PMID- 35837739
OWN - NLM
STAT- MEDLINE
DCOM- 20221011
LR  - 20221011
IS  - 1945-8932 (Electronic)
IS  - 1945-8932 (Linking)
VI  - 36
IP  - 6
DP  - 2022 Nov
TI  - Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With 
      Nasal Polyps and Asthma: EVEREST Trial Design.
PG  - 788-795
LID - 10.1177/19458924221112211 [doi]
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.
FAU - De Prado Gomez PharmD MSc, Lucia
AU  - De Prado Gomez PharmD MSc L
AUID- ORCID: 0000-0002-9464-2201
AD  - Sanofi, Reading, UK.
FAU - Khan Mbbs Mph, Asif H
AU  - Khan Mbbs Mph AH
AD  - Sanofi, Chilly-Mazarin, France.
FAU - Peters Md, Anju T
AU  - Peters Md AT
AUID- ORCID: 0000-0003-0745-2379
AD  - Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
FAU - Bachert Md PhD, Claus
AU  - Bachert Md PhD C
AD  - 26656Ghent University, Ghent, Belgium.
FAU - Wagenmann Md, Martin
AU  - Wagenmann Md M
AUID- ORCID: 0000-0002-9734-0241
AD  - University of Dusseldorf, Dusseldorf, Germany.
FAU - Heffler Md PhD, Enrico
AU  - Heffler Md PhD E
AD  - Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center 
      IRCCS, Rozzano, Milan, Italy.
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, 
      Italy.
FAU - Hopkins BMBCh, Claire
AU  - Hopkins BMBCh C
AD  - Guy's Hospital & King's College London, London, UK.
FAU - Hellings Md PhD, Peter W
AU  - Hellings Md PhD PW
AD  - 26656Ghent University, Ghent, Belgium.
AD  - University Hospitals Leuven, Leuven, Belgium.
FAU - Zhang PhD, Mei
AU  - Zhang PhD M
AD  - Sanofi, Bridgewater, New Jersey, USA.
FAU - Xing PhD, Jun
AU  - Xing PhD J
AD  - Sanofi, Bridgewater, New Jersey, USA.
FAU - Rowe Md, Paul
AU  - Rowe Md P
AD  - Sanofi, Bridgewater, New Jersey, USA.
FAU - Jacob-Nara Md Mph DHSc, Juby A
AU  - Jacob-Nara Md Mph DHSc JA
AD  - Sanofi, Bridgewater, New Jersey, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04998604
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220715
PL  - United States
TA  - Am J Rhinol Allergy
JT  - American journal of rhinology & allergy
JID - 101490775
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Biological Products)
RN  - 0 (Interleukin-13)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
RN  - 420K487FSG (dupilumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized
MH  - *Asthma/complications/drug therapy
MH  - *Biological Products
MH  - Chronic Disease
MH  - Humans
MH  - Immunoglobulin E
MH  - Interleukin-13
MH  - *Nasal Polyps/complications/drug therapy
MH  - Omalizumab/therapeutic use
MH  - *Rhinitis/complications/drug therapy
MH  - *Sinusitis/complications/drug therapy
OTO - NOTNLM
OT  - Asthma
OT  - CRSwNP
OT  - EVEREST trial
OT  - biologics
OT  - chronic rhinosinusitis with nasal polyps
OT  - dupilumab
OT  - omalizumab
OT  - phase 4
OT  - study design
OT  - type 2 inflammatory
EDAT- 2022/07/16 06:00
MHDA- 2022/10/12 06:00
CRDT- 2022/07/15 03:33
PHST- 2022/07/16 06:00 [pubmed]
PHST- 2022/10/12 06:00 [medline]
PHST- 2022/07/15 03:33 [entrez]
AID - 10.1177/19458924221112211 [doi]
PST - ppublish
SO  - Am J Rhinol Allergy. 2022 Nov;36(6):788-795. doi: 10.1177/19458924221112211. Epub 
      2022 Jul 15.