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真实世界数据显示,度普利尤单抗在慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)患者中的治疗效果可维持 3 年以上。

Real-world data show sustained therapeutic effects of dupilumab in chronic rhinosinusitis with nasal polyps (CRSwNP) over 3 years.

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Ludwig Maximilian University of Munich, Munich, Germany.

Department of Otorhinolaryngology, Charité-Universitätsmedizin, Berlin, Germany.

出版信息

Allergy. 2024 Nov;79(11):3108-3117. doi: 10.1111/all.16263. Epub 2024 Aug 7.

Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a prevalent chronic inflammatory condition affecting the nose and paranasal sinuses, posing a significant socio-economic impact with substantial challenges in management. Biologics targeting type 2 inflammation such as dupilumab, have emerged as promising options. This study addresses a critical knowledge gap by comprehensively evaluating the 3-year impact of sustained dupilumab therapy in CRSwNP.

METHODS

A multicentric, retrospective collection of real-world data from five tertiary referral centers in Germany was conducted, enrolling 150 adult patients. The study investigated patient-reported outcomes, disease-specific indices and clinical measures, focusing on therapeutic response persistence, adverse events, and factors influencing treatment continuity.

RESULTS

Results indicate significant improvements in clinical parameters from baseline (n = 150) with sustained effectiveness after 36 months (n = 138) as indicated in mean score ± standard deviation. Dupilumab treatment significantly improved overall disease-related impairment (VAS score: 7.5 ± 2.5 to 1.6 ± 1.3) and rhinosinusitis symptoms (SNOT-22: 59.4 ± 19.4 to 18.0 ± 15.0). Nasal Polyp Scores (NPS) decreased (5.3 ± 1.8 to 0.7 ± 1.1), and olfactory function improved (3.2 ± 2.5 to 8.4 ± 2.8), with three out of four patients achieving normosmia or hyposmia after 36 months. An "Excellent" treatment response according to EUFOREA23 criteria was observed in 76.5% of patients after 36 months. Sixteen patients discontinued Dupilumab, 12 permanently. Adverse events totaled 69 in 48 patients, commonly self-limiting.

CONCLUSION

The study highlights the enduring effectiveness and lack of habituation to dupilumab after a sustained therapy of 3 years, providing valuable insights into its long-term therapeutic implications for CRSwNP patients.

摘要

背景

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)是一种常见的慢性炎症性疾病,影响鼻腔和鼻旁窦,对社会经济造成重大影响,管理方面存在巨大挑战。针对 2 型炎症的生物制剂,如度普利尤单抗,已成为有前途的选择。本研究通过全面评估持续度普利尤单抗治疗 CRSwNP 的 3 年影响,解决了一个关键的知识空白。

方法

在德国的五家三级转诊中心进行了一项多中心、回顾性的真实世界数据收集,共纳入 150 名成年患者。该研究调查了患者报告的结果、疾病特异性指数和临床指标,重点关注治疗反应的持续性、不良反应以及影响治疗连续性的因素。

结果

结果表明,从基线(n=150)开始,临床参数显著改善,36 个月后(n=138)持续有效,平均评分±标准差显示。度普利尤单抗治疗显著改善了整体与疾病相关的损伤(VAS 评分:7.5±2.5 至 1.6±1.3)和鼻窦炎症状(SNOT-22:59.4±19.4 至 18.0±15.0)。鼻息肉评分(NPS)降低(5.3±1.8 至 0.7±1.1),嗅觉功能改善(3.2±2.5 至 8.4±2.8),36 个月后四分之三的患者达到正常或低嗅觉。根据 EUFOREA23 标准,16 名患者因不良反应永久停药,12 名患者因其他原因停药,69 例患者(48 名)共发生 69 例不良反应,多为自限性。16 名患者(10.7%)因疗效欠佳而停药。

结论

该研究强调了在持续治疗 3 年后,度普利尤单抗的持久疗效和无习惯性,为 CRSwNP 患者的长期治疗提供了有价值的见解。

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