Health-related quality of life impairment among patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 trial

Maspero, Jorge F., Khan, Asif H., Philpott, Carl, Hellings, Peter W., Hopkins, Claire, Wagenmann, Martin, Siddiqui, Shahid, Msihid, Jérôme, Nash, Scott, Chuang, Chien Chia, Kamat, Siddhesh, Rowe, Paul J., Deniz, Yamo and Jacob-Nara, Juby A. (2023) Health-related quality of life impairment among patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 trial. Journal of Asthma and Allergy, 16. pp. 323-332. ISSN 1178-6965

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Abstract

Purpose: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. Methods: In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50 for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4−83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. Results: In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. Conclusion: In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

Item Type: Article
Additional Information: The abstract of this paper was presented at the American Academy of Allergy Asthma & Immunology (AAAAI) 2021 Annual Meeting as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in J Allergy Clin Immunol 2021;147(2): AB133. Abstract 425. doi: https://doi.org/10.1016/j.jaci.2020.12.485 Funding Information: Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT02912468 (SINUS-24). Medical writing/editorial assistance provided by Dorothy Keine, PhD and Adelphi Group, funded by Sanofi and Regeneron Pharmaceuticals Inc. The authors thank Christine Taniou and Carole Mercier, analysts from Aixial, Boulogne-Billancourt, France, funded by Sanofi and Regeneron Pharmaceuticals Inc.
Uncontrolled Keywords: chronic rhinosinusitis with nasal polyps,health-related quality of life,symptom burden,immunology and allergy,pulmonary and respiratory medicine,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2723
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Respiratory and Airways Group
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
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Depositing User: LivePure Connector
Date Deposited: 22 Jul 2024 16:32
Last Modified: 06 Feb 2025 12:06
URI: https://ueaeprints.uea.ac.uk/id/eprint/96002
DOI: 10.2147/JAA.S372598

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