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Phase III Study Reveals Potential New Therapy for Gout

by VR Sreeraman on November 11, 2007 at 2:42 PM
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Phase III Study Reveals Potential New Therapy for Gout

Rilonacept (IL-1 Trap) may substantially decrease both disease activity and pain in patients with chronic active gout, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Boston, Mass.

Gout is a painful and potentially disabling form of arthritis that has been recognized since ancient times. Initial symptoms usually consist of intense episodes of painful swelling in single joints, most often in the feet, especially the big toe.

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Rilonacept, a potential new therapy currently being tested in the treatment of inflammatory conditions, prevents interleukin-1 from attaching to cell-surface receptors - creating a flare in disease. Interleukin-1 is a protein secreted by many cells in the body; secreted in excess, IL-1 can trigger disease activity in gout.

To assess the safety and change in disease activity in patients with chronic, active, gouty arthritis after treatment with rilonacept, researchers followed 10 patients who participated in a multi-center, non-randomized, single-blind, placebo-controlled study.
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The participants were on average 62 years old, had gout for an average of 13 years, and had suffered from chronic gout. Participants received twice-weekly subcutaneous injections of placebo followed by six weekly injections of rilonacept. Gout activity was assessed by the degree of pain reported by the patient, overall disease assessment, the number of joints experiencing joint pain, and a C-reactive protein blood test used to measure inflammation in the body.

There were no reported deaths or serious adverse events. Drug-related adverse events were most often associated with mild-to-moderate reactions at the injection site.

In the second through eighth week of treatment, 70 percent of participants had at least a 50 percent improvement in pain, and 60 percent of participants had at least a 75 percent improvement in pain. No participants on placebo showed improvement.

Inflammation levels detected in the blood decreased by 59 percent by the eight week of rilonacept therapy, and at week 14, a trend toward baseline levels was observed.

"The last two decades have seen a remarkable resurgence of gout in the USA, and practitioners are facing increasingly complex, refractory cases in which advanced age, co-morbidities including chronic kidney disease, and concomitant medications impose difficult management decisions," said Robert Terkeltaub, MD, section chief, rheumatology-allergy, VA Medical Center, San Diego; professor of medicine, University of California, San Diego; and an investigator in the study. "Practitioners are further limited by the lack of new FDA-approved therapeutic options for gouty inflammation and hyperuricemia management for patients who present with 'difficult gout' - particularly those who have extensive gouty skin and joint deposits of tophi and frequent or persistent inflammation of multiple joints. Experimental gouty inflammation is clearly IL-1beta-driven, and preliminary studies of gout patients suggest therapeutic benefit of IL-1 receptor antagonism, reinforced by this small pilot study of rilonacept in a group of refactory patients."

Source: Newswise
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