This protocol addresses refractory gout in patients for whom standard urate-lowering therapy has been escalated and optimised yet the serum uric acid target remains unachieved. It defines the next clinical step after that failure.
Prior therapy included switching allopurinol to febuxostat, adding or substituting uricosurics (benzbromarone or probenecid), or combining allopurinol with a uricosuric — each taken to the maximal tolerated dosage. Despite these measures, the serum uric acid level remained at or above 6 mg/dL (360 mmol/L). In patients with severe gout, the stricter target of <5 mg/dL (300 mmol/L) was also not reached. This protocol is indicated when no other available drug or combination can achieve the goal.
When all prior oral urate-lowering options have been exhausted at maximum dosage, this protocol involves an intravenous urate-lowering agent administered on a defined schedule. The complete regimen — including the agent, dose, interval, and monitoring requirements — is in the full protocol.
Serum uric acid level below 6 mg/dL (360 mmol/L), with resolution of tophi as evidence of sustained urate crystal dissolution.
DOI: 10.1136/annrheumdis-2016-209707
In patients with crystal-proven, severe debilitating chronic tophaceous gout and poor quality of life, in whom the SUA target cannot be reached with any other available drug at the maximal dosage (including combinations), pegloticase is indicated.
In this study, the percentage of responders (SUA level <6 mg/dL) was 42%, on average, in patients who received pegloticase, 8 mg, every 2 weeks and 0% in the placebo group.
Effective ULT reduces the size and number of tophi and facilitates their disappearance, thereby improving the quality of life of patients with gout.
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