The efficacy and safety of dupilumab for moderate-to-severe asthma: a systematic review and meta-analysis.

UNLABELLED: 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. PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov were searched from database inception to January 28, 2026. 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 = -0.35, 95% CI: -0.44 to -0.26; 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: 0.11-0.29; 24 weeks MD = 0.25, 95% CI: 0.18-0.32, all p < 0.05), and enhanced forced expiratory volume in one second (FEV1) (12 weeks MD = 0.15, 95% CI: 0.12-0.17; 24 weeks MD = 0.15, 95% CI: 0.13-0.18, 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.