Assessment of dupilumab in children with moderate‐to‐severe type 2 asthma with or without evidence of allergic asthma
Nikolaos G. Papadopoulos, Stanley J. Szefler, Leonard B. Bacharier, Jorge Máspero, Christian Domingo, Alessandro Fiocchi, Jason K. Lee, Nadia Daizadeh, David J. Lederer, Megan Hardin, Rebecca Gall, Michel Djandji, Shahid Siddiqui, Juby A. Jacob‐Nara, Yamo Deniz, Paul J. Rowe
Abstract
Abstract Background Cytokines, such as interleukins (IL)‐4/5/13, play a key role in multiple type 2 inflammatory diseases, including allergic asthma. Dupilumab, a human monoclonal antibody, blocks the shared receptor component for IL‐4/IL‐13, inhibiting signaling. In this post hoc analysis of VOYAGE (NCT02948959), dupilumab efficacy was evaluated in patients aged 6–11 years with type 2 asthma with or without evidence of allergic asthma (baseline serum total IgE ≥30 IU/mL and ≥1 perennial aeroallergen‐specific IgE ≥0.35kU/L). Methods Annualized severe exacerbation rates (AER) and changes in pre‐bronchodilator (Pre‐BD) forced expiratory volume in one second (FEV 1 ), percent‐predicted pre‐BD FEV 1 (ppFEV 1 ), and Asthma Control Score (ACQ)‐7 were assessed during the treatment period. Results 350 children (261 with and 89 without evidence of allergic asthma) were included. Dupilumab versus placebo significantly reduced AER in patients with (0.24 vs. 0.62, relative risk reduction [RRR]: 62% [95% CI, 39–76], P < .0001) and without (0.39 vs. 0.80, RRR: 51% [95% CI, 0–76], P < .05) evidence of allergic asthma. Significant improvements in ppFEV 1 , pre‐bronchodilator FEV 1 , and ACQ‐7 scores were observed in dupilumab versus placebo throughout the treatment period in patients with evidence of allergic asthma. In patients without evidence of allergic asthma, numerical improvements in pre‐bronchodilator FEV 1 and asthma control were observed by Week 52. Conclusion Dupilumab versus placebo reduced asthma exacerbations in children with type 2 asthma irrespective of evidence of allergic asthma; similar trends were observed in changes in lung function. Significant improvement in asthma control was observed in patients with evidence of allergic asthma, but not in those without.