Dupilumab Induces Long-Term On-Treatment Clinical Remission in Patients With Type 2 Asthma.

Asthma Dupilumab Exacerbations Remission Type 2 inflammation

Journal

The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220

Informations de publication

Date de publication:
16 Oct 2024
Historique:
received: 23 06 2023
revised: 18 09 2024
accepted: 07 10 2024
medline: 19 10 2024
pubmed: 19 10 2024
entrez: 18 10 2024
Statut: aheadofprint

Résumé

Remission is proposed as a multicomponent outcome for patients with severe asthma. This post hoc analysis of QUEST (NCT02414854) and TRAVERSE (NCT02134028) evaluated whether dupilumab treatment leads to clinical asthma remission (≥12 months with no severe exacerbations, zero oral corticosteroids [OCS] use, stabilized or improved lung function, patient-reported asthma control <1.5) and assessed its durability in patients with uncontrolled, moderate-to-severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb at parent-study baseline) who are not on maintenance OCS. In QUEST, patients (≥12 years) were randomized to dupilumab 200/300 mg or placebo every 2 weeks (q2w) for 52 weeks. In TRAVERSE, all patients received dupilumab 300 mg q2w for up to 96 weeks. We assessed proportion of patients meeting criteria for on-treatment clinical remission up to 48 weeks of TRAVERSE. At QUEST baseline, 1040 patients receiving dupilumab and 544 on placebo had type 2 asthma; of those, 842 (dupilumab/dupilumab) and 437 (placebo/dupilumab) enrolled in TRAVERSE. At QUEST Week 52 (Year 1), 37.2% of patients receiving dupilumab met clinical remission criteria, compared with 22.2% on placebo (all P < .001). At Week 48 of TRAVERSE (Year 2 overall), 42.8% (dupilumab/dupilumab) and 33.4% (placebo/dupilumab) of patients met clinical remission criteria. Overall, 29.5% of patients in the dupilumab/dupilumab group met the criteria at both Years 1 and 2. Dupilumab treatment enabled approximately one-third of patients with type 2 asthma to meet the multicomponent endpoint for on-treatment clinical asthma remission for up to 2 years.

Sections du résumé

BACKGROUND BACKGROUND
Remission is proposed as a multicomponent outcome for patients with severe asthma.
OBJECTIVE OBJECTIVE
This post hoc analysis of QUEST (NCT02414854) and TRAVERSE (NCT02134028) evaluated whether dupilumab treatment leads to clinical asthma remission (≥12 months with no severe exacerbations, zero oral corticosteroids [OCS] use, stabilized or improved lung function, patient-reported asthma control <1.5) and assessed its durability in patients with uncontrolled, moderate-to-severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb at parent-study baseline) who are not on maintenance OCS.
METHODS METHODS
In QUEST, patients (≥12 years) were randomized to dupilumab 200/300 mg or placebo every 2 weeks (q2w) for 52 weeks. In TRAVERSE, all patients received dupilumab 300 mg q2w for up to 96 weeks. We assessed proportion of patients meeting criteria for on-treatment clinical remission up to 48 weeks of TRAVERSE.
RESULTS RESULTS
At QUEST baseline, 1040 patients receiving dupilumab and 544 on placebo had type 2 asthma; of those, 842 (dupilumab/dupilumab) and 437 (placebo/dupilumab) enrolled in TRAVERSE. At QUEST Week 52 (Year 1), 37.2% of patients receiving dupilumab met clinical remission criteria, compared with 22.2% on placebo (all P < .001). At Week 48 of TRAVERSE (Year 2 overall), 42.8% (dupilumab/dupilumab) and 33.4% (placebo/dupilumab) of patients met clinical remission criteria. Overall, 29.5% of patients in the dupilumab/dupilumab group met the criteria at both Years 1 and 2.
CONCLUSIONS CONCLUSIONS
Dupilumab treatment enabled approximately one-third of patients with type 2 asthma to meet the multicomponent endpoint for on-treatment clinical asthma remission for up to 2 years.

Identifiants

pubmed: 39424189
pii: S2213-2198(24)01063-8
doi: 10.1016/j.jaip.2024.10.009
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Ian D Pavord (ID)

NIHR Oxford Respiratory Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.

Klaus F Rabe (KF)

LungenClinic Grosshansdorf and Christian Albrechts University of Kiel, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.

Elliot Israel (E)

Harvard Medical School, Boston, MA, USA; Brigham & Women's Hospital, Boston, MA, USA.

Stanley J Szefler (SJ)

University of Colorado School of Medicine, Aurora, CO, USA.

Guy Brusselle (G)

Ghent University Hospital, Ghent, Belgium.

Nami Pandit-Abid (N)

Sanofi, Bridgewater, NJ, USA.

Arman Altincatal (A)

Sanofi, Cambridge, MA, USA.

Zhen Chen (Z)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Nikhil Amin (N)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Asif H Khan (AH)

Sanofi, Chilly-Mazarin, France.

David J Lederer (DJ)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Yi Zhang (Y)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Paul J Rowe (PJ)

Sanofi, Bridgewater, NJ, USA.

Yamo Deniz (Y)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Amr Radwan (A)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Juby A Jacob-Nara (JA)

Sanofi, Bridgewater, NJ, USA.

William W Busse (WW)

University of Wisconsin School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.

Classifications MeSH