Sanofi and Regeneron’s Dupixent significantly reduced severe asthma attacks and rapidly improved lung function in children aged six to 11 years old with uncontrolled moderate-to-severe asthma, according to detailed results from a Phase III trial.
In addition, Dupixent (dupilumab) was found to improve overall asthma control and reduce fractional exhaled nitric oxide (FeNO), an airway biomarker of type 2 inflammation which plays a key role in asthma, in the VOYAGE trial.
“Children living with uncontrolled moderate-to-severe asthma experience serious and persistent symptoms that can impact many crucial aspects of their lives including school, sleep and exercise,” said Leonard Bacharier, principal investigator of the trial.
“The trial results show that dupilumab, when added to standard of care therapy, significantly reduced asthma attacks, rapidly improved lung function and improved asthma control, which is especially important to these children during a particularly formative time in their lives,” he added.
The VOYAGE trial evaluated the safety and efficacy of Dupixent combined with standard of care (SoC) in 408 children with uncontrolled moderate-to-severe asthma.
The trial split the participants into two groups: patients with baseline blood eosinophils (EOS) ≥300 cells/μl and patients with FeNO ≥20 parts per billion (ppb) or EOS ≥150 cells/μl.
Top-line results from this study, previously reported on in October 2020, found that patients who added Dupixent to SoC experienced significantly reduced rates of severe asthma attacks, with a 65% and 59% average reduction over one year compared with placebo.
Patients also had improved lung function, observed as early as two weeks and sustained for up to 52 weeks.