Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double‐Blind, Phase 3 Trial in China
Primary result · Responder rate (serum urate ≤6.0 mg/dL)Result — go to the resultAdjusted difference 35.9% 95% CI 27.4%–44.4%Authors' conclusion
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.
Study context
- Population
- Chinese patients with gout441 in full analysis set (FAS)
- Participants
- 451 patients
- Comparison
- Oral dotinurad vs febuxostat 40 mg/day
- Primary endpoint
- Responder rate (serum urate ≤6.0 mg/dL), superiority of dotinurad 4 mg/day vs febuxostat 40 mg/day, FAS
- Follow-up
- Week 24
Methodological detailsphase 3, multicentre, double-blind, parallel-group
- Phase 3
- Multicentre
- Double-blind
- Parallel-group
Primary result
Responder rate (serum urate ≤6.0 mg/dL)
Adjusted difference
35.9%
95% CI 27.4%–44.4%
P < 0.0001
By group
Dotinuradvs Febuxostat
adjusted difference 35.9% (95% CI 27.4%–44.4%); P < 0.0001
As reported in the abstract
Secondary outcomes
| Outcome | Dotinurad | Febuxostat | Adjusted difference (95% CI) | |
|---|---|---|---|---|
| Responder rate, dotinurad 2 mg/day (noninferiority) · week 12Dotinurad 2 mg/day · noninferior | 55.5% | 50.5% | 5.2% (−3.7% to 14.2%) | |
| −1001020Difference (linear scale) |
Safety
- Incidences of treatment-emergent adverse events (TEAEs) similar in dotinurad and febuxostat groups
Original publication
Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double‐Blind, Phase 3 Trial in China. Arthritis Rheumatol. Published 8 September 2025. doi:10.
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