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Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: Results of a phase II randomized study
Arthritis & Rheumatism, 09/03/08
Sundy JS et al. – Pegloticase, administered in multiple doses, was effective in rapidly reducing and maintaining plasma urate levels at ≤6 mg/dl in most patients in whom conventional therapy had been unsuccessful due to lack of response, intolerability, or contraindication.
Methods- Study to assess the efficacy of pegloticase in achieving and maintaining plasma urate levels of <6 mg/dl in gout pts
- 41 pts randomized to undergo 12-14 wks of treatment with pegloticase: 4 mg every 2 wks, 8 mg every 2 wks, 8 mg every 4 wks, or 12 mg every 4 wks
- Plasma uricase activity, plasma urate, and antipegloticase abs were measured, pharmacokinetic parameters were assessed, and AEs were recorded
- The mean plasma urate level was reduced to ≤6 mg/dl within 6 h in all dosage groups; sustained in the 8 mg and 12 mg dosage groups
- The most effective dosage was 8 mg every 2 wks
- In 50-80% pts primary efficacy end point was achieved
- Gout flares occurred in 88% of the pts
- AEs were unrelated to treatment and were mild or moderate in severity
- Infusion-day AEs were the most common reason for study withdrawal
- There were no anaphylactic reactions
- Antipegloticase ab was associated with reduced circulating half-life of pegloticase in some pts
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