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Pegloticase (Krystexxa), an intravenous uricase, was FDA-approved for treatment of chronic gout in 2010. In two trials of pegloticase, researchers enrolled 225 patients who had serum urate concentrations >8.0 mg/dL (and either failure with or intolerance of allopurinol) and at least one of the following: self-reported gout attacks (>3 in 18 months); >1 tophi; or joint damage caused by gout. In both trials, patients were randomized to biweekly or monthly infusions of pegloticase or to placebo for 6 months.
The primary endpoint, a uric acid level <6.0 mg/dL, was met by 42% of patients in the biweekly groups, 35% in the monthly groups, and 0% in the placebo groups. Gout flares were more frequent with pegloticase than with placebo during the fir…