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Clinical trial demonstrates that rilonacept significantly reduces gout flares
Date:1/4/2012

the risk of gout flares when initiating uric-acid lowering therapy could make patients more likely to continue important long-term treatments that control gout," added Dr. Schumacher.

Rilonaceptmarketed under the brand name ARCALYST to treat another diseaseis designed to neutralize the protein IL-1 before it produces signals that can trigger inflammation. Thus, researchers looked to test the effectiveness of rilonacept in preventing gout flares and enrolled 83 patients at 27 study centers across the U.S. for a phase II clinical trial. Participants were 18 years of age or older and had gout, including a history of two or more gout flares within the prior year, as well as elevated blood levels of uric acid. Participants were randomized in a double blind fashion, with 41 administered rilonacept via subcutaneous injection (a double dose [320 mg], followed by (160 mg weekly for 16 weeks) and 42 administered weekly placebo. All patients were started on allopurinol (300mg/day) to reduce uric acid levels.

Trial results revealed a significantly lower number of gout flares in participants taking rilonacept with only 6 flares in the rilonacept arm compared with 33 in the placebo group. Researchers also observed fewer flares in patients treated with rilonacept as early as four weeks following the start of therapy. At the 12-week study point, only 15% of patients taking rilonacept had experienced gout flares compared to 45% of those in the placebo group. No deaths or serious infections occurred in either group. Common adverse events included infections reported in 15% of the rilonacept group compared with 26% with the placebo.

"This trial provides well-controlled evidence that this IL-1 blocker is effective in preventing acute gout flares in this setting," confirmed Dr. Schumacher. "Rilonacept appears safe and well tolerated and could increase patient adherence to long-term urate-lowering therapy." The authors recommend further evaluation of rilonace
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Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

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