Lesinurad: Phase III data
Top-line data from the double-blind, placebo-controlled, international Phase III CRYSTAL trial in 324 gout patients with tophi (visible nodules of uric acid crystals that are deposited in joints and skin) showed that once-daily 400 mg lesinurad plus febuxostat met the primary endpoint of improving the proportion of patients achieving target sUA levels of <5 mg/mL at month 6 vs. febuxostat alone (p<0.0001). The once-daily 200 mg dose of lesinurad plus febuxostat missed the primary endpoint at month 6 (p=0.13), but was significant on the measure at months 1-5, 8, 10 and 12 (p<0.05 for all). The most common adverse events reported with lesinurad plus febuxostat were nasopharyngitis, arthralgia and upper respiratory tract infection. Patients who complete the trial have the option to receive 200 and 400 mg lesinurad plus febuxostat in an open-label extension study. ...