Dupilumab improves asthma control, quality of life in children

Dupilumab significantly improved asthma control and quality of life among children aged 6 to 11 years with uncontrolled moderate to severe asthma, researchers reported at the virtual European Respiratory Society International Congress.

“Despite optimizing the standard of care therapy, the prevalence of asthma that remains uncontrollable is still high in children,” Alessandro G. Fiocchi, MD, director of allergy at Bambino Gesù Children’s Hospital (IRCCS) in Rome, said during a presentation. “We assessed the impact of dupilumab in improving asthma control and health-related quality of life in this study.”

The 52-week, randomized, double-blind, phase 3 LIBERTY ASTHMA VOYAGE study enrolled children aged 6 to 11 years with uncontrolled moderate to severe asthma. Patients were randomly assigned to receive add-on dupilumab (Dupixent, Sanofi/Regeneron) at 100 mg or 200 mg depending on body weight or matching placebo every 2 weeks for 52 weeks. Patients were on background therapy including a medium-dose inhaled corticosteroid (ICS) with second controller medication or a high-dose ICS alone or high-dose ICS with a second controller medication for at least 3 months with a stable dose at least 1 month before screening.

Researchers evaluated two primary efficacy populations: children with baseline blood eosinophil counts of 150 cells/µL or greater or a fractional exhaled nitric oxide (FeNO) level of 20 parts per billion or more (type 2 population) and children with baseline blood eosinophil counts of 300 cells/µL or more.

Asthma control was assessed via the interview-administered seven-item Asthma Control Questionnaire (ACQ-7-IA) and disease-specific health-related quality of life was assessed via the interview-administered Pediatric Asthma Quality of Life Questionnaire (PAQLQ[S]-IA) with standardized activities.

Compared with placebo, dupilumab resulted in a significant and rapid improvement in asthma control by week 4, Fiocchi said. This improvement was sustained through 52 weeks.

Significantly more children assigned dupilumab, compared with placebo, had a clinically significant improvement in asthma control (ACQ-7-IA score change 0.5) and achieved well-controlled asthma (ACQ-7-IA score 0.75) by week 24 and week 52. In the type 2 population, there was a clinically significant improvement in asthma control in 79.2% vs. 69.3% at week 24 (OR = 1.82; 95% CI, 1.02-3.24) and 86.4% vs. 74.6% at week 52 (OR = 2.57; 95% CI, 1.33-4.98) and well-controlled asthma in 61% vs. 43% at week 24 (OR = 2.23; 95% CI, 1.38-3.61) and 69.5% vs. 45.6% at week 52 (OR = 3; 95% CI, 1.79-5.01). In children with blood eosinophils 300 cells/µL, there was a clinically significant improvement in asthma control in 80.6% vs. 64.3% at week 24 (OR = 2.79; 95% CI, 1.43-5.44) and 86.9% vs. 70.2% at week 52 (OR = 3.67; 95% CI, 1.7-7.94) and well-controlled asthma in 60% vs. 38.1% at week 24 (OR = 2.65; 95% CI, 1.5-4.68) and 67.4% vs. 40.5% at week 52 (OR = 3.29; 95% CI, 1.78-6.07), according to the results.

Dupilumab, compared with placebo, was also associated with improvements in quality of life, based on change from baseline in disease-specific health-related quality of life PAQLQ[S]-IA scores, by week 52 in the type 2 population (P < .001) and in the population with baseline blood eosinophils 300 cells/µL (P < .01).

Dupilumab, compared with placebo, significantly improved quality of life across all domains, including symptom score, activity limitation and emotional function, Fiocchi said.

“In conclusion, dupilumab significantly improved asthma control and quality of life compared with placebo in children with uncontrolled moderate to severe asthma and greater proportions of patients achieved clinically meaningful improvements in asthma control and disease-specific health-related quality of life across all domains,” Fiocchi said. “These improvements in asthma control and quality of life were rapid and sustained until week 52.”

Healio previously reported other outcomes of the LIBERTY ASTHMA VOYAGE study that demonstrated dupilumab reduced severe asthma exacerbations and improved lung function in children aged 6 to 11 years with uncontrolled moderate to severe asthma and evidence of type 2 inflammation.