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Positive data in study of Krystexxa (Savient Pharma) in patients with Gout

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Last updated: 3rd Jul 2012
Published: 3rd Jul 2012
Source: Pharmawand
New results show that adult patients with refractory chronic Gout (RCG) treated bi-weekly with Krystexxa (pegloticase), from Savient Pharma, experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies. Results at week 25 demonstrated that mean improvements from baseline were statistically significant and exceeded minimum clinically important differences. The data demonstrate that at least 50% of patients showed improvements in HRQOL parameters except for the Health Assessment Questionnaire-Disability Index 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. See: "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." Vibeke Strand et al. The Journal of Rheumatology vol. 39 no. 7 1450-1457 Published online before print June 1, 2012, doi: 10.3899/jrheum.111375
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