Dupilumab 200 mg was efficacious in children (6-11 years) with moderate-to-severe asthma for up to 2 years: EXCURSION open-label extension study.
Pediatric asthma
exacerbations
lung function
prebronchodilator FEV1
Journal
Pediatric pulmonology
ISSN: 1099-0496
Titre abrégé: Pediatr Pulmonol
Pays: United States
ID NLM: 8510590
Informations de publication
Date de publication:
17 Jul 2024
17 Jul 2024
Historique:
revised:
07
06
2024
received:
14
02
2024
accepted:
25
06
2024
medline:
17
7
2024
pubmed:
17
7
2024
entrez:
17
7
2024
Statut:
aheadofprint
Résumé
The phase 3 VOYAGE (NCT02948959) and open-label extension EXCURSION (NCT03560466) studies evaluated dupilumab in children (6-11 years) with uncontrolled moderate-to-severe asthma. This post hoc analysis assessed the efficacy and safety of add-on dupilumab 200 mg every 2 weeks (q2w), the largest dose cohort in both studies, in children from VOYAGE who participated in EXCURSION. Annualized rate of severe asthma exacerbations (AERs), change in prebronchodilator percent predicted forced expiratory volume in 1 s (ppFEV In the overall population, dupilumab reduced AER and improved prebronchodilator ppFEV In children (6-11 years) with uncontrolled moderate-to-severe type 2 asthma, dupilumab 200 mg reduced exacerbation rates and improved lung function for up to 2 years and showed safety consistent with the known dupilumab safety profile.
Sections du résumé
BACKGROUND
BACKGROUND
The phase 3 VOYAGE (NCT02948959) and open-label extension EXCURSION (NCT03560466) studies evaluated dupilumab in children (6-11 years) with uncontrolled moderate-to-severe asthma. This post hoc analysis assessed the efficacy and safety of add-on dupilumab 200 mg every 2 weeks (q2w), the largest dose cohort in both studies, in children from VOYAGE who participated in EXCURSION.
METHODS
METHODS
Annualized rate of severe asthma exacerbations (AERs), change in prebronchodilator percent predicted forced expiratory volume in 1 s (ppFEV
RESULTS
RESULTS
In the overall population, dupilumab reduced AER and improved prebronchodilator ppFEV
CONCLUSION
CONCLUSIONS
In children (6-11 years) with uncontrolled moderate-to-severe type 2 asthma, dupilumab 200 mg reduced exacerbation rates and improved lung function for up to 2 years and showed safety consistent with the known dupilumab safety profile.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Regeneron Pharmaceuticals Inc.
Organisme : Sanofi
Informations de copyright
© 2024 Sanofi and The Author(s). Pediatric Pulmonology published by Wiley Periodicals LLC.
Références
Centers for Disease Control and Prevention. Most Recent National Asthma Data. Centers for Disease Control and Prevention; 2023. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Global Initiative for Asthma; 2024. https://ginasthma.org/2024-report/
Serebrisky D, Wiznia A. Pediatric asthma. A global epidemic. Ann Glob Health. 2019;85(1):6.
Bui DS, Walters HE, Burgess JA, et al. Childhood respiratory risk factor profiles and middle‐age lung function: a prospective cohort study from the first to sixth decade. Ann Am Thorac Soc. 2018;15(9):1057‐1066.
Fahy JV. Type 2 inflammation in asthma—present in most, absent in many. Nat Rev Immunol. 2015;15(1):57‐65.
Macdonald LE, Karow M, Stevens S, et al. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes. Proc Natl Acad Sci USA. 2014;111(14):5147‐5152.
Murphy AJ, Macdonald LE, Stevens S, et al. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad Sci USA. 2014;111(14):5153‐5158.
Gandhi NA, Pirozzi G, Graham NMH. Commonality of the IL‐4/IL‐13 pathway in atopic diseases. Expert Rev Clin Immunol. 2017;13(5):425‐437.
Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discovery. 2016;15(1):35‐50.
Le Floc'h A, Allinne J, Nagashima K, et al. Dual blockade of IL‐4 and IL‐13 with dupilumab, an IL‐4Rα antibody, is required to broadly inhibit type 2 inflammation. Allergy. 2020;75(5):1188‐1204.
Bacharier LB, Maspero JF, Katelaris CH, et al. Dupilumab in children with uncontrolled moderate‐to‐severe asthma. N Engl J Med. 2021;385(24):2230‐2240.
Bacharier LB, Maspero JF, Katelaris CH, et al. Assessment of long‐term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open‐label extension study. Lancet Respir Med. 2023;12(1):45‐54.
DUPIXENT® (dupilumab). Summary of Product Characteristics. European Medicines Agency. Accessed November 30, 2023. https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
Juniper EF, O′Byrne PM, Guyatt G, Ferrie P, King D. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14(4):902‐907.
Roncada C, Mattiello R, Pitrez PM, Sarria EE. Specific instruments to assess quality of life in children and adolescents with asthma. J Pediatr (Rio J). 2013;89(3):217‐225.
Stelmach I, Podlecka D, Smejda K, et al. Pediatric asthma caregiver's quality of life questionnaire is a useful tool for monitoring asthma in children. Qual Life Res. 2012;21(9):1639‐1642.
XOLAIR (omalizumab). Highlights of Prescribing Information. Genentech Inc; 2003. https://www.gene.com/download/pdf/xolair_prescribing.pdf
DUPIXENT® (dupilumab). Highlights of Prescribing Information. US Food and Drug Administration. https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf
NUCALA (mepolizumab). Highlights of Prescribing Information. GlaxoSmithKline LLC; 2023. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF
Akar‐Ghibril N, Casale T, Custovic A, Phipatanakul W. Allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8(2):429‐440.
Bacharier LB, Maspero JF, Katelaris CH, et al. Assessment of the long‐term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION Study). Chest. 2022;162(suppl 4):A2677‐A2679.