This protocol addresses a specific and challenging clinical scenario: patients with gout who experience frequent flares but cannot use colchicine, NSAIDs, or corticosteroids (oral or injectable), and in whom prior urate-lowering therapy — even at maximal dosage and in combination — has failed to achieve the required serum uric acid targets.
In patients with these combined contraindications to standard anti-inflammatory agents, IL-1 blockers should be considered for managing flares. The absence of a current infection is a prerequisite, as active infection is a contraindication to IL-1 blocker use.
Prior urate-lowering therapy — including switching xanthine oxidase inhibitors, adding a uricosuric agent, or combining agents at maximal dosage — did not achieve the required targets:
Failure to reach these targets despite maximal available oral therapy, including combination regimens, defines the threshold for escalation to this next-line protocol.
For patients with crystal-proven, severe, debilitating chronic tophaceous gout and poor quality of life — in whom the serum uric acid target cannot be reached with any available drug at maximal dosage, including combinations — an intravenous recombinant uricase-based therapy is indicated.
The complete eligibility criteria, monitoring requirements, administration schedule, and full clinical algorithm are available in the structured protocol below.
Effective urate-lowering therapy reduces the size and number of tophi and facilitates their disappearance, improving quality of life in patients with gout.
DOI: 10.1136/annrheumdis-2016-209707
In patients with frequent flares and contraindications to colchicine, NSAIDs and corticosteroid (oral and injectable), IL-1 blockers should be considered for treating flares.
Current infection is a contraindication to the use of IL-1 blockers.
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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