Dupilumab improved lung function and reduced severe asthma exacerbation rates in children with moderate to severe asthma with or without atopic comorbidities.
Significant improvement in lung function and reduction of severe asthma attacks among children with moderate to severe asthma was achieved with dupilumab, regardless of the presence of atopic comorbidities, such as chronic rhinosinusitis, nasal polyps, and eosinophilic esophagitis (EoE), according to new study findings.
Presented today at the 2022 American Thoracic Society (ATS) International Conference, the abstract is a post hoc analysis of the phase 3 Liberty Asthma VOYAGE (Evaluation of Dupilumab in Children with Uncontrolled Asthma; NCT02948959) trial, which evaluated the efficacy of dupilumab 100/200 mg every 2 weeks vs placebo in children aged 6 to 11 years with uncontrolled persistent asthma.
As one of the most common chronic childhood diseases, asthma is often associated with many comorbid atopic disorders and type 2 inflammation. A recent study found that 60% of patients with severe asthma had a medical diagnosis for at least one other type 2 inflammatory disease, in which these patients with higher inflammatory disease burden were more likely to experience asthma exacerbations and less likely to achieve asthma control.
Dupilumab, a fully human monoclonal antibody that blocks 2 key and central drivers of type 2 inflammation (interleukin [IL]-4 and IL-13) was shown in prior findings to reduce severe asthma exacerbations and improve lung function after 12 weeks, with an acceptable safety profile also observed. The biologic was approved by the FDA for the treatment of children aged 6-11 years last year.
For the post hoc analysis, patients treated with dupilumab or placebo without, with 1, or with greater than 1 ongoing comorbid disease were evaluated over the course of a 52-week treatment period. Participants were assessed via the annualized rate of severe asthma exacerbations (AER) and lung function, measured by change from baseline in percent predicted prebronchodilator forced expiratory volume in 1 second (FEV1pp).
“Comorbid diseases were self-reported at study baseline and included atopic dermatitis, allergic conjunctivitis, allergic rhinitis, chronic rhinosinusitis (chronic rhinitis or chronic sinusitis), nasal polyposis, EoE, food allergy, and hives,” said researchers.
A total of 408 patients without (dupilumab, n = 33; placebo, n = 28), with 1 (dupilumab, n = 91; placebo, n = 41), or with greater than 1 ongoing comorbid atopic diseases (dupilumab, n = 149; placebo, n = 66) were included in the post hoc analysis.
Findings indicated that AER was reduced among patients treated with dupilumab vs placebo who presented with no comorbid disease (relative risk [RR], 0.284; 95% CI, 0.072-1.117; percent reduction, 71.6%; P = .07), 1 ongoing comorbid disease (RR, 0.980; 95% CI, 0.438-2.194; percent reduction, 2%; P = .96), and greater than 1 comorbid diseases (RR, 0.315; 95% CI, 0.207-0.479; percent reduction, 68.5%; P < .0001).
Regarding lung function, patients with multiple atopic comorbidities treated with dupilumab vs placebo exhibited significant short-term improvement in pre-bronchodilator FEV1pp after 12 weeks (1 comorbid disease: least square mean difference [LSMD], 5.37; 95% CI, −0.18 to 10.93; P = .058; > 1 comorbid disease: LSMD, 5.34; 95% CI, 1.58 to 9.11; P = .006).
No difference in changes from baseline in pre-bronchodilator FEV1pp were observed among patients with no atopic comorbidities at 12 weeks (LSMD, –0.96; 95% CI, –9.04 to 7.11; P = .812)
After 52 weeks, dupilumab was associated with improvement in the change from baseline in pre-bronchodilator FEV1pp for all patients compared with placebo:
“Dupilumab reduced severe exacerbation rates and by the end of treatment, had improved the percent predicted pre-bronchodilator FEV1 in children aged 6 to 11 years with uncontrolled, moderate to severe asthma, in patients with or without atopic comorbidities,” concluded researchers.
Guilbert TW, Deschildre A, Jackson DJ, et al. Efficacy of dupilumab in pediatric patients with uncontrolled, moderate-to-severe asthma with and without ongoing atopic comorbid disease: LIBERTY ASTHMA VOYAGE Study. Presented at 2022 ATS International Conference.