Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase
2005

Treatment of Refractory Gout with PEGylated Uricase

Sample size: 13 publication Evidence: moderate

Author Information

Author(s): Ganson Nancy J, Kelly Susan J, Scarlett Edna, Sundy John S, Hershfield Michael S

Primary Institution: Duke University Medical Center

Hypothesis

Can PEGylated urate oxidase effectively control hyperuricemia in patients with refractory gout?

Conclusion

PEGylated uricase significantly reduced plasma uric acid levels in patients with severe, refractory gout, but some developed antibodies against PEG.

Supporting Evidence

  • Plasma uric acid levels decreased by an average of 7.9 mg/dl by day seven after injection.
  • 11 out of 13 subjects normalized their plasma uric acid levels.
  • Antibodies against PEG were detected in some subjects, which may limit treatment efficacy.

Takeaway

This study tested a new treatment for gout that helps lower uric acid levels, but some people had reactions to it.

Methodology

An open-label phase I trial with subcutaneous injections of PEG-uricase in varying doses to assess efficacy and safety.

Potential Biases

Potential bias due to the small sample size and early termination of the trial.

Limitations

The trial was stopped early due to hypersensitivity reactions in some subjects.

Participant Demographics

13 subjects with symptomatic gout, 11 with tophi, and varying levels of uric acid.

Digital Object Identifier (DOI)

10.1186/ar1861

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