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Omalizumab safe, effective for severe chronic rhinosinusitis with nasal polyps

20 Sep 2020

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.

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Most Read Articles
Jairia Dela Cruz, 05 Oct 2020
Drinking more than two cups of coffee per day may just be the intervention that prevents hundreds of thousands of liver disease‐related deaths globally, a study reports.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 12 Oct 2020

Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.

Stephen Padilla, 2 days ago
Use of systemic corticosteroids does not reduce in-hospital mortality for patients with severe or critical coronavirus disease (COVID-19), which is in stark contrast to that observed in the RECOVERY clinical trial, according to a study in Wuhan, China.