Savient Pharma (SVNT) Reports Publication of Statistically Significant Data from KRYSTEXXA Phase III
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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 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.
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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.
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