Omalizumab safe, effective for severe chronic rhinosinusitis with nasal polyps

Omalizumab shows good clinical and endoscopic efficacy in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), reports two phase III trials, POLYP1 and POLYP2.

POLYP1 and POLYP2 randomized 138 and 127 patients, respectively, to receive either omalizumab or placebo with background intranasal mometasone. The trials lasted for 24 weeks and the coprimary endpoints were the change in endoscopic nasal polyp score (NPS) from baseline and mean daily nasal congestion score (NCS). Patients were eligible only if they had previously shown inadequate response to intranasal corticosteroids.

In both cohorts, omalizumab-treated patients showed significantly better improvements, relative to placebo, in mean NPS and daily NCS after 24 weeks of intervention. In POLYP1, NPS scores dropped by an average of 1.14 points more in the omalizumab compared to the placebo arm (95 percent confidence interval [CI], –1.59 to –0.69; p<0.0001).

In POLYP2, the difference in NPS change values was lower but still significant in favour of omalizumab (treatment difference, –0.59, 95 percent CI, –1.05 to –0.12; p=0.0140).

Similar findings were found for NCS, which decreased with a significantly greater magnitude in both POLYP1 (treatment difference, –0.55, 95 percent CI, –0.84 to –0.25; p=0.0004) and POLYP2 (treatment difference, –0.50, 95 percent CI, –0.80 to –0.19; p=0.0017).

Omalizumab’s efficacy came with no strong safety concerns. The prevalence of at least one treatment-emergent adverse event (AE) was 58.5 percent in the placebo arm and 50.4 percent in the treatment arm. AEs suspected to be related to omalizumab occurred in 3.8 percent of placebo patients and 6.7 percent in the treatment group. Most events across both cohorts were mild or moderate in intensity.