Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION) : an open-label extension study
Copyright © 2024 Elsevier Ltd. All rights reserved..
BACKGROUND: Dupilumab efficacy and safety in children aged 6-11 years with uncontrolled, moderate-to-severe asthma were shown in the VOYAGE study-a 52-week, multinational, multicentre, phase 3 randomised, double-blind, placebo-controlled trial. We aimed to evaluate the long-term safety and efficacy of dupilumab in children with moderate-to-severe asthma who previously participated in the VOYAGE study.
METHODS: 365 of 408 children with moderate-to-severe asthma from VOYAGE enrolled in EXCURSION, a 52 week, open-label extension study conducted at 70 centres across 17 countries. 240 children continued with add-on dupilumab (dosed according to bodyweight: 100 mg for those weighing ≤30 kg and 200 mg for those weighing more than 30 kg at EXCURSION baseline) once every 2 weeks administered by subcutaneous injection (dupilumab/dupilumab group) and 125 children on placebo during VOYAGE initiated dupilumab (100 or 200 mg, according to bodyweight), once every 2 weeks administered by subcutaneous injection (placebo/dupilumab group). Following a protocol amendment, for a subset of children weighing 30 kg or less, the dose was changed to 300 mg once every 4 weeks. The primary endpoint for the open-label extension study was the number and proportion of patients with any treatment-emergent adverse event (TEAE) during the 52-week study period in the overall population (defined as children aged 6-11 years old with moderate-to-severe asthma who previously completed VOYAGE). Statistical analyses were descriptive. This study is registered with ClinicalTrials.gov (NCT03560466; EXCURSION).
FINDINGS: Children who completed VOYAGE were eligible to enrol in EXCURSION between June 21, 2018 and Aug 18, 2020. During EXCURSION, the safety profile and proportion of patients reporting TEAEs were consistent with those observed during the parent study (VOYAGE). In the overall population, 232 (63·6%) of 365 patients experienced at least one TEAE (dupilumab/dupilumab: 147 [61·3%]; placebo/dupilumab: 85 [68·0%]). The most frequently reported TEAEs were nasopharyngitis, pharyngitis, and upper respiratory tract infections.
INTERPRETATION: In EXCURSION, long-term treatment with dupilumab was well tolerated with an acceptable safety profile.
FUNDING: Sanofi and Regeneron Pharmaceuticals.
| 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 Lancet. Respiratory medicine - 12(2024), 1 vom: 10. Jan., Seite 45-54 |
| 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 19.01.2024 Date Revised 19.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT03560466 Citation Status MEDLINE |
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| doi: |
10.1016/S2213-2600(23)00303-X |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364483229 |
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| 245 | 1 | 0 | |a Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION) |b an open-label extension study |
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| 500 | |a Date Revised 19.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03560466 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Elsevier Ltd. All rights reserved. | ||
| 520 | |a BACKGROUND: Dupilumab efficacy and safety in children aged 6-11 years with uncontrolled, moderate-to-severe asthma were shown in the VOYAGE study-a 52-week, multinational, multicentre, phase 3 randomised, double-blind, placebo-controlled trial. We aimed to evaluate the long-term safety and efficacy of dupilumab in children with moderate-to-severe asthma who previously participated in the VOYAGE study | ||
