Published online: June 7, 2020
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common but severe disorder of the sinonasal passages which is associated with significant healthcare costs and loss of quality of life. Many patients with this disorder remain inadequately controlled despite treatment with intranasal or oral corticosteroids or sinus surgery to remove polyps. Immunoglobulin E (IgE) has been implicated in the inflammatory process underlying nasal polyps. Several small studies have demonstrated efficacy of omalizumab, a monoclonal antibody that binds to and neutralizes IgE, in treating CRSwNP.
In a research article recently published in The Journal of Allergy and Clinical Immunology (JACI), Gevaert and his colleagues present the results of two replicate randomized, controlled trials, POLYP 1 and POLYP 2. The trials assessed the safety and efficacy of omalizumab for the treatment of severe CRSwNP in adult patients with an inadequate response to intranasal corticosteroids. POLYP 1 and POLYP 2 enrolled 138 and 127 patients, respectively, who were followed for 24 weeks.
Both studies met their co-primary endpoints with significant reductions from baseline at Week 24 in nasal polyps and nasal congestion scores in patients who were treated with omalizumab compared with those treated with placebo. These measures indicate that nasal polyp size decreased, and that patients’ noses were less blocked when they were treated with omalizumab. Quality of life and other symptoms, including loss of smell, were also significantly improved in the omalizumab-treated group. Improvements were noted at the earliest time point examined (4 or 8 weeks) and were maintained through 24 weeks. The number of patients experiencing an adverse event was similar for the omalizumab and placebo arms in POLYP 1 and POLYP 2. The overall safety was consistent with the profile established from more than 16,000 patient-years of usage in clinical trials and more than 1.3 million patient-years of usage in clinical practice.
The findings of these studies suggest that omalizumab offers a new, non-invasive treatment option for patients with CRSwNP who had an inadequate response to intranasal corticosteroids.
The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.