New data from a phase 3 clinical trial shows that dupilumab (Dupixent) significantly reduces asthma exacerbations and improves disease control in children with uncontrolled moderate to severe asthma, regardless of how long they have had the condition.
The findings, presented at the American Thoracic Society International Conference in San Francisco, demonstrate that the biologic therapy provides consistent clinical benefits even among children who have lived with asthma for many years.
Dupilumab Effective Across All Disease Duration Groups
The post-hoc analysis of the VOYAGE trial, presented by Dr. Wanda Phipatanakul, Director of the Division of Immunology Research Center at Boston Children's Hospital, examined whether the length of time a child had asthma affected treatment outcomes with dupilumab.
"There is evidence that increased length of time with asthma can increase symptoms and lead to persistent disease," Dr. Phipatanakul explained. "We wanted to understand whether disease duration affected how dupilumab impacted key clinical outcomes."
The 52-week, double-blind trial included 350 children aged 6 to 11 years with uncontrolled, moderate to severe type 2 inflammatory asthma. Participants were randomized in a 2:1 ratio to receive either dupilumab (100 mg or 200 mg based on body weight) or placebo every two weeks.
Researchers stratified participants into three cohorts based on asthma duration:
- 4 years or fewer (31.8% of dupilumab group, 37.7% of placebo group)
- More than 4 to fewer than 7 years (36.9% of dupilumab group, 36.8% of placebo group)
- 7 years or more (31.4% of dupilumab group, 25.4% of placebo group)
Significant Reduction in Exacerbations
The analysis revealed that across all disease duration groups, children treated with dupilumab were significantly more likely to remain free from severe exacerbations throughout the 52-week study period compared to those receiving placebo:
- Among children with asthma for 4 years or less: 86.7% (dupilumab) versus 72.1% (placebo), P = .0439
- Among children with asthma for more than 4 to fewer than 7 years: 71.3% (dupilumab) versus 54.8% (placebo), P = .0359
- Among children with asthma for 7 years or longer: 74.3% (dupilumab) versus 48.3% (placebo), P = .0046
Dupilumab also demonstrated significant reductions in adjusted annualized exacerbation rates compared to placebo across all disease duration cohorts.
Improved Asthma Control
The study defined well-controlled asthma as a score of 0.75 or lower on the Interviewer-Administered 7-item Asthma Control Questionnaire (ACQ-7-IA). By this measure, dupilumab significantly improved asthma control regardless of disease duration:
- Among children with asthma for 4 years or less: 78.7% (dupilumab) versus 55.8% (placebo), P = .011
- Among children with asthma for more than 4 to fewer than 7 years: 67.8% (dupilumab) versus 42.9% (placebo), P = .0104
- Among children with asthma for 7 years or longer: 62.2% (dupilumab) versus 34.5% (placebo), P = .0189
Clinical Implications for Pediatric Asthma Management
While the study confirmed that longer asthma duration was associated with more frequent exacerbations and lower rates of disease control overall, the researchers emphasized that dupilumab provided consistent benefits regardless of how long a child had been living with asthma.
"The fact that dupilumab improves outcomes regardless of previous asthma duration further emphasizes its already well-established safety and efficacy," Dr. Phipatanakul noted. "This is especially important for young children who are particularly vulnerable as their lungs are still developing, so reducing exacerbations and improving control could help reduce the impact of persistent symptoms on the lungs."
About Dupilumab and the VOYAGE Trial
Dupilumab is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) by targeting their shared receptor subunit. These interleukins are key drivers of type 2 inflammation in asthma.
The VOYAGE trial defined type 2 inflammatory asthma as having blood eosinophil counts of 150 cells/μL or higher or fractional exhaled nitric oxide (FeNO) of 20 parts per billion or higher.
The study population had an average age of 9 years, with 64% being male. Approximately 5% of participants were Black/African American, 0.5% were Asian/Asian American, and 0.2% were American Indian/Alaska Native, reflecting the demographic makeup of the study regions.
Dr. Phipatanakul noted that there are no restrictions on the duration of asthma before dupilumab can be prescribed. "But these data show physicians that regardless of the duration of their patient's disease, dupilumab can provide clinically meaningful improvements in signs and symptoms in children," she concluded.
The findings provide valuable insights for clinicians managing pediatric asthma, suggesting that even children with longstanding disease can benefit significantly from dupilumab therapy.
