PRS2 PROPORTION OF PATIENTS WITH NASAL POLYPOSIS ACHIEVING CLINICALLY IMPORTANT IMPROVEMENTS IN QUALITY OF LIFE WITH OMALIZUMAB TREATMENT

Abstract

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. 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). 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]). 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.