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ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

-related signs and symptoms (7.3% with ARCALYST and 7.3% with placebo), and taking more than the recommended dose (5.6% with ARCALYST and 6.4% with placebo).

About GoutGout is a condition that occurs when the bodily waste product, uric acid, is deposited in the joints and/or soft tissues.  In the joints, these uric acid crystals cause inflammation, which leads to pain, swelling, redness, heat, and stiffness in the joints.  Treatment guidelines recommend that patients with elevated uric acid levels who experience multiple gout attacks each year should receive chronic uric acid-lowering therapy, such as allopurinol.  Allopurinol reduces the production of uric acid in the body to prevent the occurrence of gout attacks with long-term use.  Approximately 750,000 gout patients initiate allopurinol therapy each year.  During the first months of allopurinol therapy while uric acid blood levels are being reduced, the break up of the uric acid crystals can result in stimulation of inflammatory mediators, including interleukin-1 (IL-1), resulting in acute flares of joint pain and inflammation.  Anti-inflammatory therapy with colchicine is sometimes used to help prevent these flares.  However, the side effects associated with colchicine, which include diarrhea, abdominal cramps, nausea, and vomiting, can limit patients' adherence to both colchicine and allopurinol treatment.

Rationale for the Clinical Exploration of Use of ARCALYST® (rilonacept) in the Treatment of GoutInterleukin-1 (IL-1) is a protein secreted by infection-fighting cells in the blood and tissues.  In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body's immune system.  In excess, it can be harmful and has been shown to be a key driver of inflammation in a variety of diseases, including gout.  In gout, uric acid crystals stimu
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SOURCE Regeneron Pharmaceuticals, Inc.
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