Author(s)
Fulton F. Velez, MD, MS, MBA
Harry J. Sacks, MD
John C. Messina, PharmD
Kate P. Anastassopoulos, MS
Ramy A. Mahmoud, MD, MPH
Affiliation(s)
OptiNose US, Inc.
Abstract:
Introduction: SNOT-22 is a widely used patient-reported outcome measure for assessing symptoms, functioning, and quality of life in patients with chronic sinusitis and nasal polyposis (NP). Patient “utility” is an important global measure of health state used particularly in economic analysis. We assess the relationship between SNOT-22 and patient utility using data from 2 large pivotal trials which evaluated the Exhalation Delivery System with fluticasone (EDS-FLU).Methods: Correlation between SF-6Dr2 (0-1; derived from SF-36) and SNOT-22 total score (0-110) were calculated at baseline, week 16, and week 24. Two generalized linear repeated measures models of SF-6Dr2 on SNOT-22 (continuous and categorical severity) controlled for visit, age, sex, race, country, and surgical eligibility.Results: Across all visits, mean (SD) SNOT-22 was 49.9 (19.60) (n=638), and SF-6Dr2 was 0.68 (0.114) (n=641); correlation -0.60. In the continuous model a 1-point decrease in SNOT-22 significantly predicted an SF-6D increase of 0.0030 (95% CI: 0.0033, 0.0028; p<0.0001). All factors except race were significant (p<0.005). The categorical model found decreasing SNOT-22 severity category significantly predicted non-overlapping higher patient utility score measured by mean SF-6Dr2: Severe, 0.66 (95% CI: 0.65 – 0.67); Moderate, 0.73 (95% CI: 0.72 – 0.74); Mild, 0.80 (95% CI: 0.79 – 0.81); and Healthy, 0.84 (95% CI: 0.82 – 0.86); (p<0.0001).Conclusions: Among patients with nasal polyposis, there is a significant relationship between SNOT-22 and utility (SF-6Dr2). SNOT-22 severity categories were associated with non-overlapping SF-6D scores suggesting that improvements in SNOT-22 severity categories would be associated with significant improvements in health utility.