Dupilumab benefits in kids with asthma hold out to 52 weeks

Pearl Toh
28 Nov 2021
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

 

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