Dupilumab Shows Superiority Over Omalizumab for Chronic Rhinosinusitis
This study is the first to compare 2 biologics for patients with chronic rhinosinusitis with nasal polyps and coexisting asthma.
In a phase 4 trial, dupilumab (Dupixent) showed superiority on all primary and secondary end points compared with omalizumab (Xolair) for patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. Data from the EVEREST (NCT04998604) trial were presented at the 2025 European Academy of Allergy and Clinical Immunology Annual Congress in Glasgow, United Kingdom.1
This study is the first to compare 2 biologics for patients with chronic rhinosinusitis with nasal polyps and coexisting asthma. | Image Credit: Crystal light - stock.adobe.com
“Patients suffering from chronic rhinosinusitis with nasal polyps often live with the constant obstruction of their nasal passages that can lead to burdensome nasal congestion and loss of smell,” Eugenio De Corso, MD, PhD, ENT specialist at the A. Gemelli University Hospital, said in a news release.1 “EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on CRSwNP end points in patients with coexisting asthma, along with generally similar safety profiles. Together, these Dupixent outcomes provide important insights that will help guide patients and physicians through the treatment decision-making process.”
In an article published in the American Journal of Rhinology and Allergy, the authors stated that “EVEREST is the first head-to-head trial assessing the comparative efficacy and safety of 2 biologics in patients with severe CRSwNP and comorbid asthma.” They explained the methods of the phase 4, randomized, double-blind trial.2
Investigators conducted the trial to evaluate the efficacy of dupilumab compared with omalizumab in reducing the polyp size and improving sense of smell. The trial lasted 38 weeks, comprising of 3 periods: a 28-day screening and run-in period, a 28-week randomized investigational medicinal product intervention period, and up to a 12-week follow-up period. Patients included were 18 years and older, had bilateral sino-nasal polyposis, had a diagnosis of asthma, were treated with intranasal mometasone, and were eligible for omalizumab. Patients received either dupilumab every 2 weeks via subcutaneous injection or omalizumab every 2 weeks or every 4 weeks via subcutaneous injection.3
The primary end points included change from baseline to week 24 nasal polyp score and change from baseline to week 24 in the University of Pennsylvania Small Identification Test. Secondary outcomes included change from baseline to week 24 in the loss of smell score of the CRSwNP nasal symptom diary, change in the nasal congestion score, change in total symptom score, change in 22-item sinonasal outcome test (SNOT), change in SNOT-22 nasal domain score, change in nasal peak inspiratory flow, change in rhinosinusitis visual analogue scale, incidence of treatment-emergent adverse events (AEs) and serious AEs, and AEs of special interest.3
Investigators included 360 adults with severe uncontrolled CRSwNP and asthma, with 181 receiving dupilumab and 179 receiving omalizumab. Mometasone furoate nasal spray was used as a background therapy. The results showed a 1.6-point superior reduction in nasal polyp size with dupilumab compared with omalizumab, an 8-point superior improvement in ability to identify different smells, a 0.58-point superior reduction in nasal congestion and obstruction, and a 0.81-point improvement in loss of smell. Further, investigators found that dupilumab had a 1.74-point reduction in symptom severity, a 12.7-point difference in health-related quality of life, a 31.27-point difference in peak nasal inspiratory flow, and a 1.87 difference in overall severity of rhinosinusitis compared with omalizumab.1
Further, investigators found that dupilumab improved asthma end points as well, including a 150 mL difference in lung function and a 0.48-point difference in asthma control compared with omalizumab. As for safety, the data were consistent with the known safety profile of dupilumab, with AEs being observed at 64% for dupilumab and 67% for omalizumab. Serious AEs were reported in 2% and 4%, respectively. For discontinuation, 3% and 1% of patients discontinued the story, respectively.1
READ MORE: Respiratory Resource Center
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