Savient Pharmaceuticals, Inc.
SVNT today announced results from new post-hoc analyses of
KRYSTEXXA^® (pegloticase) pivotal Phase III and open-label extension trials
that reinforced the health-related quality of life (HRQOL) benefits of
KRYSTEXXA treatment in adult patients with refractory chronic gout (RCG),
including tophus reduction outcomes. New data also demonstrated that guidance
on measuring serum uric acid (sUA) levels as a biomarker of therapeutic
response and infusion reaction (IR) risk significantly reduced the rate of IRs
in the post-approval setting, as compared to rates seen during randomized
clinical trials. These data will be presented this week at the American
College of Rheumatology/Associate Rheumatology Health Professional (ACR/ARHP)
Annual Meeting this week, November 9-14, 2012.
An analysis examining relative risk of IRs with KRYSTEXXA during a defined
post-approval period (September 2010 – September 2012) supported the
effectiveness of the clinical guidance contained in the current U.S. label
designed to identify patients at potentially higher risk for IRs by monitoring
sUA response and discontinuing treatment if levels increase to above 6 mg/dL,
particularly when two consecutive levels above 6 mg/dL are observed. The
analysis showed that there was an approximate two-thirds reduction in the
incidence of IRs in the post-approval period compared to the rate seen in the
randomized clinical trials where there was no clinical guidance in effect.
In another analysis, researchers observed sustained patient-reported HRQOL
improvements among participants identified as responders during their first
six months of treatment in the six-month, randomized, placebo-controlled Phase
III trials for an additional two-and-a-half years when treated with KRYSTEXXA
8 mg every two weeks during open-label extension study. These outcomes were
measured through widely-utilized assessment tools, including Medical Outcomes
Study Short Form-36 (SF-36) physical component summary scores and the Health
Assessment Questionnaire-Disability Index (HAQ-DI).
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