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评估度普利尤单抗延长给药间隔(每2周一次[双周一次]对比每4周一次[每月一次])用于伴鼻息肉的慢性鼻-鼻窦炎:沙特阿拉伯的一项真实世界研究:伴鼻息肉的慢性鼻-鼻窦炎中延长度普利尤单抗给药方案。

Evaluation of extended dupilumab dosing intervals Q2W (biweekly) versus Q4W (monthly) in chronic rhinosinusitis with nasal polyposis: a real-world study from Saudi Arabia : Extended dupilumab dosing in CRSwNP.

作者信息

Alghamdi Abdullah S, Saati Faisal A, Alkhammash Salma, Bulkhi Adeeb A, Muathen Sumaiya H, Abu Suliman Omar A

机构信息

Department of Rhinology, Endoscopic Sinus & Skull Base, King Abdullah Medical City, Makkah, Saudi Arabia.

Department of Allergy and Immunology, Department of Specialized Internal Medicine, King Abdullah Medical City, Makkah, Saudi Arabia.

出版信息

Eur Arch Otorhinolaryngol. 2025 Sep 18. doi: 10.1007/s00405-025-09677-2.

DOI:10.1007/s00405-025-09677-2
PMID:40968202
Abstract

BACKGROUND

Chronic rhinosinusitis with nasal polyposis (CRSwNP), often Linked to asthma, significantly affects quality of life. While dupilumab 300 mg every two weeks (Q2W) is effective, it is costly. This real-world Saudi study evaluated whether extending dosing to every four weeks (Q4W) maintains effectiveness in patients with or without asthma.

METHODS

In this retrospective single-cohort study, 42 adults with CRSwNP who completed at least one year of stable Q2W dupilumab therapy were transitioned to Q4W and followed for one additional year. Clinical, biomarker, and imaging outcomes were analyzed.

RESULTS

Clinical outcomes between Q2W and Q4W were largely comparable. Eight CRSwNP patients had comorbid asthma (19%). Median nasal polyp scores remained stable, and symptom scores for nasal congestion, discharge, smell loss, and fatigue showed no significant changes. Sino-Nasal Outcome Test (SNOT)-22 and Lund-Mackay scores trended lower in the Q4W group compared to Q2W group but were not statistically significant. Blood eosinophils were modestly reduced, while asthma control remained stable, with high asthma control test scores. Total IgE levels (IU/mL) were significantly lower in the Q4W group (32.5 [10.1-76.4] vs. 52.7 [19.8-215], p<0.001), suggesting immunologic benefit. Fractional exhaled nitric oxide (FeNO) levels were unchanged. Overall, 92.9% maintained symptom control on Q4W for one year; three reverted to Q2W due to worsening of asthma control symptoms.

CONCLUSION

Transitioning from Q2W to Q4W dupilumab dosing is effective for most CRSwNP patients, including those with asthma, after one year of stable therapy. This approach may reduce treatment burden without compromising clinical outcomes.

摘要

背景

伴有鼻息肉的慢性鼻-鼻窦炎(CRSwNP)常与哮喘相关,严重影响生活质量。虽然每两周一次(Q2W)皮下注射300mg度普利尤单抗有效,但成本高昂。这项沙特的真实世界研究评估了将给药间隔延长至每四周一次(Q4W)对有或无哮喘的患者是否仍保持疗效。

方法

在这项回顾性单队列研究中,42例接受至少一年稳定的Q2W度普利尤单抗治疗的CRSwNP成年患者转为Q4W给药,并继续随访一年。分析临床、生物标志物和影像学结果。

结果

Q2W和Q4W之间的临床结果在很大程度上具有可比性。8例CRSwNP患者合并哮喘(19%)。鼻息肉评分中位数保持稳定,鼻塞、流涕、嗅觉减退和疲劳的症状评分无显著变化。与Q2W组相比,Q4W组的鼻窦结局测试(SNOT)-22和Lund-Mackay评分呈下降趋势,但无统计学意义。血液嗜酸性粒细胞略有减少,而哮喘控制保持稳定,哮喘控制测试得分较高。Q4W组的总IgE水平(IU/mL)显著降低(32.5[10.1-76.4] vs. 52.7[19.8-215],p<0.001),提示有免疫学益处。呼出一氧化氮(FeNO)分数水平无变化。总体而言,92.9%的患者在Q4W给药方案下维持症状控制达一年;3例因哮喘控制症状恶化而恢复为Q2W给药。

结论

在一年的稳定治疗后,将度普利尤单抗给药方案从Q2W转换为Q4W对大多数CRSwNP患者有效,包括那些合并哮喘的患者。这种方法可以减轻治疗负担,而不影响临床疗效。

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