June 09, 2017
Lesinurad in Combo With Febuxostat in Patients With Tophaceous Gout
Title: Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: A Phase III Clinical Trial
Dalbeth, N et al.
What You Need to Know:
In patients with tophaceous gout, combination therapy of lesinurad plus febuxostat is more effective at reducing serum urate (sUA) levels as well as total target tophi area compared to febuxostat monotherapy.
- Randomized, placebo-controlled, phase 3 study evaluated the safety and efficacy of lesinurad + febuxostat compared to febuxostat alone in patients with tophaceous gout
- “Patients with serum urate (sUA) ≥8.0 mg/dL (≥6.0 mg/dl on urate-lowering therapy) and ≥1 measurable target tophus were given febuxostat 80mg daily for 3 weeks before randomization to lesinurad (200 or 400mg daily) or placebo added to febuxostat”
- Primary endpoint: percent of patients attaining sUA <5.0 mg/dL at month 6
- Secondary endpoint: percent of patients with resolution of ≥1 target tophus at month 12
- Additional endpoints: change in percent of total target tophi area, safety assessments (adverse events, laboratory findings)
- 76.1% of patients receiving 400mg of lesinurad (P<0.0001) and 56.6% of patients receiving 200mg lesinurad (P=0.13) achieved sUA target by Month 6 vs 46.8% of patients receiving febuxostat alone
- “At all other timepoints, significantly more patients in the lesinurad 200mg group achieved sUA target”
- No difference in complete tophus resolution observed between groups
- Total target tophi area was reduced in patients receiving 200mg and 400mg of lesinurad + febuxostat compared to febuxostat monotherapy (50.1% and 52.9% vs 28.3%, respectively; P<0.05)
- Safety assessments were similar among groups, however higher rates of reversible serum creatinine elevation was observed in the lesinurad-treated groups