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Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Date:10/27/2008

ajority of subjects who develop a high titer

of anti-pegloticase antibody, with subsequent loss of uric acid

control, have done so by the fourth month of treatment in the double

blind studies. The proportion of patients who had lost uric acid

control remained relatively constant during extended therapy with

pegloticase.

- Neutralizing antibodies and clinically relevant titers of anti

pegloticase IgE were not present in any of the patients with

continued use of pegloticase out to as long as 18 months.

These results are consistent with those previously reported for the

GOUT 1 and GOUT 2 studies. Further, the Company believes that the

immunology results are consistent with the continuing and increasing

clinical benefits that appear to be accruing to patients with

continuing longer-term pegloticase treatment, e.g. control of

hyperuricemia, elimination of gout tophi, and the reduction in gout

flare frequency.

-- Safety: As previously reported, the pegloticase clinical development

program (GOUT 1, GOUT 2, and GOUT 3) identified two adverse safety

signals: the transient increase in gout flares in Months 1-3 and the

occurrence of infusion reactions. As mentioned above, new data

presented at ACR demonstrated that in Months 4-6 of the GOUT 1 and GOUT

2 studies, the incidence of gout flares in the every 2 weeks dosing

group was significantly below that of placebo patients in the pooled

analysis and at the same level as placebo patients in the every 4 weeks

dosing group.

Additional new results presented from the GOUT 3 study extended this

improvement noting a 9-fold and 4-fold reduction in the frequency of

gout flares against initial study entry baseline for the every 2 weeks

and every 4 weeks dosing group
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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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