Analysis of Krystexxa Phase III Data Demonstrates Improved Health-Related Quality of Life and Physical Function in Refractory Chronic Gout Patients

Adult patients with refractory chronic gout (RCG) treated bi-weekly with Krystexxa (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain, and physical function, according to an analysis in The Journal of Rheumatology.

Savient Pharmaceuticals, Inc recently announced a new publication showing that adult patients with refractory chronic gout (RCG) treated bi-weekly with Krystexxa (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain, and physical function. The article confirms that chronic gout, especially refractory chronic gout, is associated with decline in HRQOL and physical functioning compared to patients without chronic gout. The results were published in the print edition of the

July 2012

issue of The Journal of Rheumatology.

"The significant improvements we observed in Krystexxa-treated patients' pain, physical function and health-related quality of life are important as the daily burden of untreated RCG can be tremendous for these patients," said

Vibeke Strand

, M.D., Adjunct Clinical Professor, division of immunology and rheumatology,

Stanford University

School of Medicine. "These improvements in quality of life measures also translate into meaningful savings in terms of cumulative treatment costs for patients with RCG."

The pre-specified, pooled analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies of patients receiving treatment with Krystexxa 8 mg every 2 weeks or every 4 weeks compared to placebo. At weeks 1 (baseline), 13, 19 and 25, investigators measured patient-reported HRQOL outcomes through four widely utilized assessment tools, namely, Medical Outcomes Study Short Form-36 (SF-36) physical component summary scores, the Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA) and pain by visual analog scale (VAS).

Results at week 25 demonstrated that mean improvements from baseline were statistically significant and exceeded minimum clinically important differences (MCID) in patients treated with Krystexxa 8 mg every 2 weeks, the approved dose and schedule. The data demonstrate that at least 50% of patients showed improvements in HRQOL parameters except for HAQ-DI in which 45% of patients showed improvements compared to placebo. Monthly pegloticase also improved HRQOL but the effects were not as robust as the bi-weekly treatment group. There was little to no improvement seen in the placebo group.

"This study underscores the severity of functional impairment experienced by many RCG patients and there is no other treatment to date that has shown to be effective in improving HRQOL and physical function in these patients as that demonstrated by Krystexxa," said

Kenneth Bahrt

, M.D., Senior Vice President and Chief Medical Officer of Savient. "We are pleased to have this analysis accepted for publication by The Journal of Rheumatology, which is a prestigious peer reviewed journal."

The article titled, "Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials," appears in the

July 2012

issue of the Journal of Rheumatology, which can be accessed online at http://www.jrheum.org.

About Krystexxa

Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme for administration by intravenous infusion for the treatment of refractory chronic gout (RCG) in adult patients. Krystexxa became commercially available in the U.S. by prescription on

December 1, 2010

and is the only United States Food and Drug Administration approved product specifically indicated for the treatment of RCG. Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia.

For more information about Krystexxa, please visit: http://www.KRYSTEXXA.com.

SOURCE: Savient Pharmaceuticals, Inc