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Savient Pharmaceuticals
today announced that new data from an open-label extension
(OLE) study published in the Annals of the Rheumatic Diseases reinforced the
safety and efficacy profile of KRYSTEXXA^® (pegloticase) treatment for
refractory chronic gout (RCG) over the long-term. OLE data aligned with
outcomes seen in the KRYSTEXXA pivotal Phase III clinical trials, with no new
safety signals identified. Improvements in clinical status were sustained or
advanced during and up to two and a half years of additional treatment as
evidenced by flare and tophus reduction first initiated in KRYSTEXXA-treated
Phase III trial participants who maintained goal range urate-lowering
responses. In addition to publication in the international peer-reviewed
journal, two posters further demonstrating the safety and efficacy seen in the
OLE study will be presented this week at the American College of
Rheumatology/Associate Rheumatology Health Professional (ACR/AHRP) Annual
Meeting, November 9-14, 2012.
"These data are encouraging because they confirm the long-term safety of
KRYSTEXXA as well as a durable and progressive response to treatment," said
Michael A. Becker, M.D., principal investigator, Professor Emeritus of
Medicine, University of Chicago. "This is great news for those patients who
have refractory chronic gout, or RCG, since treatment options are limited for
this severe, debilitating and progressive form of gout."
The study enrolled 151 patients who completed one of the two Phase III
randomized, double-blind, placebo-controlled registration trials. Patients
received either 8 mg KRYSTEXXA every two weeks, or the same dose every four
weeks, for the management of RCG. Consistent with Phase III trials, gout
flares and injection reactions were the most frequently reported adverse
events (71 percent and 44 percent of patients, respectively), and they were
least common in patients with a sustained response to KRYSTEXXA and those
receiving treatment every two weeks. In most patients defined as KRYSTEXXA
responders in the Phase III trials, plasma and serum uric acid levels remained
less than 6 mg/dL, and sustained and progressive improvements in tophus
resolution and flare incidence were seen throughout the study period.
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