Impact of Exacerbation History on Dupilumab Efficacy in Children with Uncontrolled Moderate-to-Severe Asthma: LIBERTY ASTHMA VOYAGE Study.

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 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 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 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.

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© 2024 Guilbert et al.

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Guilbert TW has received personal fees and/or grants from AiCME, Amgen, AstraZeneca, Best Pharmaceuticals for Children Act (BPCA), Genentech, GSK, NIH, Novartis, OM Pharma, Polarean, Polaris, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from UpToDate. Tolcachier A has conducted clinical trials for AstraZeneca, GSK, Novartis, and Sanofi, and received fees as a speaker for Novartis, Merck, and Sanofi. Fiocchi AG has acted as an advisor for Abbott, Danone, DBV Technologies, HiPP Organic, Novartis, and Stallergenes Greer, and received research sponsorship from Danone, Ferrero, HiPP Organic, and Sanofi. Katelaris CH was Principal Investigator of the dupilumab asthma phase 2b (NCT01854047) and phase 3 (NCT02414854) studies for Regeneron Pharmaceuticals Inc. and Sanofi. Phipatanakul W has acted as a consultant for and received clinical trial support/medication support from AstraZeneca, Genentech, GSK for Asthma Therapeutics, Merck, Regeneron Pharmaceuticals Inc., and Sanofi. Begin P has acted as Principal Investigator for DBV Technologies, Novartis, Regeneron Pharmaceuticals Inc., and Sanofi, and has received speaker/consulting fees from ALK, AstraZeneca, Aralez Bio, Bausch Health, DBV Technologies, Novartis, Pfizer, Sanofi, and Valeo Pharma. de Mir I has received fees for lectures, boards, and conferences from Aldo-Unión, GSK, and Novartis. Altincatal A is a Sanofi employee and may hold stock and/or stock options in the company. Gall R is a Regeneron Pharmaceuticals Inc. employee and shareholder. Ledanois O is a Sanofi employee and may hold stock and/or stock options in the company. Radwan A is a Regeneron Pharmaceuticals Inc. employee and shareholder. Jacob-Nara JA is a Sanofi employee and may hold stock and/or stock options in the company. Deniz Y is a Regeneron Pharmaceuticals Inc. employee and shareholder. Rowe PJ is a Sanofi employee and may hold stock and/or stock options in the company. The authors report no other conflicts of interest in this work.