In a Phase 3 trial, lesinurad combined with febuxostat showed superior serum urate (sUA) reduction vs. febuxostat alone in patients with tophaceous gout requiring additional therapy. Full findings from the study are published in Arthritis & Rheumatology.

The 12-month trial included 324 patients with sUA ≥8.0mg/dL (≥6.0mg/dL on urate-lowering therapy) and ≥1 measurable target tophus. Study patients were given febuxostat 80mg daily for 3 weeks before being randomized to either lesinurad 200mg or 400mg daily or placebo added to febuxostat. 

The primary endpoint was proportion of patients attaining sUA <5.0mg/dL at Month 6. Major secondary endpoints included percent change in total target tophi area. 

When lesinurad 400mg was added to febuxostat, significantly more patients achieved target sUA by Month 6 (76.1%; P<0.0001) vs. febuxostat alone (46.8%); however, this was not seen with adding lesinurad 200mg (56.6%; P=0.13). For all other timepoints, significantly more patients in the lesinurad 200mg group achieved the target sUA. 

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Study authors noted no difference between the groups regarding complete tophus resolution. Both lesinurad doses plus febuxostat lowered total target tophi area vs. febuxostat alone (50.1% [lesinurad 200mg] and 52.9% [lesinurad 400mg] vs. 28.3%; P<0.05). 

Higher rates of serum creatinine elevation were seen particularly with lesinurad 400mg; otherwise, safety was generally similar to febuxostat alone. 

Overall, researchers concluded lesinurad plus febuxostat led to superior sUA reduction vs. febuxostat alone “with clinically relevant added impact on tophi and an acceptable safety profile with lesinurad 200mg” in these patients.

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