Dupilumab benefits in kids with asthma hold out to 52 weeks

Dupilumab significantly continues to improve lung function — including measures of the large and small airways — out to 52 weeks in children with uncontrolled, moderate-to-severe asthma, according to 52-week data of the LIBERTY ASTHMA VOYAGE trial.

“Asthma, the most prevalent chronic disease in children, can lead to abnormal lung function and be a risk factor for abnormal lung growth and chronic obstructive lung disease in adulthood,” said lead author Dr Leonard Bacharier of Vanderbilt University Medical Center in Nashville, Tennessee, US, during a presentation at the CHEST 2021 Congress.

“Type 2 inflammation is the most common driver of asthma in children,” he explained. “Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases.”

In the phase III, double-blind, LIBERTY ASTHMA VOYAGE trial, 350 children were randomized in a 2:1 ratio to receive add-on dupilumab based on body weight (200 mg or 100 mg Q2W for >30 kg or ≤30 kg, respectively) or a matching placebo for 52 weeks. Eligible patients were children aged 6–11 years who had uncontrolled, moderate-to-severe asthma with a type 2 inflammatory phenotype. [CHEST 2021;doi:10.1016/j.chest.2021.07.1677

Dupilumab led to improved pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) by an additional 0.06 L at 2 weeks (p=0.025) and 0.17 L (p<0.0001) at 52 weeks compared with placebo.

Post-BD FEV1 similarly increased by 0.09 L (p=0.015) at 52 weeks.

In addition, predicted post-BD FEV1 significantly improved by 4.37 percentage points (p=0.012) in the dupilumab arm vs the placebo arm at 52 weeks.

Similarly, improvement in FEF 25–75%*was greater in the dupilumab arm than the placebo arm (least-squares [LS] mean difference, 0.30 L/s; p<0.0001), as was percent predicted FEF 25-75% (LS mean difference, 12.02 percentage points; p<0.0001).

There was also significant increase in forced vital capacity at 52 weeks (LS mean difference, 0.10 L; p=0.007).

“Dupilumab may improve lung function in children aged 6–11 years with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory phenotype,” Bacharier concluded.  

For the study, type 2 phenotype was defined as blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide of ≥20 parts/billion at baseline.

Previously, the primary analysis has shown significant improvements with dupilumab in percent predicted pre-BD FEV1 compared with placebo at 12 weeks. The current analysis evaluated additional lung measures over the long term out to 52 weeks.

*FEF 25–75%: percentage of the predicted value for forced expiratory flow at 25–75% of forced vital capacity