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Data from the phase 4 head-to-head EVEREST trial further indicates dupilumab's benefit for type 2 inflammatory airway disease.
Dupilumab (Dupixent) provided greater improvement in both large and small airway function outcomes than omalizumab (Xolair) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and uncontrolled asthma in data presented at the American College of Chest Physicians (CHEST) 2025 Annual Meeting this week.1
The findings from the phase 4 EVEREST trial, presented during late-breaking sessions at the annual meeting, showed distinct efficacy outcomes in the 2 biologics as it relates to physiological approaches to improve asthma control and reduce exacerbations among patients with coexisting CRSwNP.
Investigators led by New York-based allergist John Oppenheimer, MD, sought to report additional lung function parameters derived from EVEREST. The original global, multicenter, randomized, active-controlled analysis was among the first head-to-head trials comparing a pair of biologic therapies with unique pathway-targeting mechanisms across a large group of participants with CRSwNP.
The original findings showed dupilumab was significantly superior to omalizumab in improvements to patients’ nasal polyp scores and University of Pennsylvania Smell Identification Test (UPSIT) at 24 weeks.2 Investigators additionally observed improved forced expiratory volume in 1 second (FEV1) by 153 mL among patients receiving dupilumab (95% CI, 52 – 255), indicating benefit to large airway function.
The fully human monoclonal antibody dupilumab inhibits interleukin 4 and 13 (IL-4; IL-13), the primary drivers of type 2 inflammation across multiple diseases; omalizumab reduces inflammation by targeting immunoglobulin E (IgE).
“Type 2 inflammation often drives the pathophysiology of both CRSwNP and asthma,” investigators wrote. “Patients with CRSwNP who have coexisting asthma are likely to have greater disease severity and higher overall disease burden. Here, we report the efficacy of dupilumab vs omalizumab for additional lung function parameters in EVEREST.”1
EVEREST included patients ≥18 years old with severe CRSwNP and coexisting uncontrolled asthma. Participants were randomized 1:1 to background mometasone furoate nasal spray and either add-on 300 mg dupilumab once every 2 weeks or 75 – 600 mg omalizuab every 2 – 4 weeks, for 24 weeks.
Oppenheimer and colleagues sought change from baseline in pre-bronchodilator forced expiratory flow (FEF) at 25 – 75% capacity — indicating small airway function — and forced vital capacity (FVC) — indicating air trapping — at weeks 12 and 24 for each treatment arm.
The total observed trial population included 181 participants receiving dupilumab and 179 receiving omalizumab. Dupilumab significantly improved pre-bronchodilator FEF capacity versus omalizumab at week 12 (least squares mean difference, 209 mL/s; 95% CI,65 – 352), and improvements were sustained through week 24 (199 mL/s; 95% CI, 42 – 357).
Investigators additionally observed significantly improved FVC in the dupilumab arm versus omalizumab arm at 12 weeks (174 mL; 95% CI, 76 – 272) and 24 weeks (185 mL; 95% CI, 73 – 298).
Dupilumab provides greater improvement than omalizumab for large and small airway lung function outcomes in patients with CRSwNP and uncontrolled coexisting asthma, which can be a surrogate for improved asthma control and reduced risk for exacerbations,” investigators concluded. “These results may aid physicians in selecting appropriate biologic therapy for patients with CRSwNP and uncontrolled asthma.”
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