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EAST BRUNSWICK, N.J. — Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.
Savient said results of phase-3, placebo-controlled trials of Krystexxa (pegloticase) showed that the drug produced significant and sustained reductions in uric acid levels in 42% patients with refractory chronic gout and clinical improvements in a substantial proportion of patients for six months. In addition, 40% of patients received complete resolution of one or more tophi, crystalline urate deposits in the joints, skin and cartilage, compared with 7% of those taking placebo.
The trials were conducted on 212 patients in the United States, Canada and Mexico between June 2006 and October 2007 who had severe gout, allopurinol intolerance or refractoriness, and serum uric acid concentration of 8 mg per deciliter or more. Patients received 12 two-week intravenous infusions with either 8 mg of Krystexxa every two weeks, Krystexxa alternating with placebo or placebo alone.