Dupilumab Efficacy and Safety in Patients With Persistent Asthma: Asia-Pacific Region.

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 (FEV1). Secondary endpoints: change from baseline to week 24 in 5-item Asthma Control Questionnaire (ACQ-5/7) scores, annualised severe exacerbation rate, and safety.

RESULTS

In the primary analysis population (n = 414), change in FEV1 by week 12 was significantly greater for dupilumab versus placebo (least squares mean difference: 0.31 L [95% CI: 0.23-0.39]; p < 0.0001). At week 24, greater reductions in ACQ-5 score were seen for dupilumab versus placebo (least squares mean difference: -0.20 [95% CI: -0.35 to -0.05]; p = 0.0097). Dupilumab reduced severe exacerbation risk by 62% versus placebo during the treatment period (relative risk: 0.38 [95% CI: 0.21-0.70]; nominal p = 0.002). Safety was similar between treatment arms; injection-site reactions were more common with dupilumab treatment (5.0%) than with placebo (1.2%). The OCS maintenance population showed similar outcomes.

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.