Post hoc analysis of the VOYAGE RCT examining dupilumab (100/200 mg q2w by weight vs. placebo for 52 weeks) in 336 children aged 6–11 with uncontrolled moderate-to-severe type 2 asthma, stratified by baseline allergen sensitization status (non-sensitized, monoallergen, multiallergen).
Dupilumab reduced annualized severe exacerbation rates vs. placebo by 45% (non-sensitized, P=.13), 75% (monoallergen, P=.04), and 60% (multiallergen, P=.0004) at 52 weeks; no significant interaction between treatment and sensitization subgroup (P=.48). Improvements in ppFEV1, ACQ-7-IA, and total IgE were consistent across all subgroups.
Post hoc subgroup analysis limits causal inference. The non-sensitized subgroup was small (n=75, 22%), contributing to the non-significant exacerbation result in that group. Sensitization was defined using total and perennial allergen-specific IgE only, which may not capture all clinically relevant sensitization patterns.
Dupilumab significantly cuts exacerbations in multiallergen- and monoallergen-sensitized children with type 2 asthma, and shows a directionally consistent but non-significant benefit even in non-sensitized children. Allergen sensitization status alone should not gate dupilumab use in children aged 6–11 with type 2 asthma.
