Dupilumab leads to better-controlled asthma and quality of life in children : the VOYAGE study
Copyright ©The authors 2023..
BACKGROUND: Dupilumab has shown long-term treatment benefits in children with uncontrolled asthma. We assessed in more detail the impact of dupilumab on asthma control and health-related quality of life (HRQoL) in children and their caregivers.
METHODS: Children aged 6-11 years with uncontrolled moderate-to-severe type 2 asthma (baseline blood eosinophils ≥150 cells·µL-1 or fractional exhaled nitric oxide ≥20 ppb; n=350) were treated with dupilumab or placebo for 52 weeks in the VOYAGE study. Primary outcomes of these analyses were asthma control (change from baseline in Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) and achieving a clinically meaningful response of ≥0.5 points); proportion of patients achieving well-controlled asthma or better (ACQ-7-IA ≤0.75 points); effect on patients' (Standardised Paediatric Asthma Quality of Life Questionnaire Interviewer-Administered (PAQLQ(S)-IA)) and caregivers' (Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)) HRQoL; and allergic rhinitis-related QoL.
RESULTS: Dupilumab versus placebo significantly improved children's ACQ-7-IA scores by week 4 with sustained improvements through week 52 (least squares mean difference at week 52: -0.44, 95% CI -0.59- -0.30; p<0.0001); a higher proportion achieved a clinically meaningful response (week 52: 86% versus 75%; p=0.0051). At weeks 24 and 52, more children who received dupilumab achieved well-controlled asthma (ACQ-7-IA ≤0.75 points: 61% versus 43%; p=0.0001 and 70% versus 46%; p<0.0001, respectively). Significant improvements in PAQLQ(S)-IA and PACQLQ scores were observed by week 52.
CONCLUSIONS: In children aged 6-11 years with moderate-to-severe type 2 asthma, dupilumab treatment was associated with rapid, sustained improvements in asthma control. HRQoL was significantly improved for children and their caregivers.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:62 |
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| Enthalten in: |
The European respiratory journal - 62(2023), 5 vom: 21. Nov. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fiocchi, Alessandro G [VerfasserIn] |
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| Links: |
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| Themen: |
420K487FSG |
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| Anmerkungen: |
Date Completed 14.11.2023 Date Revised 14.11.2023 published: Electronic-Print ClinicalTrials.gov: NCT02948959 Citation Status MEDLINE |
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| doi: |
10.1183/13993003.00558-2023 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362314535 |
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| 100 | 1 | |a Fiocchi, Alessandro G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Dupilumab leads to better-controlled asthma and quality of life in children |b the VOYAGE study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 14.11.2023 | ||
| 500 | |a Date Revised 14.11.2023 | ||
| 500 | |a published: Electronic-Print | ||
| 500 | |a ClinicalTrials.gov: NCT02948959 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright ©The authors 2023. | ||
| 520 | |a BACKGROUND: Dupilumab has shown long-term treatment benefits in children with uncontrolled asthma. We assessed in more detail the impact of dupilumab on asthma control and health-related quality of life (HRQoL) in children and their caregivers | ||
| 520 | |a METHODS: Children aged 6-11 years with uncontrolled moderate-to-severe type 2 asthma (baseline blood eosinophils ≥150 cells·µL-1 or fractional exhaled nitric oxide ≥20 ppb; n=350) were treated with dupilumab or placebo for 52 weeks in the VOYAGE study. Primary outcomes of these analyses were asthma control (change from baseline in Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) and achieving a clinically meaningful response of ≥0.5 points); proportion of patients achieving well-controlled asthma or better (ACQ-7-IA ≤0.75 points); effect on patients' (Standardised Paediatric Asthma Quality of Life Questionnaire Interviewer-Administered (PAQLQ(S)-IA)) and caregivers' (Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)) HRQoL; and allergic rhinitis-related QoL | ||
| 520 | |a RESULTS: Dupilumab versus placebo significantly improved children's ACQ-7-IA scores by week 4 with sustained improvements through week 52 (least squares mean difference at week 52: -0.44, 95% CI -0.59- -0.30; p<0.0001); a higher proportion achieved a clinically meaningful response (week 52: 86% versus 75%; p=0.0051). At weeks 24 and 52, more children who received dupilumab achieved well-controlled asthma (ACQ-7-IA ≤0.75 points: 61% versus 43%; p=0.0001 and 70% versus 46%; p<0.0001, respectively). Significant improvements in PAQLQ(S)-IA and PACQLQ scores were observed by week 52 | ||
| 520 | |a CONCLUSIONS: In children aged 6-11 years with moderate-to-severe type 2 asthma, dupilumab treatment was associated with rapid, sustained improvements in asthma control. HRQoL was significantly improved for children and their caregivers | ||
| 650 | 4 | |a Controlled Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anti-Asthmatic Agents |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a dupilumab |2 NLM | |
| 650 | 7 | |a 420K487FSG |2 NLM | |
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| 700 | 1 | |a Durrani, Sandy R |e verfasserin |4 aut | |
| 700 | 1 | |a Cole, Jeremy |e verfasserin |4 aut | |
| 700 | 1 | |a Msihid, Jérôme |e verfasserin |4 aut | |
| 700 | 1 | |a Gall, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob-Nara, Juby A |e verfasserin |4 aut | |
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| 700 | 1 | |a Zhang, Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Khan, Asif H |e verfasserin |4 aut | |
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