Zurampic lesinurad: Additional Phase III data

AstraZeneca reported additional data from the double-blind, placebo-controlled, international Phase III CRYSTAL trial of lesinurad in 324 gout patients with tophi (visible nodules of uric acid crystals that are deposited in joints and skin). In the analysis, patients were stratified by baseline renal function using estimated creatinine clearance (eCrCl) levels of <60, <=90 and >=90 mL/min. In patients with a baseline eCrCl of <60 mL/min, 67.9% and 77.3% of patients receiving once-daily 200 and 400 mg lesinurad plus febuxostat achieved target sUA levels of <5 mg/mL at month 6, the primary endpoint, vs. 48% of patients receiving febuxostat alone (p<0.05 for high-dose lesinurad). Additionally, 64.3% and 59.1% of patients receiving low- and high-dose lesinurad plus febuxostat achieved the endpoint at month 12 vs. 56% of patients receiving febuxostat alone. In patients with a baseline eCrCl of <90 mL/min, 62.1% and 79.1% of patients receiving low- and high-dose lesinurad plus febuxostat achieved the endpoint at month 6 vs. 53.2% of patients receiving febuxostat alone (p<0.001 for high-dose lesinurad). Additionally, 65.2% and 68.7% of patients receiving low- and high dose lesinurad plus febuxostat achieved the endpoint at month 12 vs. 49.4% of patients receiving febuxostat alone (p<0.05 for both). ...