Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Tophus Response

Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.

Time frame: Up to 2 years

Patient Reported Outcome: SF-36 Physical Component Summary Score

SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status.

Time frame: RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101

Gout Flare Frequency

The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment

Time frame: Up to 2 years

Gout Flare Incidence

Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.

Time frame: Assessed in 3-month intervals up to 2 years