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

Jorge F. Maspero; Asif H. Khan; Carl Philpott; Peter W. Hellings; Claire Hopkins; Martin Wagenmann; Shahid Siddiqui; Jérôme Msihid; Scott Nash; Chien Chia Chuang; Siddhesh Kamat; Paul J. Rowe; Yamo Deniz; Juby A. Jacob-Nara

doi:10.2147/JAA.S372598

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

Jorge F. Maspero, Asif H. Khan, Carl Philpott, Peter W. Hellings, Claire Hopkins, Martin Wagenmann, Shahid Siddiqui, Jérôme Msihid, Scott Nash, Chien Chia Chuang, Siddhesh Kamat, Paul J. Rowe, Yamo Deniz, Juby A. Jacob-Nara

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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.

Original language	English
Pages (from-to)	323-332
Number of pages	10
Journal	Journal of Asthma and Allergy
Volume	16
DOIs	https://doi.org/10.2147/JAA.S372598
Publication status	Published - 29 Mar 2023

Keywords

chronic rhinosinusitis with nasal polyps
health-related quality of life
symptom burden

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Maspero, J. F., Khan, A. H., Philpott, C., Hellings, P. W., Hopkins, C., Wagenmann, M., Siddiqui, S., Msihid, J., Nash, S., Chuang, C. C., Kamat, S., Rowe, P. J., Deniz, Y., & Jacob-Nara, J. 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, 323-332. https://doi.org/10.2147/JAA.S372598

@article{557e17bd7cf74845a337c5d67e2c2e87,

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

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.",

keywords = "chronic rhinosinusitis with nasal polyps, health-related quality of life, symptom burden",

author = "Maspero, {Jorge F.} and Khan, {Asif H.} and Carl Philpott and Hellings, {Peter W.} and Claire Hopkins and Martin Wagenmann and Shahid Siddiqui and J{\'e}r{\^o}me Msihid and Scott Nash and Chuang, {Chien Chia} and Siddhesh Kamat and Rowe, {Paul J.} and Yamo Deniz and Jacob-Nara, {Juby A.}",

note = "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{\textquoteright}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. ",

year = "2023",

month = mar,

day = "29",

doi = "10.2147/JAA.S372598",

language = "English",

volume = "16",

pages = "323--332",

journal = "Journal of Asthma and Allergy",

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Maspero, JF, Khan, AH, Philpott, C, Hellings, PW, Hopkins, C, Wagenmann, M, Siddiqui, S, Msihid, J, Nash, S, Chuang, CC, Kamat, S, Rowe, PJ, Deniz, Y & Jacob-Nara, JA 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, vol. 16, pp. 323-332. https://doi.org/10.2147/JAA.S372598

TY - JOUR

T1 - Health-related quality of life impairment among patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 trial

AU - Maspero, Jorge F.

AU - Khan, Asif H.

AU - Philpott, Carl

AU - Hellings, Peter W.

AU - Hopkins, Claire

AU - Wagenmann, Martin

AU - Siddiqui, Shahid

AU - Msihid, Jérôme

AU - Nash, Scott

AU - Chuang, Chien Chia

AU - Kamat, Siddhesh

AU - Rowe, Paul J.

AU - Deniz, Yamo

AU - Jacob-Nara, Juby A.

N1 - 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.

PY - 2023/3/29

Y1 - 2023/3/29

N2 - 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.

AB - 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.

KW - chronic rhinosinusitis with nasal polyps

KW - health-related quality of life

KW - symptom burden

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ER -

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

Abstract

Keywords

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