Fully human monoclonal antibody dupilumab works by blocking the shared receptor component for interleukin (IL)-4/IL-13. Phase IIB and III studies observed reductions in severe exacerbations and improvements in pre-bronchodilator forced expiratory volume in 1 second (FEV1) in cases of uncontrolled, moderate-to-severe asthma. Outcomes were more significant in patients whose type 2 biomarkers were higher at baseline.
A new report published by the Global Initiative for Asthma established type 2 inflammatory asthma cutoffs as baseline blood eosinophils ≥150 cells/μL and/or baseline fractional exhaled nitric oxide (FeNO) ≥20 ppb. The present study, which was published as part of the AAAAI Annual Meeting, evaluated the efficacy of dupilumab in patients meeting one of the criteria for type 2 inflammatory asthma.
To examine the efficacy of dupilumab, the researchers evaluated annualized severe exacerbations during the 24-week (P2) and 52-week (P3) treatment periods, as well as 12-week changes in FEV1. Patients were treated with dupilumab 200 mg or 300 mg every two weeks or placebo.
Patients treated with dupilumab had significant improvements in reduced severe exacerbations (eosinophils ≥150 cells/μL, P2: 72% vs. 73%; P3: 56% vs. 60%; FeNO ≥20ppb, P2: 70% vs. 80%; P3: 65% vs. 58%) and improved FEV1 (eosinophils ≥150 cells/μL, P2: 0.23 L vs. 0.18 L; P3: 0.17 L vs. 0.15 L; FeNO ≥20 ppb, P2: 0.22 ppb vs. 0.20 ppb; P3: 0.22 ppb vs. 0.20 ppb) compared with placebo (P<0.01 for all). The most common adverse events in the dupilumab and placebo groups were upper respiratory tract infection and injection-site reaction.