in this treatment arm before returning to the placebo level.
The reduction of gout flares, by approximately 40%, in the every two-
week dosing arm of these randomized, controlled, clinical trials is
believed to be the first time a urate lowering therapy has demonstrated
a reduction of gout flares versus a placebo.
New results presented from the GOUT 3 study show that for patients who
have been treated with pegloticase continuously for at least 12
months, the frequency of gout flares was reduced to approximately 0.2
flares per three months in the pegloticase every two weeks group, and
0.4 flares per 3 months in the every four weeks group. This represents
a 9-fold and 4-fold reduction in the frequency of gout flares after 12
months of continuous therapy for the every two and every four weeks
groups compared to the flare frequency reported prior to study entry.
Patients and their physicians participating in GOUT 3 study view this
reduction in gout flare frequency as an important clinical benefit and
the Company believes this benefit contributes to their joint decision
to continue therapy.
-- Immunology: The Company previously reported on the immune response to
pegloticase treatment in the GOUT 1 and GOUT 2 studies, showing a high
rate of seroconversion. The presence of anti-pegloticase antibodies
was predictive of a loss of uric acid control and a greater increase in
the risk of infusion reactions, but not a greater severity of infusion
reactions, particularly in the subset of patients with the highest one-
third of antibody titer.
Results of the GOUT 3 study reported confirm that for patients treated
with pegloticase for up to 12 months showed that:
- The overwhelming m
|SOURCE Savient Pharmaceuticals, Inc.|
Copyright©2008 PR Newswire.
All rights reserved