OBJECTIVES: Nasal polyps are associated with substantial quality of life (QoL) impairment. The 22-item sinonasal outcome test (SNOT-22) questionnaire is a widely accepted measure to evaluate the impact of chronic rhinosinusitis with nasal polyps (CRSwNP) on QoL over 4 symptom domains (nasal, otological, sleep, psychological). We examined QoL improvements using SNOT-22 total score (0–110; higher scores=greater impairment) in CRSwNP patients receiving omalizumab vs placebo in two replicate phase III, randomized, placebo-controlled, omalizumab studies, POLYP 1 and POLYP 2.

METHODS: Post-hoc analyses of data from POLYP 1 (n=138) and POLYP 2 (n=127) were performed. The proportion of patients achieving the minimal clinically important difference (MCID) of ≥8.9 point improvement, and adjusted mean change from baseline (95% CI) difference on SNOT-22 total score at Weeks 4, 8, 16 and 24 in omalizumab vs placebo groups are presented for the pooled POLYP 1/2 population. Safety results have been presented previously (Gevaert P, Ann Allergy Asthma Immunol 2019;123[5]:S17).

RESULTS: Baseline mean (SD) SNOT-22 total scores were similar for omalizumab- and placebo-treated patients (59.5 [20.0]; N=134 vs 60.1 [16.7]; N=131, respectively). At each study time point, the MCID in SNOT-22 total score was achieved with omalizumab, and SNOT-22 total score improvements were greater vs placebo (adjusted mean differences [95% CI]: -9.38 [-12.78, -5.99], -13.18 [-16.99, -9.38], -15.71 [‑19.67, -11.74], and -15.36 [-19.57, -11.16] at Weeks 4, 8, 16, and 24, respectively). Omalizumab-treated patients were more likely than placebo-treated patients to achieve MCID in SNOT-22 at Weeks 4 (66.7% vs 45.7%; OR=2.42; [95% CI: 1.46, 4.01]), 8 (78.2% vs 48.8%; OR=3.91; [2.27, 6.76]), 16 (79.2% vs 45.0%; OR=4.91 [2.81, 8.60]), and 24 (73.4% vs 43.8%; OR=3.66 [2.15, 6.23]).

CONCLUSIONS: Omalizumab treatment resulted in placebo-corrected mean SNOT-22 clinically meaningful differences, with a substantially higher proportion of omalizumab-treated patients achieving a clinically important improvement in QoL.