New Gout Drug Proves Effective

by Sheela Philomena on  August 17, 2011 at 12:33 PM Drug News
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 New Gout Drug Proves Effective
Patients with chronic gout who received the medication pegloticase showed greater improvement in uric acid measures as well as physical function and quality of life, shows study.

Long-term urate (a salt derived from uric acid) lowering therapy in gout aims to maintain concentrations of uric acid (UA) below a certain level. However, it is common for UA levels to exceed a recommended goal urate range during oral urate-lowering therapy among the 5 to 6 million U.S. patients with gout, according to background information in the article. Although available oral urate-lowering agents can achieve target UA in most patients, urate-lowering therapy fails for perhaps 3 percent of patients because of refractoriness (resistant to treatment), contraindication, or intolerance. Without effective urate lowering, many such patients may progress to severe chronic gout characterized by symptoms including frequent arthritic flares and chronic arthropathy (a joint disease), often accompanied by deformity, chronic pain, functional disability, and impaired health-related quality of life (QOL). Pegloticase, a recently approved drug, was developed for patients in whom conventional urate-lowering agents are not effective. The drug is intravenously administered and remains in the circulation where it degrades urate.

John S. Sundy, M.D., Ph.D., of Duke University Medical Center, Durham, N.C., and colleagues report results of two randomized, placebo-controlled, 6-month trials of the urate-lowering and clinical efficacy and tolerability of pegloticase in patients with refractory gout. The trials (C0405 and C0406) were conducted between June 2006 and October 2007 at 56 rheumatology practices in the United States, Canada, and Mexico in patients with severe gout, allopurinol (a drug to treat gout) intolerance or refractoriness, and serum uric acid concentration of 8.0 mg/dL or greater. A total of 225 patients participated: 109 in trial C0405 and 116 in trial C0406. Patients received 12 biweekly intravenous infusions containing either pegloticase 8 mg at each infusion (biweekly treatment group), pegloticase alternating with placebo at successive infusions (monthly treatment group), or placebo. The primary measured outcome was plasma uric acid levels of less than 6.0 mg/dL measured at months 3 and 6.

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