Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials.

ABSTRACT BACKGROUND Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously. OBJECTIVE To determine omalizumab safety/efficacy in CRSwNP in phase 3 trials (POLYP 1, POLYP 2). METHODS Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS). Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), sense of smell, postnasal drip, runny nose, and adverse events (AEs). RESULTS Patients in POLYP 1 (n=138) and POLYP 2 (n=127) exhibited severe CRSwNP and substantial quality-of-life impairment evidenced by mean NPS >6 and SNOT-22 of ∼60. Both studies met both coprimary end points. SNOT-22, UPSIT, sense of smell, postnasal drip and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, mean changes from baseline at week 24 for omalizumab versus placebo were: NPS, –1.08 versus 0.06 (P CONCLUSION Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and was well tolerated.