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Dupilumab Improves Quality of Life in Caregivers of Children with Uncontrolled Moderate-to-Severe Asthma: Liberty Asthma Voyage Study

Speaker(s)

Fiocchi AG1, Phipatanakul W2, Durrani S3, Cole J4, Msihid J5, Lederer DJ6, Hardin M7, Zhang Y6, Khan AH5
1Bambino Gesù Children’s Hospital IRCCS, Rome, RM, Italy, 2Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA, 3Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA, 4OK Clinical Research, Edmond, OK, USA, 5Sanofi, Chilly-Mazarin, France, 6Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 7Sanofi, Cambridge, MA, USA

OBJECTIVES: Children with uncontrolled treatment-refractory asthma have poor quality of life (QoL), which also affects their caregivers. Dupilumab blocks interleukin (IL)-4/IL-13 signaling, key and central drivers of type 2 inflammation. In VOYAGE, a 52-week (wk), randomized, double-blind, placebo-controlled phase–3 study (NCT02948959), add-on dupilumab demonstrated efficacy/safety in children aged 6–11 years with uncontrolled moderate-to-severe type 2 asthma. This analysis assessed QoL in caregivers of pediatric participants in VOYAGE.

METHODS: Caregivers of children aged 7–11 years, who received add-on dupilumab or matched placebo by bodyweight, completed the pediatric asthma caregiver QoL questionnaire (PACQLQ) over the study-period. PACQLQ global scores (range 1–7; higher scores indicate better QoL) were analyzed for caregivers of children with type 2 asthma (baseline blood eosinophils ≥150cells/µL or FeNO ≥20ppb; n=318) or with baseline eosinophils ≥300cells/µL (n=239) with post hoc analysis for caregivers of children with comorbid allergic rhinitis (AR) in both groups.

RESULTS: At baseline, 25% of caregivers reported their work was impacted a lot by the child’s asthma. For caregivers of dupilumab- vs placebo-treated children with type 2 asthma, global PACQLQ scores significantly improved by Wk36 and onwards (LS mean difference [LSMD] [95% CI] in change from baseline: 0.40 [0.16;0.64] P=0.0013) and by Wk12 and onwards in caregivers of children with baseline eosinophils ≥300cells/µL (LSMD [95% CI]: 0.34 [0.01;0.67], P=0.0445). Comorbid AR was observed in 77% and 81% of children with type 2 asthma and baseline eosinophils ≥300cells/µL, respectively. For caregivers of these children PACQLQ global score significantly improved as early as Wk12 (type 2-LSMD [95% CI]: 0.41 [0.11;0.72] P=0.0084; eosinophils ≥300cells/µL-LSMD [95% CI]: 0.46 [0.10;0.82] P=0.0127) and beyond for caregivers of dupilumab- vs placebo-treated children.

CONCLUSIONS: Dupilumab treatment of children aged 7-11 years with moderate-to-severe type 2 asthma, including patients with comorbid AR, may improve QoL in the caregivers of these children.

Code

CO159

Topic

Clinical Outcomes, Economic Evaluation, Epidemiology & Public Health

Topic Subcategory

Budget Impact Analysis, Clinical Outcomes Assessment, Safety & Pharmacoepidemiology

Disease

Respiratory-Related Disorders