EDS-FLU Improves Quality of Life and Health Status: Pooled Analysis of Phase 3 Trials Navigate I and II
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Fulton F. Velez, MD, Emmanuel M. Mahlis, MD, John C. Messina Jr., PharmD, Sam Colman, Kate Anastassopoulos, Ramy A. Mahmoud, MD, MPH

Chronic rhinosinusitis (CRS) seriously impairs health-related quality of life (HRQoL). Trials in CRS patients showed that EDS-FLU produced robust improvements in CRS symptoms, polyp grade, and surgical eligibility. This analysis describes the impact of EDS-FLU on individual domains of the 36-Item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form Six-Dimension (SF-6D).


Pooled randomized clinical trial data (NAVIGATE I and II; N=641) were analyzed to examine SF-36v2 and SF-6D change from baseline to end-of-double-blind (EODB: 16 weeks) and end-of-study (EOS: 24 weeks; 8 weeks open-label treatment). The SF-36v2 was scored using 2009 U.S. population norms (50 = general population t-score); the SF-6D was calculated from UK population non-parametric preference weights.


Mean baseline SF-36v2 scores were below population norms across treatment arms. At EODB, mean improvement was significantly greater for all SF-36v2 domain/summary scores with EDS-FLU (range: 2.9/physical functioning to 5.11/bodily pain) vs. EDS-placebo (range: 0.81/mental health to 2.87/bodily pain) (each comparison P<0.01). Similarly, SF-6D scores were significantly improved vs. placebo (0.058 vs. 0.023; P<0.001). Nine out of ten mean EODB domain/summary scores were at or above population norms for EDS-FLU vs. 4 out of 10 for placebo. At EOS, SF-36v2 and SF-6D scores improved in all treatment arms; all scored at or above SF-36v2 population norms.


In this pooled analysis of two large pivotal EDS-FLU trials, health domain and health utilities improvements were ≈2-3 times greater with EDS-FLU than EDS-placebo after 16 weeks. End-of-study improvements were at or above population norms for all treatment arms.