Monday, August 13, 2012

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

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 (pegloticase, see structure) 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.



Savient announces results from KRYSTEXXA Phase III trials on gout-related kidney disease: Savient Pharmaceuticals, Inc. announced 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.

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