Savient Pharmaceuticals Announces Publication Of Pivotal Phase III KRYSTEXXAÂ® Data In JAMA Demonstrating Significant Benefits In Refractory Chronic Gout Patients
EAST BRUNSWICK, N.J., Aug. 16, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that results from two pivotal KRYSTEXXA® (pegloticase) Phase III clinical studies in patients with refractory chronic gout (RCG) have been published in The Journal of the American Medical Association ( JAMA). The data demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial proportion of RCG patients for six months, a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies.
The two replicate, randomized, double-blind, placebo-controlled Phase III studies were designed to evaluate the efficacy and tolerability of treatment with KRYSTEXXA 8 mg every two weeks or every four weeks compared to placebo for the management of RCG patients. Pooled results from these studies demonstrated that treatment with KRYSTEXXA every two weeks, the U.S. Food and Drug Administration (FDA)-approved dose, resulted in a statistically significant and sustained reduction in uric acid levels below 6 mg/dL in 42 percent of patients, compared to zero percent of patients receiving placebo (p<0.001).
In addition, 40 percent of patients with tophi receiving KRYSTEXXA every two weeks experienced complete resolution of one or more tophi, which are deposits of crystalline urate in joints, skin or cartilage, by the final study visit, compared to seven percent of patients on placebo (p=0.002). A tophus complete response was defined as 100 percent reduction in the measured area of at least one tophus without growth of any baseline tophus or appearance of any new tophus.
"When effective lowering of uric acid levels cannot be achieved with oral medications, many gout patients progress to a severe form of the condition known as refractory chronic gout, which is characterized by frequent arthritic flares, chronic pain, physical disability and poor quality of life," said Michael A. Becker, M.D., Professor Emeritus of Medicine at The University of Chicago. "The data from these studies demonstrated that significant and rapid clinical benefits can be shown in such severely affected patients during KRYSTEXXA treatment."Improved patient-reported outcomes in physical function, pain and quality of life were also observed in KRYSTEXXA-treated patients.
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