Dupilumab Improves Lung Function Parameters in Pediatric Type 2 Asthma : VOYAGE Study
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for IL-4 and IL-13, key drivers of type 2 inflammation.
OBJECTIVE: To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959).
METHODS: Children with asthma were randomized 2:1 to add-on dupilumab 100/200 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline) and within subgroups defined by baseline blood eosinophils or FeNO values.
RESULTS: A total of 116 (49%) dupilumab-treated children and 59 (52%) on placebo had impaired lung function (prebronchodilator percent-predicted forced expiratory volume in 1 second [ppFEV1] <80%) at baseline. Dupilumab improved pre- and postbronchodilator ppFEV1 as early as week 2, sustained for up to 52 weeks (least-squares mean difference vs placebo at week 52: 7.79 percentage points; 95% confidence interval [CI]: 4.36-11.22; P < .001 and 4.37 points; 95% CI: 0.95-7.78; P = .01, respectively). Sustained improvements were also observed in other lung function parameters, including pre- and postbronchodilator forced vital capacity (FVC), prebronchodilator forced expiratory flow, and FEV1/FVC ratio across all populations.
CONCLUSIONS: Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
The journal of allergy and clinical immunology. In practice - 12(2024), 4 vom: 13. Apr., Seite 948-959 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bacharier, Leonard B [VerfasserIn] |
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| Links: |
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| Themen: |
420K487FSG |
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| Anmerkungen: |
Date Completed 09.04.2024 Date Revised 26.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT02948959 Citation Status MEDLINE |
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| doi: |
10.1016/j.jaip.2023.12.006 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365829293 |
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| 100 | 1 | |a Bacharier, Leonard B |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Dupilumab Improves Lung Function Parameters in Pediatric Type 2 Asthma |b VOYAGE Study |
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| 500 | |a Date Completed 09.04.2024 | ||
| 500 | |a Date Revised 26.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02948959 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for IL-4 and IL-13, key drivers of type 2 inflammation | ||
| 520 | |a OBJECTIVE: To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959) | ||
| 520 | |a METHODS: Children with asthma were randomized 2:1 to add-on dupilumab 100/200 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline) and within subgroups defined by baseline blood eosinophils or FeNO values | ||
| 520 | |a RESULTS: A total of 116 (49%) dupilumab-treated children and 59 (52%) on placebo had impaired lung function (prebronchodilator percent-predicted forced expiratory volume in 1 second [ppFEV1] <80%) at baseline. Dupilumab improved pre- and postbronchodilator ppFEV1 as early as week 2, sustained for up to 52 weeks (least-squares mean difference vs placebo at week 52: 7.79 percentage points; 95% confidence interval [CI]: 4.36-11.22; P < .001 and 4.37 points; 95% CI: 0.95-7.78; P = .01, respectively). Sustained improvements were also observed in other lung function parameters, including pre- and postbronchodilator forced vital capacity (FVC), prebronchodilator forced expiratory flow, and FEV1/FVC ratio across all populations | ||
| 520 | |a CONCLUSIONS: Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Asthma control | |
| 650 | 4 | |a Dupilumab | |
| 650 | 4 | |a Lung function | |
| 650 | 4 | |a Pediatric asthma | |
| 650 | 4 | |a Type 2 inflammation | |
| 650 | 7 | |a dupilumab |2 NLM | |
| 650 | 7 | |a 420K487FSG |2 NLM | |
| 650 | 7 | |a Anti-Asthmatic Agents |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 700 | 1 | |a Guilbert, Theresa W |e verfasserin |4 aut | |
| 700 | 1 | |a Katelaris, Constance H |e verfasserin |4 aut | |
| 700 | 1 | |a Deschildre, Antoine |e verfasserin |4 aut | |
| 700 | 1 | |a Phipatanakul, Wanda |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Dongfang |e verfasserin |4 aut | |
| 700 | 1 | |a Altincatal, Arman |e verfasserin |4 aut | |
| 700 | 1 | |a Mannent, Leda P |e verfasserin |4 aut | |
| 700 | 1 | |a Amin, Nikhil |e verfasserin |4 aut | |
| 700 | 1 | |a Laws, Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Akinlade, Bolanle |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob-Nara, Juby A |e verfasserin |4 aut | |
| 700 | 1 | |a Deniz, Yamo |e verfasserin |4 aut | |
| 700 | 1 | |a Rowe, Paul J |e verfasserin |4 aut | |
| 700 | 1 | |a Lederer, David J |e verfasserin |4 aut | |
| 700 | 1 | |a Hardin, Megan |e verfasserin |4 aut | |
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