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 ORCID: https://orcid.org/0000-0002-1125-3236, 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: 09 Aug 2024 00:32
URI: https://ueaeprints.uea.ac.uk/id/eprint/96002
DOI: 10.2147/JAA.S372598

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