TY - JOUR
T1 - Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With Nasal Polyps and Asthma
T2 - EVEREST Trial Design
AU - De Prado Gomez, PharmD, MSc, Lucia
AU - Khan, MBBS, MPH, Asif H.
AU - Peters, MD, Anju T.
AU - Bachert, MD, PhD, Claus
AU - Wagenmann, MD, Martin
AU - Heffler, MD, PhD, Enrico
AU - Hopkins, BMBCh, Claire
AU - Hellings, MD, PhD, Peter W.
AU - Zhang, PhD, Mei
AU - Xing, PhD, Jun
AU - Rowe, MD, Paul
AU - Jacob-Nara, MD, MPH, DHSc, Juby A.
N1 - Funding Information:
We thank Megan Hardin, Leda Mannent, Maria Jesus Arque of Sanofi for providing insights into the study design and protocol development. Medical Writing and editorial assistance in the development of this manuscript were provided by Geetika Kainthla (MSc). of Sanofi. This research is sponsored by Sanofi. ClinicalTrials.gov Identifiers: NCT04998604.
Publisher Copyright:
© The Author(s) 2022.
PY - 2022/11
Y1 - 2022/11
N2 - 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.
AB - 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.
KW - Asthma
KW - CRSwNP
KW - EVEREST trial
KW - biologics
KW - chronic rhinosinusitis with nasal polyps
KW - dupilumab
KW - omalizumab
KW - phase 4
KW - study design
KW - type 2 inflammatory
UR - http://www.scopus.com/inward/record.url?scp=85134345797&partnerID=8YFLogxK
U2 - 10.1177/19458924221112211
DO - 10.1177/19458924221112211
M3 - Article
C2 - 35837739
AN - SCOPUS:85134345797
SN - 1945-8924
VL - 36
SP - 788
EP - 795
JO - American Journal of Rhinology and Allergy
JF - American Journal of Rhinology and Allergy
IS - 6
ER -