Dupilumab Improves Asthma Control Among Children Despite Duration of Condition

Dupilumab (Dupixent) treatment of uncontrolled moderate-to-severe type 2 asthma leads to consistent clinical improvements compared to placebo among children, new findings suggest, regardless of how long they had been living with asthma.1

These post-hoc analysis data were presented at the American Thoracic Society (ATS) International Meeting in San Franciso, and the poster was titled ‘Dupilumab Reduces Exacerbations and Improves Asthma Control in Children Regardless of Asthma Duration.’1 The research was presented by Wanda Phipatanakul, MD, MS, director of the Division of Immunology Research Center at Boston Children's Hospital.

Phipatanakul and colleagues noted prior data point to an association between a longer duration of asthma and increased symptom burden among patients. Such data suggest that earlier diagnosis and management of asthma could help to diminish the likelihood of persistent disease in children.

The phase 3 VOYAGE trial was conducted to assess dupilumab, a fully human monoclonal antibody formulated to inhibit signaling of interleukin (IL)-4 and IL-13 through the targeting of their shared receptor subunit.2 This trial already established the safety and efficacy of dupilumab in pediatric asthma, but the new post hoc analysis presented at ATS was designed to determine whether the length of time a child was living with asthma prior to enrollment had an impact on dupilumab’s effectiveness.

The 52-week VOYAGE trial had a double-blind, randomized trial design, with Phipatanakul and colleagues enrolling 350 children as study subjects who were in the age range of 6 - 11 years.2 These subjects would also report having uncontrolled moderate-to-severe asthma, and they were randomized in a 2:1 ratio to be treated wiith either dupilumab (100 or 200 mg based on subject weight) or a placebo every 2 weeks.

Type 2 inflammatory asthma was defined by the investigative team as having a blood eosinophil count of ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥20 parts per billion. The team stratified them into 3 cohorts that they based on time since the subjects’ first asthma diagnosis: ≤4 years, >4 to <7 years, and ≥7 years.

Among the outcomes they evaluated were adjusted annualized exacerbation rates (AER), the percentage of subjects who did not have severe exacerbations reported over 52 weeks, and the proportion of trial participants who had well-controlled disease. The latter was defined by Phipatanakul and coauthors as an ACQ-7-IA score ≤0.75 at the 52-week mark.

Overall, distribution across the 3 asthma duration categories was reported by the investigators as follows:

• ≤4 years: 37.7% (placebo group), 31.8% (dupilumab group)
• 4 to <7 years: 36.8% (placebo group), 36.9% (dupilumab group)
• ≥7 years: 25.4% (placebo group), 31.4% (dupilumab group)

The coauthors highlighted that, across all duration subgroups, the proportion of children who did not show severe asthma exacerbations by the 52-week mark favored dupilumab:

• ≤4 years: 86.7% (dupilumab) versus 72.1% (placebo), P = .0439
• 4 to <7 years: 71.3% (dupilumab) versus 54.8% (placebo), P = .0359
• ≥7 years: 74.3% (dupilumab) versus 48.3% (placebo), P = .0046

Dupilumab also led to a notable reduction in adjusted AER compared to placebo (data shown in figure). Additionally, a significantly higher percentage of children receiving dupilumab achieved well-controlled asthma at Week 52 across all groups:

• ≤4 years: 78.7% (dupilumab) versus 55.8% (placebo), P = .0110
• 4 to <7 years: 67.8% (dupilumab) versus 42.9% (placebo), P = .0104
• ≥7 years: 62.2% (dupilumab) versus 34.5% (placebo), P = .0189

Overall, the investigative team pointed to consistent clinical benefits that they observed over placebo among children with uncontrolled moderate-to-severe type 2 asthma, regardless of how long they had been living with the condition. Nevertheless, they did highlight that longer asthma duration showed an association with more frequent exacerbations as well as diminished rates of disease control.

References

1. Phipatanakul W, Guilbert T, Hamelmann E, et al. (Poster Board # P1416) Dupilumab Reduces Exacerbations and Improves Asthma Control in Children Regardless of Asthma Duration. Abstract presented at the American Thoracic Society (ATS) International Conference 2025 in San Francisco, CA, from May 18 - May 21, 2025.

2. Theresa W. Guilbert, MD, MS, et al. Dupilumab Shows Promise in Improving Lung Function in Children with Asthma. Paper presented at: European Respiratory Society (ERS) International Congress 2023; September 9 – 13. Milan, Italy. Accessed May 19, 2025.