Efficacy and safety of dotinurad versus febuxostat for the treatment of gout: a randomised, multicentre, double‐blind, phase 3 trial in China

Objectives Dotinurad is a selective urate reabsorption inhibitor that reduces serum urate levels. We compared the efficacy and safety of dotinurad with febuxostat in Chinese patients with gout. Methods This phase 3, multicentre, randomised, double‐blind, parallel‐group study randomly allocated (1:1) eligible patients with gout to receive oral dotinurad or febuxostat. The primary endpoint was the responder rate (proportion of patients achieving serum urate levels ≤6.0 mg/dL) at week 24 in the full analysis set (FAS) to demonstrate superiority of dotinurad 4 mg/day to febuxostat 40 mg/day. The secondary endpoints included the responder rate at week 12 to show the non‐inferiority of dotinurad 2 mg/day to febuxostat 40 mg/day. Treatment‐emergent adverse events (TEAEs) were also recorded. Results A total of 451 patients were randomised and 441 were included in the FAS. Baseline characteristics were well‐balanced between treatment groups. The responder rate at week 24 was significantly higher for dotinurad 4 mg/day vs febuxostat 40 mg/day (73.6% vs 38.1%; adjusted difference 35.9% [95% confidence interval (CI) 27.4%, 44.4%]; p<0.0001), and that at week 12 in the dotinurad 2 mg/day was non‐inferior to the febuxostat 40 mg/day (55.5% vs 50.5%; adjusted difference 5.2% [95% CI −3.7%, 14.2%]). Incidences of TEAEs in the dotinurad and febuxostat groups were similar. Conclusions Dotinurad 4 mg/day was superior to febuxostat 40 mg/day in achieving serum urate levels ≤6.0 mg/dL at week 24 and was well tolerated in Chinese patients with gout.