Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial

Figures & data

Table 1 Demographics and Baseline Disease Characteristics in the SINUS-24 Study (ITT Population)

	Overall (N=276)
Age, mean (SD), years	50.5 (13.4)
Male sex, n (%)	158 (57.2%)
NP duration since diagnosis, mean (SD), years	11.1 (9.2)
Bilateral endoscopic NPS, range 0–8, mean (SD)^a	5.75 (1.28)
Daily NC score, range 0–3, mean (SD)^a	2.35 (0.57)
LMK-CT score, range 0–24, mean (SD)^a	19.03 (4.44)
Prior NP surgery, n (%)	198 (71.7)
Previous SCS and prior NP surgery, n (%)^b	106 (38.4)
Previous SCS and no prior NP surgery, n (%)^b	73 (26.4)
Comorbid asthma, n (%)	161 (58.3)
Comorbid NSAID-ERD, n (%)	84 (30.4)
Anosmia, n (%)^c	208 (76.2)

Notes: ^aHigher scores indicate more severe disease. ^bIn the preceding 2 years. ^cUPSIT score <19.

Abbreviations: ITT, intention-to-treat; LMK-CT, Lund-Mackay computed tomography; NC, nasal congestion; NP, nasal polyp; NPS, nasal polyp score; NSAID-ERD, non-steroidal anti-inflammatory drug-exacerbated respiratory disease; q2w, every 2 weeks; SCS, systemic corticosteroids; SD, standard deviation.

Table 2 SF-36 and EQ-VAS Scores of Patients with Severe CRSwNP in SINUS-24 (ITT Population)

Mean (SD)	SF-36 PCS Score (0–100)	SF-36 MCS Score (0–100)	EQ-VAS (0–100)
Population norm^a	50	50	70.4–83.3
Overall study population (n=276)	46.4 (8.5)	48.6 (10.5)	66.0 (20.3)
Surgery
Prior NP surgery (n=198)	46.6 (8.0)	48.0 (10.9)	65.3 (19.6)
No prior NP surgery (n=78)	45.9 (9.7)	50.0 (9.4)	68.0 (22.1)
SCS and surgery^b
Previous SCS and prior NP surgery (n=106)	46.8 (7.3)	47.0 (10.9)	64.3 (21.2)
Previous SCS and no prior NP surgery (n=73)	46.3 (9.1)	50.0 (9.4)	68.4 (21.8)
Asthma
Comorbid asthma (n=161)	44.5 (9.1)	48.1 (11.3)	64.8 (20.3)
No comorbid asthma (n=115)	49.0 (6.8)	49.3 (9.3)	67.7 (20.4)
NSAID-ERD
Comorbid NSAID-ERD (n=84)	44.4 (7.9)	48.1 (12.1)	62.4 (20.2)
No comorbid NSAID-ERD (n=192)	47.3 (8.6)	48.8 (9.8)	67.6 (20.2)
Anosmia
Yes (n=208)	45.4 (8.7)	48.3 (10.9)	63.9 (20.4)
No (n=65)	49.7 (6.9)	49.5 (9.2)	73.2 (18.8)

Notes: ^aPopulation norm range presented for EQ-VAS. ^bIn the subgroup of patients with CRSwNP with previous SCS use within the preceding 2 years (n=179).

Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; EQ-VAS, EuroQoL-5 Dimension visual analog scale; MCS, mental component summary; PCS, physical component summary; NP, nasal polyps; NSAID-ERD, non-steroidal anti-inflammatory drug-exacerbated respiratory disease; SCS, systemic corticosteroids; SD, standard deviation; SF-36, 36-item Short Form questionnaire.

Figure 1 SF-36 and EQ-VAS scores for patients with CRSwNP from SINUS-24 vs patients with other chronic diseases [references: SF-36;^24–26 EQ-VAS³¹].

Notes: Populations: CRSwNP (SINUS-24, A–C), international patients with NPS of at least 5 (of a maximum 8) despite treatment with SCS in the preceding 2 years (or a medical contraindication or intolerance to SCS) or previous sinonasal surgery; rheumatoid arthritis (A and B), Norwegian real-world population with late-stage disease according to duration (>3 – <20 years), (C) US real-world population with any level of disease severity; type 2 diabetes (A and B), patients from the Swedish National Diabetes Register, (C) US real-world population with any level of disease severity; asthma (A and B), European patients with diagnosis of asthma confirmed by a doctor and at least one respiratory symptom (wheeze, nocturnal chest tightness, attack of breathlessness after activity; at rest or at night) or asthma attack or use of inhaled/oral medicines because of breathing problem in the last 12 months, (C) US real-world population with any level of disease severity. Higher GINA category indicates more severe disease.

Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; EQ-VAS, EuroQoL-5 Dimension visual analog scale; GINA, Global Initiative for Asthma; MCS, mental component summary; PCS, physical component summary; SF-36, 36-item Short Form questionnaire.

Table 3 Association Between SF-36 PCS and MCS and Clinical and PRO Measures at Baseline in SINUS-24 (Overall Study Population)

	Spearman Correlation Coefficient
	SF-36 PCS Score	SF-36 MCS Score
NPS	–0.09	0.17
LMK-CT score	–0.10	–0.08
UPSIT	0.17	0.06
NC	–0.19	–0.09
Daily LoS score	–0.02	0.00
TSS	–0.23	–0.12
Rhinosinusitis VAS	–0.25	–0.07
SNOT-22 total score	–0.42	–0.44
Domain score^Citation23
Ear/facial	–0.31	–0.40
Emotion	–0.24	–0.60
Function	–0.39	–0.46
Nasal	–0.40	–0.23
Sleep	–0.34	–0.32
EQ-VAS	0.41	0.34

Abbreviations: CT, computed tomography; EQ-VAS, EuroQoL-5 Dimension visual analog scale; LMK-CT, Lund-Mackay computed tomography; LoS, loss of smell; MCS, mental component summary; NC, nasal congestion/obstruction; NPS, nasal polyp score; PCS, physical component summary; PRO, patient-reported outcome; SNOT-22, 22-item Sino-Nasal Outcome Test; TSS, total symptom score; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale.

Scott M, Chuang C-C, Khan A, Small M, Kamat SA. Clinical characteristics and patient-reported outcomes (PROs) among chronic rhinosinusitis with nasal polyps (CRSwNP) patients with a history of sinus surgery. American Rhinologic Society (ARS) 2019 Annual Meeting; September 13–14; New Orleans, LA, USA; 2019.

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