Dupilumab outperformed omalizumab across every pre-specified efficacy endpoint in a head-to-head trial of patients with severe chronic rhinosinusitis with nasal polyps and coexisting asthma, according to abstracts presented at the 80th Annual Scientific Meeting of the Canadian Society of Allergy and Clinical Immunology and published as a collection of meeting summaries in the journal Allergy, Asthma & Clinical Immunology.
The head-to-head result comes from the EVEREST trial, a multicenter, double-blind phase 4 study registered as NCT04998604. Investigators randomized 360 adults with severe chronic rhinosinusitis with nasal polyps and coexisting asthma to receive either dupilumab 300 milligrams every two weeks or omalizumab at doses of 75 to 600 milligrams every two or four weeks, both given for 24 weeks on top of background mometasone furoate nasal spray.
By week 24, improvements were significantly greater with dupilumab than omalizumab for all primary and secondary efficacy endpoints. The least squares mean difference in change from baseline favored dupilumab by 1.60 points on the nasal polyp score, which ranges from 0 to 8, with a 95 percent confidence interval of 1.96 to 1.25 and a p value below 0.001. On the University of Pennsylvania Smell Identification Test, which ranges from 0 to 40, dupilumab led by 8.0 points, with a 95 percent confidence interval of 6.3 to 9.7 and the same p value threshold. Sino-Nasal Outcome Test improvements in the functional domain score, which ranges from 0 to 5, were also substantially better with dupilumab, showing a week 24 least squares mean difference of 0.5 points with a 95 percent confidence interval of 0.7 to 0.3.
Asthma outcomes moved in the same direction. The week 24 least squares mean difference favoring dupilumab was 0.15 liters for pre-bronchodilator forced expiratory volume in one second, with a 95 percent confidence interval of 0.05 to 0.26 liters, and 0.48 points on the 7-item Asthma Control Questionnaire, which ranges from 0 to 6, with a 95 percent confidence interval of 0.65 to 0.31. Safety profiles of the two biologics were comparable in the trial. The investigators concluded that dupilumab demonstrated superiority over omalizumab for all outcomes pre-specified in the testing hierarchy, supporting its efficacy in comorbid type 2 respiratory diseases against an active biologic comparator and reinforcing the known safety profiles of both drugs.
A second abstract in the collection tackled a question that has long divided pediatric asthma practice: which biologic works best for children with severe disease? A team from Western University, the University of Alberta and McMaster University conducted a systematic review and meta-analysis comparing benralizumab, dupilumab, omalizumab and mepolizumab in pediatric patients with a mean age under 18 years. The researchers searched five databases from 1974 to 2025 for English-language publications, including both randomized and non-randomized studies, and ultimately pooled data from 32 studies covering 6,372 children. Asthma, the authors note, is the most common chronic respiratory disease in children, affecting approximately 14 percent of children worldwide, and successful treatment focuses on reducing acute attacks, minimizing symptoms and limiting the need for rescue medication.
The meta-analysis quantified gains in lung function and reductions in flare-ups for each biologic. The mean increase in percent predicted forced expiratory volume in one second before and after biologic treatment was 12.29 percent in the dupilumab group, with a 95 percent confidence interval of 12.13 to 12.45, and 6.04 percent in the omalizumab group, with a 95 percent confidence interval of 3.45 to 8.63. The placebo group showed a 3.45 percent increase, with a 95 percent confidence interval of 2.02 to 4.87. Annual asthma exacerbation rates fell by 2.94 exacerbations per year with omalizumab, with a 95 percent confidence interval of 3.89 to 2.00, by 2.24 exacerbations per year with dupilumab, with a 95 percent confidence interval of 2.42 to 2.07, and by 1.74 exacerbations per year with mepolizumab, with a 95 percent confidence interval of 2.04 to 1.44.
The authors of that meta-analysis concluded that multiple biologic therapies approved over the past two decades show clinical efficacy in severe childhood asthma when measured across pooled studies, while emphasizing that future research is needed to identify biomarkers and tools to personalize management plans for each patient’s specific asthma phenotype.
Safety questions also featured in the collection. Researchers from Queen's University and the Kingston Health Sciences Centre Allergy Research Unit assessed the safety of nasal allergen challenge, a controlled method to induce allergic rhinitis symptoms for mechanistic and interventional studies, in individuals with allergic rhinitis and moderate-to-severe asthma, noting that its safety in participants with moderate-to-severe asthma had not previously been assessed using their protocol. Seventeen participants, 11 allergic and 6 non-allergic, underwent nasal allergen challenge with house dust mite, ragweed, Timothy grass or birch allergen extract. The team measured total nasal symptom scores, which range from 0 to 12 and sum rhinorrhea, nasal congestion, sneezing and itchy nose, alongside a total asthma safety score ranging from 0 to 12 that sums coughing, wheezing, shortness of breath and chest tightness, plus peak expiratory flow rate and forced expiratory volume in one second, both before and up to 24 hours after the challenge.
Total nasal symptom scores were higher in allergic than non-allergic participants, with a mean difference of 2.74 points, a 95 percent confidence interval of 0.969 to 4.43 and a p value of 0.005, and significant differences at 15 minutes, 30 minutes and one hour after challenge. Total asthma safety scores were also significantly higher in allergic participants, with a mean difference of 0.684 points, a 95 percent confidence interval of 0.027 to 1.34 and a p value of 0.042, but most participants experienced only mild asthma symptoms, with seven reporting mild symptoms and two reporting none. One participant reported severe asthma symptoms, scoring 9 at 15 minutes, and was treated with salbutamol without needing further intervention. No changes were observed in forced expiratory volume in one second or peak expiratory flow rate between baseline and 24 hours after the challenge in allergic participants. The team concluded that the results support the preliminary safety of their nasal allergen challenge protocol in this population when conducted under appropriate medical supervision, which is already standard practice for nasal allergen challenge.
Subject of Research: Clinical efficacy and safety of biologic therapies and nasal allergen challenge in severe asthma and allergic rhinitis
Article Title: 2025 abstracts from the 80th Annual Scientific Meeting of the Canadian Society of Allergy and Clinical Immunology
Article References: 2025 abstracts from the 80th Annual Scientific Meeting of the Canadian Society of Allergy and Clinical Immunology. (2026). Allergy, Asthma & Clinical Immunology, 22(2), 42. https://doi.org/10.1186/s13223-026-01031-3 (Author names are not included in the publisher’s citation export.)
Image Credits: AI Generated
DOI: 10.1186/s13223-026-01031-3
Keywords: dupilumab, omalizumab, severe asthma, pediatric asthma, chronic rhinosinusitis with nasal polyps, nasal allergen challenge, meta-analysis, phase 4 trial, biologics, allergic rhinitis, lung function, exacerbations
News Source: Ophelia Keating. (November 5, 2026). Biologics, nasal challenges and head-to-head asthma data take the stage at Canadian allergy meeting. Scienmag.
