Abstract
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 [FeNO] ≥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 Interviewer-Administered 7-item Asthma Control Questionnaire [ACQ-7-IA] and achieving a clinically meaningful response of ≥0.5]; proportion of patients achieving well-controlled asthma or better [ACQ-7-IA ≤0.75]), effect on patients’ (Standardised Paediatric Asthma Quality of Life Questionnaire [PAQLQ[S]-IA]), and caregivers’ (Paediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ] score) 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 to −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: 61% versus 43%, p=0.0001; 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.
Funding Sanofi and Regeneron Pharmaceuticals Inc.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interests: A.G. Fiocchi has served as an advisory board member for Abbott, Danone, DBV Technologies, HiPP Organic, Novartis and Stallergenes Greer, and reports research sponsorship from Danone, Ferrero, HiPP Organic, and Sanofi.
Conflict of interests: W. Phipatanakul has served as a consultant and has received clinical trial support/medicationsupport from Genentech, GSK for Asthma Therapeutics, Merck, Regeneron Pharmaceuticals Inc., and Sanofi.
Conflict of interests: R.S. Zeiger has served as a deputy editor for AAAAI and a consultant for ACAAI, received research support from ALK, and NIH, received research support from and served as an advisory board member for AstraZeneca, Genentech/Novartis, GSK, and Teva, served as an advisory board member for Sanofi-Regeneron Pharmaceuticals Inc., and reports royalties from UpToDate.
Conflict of interests: J. Cole has no conflicts of interest to disclose.
Conflict of interests: J Msihid, J.A.Jacob-Nara, P.J. Rowe, M. Hardin, and A.H. Khan are Sanofi employees and may hold stock and/or stock options in the company.
Conflict of interests: S.R. Durrani, J. Gall, Y. Deniz, and D.J. Lederer are employees and shareholders of Regeneron Pharmaceuticals Inc.
Conflict of interests: Y. Zhang is a former employee of Regeneron and may hold shares and/or share options in the company.
- Received March 31, 2023.
- Accepted September 13, 2023.
- Copyright ©The authors 2023. For reproduction rights and permissions contact permissions{at}ersnet.org
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