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Purpose: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4/-13, key and central drivers of type 2 inflammation in multiple diseases.This post hoc analysis of the Phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959) evaluated the efficacy of dupilumab in children aged 6 to 11 years with moderate-to-severe asthma with a type 2 inflammatory phenotype (blood eosinophil count ≥150 cells/µL or fractional exhaled nitric oxide FeNO ≥20 ppb) and a history of 1, 2, or ≥3 prior exacerbations.The impact of baseline type 2 biomarker levels on the efficacy of dupilumab in this population was also investigated.Patients and Methods: Patients were stratified by the number of exacerbations in the prior year (1, 2, or ≥3) and level of FeNO or blood eosinophil count at baseline.Endpoints included rate of severe exacerbations, percentage of non-exacerbators, and change from baseline in both lung function parameters (pre-and post-bronchodilator BD percent predicted forced expiratory volume in 1 s (ppFEV 1 ) and ppFEV 1 /forced vital capacity FVC ratio) and Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) score.Results: A total of 350 patients were included in this analysis.Across patients with 1, 2, or ≥3 prior exacerbations and different levels of type 2 biomarkers, dupilumab reduced the risk of severe asthma exacerbations vs placebo by 53.0-96.0%and improved both pre-BD ppFEV 1 and pre-BD FEV 1 /FVC ratio at Week 52.Dupilumab led to significant reductions in ACQ-7-IA scores in all groups of patients by Week 52. Conclusion:In children with uncontrolled, moderate-to-severe asthma with a type 2 phenotype, dupilumab consistently reduced the risk of asthma exacerbations, improved lung function, and reduced ACQ-7-IA scores, regardless of exacerbation history.
Guilbert et al. (Fri,) studied this question.