Efficacy and Safety of Dupilumab in Chinese Adult Patients With Chronic Rhinosinusitis With Nasal Polyps: A Randomized, Placebo-Controlled, Phase III Trial.

BACKGROUND

Dupilumab has shown efficacy in patients with uncontrolled CRSwNP in clinical trials and real-world practice, but data in Chinese patients are limited. This study investigated the efficacy and safety of dupilumab in Chinese patients with severe CRSwNP who were not controlled on standard of care.

METHODS

This placebo-controlled, Phase III trial randomized patients 1:1 to dupilumab 300 mg every 2 weeks or matching placebo for 24 weeks as add-on treatment with daily intranasal corticosteroids. The primary efficacy endpoint was change from baseline in nasal polyp score (NPS) at week 24. Patient-reported outcomes and safety were also assessed.

RESULTS

63 patients were randomized (dupilumab n = 31, placebo n = 32). Baseline characteristics were well balanced between the groups. Improvement in NPS at week 24 was significantly greater with dupilumab than placebo (least square mean difference [LSMD] -1.84 [95% CI -2.53, -1.15], p < 0.0001). Dupilumab also improved patient-reported outcomes vs. placebo: nasal congestion score (LSMD -0.54 [95% CI -0.97, -0.12], p = 0.0126); total symptom score (-1.68 [-2.67, -0.69], p = 0.0008); loss of smell score (-0.62 [-1.08, -0.17], p = 0.0072); and health-related quality of life (22-item sino-nasal outcome test score) (-9.52 [-16.81, -2.24], p = 0.0104). The incidence of treatment-emergent adverse events was similar between the groups.

CONCLUSIONS

Dupilumab is efficacious in Chinese patients with CRSwNP, with tolerability consistent with the known safety profile. These results support the benefits of dupilumab in Chinese patients with severe CRSwNP who are uncontrolled on standard of care therapy.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05878093.