Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With Nasal Polyps and Asthma: EVEREST Trial Design
| Autor: | Lucia De Prado Gomez, PharmD, MSc, Asif H. Khan, MBBS, MPH, Anju T. Peters, MD, Claus Bachert, MD, PhD, Martin Wagenmann, MD, Enrico Heffler, MD, PhD, Claire Hopkins, BMBCh, Peter W. Hellings, MD, PhD, Mei Zhang, PhD, Jun Xing, PhD, Paul Rowe, MD, Juby A. Jacob-Nara, MD, MPH, DHSc |
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| Přispěvatelé: | Ear, Nose and Throat |
| Rok vydání: | 2022 |
| Předmět: |
Adult
Biological Products Interleukin-13 CRSwNP General Medicine Immunoglobulin E Antibodies Monoclonal Humanized EVEREST trial chronic rhinosinusitis with nasal polyps Asthma Nasal Polyps study design Otorhinolaryngology dupilumab Chronic Disease phase 4 type 2 inflammatory Humans omalizumab Immunology and Allergy biologics Sinusitis Rhinitis |
| Zdroj: | American journal of rhinology & allergy, 36(6), 788-795. OceanSide Publications Inc. |
| ISSN: | 1945-8932 1945-8924 |
| DOI: | 10.1177/19458924221112211 |
| Popis: | Background Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are chronic type 2 inflammatory diseases that are frequently associated with each other. Dupilumab inhibits the dual signaling pathways of interleukin (IL)-4 and IL-13, which are key and central drivers of type 2 inflammation in CRSwNP. Omalizumab blocks the action of immunoglobulin E. Head-to-head studies are required to investigate the comparative efficacy and safety of these interventions. EVEREST (EValuating trEatment RESponses of dupilumab vs omalizumab in Type 2 patients) trial is designed to evaluate whether the efficacy of dupilumab is superior to omalizumab in treating patients with CRSwNP and comorbid asthma (ClinicalTrials.gov Identifiers: NCT04998604). Objective Here, we describe the EVEREST study design to compare the efficacy and safety of dupilumab compared to omalizumab over 24 weeks of treatment in patients with severe CRSwNP and comorbid asthma. Methods EVEREST is a global, phase 4 multicenter, randomized (1:1), double-blind, active-controlled trial. Approximately 422 adult patients with severe CRSwNP, symptoms of nasal congestion and loss of smell, and coexisting asthma will be recruited across 15 countries. The primary objective is to assess the efficacy of dupilumab compared to omalizumab in reducing the nasal polyp size and improving the sense of smell. The key secondary objectives are to evaluate the comparative efficacy in improving CRSwNP symptoms (eg, nasal congestion) and lung function. The safety will be evaluated in terms of treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest. Conclusions 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. The study will provide evidence to help optimize treatment plans for patients that suffer from severe CRSwNP and comorbid asthma. |
| Databáze: | OpenAIRE |
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