Dupilumab leads to better-controlled asthma & quality of life in children: the VOYAGE study.

Abstract

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. 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. 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. 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. Sanofi and Regeneron Pharmaceuticals Inc.