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.

Graphical Abstract

Keywords:

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

Abbreviations

CRSwNP, Chronic rhinosinusitis with nasal polyps; EQ-VAS, EuroQoL-5 Dimension visual analog scale; HRQoL, health-related quality of life; ITT, intention-to-treat; LMK-CT, Lund-Mackay computed tomography; LoS, daily loss of smell; MCS, mental component summary; NC, nasal congestion; NP, nasal polyps; NPS, nasal polyp score; NSAID-ERD, non-steroidal anti-inflammatory drug-exacerbated respiratory disease; PCS, physical component summary; SCS, systemic corticosteroid; SF-36 V2, 36-item Short Form questionnaire version 2; SNOT-22, 22-item Sino-Nasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test.

Data Sharing Statement

Qualified researchers may request access to data and related study documents. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial patients. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.vivli.org/.

Ethics Approval and Informed Consent

The SINUS-24 study was conducted in accordance with the Declaration of Helsinki, approved by the local institutional review board or ethics committee at each study site (see Table S1), and all patients provided written informed consent.

Acknowledgments

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. 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

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

JFM reports research grants, speaker fees, and advisory board membership from AstraZeneca, Novartis, and Sanofi, speaker fees and advisory board membership from Boehringer Ingelheim, research grants and advisory board membership from GlaxoSmithKline, speaker fees from Menarini and Uriach, and advisory board membership from Merck Sharpe & Dohme. AHK, JM, C-CC, PJR, and JAJ-N are employees and may hold stock and/or stock options in Sanofi. CP reports advisory board membership and/or consultancy fees from GlaxoSmithKline, Guidepoint, M3 Global Research, Olympus, Sanofi, and Stryker, receiving grants from the Bernice Bibby Research Trust, NIHR, Rosetrees Trust, Royal College of Surgeons, and Sir Jules Thorn Trust, and is a trustee of Fifth Sense. PWH reports advisory board membership of Regeneron Pharmaceuticals Inc. and Sanofi. CH reports advisory board membership from GlaxoSmithKline, OptiNose, Sanofi, and Smith & Nephew. MW is a member of national and international scientific advisory board (consulting), has received fees for lectures, grants for research projects from ALK-Abelló A/S, Allakos, AstraZeneca, GlaxoSmithKline, HAL, Meda Pharmaceuticals, Novartis, Otonomy, Inc., Roche, Sanofi-Aventis, Stallergenes Greer, Strekin AG, and Teva Pharmaceuticals. SS is a former employee and may hold stock and/or stock options in Regeneron Pharmaceuticals Inc. SN, SK, and YD are employees and may hold stock and/or stock options in Regeneron Pharmaceuticals Inc. The authors report no other conflicts of interest in this work.

Additional information

Funding

Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT02912468 (SINUS-24).