Long-term safety of pegloticase in chronic gout refractory to conventional treatment

Journal Article

Objective: To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout. Methods: This open-label extension (OLE) study was conducted at 46 sites in the USA, Canada and Mexico. Patients completing either of two replicate randomised placebo-controlled 6-month trials received pegloticase 8 mg every 2 weeks (biweekly) or every 4 weeks (monthly). Safety was evaluated as the primary outcome, with special interest in gout flares and infusion-related reactions (IRs). Secondary outcomes included uratelowering and clinical efficacy. Results: Patients (n=149) received a mean±SD of 28±18 pegloticase infusions and were followed for a mean of 25±11 months. Gout flares and IRs were the most frequently reported adverse events; these were least common in patients with a sustained urate-lowering response to treatment and those receiving biweekly treatment. In 10 of the 11 patients with a serious IR, the event occurred when uric acid exceeded 6 mg/dl. Plasma and serum uric acid levels remained <6 mg/dl in most randomised controlled trial (RCT)-defined pegloticase responders throughout the OLE study and were accompanied by sustained and progressive improvements in tophus resolution and flare incidence. Conclusions: The safety profile of long-term pegloticase treatment was consistent with that observed during 6 months of RCT treatment; no new safety signals were identified. Improvements in clinical status, in the form of flare and tophus reduction initiated during RCT pegloticase treatment in patients maintaining goal range urate-lowering responses were sustained or advanced during up to 2.5 years of additional treatment.

Full Text

Duke Authors

Cited Authors

  • Becker, MA; Baraf, HSB; Yood, RA; Dillon, A; Vázquez-Mellado, J; Ottery, FD; Khanna, D; Sundy, JS

Published Date

  • 2013

Published In

Volume / Issue

  • 72 / 9

Start / End Page

  • 1469 - 1474

International Standard Serial Number (ISSN)

  • 0003-4967

Digital Object Identifier (DOI)

  • 10.1136/annrheumdis-2012-201795