Serum Urate–Lowering Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia: A Randomized, Double‐Blind, Placebo‐Controlled, Dose‐Finding Trial
Authors' conclusion
Tigulixostat significantly lowered serum urate compared to placebo at all doses studied with an acceptable safety profile.
Study context
- Population
- Gout patients with hyperuricemia, after washout; colchicine flare prophylaxis in allrandomised
- Participants
- 143 patients
- Comparison
- Tigulixostat 50 mg, 100 mg or 200 mg daily orally vs placebo for 12 weeks
- Tigulixostat 50 mgn = 34
- Tigulixostat 100 mgn = 38
- Tigulixostat 200 mgn = 37
- Placebon = 34reference
- Primary endpoint
- Proportion with serum urate <5.0 mg/dl
- Follow-up
- Week 12
Methodological detailsmulticentre, phase II, double-blind, placebo-controlled, parallel-group, dose-finding
- Multicentre
- Phase II
- Double-blind
- Placebo-controlled
- Parallel-group
- Dose-finding
Primary result
As reported in the abstract
Serum urate <5.0 mg/dl
P < 0.0001
Further findings
- Mean percentage change in serum urate from baseline · all time points — Tigulixostat groups, mean % change range · Tigulixostat 50 mg, 100 mg and 200 mg vs Placebo · significantly greater in tigulixostat groups
- −38.8% to −61.8% · P < 0.0001
Safety
Gout flares requiring rescue treatment
- Range across tigulixostat and placebo groups
- 9.4% to 13.2%
Adverse events
- Incidence range across all groups
- 50.0% to 56.8%
- Severity mild or moderate
Original publication
Serum Urate–Lowering Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia: A Randomized, Double‐Blind, Placebo‐Controlled, Dose‐Finding Trial. Arthritis Rheumatol. Published 26 April 2023. doi:10.
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