TOPLINE

Dupilumab reduced severe exacerbations of asthma, levels of total serum immunoglobulin E (IgE), and improved lung function and asthma control in children with uncontrolled moderate-to-severe type 2 asthma with monoallergen or multiallergen sensitization.

METHODOLOGY

• Researchers conducted a post hoc analysis of the VOYAGE trial to assess whether dupilumab was effective in children aged 6-11 years with moderate-to-severe asthma regardless of allergen sensitization status; participants were randomly assigned to receive 100 or 200 mg dupilumab every 2 weeks or a matching placebo.
• They included 336 children with moderate-to-severe type 2 asthma, defined as having blood eosinophil counts ≥ 150 cells/μL or fractional exhaled nitric oxide levels ≥ 20 ppb and known status for allergen sensitization and IgE levels at baseline.
• Children were stratified into three groups based on total serum IgE levels and perennial allergen-specific IgE levels: non-sensitized, monoallergen-sensitized, and multiallergen-sensitized.
• The primary endpoint was severe exacerbation of asthma, defined as a deterioration in asthma control, resulting in treatment with systemic glucocorticoids, hospitalization, or an emergency department visit requiring systemic glucocorticoids; an additional endpoint was change in pre- and post-bronchodilator percent-predicted forced expiratory volume in 1 second (ppFEV₁).

TAKEAWAY

• Patients who received dupilumab had significantly lower annual rates of severe exacerbations than those who received placebo in both the monoallergen-sensitized (rate reduction, 75.1%; P = .0376) and multiallergen-sensitized (rate reduction, 59.6%; P = .0004) groups.
• At week 52, dupilumab significantly improved pre-bronchodilator ppFEV₁ in the monoallergen-sensitized compared with the placebo (least squares mean difference [LSMD], 10.1 percentage points; P = .001) and multiallergen-sensitized (LSMD, 9.0; P < .001) groups.
• Significant improvements in post-bronchodilator ppFEV₁ were seen with dupilumab vs placebo in children with monoallergen sensitization (P = .01).
• Dupilumab significantly improved asthma control in children with monoallergen sensitization and multiallergen sensitization compared with placebo and reduced total serum IgE levels across all sensitization subgroups at week 52.

IN PRACTICE

“In children with moderate-to-severe asthma, dupilumab demonstrated significant efficacy in allergen-sensitized patients, while non-sensitized patients had less pronounced yet numerically greater improvements. This study extends our knowledge of dupilumab efficacy by patient allergen sensitization status,” the authors wrote. 

SOURCE

Wanda Phipatanakul, MD, with the Boston Children's Hospital, Boston, was the corresponding author of the study, which was published online on June 18 in The Journal of Allergy and Clinical Immunology: In Practice. 

LIMITATIONS

This study did not include 18% of children from the original trial who did not have type 2 inflammation at baseline and was not powered to detect statistical significance in each sensitization group. 

DISCLOSURES

This study was supported by Sanofi and Regeneron Pharmaceuticals Inc. Some authors, including the lead author, reported receiving clinical trial support or grants, medication support, royalties, and research funding and serving as consultants or advisory board members of various pharmaceutical companies, including the funding agencies. Some of the authors declared being employees and shareholders in and possibly holding stock and/or stock options at Regeneron Pharmaceuticals or Sanofi. Detailed disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.