The impact of mepolizumab on sleep impairment in CRSwNP: post hoc analyses of SYNAPSE and MUSCA.

IF 5.4 3区材料科学 Q2 CHEMISTRY, PHYSICAL ACS Applied Energy Materials Pub Date : 2024-09-27 DOI:10.4193/Rhin24.021

J Mullol, W J Fokkens, S G Smith, T Keeley, L Zhang, P Howarth, R H Chan, C Bachert

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Abstract

Background: The impact of mepolizumab on impaired sleep, one of the most bothersome symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), is unknown. This study aimed to determine the effect of mepolizumab and impact of comorbid upper and lower airway disease and blood eosinophil count (BEC) on sleep-/fatigue-related outcomes in CRSwNP.

Methods: This was an analysis of the Phase III SYNAPSE and MUSCA (NCT03085797/NCT02281318) trials of mepolizumab in patients with severe CRSwNP and severe asthma, respectively. Endpoints included change from baseline in 22-item Sino-Nasal Outcome Test (SNOT-22) sleep and fatigue domains (SYNAPSE: Weeks 24 and 52; MUSCA: Week 24) in the overall populations and post hoc subgroups (SYNAPSE: comorbid asthma, comorbid non-steroidal anti-inflammatory drug-exacerbated respiratory disease [N-ERD] and BEC; MUSCA: comorbid CRSwNP).

Results: In SYNAPSE, 289/407 patients with severe CRSwNP had comorbid asthma, 108 had N-ERD, and 278 had BEC ≥300 cells/µL. In MUSCA, 105/551 patients with severe asthma had comorbid CRSwNP. Baseline sleep and fatigue scores were worse in patients with comorbid airway disease and higher BEC. Improvements from baseline in sleep and fatigue scores were greater with mepolizumab versus placebo at Week 52 in SYNAPSE (difference in least squares mean change: -2.7 [sleep], -3.4 [fatigue], and Week 24 in SYNAPSE (-1.6 and -2.2) and MUSCA (-0.8 and -1.2), with consistent results across comorbidity and BEC subgroups.

Conclusion: Mepolizumab improves sleep and fatigue in severe CRSwNP, irrespective of comorbid airway disease and BEC, with consistent effects in severe asthma with and without comorbid CRSwNP.

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甲泼尼单抗对 CRSwNP 睡眠障碍的影响：SYNAPSE 和 MUSCA 的事后分析。

背景：睡眠障碍是伴有鼻息肉的慢性鼻炎患者（CRSwNP）最令人烦恼的症状之一，但目前尚不清楚甲泼尼单抗对睡眠障碍的影响。本研究旨在确定美泊利珠单抗的效果以及合并上下气道疾病和血液嗜酸性粒细胞计数（BEC）对 CRSwNP 患者睡眠/疲劳相关结果的影响：这是对SYNAPSE和MUSCA（NCT03085797/NCT02281318）分别针对重度CRSwNP和重度哮喘患者进行的mepolizumab III期试验的分析。终点包括总体人群和事后分组（SYNAPSE：合并哮喘、合并非甾体抗炎药加重的呼吸系统疾病 [N-ERD] 和 BEC；MUSCA：合并 CRSwNP）中 22 项中国鼻科结果测试 (SNOT-22) 睡眠和疲劳领域（SYNAPSE：第 24 周和第 52 周；MUSCA：第 24 周）与基线相比的变化：在SYNAPSE中，289/407名重度CRSwNP患者合并哮喘，108名患者合并N-ERD，278名患者的BEC≥300 cells/μL。在 MUSCA 中，每 551 名重症哮喘患者中就有 105 人合并有 CRSwNP。在合并气道疾病和 BEC 较高的患者中，基线睡眠和疲劳评分较差。在第 52 周，SYNAPSE（最小二乘法均值变化差：-2.7 [睡眠]、-3.4 [疲劳]）和第 24 周，SYNAPSE（-1.6 和 -2.2）和 MUSCA（-0.8 和 -1.2）的睡眠和疲劳评分与安慰剂相比有更大的改善，不同合并症和 BEC 亚组的结果一致：结论：无论是否合并气道疾病和BEC，美泊利珠单抗都能改善重度CRSwNP患者的睡眠和疲劳，对合并或不合并CRSwNP的重度哮喘患者效果一致。

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来源期刊

ACS Applied Energy Materials Materials Science-Materials Chemistry

CiteScore

10.30

自引率

6.20%

发文量

1368

期刊介绍： ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.