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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., Competing Interests: 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., (© 2023 Maspero et al.)

Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, increasing disease burden and complicating treatment. These post hoc analyses investigated disease-specific health-related quality of life (HRQoL) and general health status in the randomized, placebo-controlled QUEST study (NCT02414854) in patients treated with dupilumab for moderate-to-severe asthma with comorbid CRS. Patients received 300 mg of dupilumab or placebo every 2 weeks for 52 weeks. CRS HRQoL was assessed by the 22-item Sino-Nasal Outcome Test (SNOT-22; items scored 0-5). The 22 items are categorized into 5 domains (nasal, ear/facial, sleep, function, and emotion), and patients report the top 5 most important items affecting their health. General health status was assessed by Euro-QoL visual analog scale (EQ-VAS). Of 1902 patients, 382 (20.1%) self-reported comorbid CRS; 193 patients receiving dupilumab 300 mg q2w or matched placebo were included in this analysis. At baseline, the most impacted SNOT-22 domain was nasal, and general health status was below population norms. Patients rated "decreased sense of taste/smell," "nasal blockage," "cough," "reduced productivity," and "wake up tired" as the 5 most important SNOT-22 items affecting their health. Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all p < 0.05). Improvements from baseline were significantly greater for dupilumab vs placebo at Week 52 for all SNOT-22 domains ( p < 0.05), except emotion. At Week 52, significant changes from baseline with dupilumab vs placebo were observed for all 5 most important SNOT-22 items affecting their health (all p < 0.05). EQ-VAS was significantly improved with dupilumab vs placebo by Week 12, with improvements sustained to Week 52 (all p < 0.01). In patients with moderate-to-severe asthma who self-reported comorbid CRS, dupilumab treatment vs placebo improved CRS-specific HRQoL and general health status., Competing Interests: C.H. reports advisory board fees from AstraZeneca, Dianosic, GlaxoSmithKline, and Sanofi. K.M.B. reports advisory board fees from AstraZeneca, GlaxoSmithKline, Regeneron, and Sanofi. E.H. reports research grants from AstraZeneca, Boehringer Ingelheim, Circassia, GlaxoSmithKline, Nestlé Purina, Novartis, Sanofi, Stallergenes-Greer, Regeneron, Teva, and Valeas. N.A.C. reports consultancy from Novartis, Oysterpoint Pharmaceuticals, and Sanofi/Regeneron, as well as licensing agreement with GeneOne Life Sciences. H.O. reports research funds from AstraZeneca GmbH, GlaxoSmithKline GmbH & Co. KG, and F. Hoffmann-La Roche Ltd, as well as advisory board fees and lecture fees from Novartis Pharma GmbH and Sanofi-Aventis Deutschland GmbH. A.H.K., J.M, J.A.J.-N., P.J.R. are employees and may hold stock and/or stock options in Sanofi. S.S, S.N., Y.D. 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., (© 2022 Hopkins et al.)