使用杜必鲁单抗治疗鼻息肉慢性鼻炎患者的轻度症状和无症状月数。

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology Pub Date : 2025-01-01 DOI:10.1016/j.anai.2024.09.015

Claus Bachert MD, PhD , Asif H. Khan MBBS , Claire Hopkins DM , Joseph K. Han MD , Wytske J. Fokkens MD , Leda P. Mannent MD , Jérôme Msihid MSc , Kinga Borsos PharmD , Siddhesh Kamat MS , Scott Nash MD , Harry Sacks MD , Paul J. Rowe MD , Yamo Deniz MD , Juby A. Jacob-Nara MD

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引用次数: 0

摘要

背景：慢性鼻炎伴鼻息肉（CRSwNP）临床试验的常见报告结果对患者的可比性可能有限：为了提高杜必鲁单抗治疗 CRSwNP 临床试验结果对患者的可比性，我们使用每日症状评分来确定新的以患者为中心的终点：轻度至无症状月（MSM）和无症状月（SFM）：方法：对每两周接受一次dupilumab 300毫克或安慰剂、持续24周（SINUS-24研究；NCT02912468）或52周（SINUS-52；NCT02898454）的患者进行事后分析。患者每天记录鼻塞、嗅觉减退、前后鼻出血等症状的严重程度，评分标准为 0-3（0 = 无症状；1 = 轻度；2 = 中度；3 = 重度）。我们评估了在随机化前28天、第24周（汇总研究）和第52周（SINUS-52）期间仅报告轻度或无症状（MSM）或无症状（SFM）的患者比例：在所有四种症状方面均达到 MSM 的杜比鲁单抗治疗患者明显多于安慰剂治疗患者（第 24 周：31.0% vs 4.4%；OR 12.9 [6.4，25.8]；第 52 周：38.3% vs 2.6%；OR 15.6 [5.9，41.0]；P 均 < .0001）。此外，在四种症状中至少有一种症状达到SFM的患者明显多于安慰剂治疗的患者（第24周：35.4% vs 10.8%；几率比[OR] 4.9 [95%置信区间3.1, 7.8]；第52周：50.0% vs 9.2%；OR 9.1 [4.6, 17.9]；均P < .0001）：结论：三分之一的重度 CRSwNP 患者在接受杜比鲁单抗治疗后，四种主要症状（鼻塞、嗅觉减退、前后鼻出血）均达到了 MSM。此外，半数患者至少对四种症状中的一种实现了 SFM。这些结果表明，dupilumab 有助于改善以患者为中心的治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Mild and symptom-free months in patients with chronic rhinosinusitis with nasal polyps treated with dupilumab

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Mild and symptom-free months in patients with chronic rhinosinusitis with nasal polyps treated with dupilumab

Background

Frequently reported outcomes of clinical trials in chronic rhinosinusitis with nasal polyps (CRSwNP) may have limited relatability for patients.

Objective

To enhance the patient relatability of outcomes in dupilumab clinical trials for CRSwNP, daily symptom scores were used to determine new patient‑centered end points: mild-to-no-symptom months (MSM) and symptom-free months (SFM).

Methods

This work is a post hoc analysis of patients receiving dupilumab 300 mg or placebo every 2 weeks for 24 weeks (SINUS-24 study; NCT02912468) or 52 weeks (SINUS‑52; NCT02898454). Patients recorded symptom severity scores daily for each of nasal congestion, loss of smell, and anterior and posterior rhinorrhea on a scale of 0 to 3 (0 = no symptoms; 1 = mild; 2 = moderate; 3 = severe). We assessed the proportions of patients reporting only MSM or SFM throughout the 28‑day period before randomization, week 24 (pooled studies), and week 52 (SINUS‑52).

Results

Significantly more dupilumab‑treated than placebo-treated patients achieved MSM for all 4 symptoms (week 24: 31.0% vs 4.4%; odds ratio [OR] 12.9 [95% CI 6.4-25.8]; week 52: 38.3% vs 2.6%; OR 15.6 [5.9-41.0]; both P < .0001). In addition, significantly more dupilumab-treated than placebo‑treated patients achieved SFM for at least 1 of the 4 symptoms (week 24: 35.4% vs 10.8%; OR 4.9 [95% CI 3.1-7.8]; week 52: 50.0% vs 9.2%; OR 9.1 [95% CI 4.6-17.9]; both P < .0001).

Conclusion

One-third of patients with severe CRSwNP treated with dupilumab achieved MSM for all 4 cardinal symptoms (nasal congestion, loss of smell, and anterior and posterior rhinorrhea). Moreover, half of the patients achieved SFM for at least 1 of the 4 symptoms. These results support the benefit of dupilumab in improving patient‑centered outcomes.

Trial Registration

ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52).

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来源期刊

Annals of Allergy Asthma & Immunology 医学-过敏

CiteScore

6.50

自引率

6.80%

发文量

437

审稿时长

33 days

期刊介绍： Annals of Allergy, Asthma & Immunology is a scholarly medical journal published monthly by the American College of Allergy, Asthma & Immunology. The purpose of Annals is to serve as an objective evidence-based forum for the allergy/immunology specialist to keep up to date on current clinical science (both research and practice-based) in the fields of allergy, asthma, and immunology. The emphasis of the journal will be to provide clinical and research information that is readily applicable to both the clinician and the researcher. Each issue of the Annals shall also provide opportunities to participate in accredited continuing medical education activities to enhance overall clinical proficiency.