The study authors noted that approximately 6 million men and women in the United States suffer from some form of gout, an illness that stems from an inability of the body to adequately dispose of uric acid accumulation. Over the last two decades the number of Americans who struggle with the disease has gone up by roughly 50 percent.
For such individuals, mounting uric acid levels give rise to tiny needle-like crystal formations, which in turn lodge in joints and tissues (most notably the big toe), causing inflammation and frequently debilitating pain.
Since 1966, orally administered allopurinol (Lopurin, Zyloprim) has been the treatment of record, helping many patients by lowering the production of uric acid while draining out unsustainable deposits through the kidneys. A second oral treatment option, called febuxostat (Uloric) was approved two years ago.
But for a small minority of patients, the pills either don't work, work too slowly or prompt severe side effects. Their gout can lead to joint disease, deformity, chronic pain, disability and diminished quality of life. And for such individuals there has been no "plan B."
For some of these patients, Becker explained, bi-weekly (every two weeks) intravenous infusions of pegloticase containing a modified version of a pig enzyme called "uricase" (lacking in humans) work by quickly converting uric acid into an alternate and easily excretable fluid.
To see how effective this novel approach might be, the study authors conducted two six-month trials in tandem, involving a final total of 212 patients with severe, chronic and previously untreatable gout who were being cared for at 56 different rheumatology facilities throughout the United States, Canada and Mexico.
Patients were randomly divided into three groups: one to receive 8 milli
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