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Real-world effectiveness of dupilumab in a European cohort of CRSwNP (CHRINOSOR).
Journal of Allergy and Clinical Immunology ( IF 11.4 ) Pub Date : 2024-10-30 , DOI: 10.1016/j.jaci.2024.10.016
Sven F Seys,Sven Schneider,Joost de Kinderen,Sietze Reitsma,Carlo Cavaliere,Peter-Valentin Tomazic,Christina Morgenstern,Geoffrey Mortuaire,Martin Wagenmann,Giulia Bettio,Andrea Ciofalo,Zuzana Diamant,Julia Eckl-Dorna,Wytske J Fokkens,Clemens Holzmeister,Gert Mariën,Simonetta Masieri,Josje Otten,Kathrin Scheckenbach,Aldine Tu,Claus Bachert,

BACKGROUND Pivotal studies with dupilumab demonstrated clinically relevant improvements in nasal polyp score (NPS), symptom and quality of life scores in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). OBJECTIVE We evaluated the effectiveness of dupilumab in a large-scale CRSwNP cohort from 6 European tertiary care centres. METHODOLOGY NPS, SinoNasal Outcome Test (SNOT)-22 score, visual analogue scale (VAS) for total sinus symptoms, loss of smell (LoS) and nasal blockage (NB), and Asthma Control Test (ACT) score were collected from hospital records and assessed at baseline, 24 and 52 weeks of treatment of dupilumab in CRSwNP patients. Treatment effectiveness was evaluated in relation to demographic and lifestyle factors, sinus surgery history, presence of comorbidities and blood eosinophil counts (BEC). Treatment response was evaluated according to EUFOREA 2021 criteria. RESULTS All patient outcomes improved at 24 and 52 weeks of treatment compared to baseline. Dupilumab showed effectiveness independent of age, sex, body mass index, smoking status, prior sinus surgery, presence of asthma, NSAID exacerbated respiratory disease (NERD), allergy or baseline BEC. 92.5% and 94.4% showed an improvement in at least 1 EUFOREA criterion at 24 and 52 weeks respectively. 54.4% and 68.2% reached all 4 of the more stringent EUFOREA criteria at 24 and 52 weeks respectively. CONCLUSIONS Real-world evaluation of dupilumab effectiveness demonstrates a robust and sustained response in at least two thirds of patients at 52 weeks of treatment. Favourable treatment response was independent of the number of sinus surgery procedures, major comorbidities or baseline systemic levels of type 2 inflammation.

中文翻译:


dupilumab 在欧洲 CRSwNP 队列中的实际有效性 (CHRINOSOR)。



背景 dupilumab 的关键研究表明,慢性鼻窦炎伴鼻息肉 (CRSwNP) 患者的鼻息肉评分 (NPS) 、症状和生活质量评分具有临床相关性的改善。目的 我们评估了 dupilumab 在来自 6 个欧洲三级保健中心的大规模 CRSwNP 队列中的有效性。方法学 从医院记录中收集 NPS、鼻窦结果测试 (SNOT)-22 评分、总鼻窦症状视觉模拟量表 (VAS)、嗅觉丧失 (LoS) 和鼻塞 (NB) 以及哮喘控制测试 (ACT) 评分,并在基线、 24 周和 52 周评估 CRSwNP 患者 dupilumab 治疗。根据人口统计学和生活方式因素、鼻窦手术史、合并症的存在和血嗜酸性粒细胞计数 (BEC) 评估治疗效果。根据 EUFOREA 2021 标准评估治疗反应。结果 与基线相比,所有患者在治疗 24 周和 52 周时均有所改善。Dupilumab 的有效性与年龄、性别、体重指数、吸烟状况、既往鼻窦手术、是否存在哮喘、NSAID 恶化呼吸系统疾病 (NERD)、过敏或基线 BEC 无关。92.5% 和 94.4% 分别在 24 周和 52 周时显示至少 1 项 EUFOREA 标准有所改善。54.4% 和 68.2% 的患者分别在 24 周和 52 周时达到所有 4 项更严格的 EUFOREA 标准。结论 dupilumab 有效性的真实世界评估表明,至少 2/3 的患者在治疗 52 周时具有强劲和持续的反应。良好的治疗反应与鼻窦手术手术的数量、主要合并症或 2 型炎症的基线全身水平无关。
更新日期:2024-10-30
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