alrijne Hospital, Leiden, the Netherlands.

出版信息

Allergy. 2025 Jun;80(6):1737-1745. doi: 10.1111/all.16579. Epub 2025 May 16.

DOI:10.1111/all.16579

PMID:40377347

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12186595/

Abstract

BACKGROUND

Patients with Non-steroidal anti-inflammatory drugs (NSAID)-Exacerbated Respiratory Disease (N-ERD) can suffer from difficult-to-treat primary diffuse type 2 chronic rhinosinusitis with nasal polyps (CRSwNP). This study evaluates dupilumab effectiveness and dose tapering in CRSwNP patients with N-ERD compared to those without.

METHODS

A real-world prospective cohort with CRSwNP patients, with N-ERD or without (CRSwNP-NOS; not otherwise specified), aged ≥ 18 treated with dupilumab 300 mg subcutaneously every 2 weeks. In case of clinical control, the interdose interval was prolonged every 6 months with steps of 2 weeks. (Clinical) data were collected at baseline, 24 weeks, and 2 years of treatment.

RESULTS

Most baseline characteristics, including Nasal Polyp Score (NPS), Sino-Nasal Outcome Test-22 (SNOT-22), and Sniffin' sticks-12 test (SSIT-12) were comparable between groups (N-ERD n = 105, CRSwNP-NOS n = 293). There was a higher prevalence (91.5% vs. 71.1%, p < 0.001) but comparable control of asthma in N-ERD patients (asthma control test [ACT]: N-ERD 66.7% less controlled/uncontrolled vs. CRSwNP-NOS 58.3%, p = 0.21). All outcomes improved significantly with dupilumab treatment at 24 weeks and remained improved after 2 years, without intergroup differences (median scores at 24 weeks for N-ERD patients vs. CRSwNP-NOS, respectively: NPS: 2 vs. 1, p = 0.65; SNOT-22: 18 vs. 19, p = 0.27; SSIT-12: 7 vs. 8, p = 0.02; ACT: 21 vs. 22, p = 0.11). Dose tapering was possible in the majority of patients, with almost half at an 8-12 weeks interval in both groups after 2 years.

CONCLUSION

Dupilumab shows comparable effectiveness and taper feasibility between CRSwNP N-ERD patients and CRSwNP-NOS patients.

摘要

背景

非甾体抗炎药（NSAID）加重的呼吸道疾病（N-ERD）患者可能患有难以治疗的原发性弥漫性2型慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）。本研究评估了度普利尤单抗在N-ERD的CRSwNP患者与非N-ERD的CRSwNP患者中的有效性及剂量递减情况。

方法

一项针对CRSwNP患者的真实世界前瞻性队列研究，患者年龄≥18岁，患有或未患有N-ERD（CRSwNP-NOS；未另作说明），每2周皮下注射300mg度普利尤单抗进行治疗。若达到临床控制，每6个月以2周为步长延长给药间隔。在基线、治疗24周和2年时收集（临床）数据。

结果

两组（N-ERD组n = 105，CRSwNP-NOS组n = 293）之间的大多数基线特征具有可比性，包括鼻息肉评分（NPS）、鼻窦结局测试-22（SNOT-22）和嗅觉棒12项测试（SSIT-12）。N-ERD患者哮喘患病率更高（91.5%对71.1%，p < 0.001），但哮喘控制情况相当（哮喘控制测试[ACT]：N-ERD组66.7%控制不佳/未控制，CRSwNP-NOS组58.3%，p = 0.21）。度普利尤单抗治疗24周时所有结局均显著改善，2年后仍保持改善，且组间无差异（N-ERD患者与CRSwNP-NOS患者在24周时的中位数评分分别为：NPS：2对1，p = 0.65；SNOT-22：18对19，p = 0.27；SSIT-12：7对8，p = 0.02；ACT：21对22，p = 0.11）。大多数患者可以进行剂量递减，2年后两组中几乎一半患者的给药间隔为8 - 12周。