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Combination lesinurad, febuxostat may reduce tophi in patients with gout

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Lesinurad, a selective uric acid reabsorption inhibitor, in combination with febuxostat may help reduce tophi and lower serum uric acid levels more effectively than febuxostat alone, according to details from the CRYSTAL phase 3 study.

Patients with gout between the ages of 18 years and 85 years (mean age: 54 years) with an average disease duration of 14.7 years were enrolled in a multinational, randomized, double-blind, placebo-controlled, phase 3 clinical trial of lesinurad combined with febuxostat compared with febuxostat monotherapy. Eligible patients had serum uric acid (sUA) higher than 8 mg/dL or higher than 6 mg/dL in the presence of urate lowering treatment and at least one tophus present.

Febuxostat was administered once daily in conjunction with placebo to 109 patients, in combination with 200 mg lesinurad to 106 patients and in combination with 400 mg lesinurad to 109 patients. The study’s primary endpoint was the proportion of patients who achieved complete resolution of one or more tophi and the percent reduction observed in tophus area at 12 months.

The mean sUA level decreased to 5.3 mg/dL at randomization compared with mean 8.7 mg/dL at baseline. Patients who received a combination of lesinurad and febuxostat were more likely to reach a sUA level lower than 5 mg/dL or lower than 3 mg/dL.

Complete resolution of at least one tophus by month 12 was achieved by 21.1% in patients who received febuxostat plus placebo, by 25.5% of patients who received febuxostat in combination with 200 mg lesinurad, and by 30.3% in patients who received febuxostat and 400 mg of lesinurad. The researchers also found the chance for kidney stones was lower in the lesinurad groups.

Adverse events included six patients without lesinurad who had renal involvement (one serious) compared with nine patients in the low-dose lesinurad group and 11 in the high-dose group. Four patients without lesinurad had kidney stones compared with one in the low-dose lesinurad group and two patients in the high-dose group.

No patients in the monotherapy group had elevations in serum creatinine, whereas three patients in the low-dose lesinurad group and seven in the high-dose group saw an increase. The levels resolved in two of the three low-dose patients and in six of seven of the high-dose patients, according to the researchers. – by Shirley Pulawski

Reference:

Dalbeth N, et al. Paper #SAT0329. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosure s : Dalbeth reports receiving grant/research support from AstraZeneca, Fonterra and Novartis; is on the speakers bureau for Savient, Menarini, Novartis and Takeda; and is on advisory boards for AstraZeneca, Fonterra, Takeda and Metabolex. Please see the full study for a list of all other authors’ relevant financial disclosures.