Arthritis Rheumatol

Investigational agent outperforms febuxostat for urate lowering in gout patients

June 16, 2025

Dotinurad 4 mg/day was superior to febuxostat 40 mg/day for achieving target serum urate in Chinese patients with gout, with comparable safety. These findings support dotinurad as an effective urate-lowering therapy option in this population, potentially expanding treatment choices for gout management.

Study details: This phase 3, multicenter, randomized, double-blind, parallel-group trial enrolled 451 Chinese patients with gout, comparing oral dotinurad (2 mg/day and 4 mg/day) with febuxostat (40 mg/day). The primary endpoint was the proportion of patients achieving serum urate ≤6.0 mg/dL at week 24 (dotinurad 4 mg/day vs. febuxostat 40 mg/day). Secondary endpoints included non-inferiority of dotinurad 2 mg/day to febuxostat at week 12 and safety assessments.

Results: Dotinurad 4 mg/day achieved a significantly higher responder rate at week 24 compared with febuxostat 40 mg/day (73.6% vs. 38.1%; adjusted difference 35.9%, 95% confidence interval [CI], 27.4–44.4; p<0.0001). Dotinurad 2 mg/day was non-inferior to febuxostat at week 12 (55.5% vs. 50.5%; adjusted difference 5.2%, 95% CI, -3.7–14.2). The incidence of treatment-emergent adverse events was similar between groups.

Source:

Sun J, et al. (2025, May 26). Arthritis Rheumatol. Efficacy and safety of dotinurad versus febuxostat for the treatment of gout: a randomised, multicentre, double-blind, phase 3 trial in China. https://pubmed.ncbi.nlm.nih.gov/40417858/