Expanded PBS Listing for Dupilumab

The Pharmaceutical Benefits Scheme (PBS) listing for dupilumab has been expanded to include the treatment of uncontrolled severe asthma in children from six years of age.

The VOYAGE study evaluated the efficacy of dupilumab in children aged 6–12 years with uncontrolled asthma. When added to standard therapy, dupilumab produced a 59.3% relative risk reduction for severe exacerbations compared to placebo (95% CI: 39.5 – 72.6, P<0.001).

The frequency of adverse effects was similar in the dupilumab and placebo groups (83.0% vs 79.9%). The most commonly reported events included injection site reactions and viral upper respiratory tract infections. Eosinophilia occurred more frequently in the dupilumab group (5.9% vs 0.7%), although most cases were asymptomatic laboratory findings that resolved without intervention.

A 52-week open-label extension study assessed the long-term safety and efficacy of dupilumab in this population. Dupilumab was associated with sustained reductions in exacerbations and systemic corticosteroid use, along with improved lung function. Children switched from placebo to dupilumab showed rapid improvements in lung function.

Uncontrolled asthma in children causes significant morbidity, frequent hospitalisation, and disruption to education, social and sporting activities. It may also lead to irreversible airflow limitation and an increased risk of chronic obstructive pulmonary disease (COPD) later in life. The addition of dupilumab to the PBS provides another specialised option for younger children with uncontrolled severe asthma.