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Dupilumab Outperforms Omalizumab in First Head-to-Head Respiratory Study for CRSwNP with Comorbid Asthma
The phase 4 EVEREST study showed statistically significant improvements in polyp size reduction and smell identification ability as early as 4 weeks of treatment.
Dupilumab (Dupixent; Sanofi) demonstrated superiority over omalizumab (Xolair; Novartis) across all primary and secondary efficacy endpoints in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma, according to results from the first-ever head-to-head respiratory study with biologic medicines.1
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Findings were presented at the 2025 European Academy of Allergy and Clinical Immunology Annual Congress, June 13-16, 2025, in Glasgow, United Kingdom and announced in a June 15 press statement from dupilumab developer Sanofi.1
The phase 4 EVEREST study showed that dupilumab achieved statistically significant improvements in nasal polyp size reduction (1.60-point superior reduction, P <.001) and smell identification ability (8.0-point superior improvement, P <.001) compared to omalizumab at 24 weeks, with benefits observed as early as 4 weeks.1
"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. What's more, a majority of these individuals also have asthma that can substantially impact their quality of life," Eugenio De Corso, MD, PhD, ENT Specialist at A. Gemelli University Hospital Foundation, IRCSS, Rome, Italy, and lead investigator of the study, said in a statement. "EVEREST is the first-ever trial to demonstrate the superiority of [dupilumab] over [omalizumab] on CRSwNP endpoints in patients with coexisting asthma, along with generally similar safety profiles."1
Dupilumab is a fully human monoclonal antibody (mAb) that inhibits interleukin-4 (IL-4) and IL-13 signaling pathways, targeting key drivers of type 2 (Th2) )inflammation that play a major role in multiple related and often comorbid diseases affecting both upper and lower respiratory tract.1 CRSwNP affects approximately half of individuals with severe eosinophilic asthma, characterized by Th2 inflammation. A better understanding of the link between the two inflammatory diseases is of particular interest given that their coexistence can be managed with the same mAbs, experts point out.2
EVEREST Phase 4 Study
The randomized, double-blind phase 4 study enrolled 360 adults with severe, uncontrolled CRSwNP and coexisting mild, moderate, or severe asthma. Participants were randomly assigned to receive either dupilumab 300 mg every 2 weeks (n=181) or weight- and immunoglobulin E (IgE) level-based dosing of omalizumab 75-600 mg every 2 to 4 weeks (n=179). Both treatments were administered alongside background mometasone furoate nasal spray.1
Beyond the primary endpoints, dupilumab demonstrated significant superiority in multiple secondary measures of CRSwNP severity at 24 weeks (P <.001 for all):
- Nasal congestion/obstruction: 0.58-point superior reduction
- Loss of smell: 0.81-point superior improvement
- Symptom severity: 1.74-point superior reduction
- Health-related quality of life: 12.7-point difference
- Peak nasal inspiratory flow: 31.27-point difference
- Overall rhinosinusitis severity: 1.87 difference
In the coexisting asthma population, dupilumab also outperformed omalizumab on respiratory function measures:
- Pre-bronchodilator FEV1: 150 mL difference (P =.003)
- Asthma control: 0.48-point difference (P <.001)
These improvements were similarly observed as early as 4 weeks into treatment.1
The safety results were generally consistent with dupilumab's known profile in approved respiratory indications. Overall adverse event (AE) rates were similar between treatment groups (64% for dupilumab vs 67% for omalizumab). Serious AEs occurred in 2% of dupilumab-treated participants vs 4% of omalizumab-treated participants, while adverse events leading to study discontinuation were reported in 3% and 1% of participants, respectively.1
The EVEREST results provide the first direct comparison between 2 approved biologics for CRSwNP in adults with concurrent asthma, a common comorbidity. The study addresses a significant unmet need in clinical decision-making for this population, Sanofi noted in the statement, and reinforces the efficacy of dupilumab in treating both upper and lower respiratory disease.
De Corso the current outcomes "provide important insights that will help guide patients and physicians through the treatment decision-making process."1
