Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease

Jun 7 2012

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced that new data presented in an oral session at the European League Against Rheumatism (EULAR) 2012 congress showed that patients with refractory chronic gout (RCG) who also suffer from chronic kidney disease (CKD) responded to treatment with KRYSTEXXA^® (pegloticase) regardless of baseline CKD stage.  CKD stage is assigned based upon level of kidney function as measured by glomerular filtration rate (GFR), with higher stages having lower GFR levels. Six additional abstracts, including a study measuring the impact of gout pain on quality of life in Western Europe, were accepted for presentation or publication at EULAR, June 6-9, 2012.

Uric acid, which is high in patients with gout, is processed and excreted primarily by the kidney.  Impairment of kidney function can alter the uric acid lowering effect of conventional gout treatments and decrease the threshold for a patient to experience treatment-related toxicity.  Some treatments for gout require a dose reduction to avoid toxicity, yet elevated uric acid has been associated with worsening kidney function.

"There are currently limited treatment options available for gout patients with CKD so these data are encouraging because they showed that KRYSTEXXA is effective regardless of CKD stage, or severity of disease, and treatment with KRYSTEXXA does not impact estimated GFR levels, an indicator of kidney function," said Robert A. Yood, M.D., Principal Investigator, Chief of Rheumatology at Reliant Medical Group, and Clinical Professor of Medicine at the University of Massachusetts Medical School.

This post-hoc analysis evaluated more than 200 patients with CKD stages one through four (n=34, 74, 80, 23, respectively) who were randomized to receive treatment with KRYSTEXXA 8 mg every other week, 8 mg every four weeks or placebo. Baseline CKD stage was similar across treatment arms, and there was no significant difference in rates of response to KRYSTEXXA by CKD stage (p<0.311). Additionally, treatment with KRYSTEXXA did not impact estimated GFR levels in patients with or without CKD. Similar results were seen in a 24-month open-label extension study.                 

In another study presented as a poster at EULAR, 35 percent of patients diagnosed with gout in Western Europe reported experiencing pain in the last 30 days (versus 20 percent in the control group of those who did not report gout; p<0.05).  Of those patients, 23 percent reported severe daily pain (versus 13.5 percent in control group; p<0.05), which impacted quality of life as assessed by the SF-12 health outcome measurement tool.  Based on study data, it is estimated that one in five gout patients in Western Europe experiences moderate to severe daily pain, one of the symptoms of gout.

"Currently there are no approved treatments for RCG in the European Union, so there remains an unmet need in Europe for treatment options for this often debilitating form of gout.  Savient remains committed to working with European regulatory authorities to bring KRYSTEXXA to market as soon as possible," said Kenneth Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient Pharmaceuticals, Inc.

Savient is seeking approval for KRYSTEXXA in Europe and filed its Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in May 2011.