Dotinurad Lowers Urate More Effectively Than Febuxostat

Medscape

12-06-2025

Dotinurad 4 mg/d was superior to febuxostat 40 mg/d in achieving target serum urate levels (≤ 6.0 mg/dL) at week 24 in patients with gout, with both the drugs showing comparable safety profiles.
METHODOLOGY:
Researchers conducted a multicenter phase 3 trial to compare the efficacy and safety of dotinurad with febuxostat in Chinese patients with gout.
They included 441 patients (mean age, 39.1 years; 1.8% women) with gout who were randomly assigned to receive either oral dotinurad (2 mg/d for 8 weeks, followed by 4 mg/d for 12 weeks) or febuxostat (40 mg/d for 20 weeks).
The primary endpoint was the responder rate, defined as the proportion of patients achieving serum urate levels ≤ 6.0 mg/dL at week 24.
Secondary outcomes included the responder rate at week 12, the mean percent reduction from baseline in serum urate levels, and the mean change from baseline in serum urate levels at week 4 through week 24.
TAKEAWAY:
At week 24, the responder rate was significantly higher for dotinurad 4 mg/d than for febuxostat 40 mg/d (73.6% vs 38.1%; adjusted difference, 35.9%; P < .0001).
< .0001). At week 12, dotinurad 2 mg/d was noninferior to febuxostat 40 mg/d in terms of the responder rate (55.5% vs 50.5%; treatment difference, 5.2%; 95% CI, -3.7% to 14.2%).
The mean percent reduction in serum urate levels from baseline at week 24 was higher in the dotinurad group than in the febuxostat group (45.9% vs 30.6%).
The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between the dotinurad and febuxostat groups, with low incidences of severe and serious TEAEs.
IN PRACTICE:
'Dotinurad may offer a new urate-lowering treatment option to Chinese patients with gout as it demonstrated both efficacy and a good safety profile overall,' the authors wrote.
SOURCE:
This study was led by Jia Sun, MD, Zhujiang Hospital of Southern Medical University, Guangzhou, and Yu Wang, MD, PhD, Peking University First Hospital, Beijing, both in China. It was published online on May 26, 2025, in Arthritis & Rheumatology .
LIMITATIONS:
The relatively short study duration limited the assessment of long-term effects on gout flare recurrence. This study population was predominantly younger men, limiting generalizability across broader demographic groups. Lastly, this study was conducted only in Chinese patients with gout.
DISCLOSURES:
This research was funded by Eisai Co., Ltd. Four authors declared being employees of Eisai China or Eisai Co., Ltd, and others reported receiving honoraria from Eisai.