Dupilumab Scores on Win-Ratio Analysis in Pediatric Asthma: Sharon Dell, MD

A win-ratio analysis of the phase 3 VOYAGE trial found children with moderate-to-severe type 2 asthma were more than twice as likely to achieve favorable outcomes on add-on dupilumab than placebo, regardless of whether they started on medium- or high-dose inhaled corticosteroids (ICS), according to Sharon Dell, MD, FRCPC, professor and head of the Division of Respiratory Medicine in the Department of Pediatrics at the University of British Columbia.

Dell discussed the findings, presented as a poster at the European Respiratory Society (ERS) International Congress, held in Barcelona from September 5-9, in an interview with HCPLive. Win-ratio analysis, still uncommon in pediatric asthma trials, compares each treated patient against each placebo patient across a hierarchy of outcomes, moving to the next-ranked outcome only when a pair ties; Dell said the method has already supported at least 2 FDA drug approvals and is more established in cardiovascular research, where it allowed rare outcomes like death to be weighed alongside more common ones.

The analysis ranked exacerbation freedom over 52 weeks as the top-priority outcome, followed by fewer exacerbations, normal lung function at week 52, and achieved asthma control (Asthma Control Questionnaire-5 score under 1.5). Dell said exacerbation freedom was placed first because exacerbations are the primary endpoint used to approve biologic therapies in asthma, while lung function was prioritized above symptom control specifically for children, since normal childhood lung function is associated with better respiratory outcomes in adulthood. Among children on high-dose ICS at baseline, dupilumab won 57.2% of pairs versus 26.7% for placebo, for an overall win ratio of 2.14 (95% CI, 1.35-3.40), with dupilumab prevailing in 68.2% of non-tied pairs.1 Among children on medium-dose ICS, the win ratio was 2.31 (95% CI, 1.45-3.68), with dupilumab winning 69.8% of non-tied pairs.1

“The win ratio analysis translates really nicely into clinical messaging, because it tells us that, overall, you're more than twice as likely to have better asthma outcomes if you take dupilumab compared to placebo,” Dell said.

Because outcomes were similar across ICS strata, Dell said the findings raise a practical question about treatment timing. In Canada, children must remain on high-dose ICS for at least 6 months before qualifying for biologic therapy, but she noted this analysis suggests similar benefit even from a medium-dose ICS starting point. “It does beg the question of are we starting too late,” she said, adding that children may be more sensitive to the effects of prolonged high-dose ICS than adults. VOYAGE previously showed that by week 52, 46% of children receiving dupilumab achieved on-treatment clinical remission.1,2

References

1. Dell S, Guilbert TW, Gappa M, Xia C, Ledanois O, Gall R, Bacharier LB. Win ratio analysis of dupilumab achieving on-treatment clinical remission in children with moderate-to-severe type 2 asthma. Poster presented at: European Respiratory Society (ERS) International Congress; September 5-9, 2026; Barcelona, Spain.

2. Bacharier LB, Guilbert TW, Zangrilli J, et al. Dupilumab in children with uncontrolled moderate-to-severe asthma. N Engl J Med. 2021;385(24):2230-2240. doi:10.1056/NEJMoa2106567