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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

t. With continued pegloticase therapy beyond 6

months in the GOUT 3 study, the proportion of patients demonstrating a

Complete Response for tophus resolution increased over time in both the

every 2 weeks and every 4 weeks groups. While other clinical

assessments also showed clinical improvements, such as a partial tophus

response, it is only the tophus Complete Response that was pre-

specified as a clinical criterion by which to measure success. It is

very encouraging that many patients, who had a tophus partial response

in the first six months of treatment, developed a Complete Response

over a longer treatment period in GOUT 3.

-- Gout Flares: The GOUT 1 and GOUT 2 pivotal studies assessed the affect

of pegloticase treatment on both an efficacy and safety secondary

endpoints in gout flares. As with all urate-lowering therapies, the

frequency of flares increased upon initiation of pegloticase treatment

as expected. The treatment-failure gout patients in the Phase 3

program had a high frequency of gout flares prior to study entry, as

shown by the approximately 1.7 flares per the initial 3-month period

for the placebo group. In the pooled analyses, pegloticase-induced

increase in gout flares occurred in both treatment groups during Months

1-3 to a frequency of about 2.3 and 2.7 respectively, whereas the

placebo group showed no change in flare frequency during the same 3-

month period.

New data presented at ACR demonstrates that in Months 4-6 patients

administered pegloticase every 2 weeks had a statistically

significant lower flare incidence and frequency compared to placebo

patients in the pooled analysis. Additionally, in Months 4-6, the

pegloticase every 4 weeks group had a frequency of gout flares similar

to placebo indi

SOURCE Savient Pharmaceuticals, Inc.
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