EAST BRUNSWICK, N.J., July 2, 2012 – Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today 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 two weeks or every four weeks compared to placebo. At weeks one (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 two 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 current 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 U.S. 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 .
IMPORTANT SAFETY INFORMATION ABOUT TREATMENT WITH KRYSTEXXA®
KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia. Patients who are at risk of having a condition known as G6PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA.
Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do not institute oral urate-lowering therapy while the patient is on KRYSTEXXA therapy.
Possible side effects of KRYSTEXXA include:
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.
ADVERSE REACTIONS
Please see the Full Prescribing Information and Medication Guide at http://www.krystexxa.com/ .
ABOUT REFRACTORY CHRONIC GOUT
ABOUT SAVIENT PHARMACEUTICALS, INC.
FORWARD-LOOKING STATEMENTS
The Journal of Rheumatology