Savient Pharmaceuticals has demonstrated positive results from two pivotal Phase III clinical studies of Krystexxa (pegloticase) as a treatment for refractory chronic gout (RCG).
Krystexxa is a PEGylated uric acid specific enzyme for administration by intravenous infusion for the treatment of RCG in adult patients.
The two replicate, randomised, double-blind, placebo-controlled Phase III studies, involving 212 patients, are designed to evaluate the efficacy and tolerability of treatment with Krystexxa 8mg every two weeks or every four weeks compared with placebo for the management of RCG patients.
The data demonstrated that 42% of RCG patients achieved significant reductions in uric acid levels that were sustained for at least six months, compared with 0% of RCG patients on placebo and 40% of RCG patients with tophi experienced complete resolution of one or more tophi, compared with 7% of patients on placebo.
Results also showed improved patient-reported outcomes in physical function, pain and quality of life in Krystexxa-treated patients.
The study findings were published in The Journal of the American Medical Association (JAMA).