Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma.
Activities of Daily Living
Anti-Asthmatic Agents
/ therapeutic use
Antibodies, Monoclonal
/ therapeutic use
Antibodies, Monoclonal, Humanized
Asthma
/ drug therapy
Female
Humans
Interleukin-4 Receptor alpha Subunit
/ antagonists & inhibitors
Male
Middle Aged
Patient Reported Outcome Measures
Placebos
/ administration & dosage
Quality of Life
/ psychology
Surveys and Questionnaires
Treatment Outcome
Journal
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
ISSN: 1534-4436
Titre abrégé: Ann Allergy Asthma Immunol
Pays: United States
ID NLM: 9503580
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
03
04
2018
revised:
07
08
2018
accepted:
13
08
2018
pubmed:
24
8
2018
medline:
17
10
2019
entrez:
24
8
2018
Statut:
ppublish
Résumé
In a pivotal, phase 2b study (NCT01854047) in patients with uncontrolled persistent asthma, despite using medium-to-high-dose inhaled corticosteroids plus long-acting β2 agonists, dupilumab improved lung function, reduced severe exacerbations, and showed an acceptable safety profile. To assess the impact of dupilumab on asthma control, symptoms, quality of life (QoL), and productivity. Data are shown for the intention-to-treat population receiving dupilumab 200/300 mg every 2 weeks (doses being assessed in phase 3; NCT02414854), or placebo. Predefined analyses of total scores were conducted at week 24 for the 5-item Asthma Control Questionnaire (ACQ-5), patient-reported morning/evening (AM/PM) asthma symptoms, Asthma Quality of Life Questionnaire (AQLQ), and asthma-related productivity loss. Responder rate analyses for these measures, subgroup analyses by baseline characteristics, and asthma-related productivity loss analyses were conducted post hoc. Data from 465 patients were analyzed (158 placebo; 307 dupilumab). Both dupilumab doses significantly improved scores through week 24 (all outcomes, overall population). The proportion of patients meeting or exceeding the minimal clinically important difference for the overall population were significantly greater vs placebo (P < .05) for ACQ-5 (range, 72.6%-76.7% vs 61.4%), for AM/PM asthma symptoms score (48.7%-54.1% vs 34.2% and 52.7%-53.5% vs 34.2%, respectively) and for AQLQ (64.0%-65.0% vs 51.3%). The effect of dupilumab was consistent across most subgroups. Productivity loss was significantly higher in placebo- vs dupilumab-treated patients (P < .0001). Dupilumab produced significant, clinically meaningful improvements in asthma control, symptoms, QoL, and productivity. ClinicalTrials.gov Identifier: NCT01854047.
Sections du résumé
BACKGROUND
In a pivotal, phase 2b study (NCT01854047) in patients with uncontrolled persistent asthma, despite using medium-to-high-dose inhaled corticosteroids plus long-acting β2 agonists, dupilumab improved lung function, reduced severe exacerbations, and showed an acceptable safety profile.
OBJECTIVE
To assess the impact of dupilumab on asthma control, symptoms, quality of life (QoL), and productivity.
METHODS
Data are shown for the intention-to-treat population receiving dupilumab 200/300 mg every 2 weeks (doses being assessed in phase 3; NCT02414854), or placebo. Predefined analyses of total scores were conducted at week 24 for the 5-item Asthma Control Questionnaire (ACQ-5), patient-reported morning/evening (AM/PM) asthma symptoms, Asthma Quality of Life Questionnaire (AQLQ), and asthma-related productivity loss. Responder rate analyses for these measures, subgroup analyses by baseline characteristics, and asthma-related productivity loss analyses were conducted post hoc.
RESULTS
Data from 465 patients were analyzed (158 placebo; 307 dupilumab). Both dupilumab doses significantly improved scores through week 24 (all outcomes, overall population). The proportion of patients meeting or exceeding the minimal clinically important difference for the overall population were significantly greater vs placebo (P < .05) for ACQ-5 (range, 72.6%-76.7% vs 61.4%), for AM/PM asthma symptoms score (48.7%-54.1% vs 34.2% and 52.7%-53.5% vs 34.2%, respectively) and for AQLQ (64.0%-65.0% vs 51.3%). The effect of dupilumab was consistent across most subgroups. Productivity loss was significantly higher in placebo- vs dupilumab-treated patients (P < .0001).
CONCLUSION
Dupilumab produced significant, clinically meaningful improvements in asthma control, symptoms, QoL, and productivity.
REGISTRATION
ClinicalTrials.gov Identifier: NCT01854047.
Identifiants
pubmed: 30138668
pii: S1081-1206(18)30665-3
doi: 10.1016/j.anai.2018.08.005
pii:
doi:
Substances chimiques
Anti-Asthmatic Agents
0
Antibodies, Monoclonal
0
Antibodies, Monoclonal, Humanized
0
IL4R protein, human
0
Interleukin-4 Receptor alpha Subunit
0
Placebos
0
dupilumab
420K487FSG
Banques de données
ClinicalTrials.gov
['NCT01854047', 'NCT02414854']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
41-49.e2Informations de copyright
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.