A post-hoc analysis of the VOYAGE study also found that the biologic improved the percent predicted pre-bronchodilator FEV1 in this patient population.
New data from a post-hoc analysis of the VOYAGE study indicates that dupilumab reduced severe exacerbation rates and improve the percent predicted pre-bronchodilator FEV1 in pediatric patients 6-11 years old with uncontrolled moderate to severe asthma with or without atopic comorbidities .
The findings were presented at the American Thoracic Society 2020 International Conference in San Francisco.
Asthma - one of the most common chronic childhood diseases- has often been associated with comorbid atopic disorders and type 2 inflammation.
Previous phase 3 data from VOYAGE found that add-on dupilumab 100/200 mg every 2 weeks reduced severe asthma exacerbations and improved percent predicted pre-bronchodilator forced expiratory volume in 1 second (FEV1pp) at Week 12 compared to placebo.
In this post-hoc analysis, investigators led by Theresa W. Guilbert, MD, MS, of the Cincinnatti Children’s Hospital, evaluated dupilumab efficacy in pediatric patients with and without one or more ongoing atopic comorbidities.
Guilbert and colleagues analyzed the annualized rate of severe asthma exacerbations (AER) and change from baseline in bronchodilator FEV1pp (%) over the course of the 52-week treatment period in patients treated with the bioligic compared to placebo. Patients with 1 or no ongoing comorbid disease were included in the analyses.
Meanwhile, comorbid diseases including atopic dermatitis, allergic conjunctivitis, allergic rhinitis, chronic rhinosinusitis, nasal polyposis, eosinophilic esophagitis, food allergy, and hives were recorded at baseline.
A total of 408 patients were included in the study.
Investigators determined thart, compared to placebo, dupilumab reduced AER by 72% (no comorbid disease, P = 0.07), 2% in patients with 1 ongoing comorbid disease (P = 0.96), and 69% in patients with >1 ongoing comorbid diseases (P < 0.001).
By Week 12, patients with no atopic comorbidities showed no differences in changes from baseline in pre-bronchodilator FEV1pp.Despite this, dupilumab improved pre-bronchodilator FEV1pp in patients with atopic comorbidities compared to placebo.
The biologic also improved the change from baseline in pre-bronchodilator FEV1pp in all patients
“Dupilumab reduced severe exacerbation rates and by the end of treatment, had improved the percent predicted pre-bronchodilator FEV1 in children aged 6to 11 years with uncontrolled, moderate-to-severe asthma, in patients with or without atopic comorbidities,” the team wrote.