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These studies were funded by GSK (GSK ID: 205687/NCT03085797; 200862 NCT02281318) . Medical writing and editorial support (in the form of writing assistance, including development of the initial draft based on author direction, assem-bling tables and figures, collating, and incorporating authors' comments on the drafts, grammatical editing, and referencing) was funded by GSK. Authors had roles in the conception, design, and acquisition of data for the study. All authors participated in the development of the manuscript and had access to the study data. The decision to submit for publication was that of the authors alone. The sponsor did not place any restrictions on access to the data or on the statements made in the manuscript. The corresponding author had final responsibility for the deci-sion to submit for publication.

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

Publicated to:Rhinology. 62 (6): 669-680 - 2024-01-01 62(6), DOI: 10.4193/Rhin24.021

Authors: Mullol, Joaquim; Fokkens, Wytske J; Fokkens, Wytske J; Smith, Steven G; Smith, Steven G; Keeley, Tom; Zhang, Lingjiao; Howarth, Peter; Chan, Robert H; Chan, Robert H; Bachert, Claus

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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 [= 300 cells/L]; 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/mu L. 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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