BACKGROUND: Asthma prevalence is increasing in the Asia-Pacific region. China and India account for >
35% of the world's population and are often underrepresented in clinical studies. This phase 3 study (NCT03782532) evaluated efficacy and safety of dupilumab, a monoclonal antibody blocking interleukin-4/13 signalling, in patients with persistent asthma from China and India. METHODS: Patients (≥ 12 years) were randomised 1:1 to dupilumab 200 mg or matched placebo every 2 weeks for 24 weeks (primary analysis population: blood eosinophils ≥ 150 cells/μL or fractional exhaled nitric oxide ≥ 25 parts per billion without maintenance oral corticosteroid [OCS]
OCS maintenance population: 300 mg OCS). PRIMARY ENDPOINT: change from baseline to week 12 in forced expiratory volume in 1 s (FEV RESULTS: In the primary analysis population (n = 414), change in FEV CONCLUSION: Dupilumab significantly improved lung function and asthma control, numerically reduced asthma exacerbations, and was well tolerated in patients from China and India with persistent asthma and evidence of either type 2 inflammation or OCS maintenance. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03782532.