Dotinurad bests febuxostat for Chinese patients with gout

In the treatment of Chinese patients with gout, the use of dotinurad results in a higher response rate compared with febuxostat, according to a phase III study.

The study included 441 adult patients with gout who had serum urate levels of >7 mg/dL at baseline. These patients were randomly assigned to receive treatment with either dotinurad 1 mg plus febuxostat-matched placebo or febuxostat 20 mg plus dotinurad-matched placebo, administered orally every day for 4 weeks during the first phase of treatment.

In the second phase of treatment, patients in the dotinurad group took dotinurad 2 mg/day plus febuxostat-matched placebo for 8 weeks followed by dotinurad 4 mg/day plus febuxostat-matched placebo for 12 weeks. Those in the febuxostat group took febuxostat 40 mg/day plus dotinurad-matched placebo for 20 weeks. Prophylactic treatment for gout flare such as NSAIDs and colchicine was not permitted during the study.

The primary endpoint was the responder rate (percentage of patients achieving serum urate levels ≤6 mg/dL) at week 24. The responder rate at week 12 was assessed as the secondary endpoint. Treatment-emergent adverse events (TEAEs) were recorded.

At week 24, the responder rate was significantly higher in the dotinurad group than in the febuxostat group (73.6 percent vs 38.1 percent; adjusted difference, 35.9 percent, 95 percent confidence interval [CI], 27.4–44.4; p<0.0001).

The responder rate at week 12 was 55.5 percent with dotinurad vs 50.5 percent with febuxostat, with the adjusted difference of 5.2 percent (95 percent CI, −3.7 to 14.2) establishing the noninferiority of dotinurad.

The incidence of TEAEs was similar in the dotinurad and febuxostat groups.