Dupixent outperforms Xolair in treating chronic rhinosinusitis with nasal polyps and asthma.

Dupixent (dupilumab) demonstrated superiority over Xolair (omalizumab) in a phase 4 head-to-head study for chronic rhinosinusitis with nasal polyps and coexisting asthma. Dupixent outperformed Xolair across all primary and secondary efficacy endpoints for CRSwNP and asthma, including improvements in nasal polyp size, sense of smell, lung function, and disease control. The results reinforce Dupixent's efficacy in targeting IL-4 and IL-13, key drivers of type 2 inflammation in both upper and lower respiratory diseases.

Title: Dupixent Demonstrates Superiority Over Xolair in Chronic Rhinosinusitis with Nasal Polyps and Coexistent Asthma

Paris and Tarrytown, NY, June 15, 2025 - Sanofi and Regeneron Pharmaceuticals, Inc. presented compelling results from the EVEREST phase 4 study, demonstrating that Dupixent (dupilumab) outperformed Xolair (omalizumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP) and coexistent asthma. The study, presented at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Glasgow, UK, highlighted Dupixent's efficacy in both upper and lower respiratory diseases by targeting IL-4 and IL-13, two key drivers of type 2 inflammation.

The EVEREST study, a randomized, double-blind phase 4 trial, compared the efficacy and safety of Dupixent and Xolair in adults with severe, uncontrolled CRSwNP and coexistent asthma. Dupixent 300 mg was administered every two weeks, while Xolair was dosed based on body weight and serum total IgE levels, every two or four weeks. Both treatments were added to background mometasone furoate nasal spray (MFNS).

Key findings from the study include:

- Primary and Secondary Endpoints: Dupixent outperformed Xolair across all primary and secondary endpoints for CRSwNP, including a 1.60-point superior reduction in nasal polyp size and an 8.0-point superior improvement in the ability to identify different smells. Dupixent also demonstrated a 0.58-point superior reduction in nasal congestion/obstruction and a 0.81-point superior improvement in loss of smell.
- Asthma Endpoints: Dupixent showed a 150 mL difference in lung function (pre-bronchodilator FEV1) and a 0.48-point difference in asthma control compared to Xolair.
- Safety Profile: The safety results were generally consistent with the known safety profile of Dupixent, with similar overall rates of adverse events (AEs) observed between Dupixent (64%) and Xolair (67%). Serious AEs were reported in 2% and 4% of patients treated with Dupixent and Xolair, respectively.

These results reinforce Dupixent's efficacy in targeting IL-4 and IL-13, which are central drivers of type 2 inflammation in multiple related and often co-morbid diseases. The study provides important insights that will guide patients and physicians through treatment decision-making processes.

References:
[1] https://www.globenewswire.com/news-release/2025/06/15/3099494/0/en/Press-Release-EAACI-Dupixent-demonstrated-superiority-over-Xolair-omalizumab-in-chronic-rhinosinusitis-with-nasal-polyps-in-patients-with-coexistent-asthma-in-first-ever-presented-.html