| 520 | |a METHODS: 365 of 408 children with moderate-to-severe asthma from VOYAGE enrolled in EXCURSION, a 52 week, open-label extension study conducted at 70 centres across 17 countries. 240 children continued with add-on dupilumab (dosed according to bodyweight: 100 mg for those weighing ≤30 kg and 200 mg for those weighing more than 30 kg at EXCURSION baseline) once every 2 weeks administered by subcutaneous injection (dupilumab/dupilumab group) and 125 children on placebo during VOYAGE initiated dupilumab (100 or 200 mg, according to bodyweight), once every 2 weeks administered by subcutaneous injection (placebo/dupilumab group). Following a protocol amendment, for a subset of children weighing 30 kg or less, the dose was changed to 300 mg once every 4 weeks. The primary endpoint for the open-label extension study was the number and proportion of patients with any treatment-emergent adverse event (TEAE) during the 52-week study period in the overall population (defined as children aged 6-11 years old with moderate-to-severe asthma who previously completed VOYAGE). Statistical analyses were descriptive. This study is registered with ClinicalTrials.gov (NCT03560466; EXCURSION) | ||
| 520 | |a FINDINGS: Children who completed VOYAGE were eligible to enrol in EXCURSION between June 21, 2018 and Aug 18, 2020. During EXCURSION, the safety profile and proportion of patients reporting TEAEs were consistent with those observed during the parent study (VOYAGE). In the overall population, 232 (63·6%) of 365 patients experienced at least one TEAE (dupilumab/dupilumab: 147 [61·3%]; placebo/dupilumab: 85 [68·0%]). The most frequently reported TEAEs were nasopharyngitis, pharyngitis, and upper respiratory tract infections | ||
| 520 | |a INTERPRETATION: In EXCURSION, long-term treatment with dupilumab was well tolerated with an acceptable safety profile | ||
| 520 | |a FUNDING: Sanofi and Regeneron Pharmaceuticals | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 7 | |a dupilumab |2 NLM | |
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| 700 | 1 | |a de Mir, Ines |e verfasserin |4 aut | |
| 700 | 1 | |a Guilbert, Theresa W |e verfasserin |4 aut | |
| 700 | 1 | |a Jackson, Daniel J |e verfasserin |4 aut | |
| 700 | 1 | |a Staudinger, Heribert W |e verfasserin |4 aut | |
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| 700 | 1 | |a Mannent, Leda P |e verfasserin |4 aut | |
| 700 | 1 | |a Akinlade, Bolanle |e verfasserin |4 aut | |
| 700 | 1 | |a Maloney, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Tawo, Kelsey |e verfasserin |4 aut | |
| 700 | 1 | |a Khokhar, Faisal A |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Ning |e verfasserin |4 aut | |
| 700 | 1 | |a Hardin, Megan |e verfasserin |4 aut | |
| 700 | 1 | |a Abdulai, Raolat M |e verfasserin |4 aut | |
| 700 | 1 | |a Lederer, David J |e verfasserin |4 aut | |
| 700 | 1 | |a Robinson, Lacey B |e verfasserin |4 aut | |
| 700 | 0 | |a Liberty Asthma EXCURSION Investigators |e verfasserin |4 aut | |
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| 700 | 1 | |a Maspero, Jorge F |e investigator |4 oth | |
| 700 | 1 | |a Katelaris, Constance H |e investigator |4 oth | |
| 700 | 1 | |a Fiocchi, Alessandro G |e investigator |4 oth | |
| 700 | 1 | |a Gagnon, Remi |e investigator |4 oth | |
| 700 | 1 | |a De Mir, Ines |e investigator |4 oth | |
| 700 | 1 | |a Guilbert, Theresa W |e investigator |4 oth | |
| 700 | 1 | |a Jackson, Daniel J |e investigator |4 oth | |
| 700 | 1 | |a Staudinger, Heribert W |e investigator |4 oth | |
| 700 | 1 | |a Laws, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Mannent, Leda P |e investigator |4 oth | |
| 700 | 1 | |a Akinlade, Bolanle |e investigator |4 oth | |
| 700 | 1 | |a Maloney, Jennifer |e investigator |4 oth | |
| 700 | 1 | |a Tawo, Kelsey |e investigator |4 oth | |
| 700 | 1 | |a Khokhar, Faisal A |e investigator |4 oth | |
| 700 | 1 | |a Li, Ning |e investigator |4 oth | |
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| 700 | 1 | |a Lederer, David J |e investigator |4 oth | |
| 700 | 1 | |a Robinson, Lacey B |e investigator |4 oth | |
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