Dupilumab improves lung function in children with moderate-to-severe type 2 asthma

Treatment with dupilumab significantly improved lung function in children with moderate-to-severe type 2 asthma compared with placebo, according to two post hoc analyses presented at ERS 2023.

The VOYAGE study analysed 315 children aged 6–11 years with uncontrolled, moderate-to-severe asthma and evidence of type 2 inflammation (blood eosinophil count of ≥150 cells/µL and fractional exhaled nitric oxide level of ≥20 parts per billion). Participants were randomly assigned to receive either dupilumab 100 or 200 mg based on body weight (n=208) or placebo (n=107) every 2 weeks for 52 weeks. [ERS 2023, abstract PA2090]

A significantly improved ppFEV₁* was observed with dupilumab vs placebo at week 12 (least square [LS] mean difference from baseline, 5.20; p=0.0009), which was sustained at week 52 (LS mean difference from baseline, 7.79; p<0.0001).

By week 12, a higher percentage of patients treated with dupilumab achieved ≥5 percent (59.7 percent vs 50.0 percent) or ≥10 percent improvement in ppFEV₁ (44.9 percent vs 31.6 percent) than those treated with placebo.

Dupilumab-treated patients who met the improvement threshold of ≥5 or ≥10 percent in ppFEV₁ also achieved 60-percent (p<0.01) and 59-percent (p<0.05) reductions in the annualized rate of severe exacerbations than placebo-treated patients.

“Overall, more patients treated with dupilumab than with placebo met the ppFEV₁ responder criteria (defined as ≥5 or ≥10 percent improvement in ppFEV₁) at week 12, leading to improved lung function and decreased severe exacerbation rates,” said lead author Dr Theresa Guilbert from Cincinnati Children's Hospital and University of Cincinnati, Ohio, US.

VOYAGE extension study

The EXCURSION study was conducted to assess the long-term effects of dupilumab on lung function in children with uncontrolled asthma who had previously participated in the VOYAGE study. All participants were given dupilumab 100 or 200 mg every 2 weeks for an additional 52 weeks. [ERS 2023, abstract PA2091]

“Patients who received placebo in the VOYAGE study showed a rapid improvement in lung function upon initiation of dupilumab in the EXCURSION study, and this was sustained through the 52-week EXCURSION study,” said Dr Leonard Bacharier from Monroe Carell Jr Children's Hospital at Vanderbilt University Medical Center in Nashville, Tennessee, US, who presented the study.

In children with moderate-to-severe type 2 asthma, dupilumab treatment led to sustained improvements in ppFEV₁ through week 104, regardless of time since asthma diagnosis, age at asthma onset, age at treatment initiation, inhaled corticosteroid dose, or asthma control, Bacharier noted.