The study was led by Dr. Jia Sun from the Department of Endocrinology, Zhujiang Hospital of Southern Medical University, Guangzhou, and colleagues. The team aimed to directly compare the
urate-lowering efficacy and safety of dotinurad against febuxostat, one of the most widely used therapies for gout.
In this multicenter, randomized, double-blind, parallel-group trial, 451 patients with gout were recruited and randomly assigned in a 1:1 ratio to receive either oral dotinurad or febuxostat. Of these, 441 participants were included in the full analysis set. Patients were followed over 24 weeks, with the primary endpoint being the proportion achieving target serum uric acid levels of ≤6.0 mg/dL.
The study led to the following notable findings:
- At week 24, 73.6% of patients receiving dotinurad 4 mg/day achieved the target serum urate level compared to 38.1% in the febuxostat 40 mg/day group.
- The adjusted difference of 35.9% was statistically significant, confirming the superiority of dotinurad.
- At week 12, dotinurad 2 mg/day was found to be noninferior to febuxostat 40 mg/day, with responder rates of 55.5% versus 50.5%.
- Treatment-emergent adverse events (TEAEs) were reported at similar rates in both groups, suggesting dotinurad is generally well tolerated.
The researchers acknowledged several limitations. The use of the LOCF (last observation carried forward) method in the primary analysis may have introduced some bias due to missing data, though sensitivity analyses supported the robustness of the results. The relatively short study duration restricted the ability to assess long-term outcomes such as recurrent gout flares or the development of tophi, which were not evaluated in this trial. Furthermore, flare prophylaxis was not permitted, leaving uncertainty about flare incidence in real-world practice.
Another limitation was the absence of a direct comparison between dotinurad 4 mg/day and the higher febuxostat dose of 80 mg/day, commonly prescribed in Western countries when 40 mg/day proves insufficient. Additionally, the study population was largely male and relatively young, limiting the generalizability of findings across sexes and age groups.
"Despite these caveats, the trial adds important evidence supporting dotinurad as an effective and safe urate-lowering agent in Chinese patients with gout. Longer and broader studies will be necessary to evaluate its impact on long-term disease outcomes and its comparative efficacy against higher doses of febuxostat," the authors concluded.
Reference:
Sun, J., Wang, Y., Cheng, Y., Guo, D., Hu, J., Liu, D., Gao, Z., Li, C., Lu, Y., Kong, X., Liu, Y., Jiang, Z., Yi, B., Zhang, H., Xu, B., Yu, S., Kokan, R., Ishikawa, K., Kawakatsu, M., . . . Zhang, Z. Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double-Blind, Phase 3 Trial in China. Arthritis & Rheumatology. https://doi.org/10.1002/art.43261
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