EDS-FLU (EXHALATION DELIVERY SYSTEM WITH FLUTICASONE) BENEFITS ON NASAL POLYP DISEASE RELATIVE TO MONOCLONAL ANTIBODIES

Introduction EDS-FLU uses a novel delivery system to place topical steroid high/deep in nasal passages. It has been studied in CRS with/without nasal polyps (CRSw/sNP). Recent phase 2 studies of monoclonal antibodies (dupilumab and others) in CRSwNP patients with large polyps have reported benefit among patients failing conventional intranasal steroids. We report the effect of EDS-FLU on outcomes in a subgroup of patients with similar polyp burden to those enrolled in mAb studies. Methods Changes in polyp grade, symptoms and SNOT-22 were assessed in a subset of subjects (N=92.7, mean age=46.4) with baseline summed bilateral NP grade ≥5 (out of 6) from two randomized, 24-week (16 double-blind+8 open-label) trials comparing twice daily EDS-FLU (186µg, or 372µg) to EDS-placebo. Patients in these trials had mostly tried prior treatments (prior steroids=92.7%, prior surgery, >54.5%). Results After 4 weeks, EDS-FLU 186µg/372µg significantly improved all 4 diagnostically defining symptoms of CRSwNP compared with EDS-placebo (congestion/obstruction, -0.51/-0.51 vs. -0.05; rhinorrhea, -0.50/-0.39 vs. -0.02; facial pain/pressure -0.18/-0.20 vs 0.13; hyposmia, -0.05/-0.28 vs. 0.07; pAfter 16 weeks, the least squares mean change in polyp grade was -2.0/-2.0 with EDS-FLU 186µg/372µg compared with -1.19 for EDS-placebo (p=NS/0.014/0.014). Polyp improvement continued to increase through week 24 with 372µg EDS-FLU. EDS-FLU significantly improved SNOT-22 scores vs EDS-placebo after 16 weeks (-20.0/-18.1 vs. -6.0, p≤0.02). Conclusions In a subpopulation of CRSwNP patients similar to those in mAb studies (large polyps, failure of conventional intranasal steroids), EDS-FLU improved symptoms, polyp grade, and quality of life to a similar degree as monoclonal antibodies.