The Efficacy and Safety of Dupilumab for Moderate-to-severe Asthma: A Systematic Review and Meta-analysis.

OBJECTIVE: Asthma poses a heavy global health burden, and severe cases are poorly controlled by conventional therapy. Dupilumab is indicated for patients aged ≥6 years with severe eosinophilic or Type 2 asthma. Patients with different baseline characteristics may respond differently to this agent. Therefore, a comprehensive analysis of its efficacy and safety was performed.Data Sources: PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched from database inception to January 28, 2026.Study Selections:Only randomized controlled trials (RCTs) of dupilumab for moderate-to-severe asthma were included; non-RCTs and reviews were excluded. RESULTS: Compared with placebo, dupilumab significantly cut annualized exacerbation rate (RR = 0.45, 95% CI: 0.39-0.51), improved Asthma Control Questionnaire-5 (ACQ-5) scores (12 weeks MD = -0.36, 95% CI: -0.47 to -0.25; 24 weeks MD = -0.26, 95% CI: -0.32 to -0.21, all P < 0.05) and Asthma Quality of Life Questionnaire (AQLQ) scores (12 weeks MD = 0.20, 95% CI: 0.11 to 0.29; 24 weeks MD = 0.25, 95% CI: 0.18 to 0.32, all P < 0.05), and enhanced Forced Expiratory Volume in one second(FEV1) (12 weeks MD = 0.15, 95% CI: 0.12 to 0.18; 24 weeks MD = 0.16, 95% CI: 0.12 to 0.20, all P < 0.05). These benefits were stronger in patients with blood eosinophils ≥300 cells/μL. The safety profile of dupilumab was similar to placebo. CONCLUSIONS: Dupilumab effectively alleviates asthma symptoms, improves lung function and quality of life, with favorable safety, proving its clinical value for severe asthma patients, particularly those with high eosinophils.