Intensive serum urate lowering with oral urate‐lowering therapy for erosive gout: A randomized double‐blind controlled trial

Objective

To determine whether intensive serum urate lowering results in improved bone erosion scores in erosive gout.

Methods

Two-year, double-blind, randomized, controlled trial of 104 participants with erosive gout on oral urate-lowering therapy (ULT) and serum urate ≥ 0.30mmol/L was undertaken. Participants were randomly assigned to serum urate target <0.20mmol/L (intensive target) or <0.30mmol/L (standard target, according to rheumatology guidelines). Oral ULT was titrated to target using a standardized protocol (using maximum approved doses of allopurinol, probenecid, febuxostat, and benzbromarone). The primary endpoint was total CT erosion score. OMERACT gout core outcome domains were secondary endpoints.

Results

Although the serum urate was significantly lower in the intensive target group compared to the standard target group (P=0.002), fewer participants in the intensive group achieved the randomized serum urate target (at Year 2, 62% vs 83%, P<0.05). The intensive target group required higher allopurinol doses (mean (SD) 746 (210) mg/day vs 496 (185) mg/day, P<0.001), and used more combination therapy (P=0.0004). Small increases in CT erosion scores were observed in both groups over two years, with no between-group difference (P=0.20). OMERACT core outcome domains (gout flares, tophus, pain, patient global assessment, health-related quality of life, and activity limitation) improved in both groups, with no between-group differences. Adverse event and serious adverse event rates were similar between groups.

Conclusion

Compared with a serum urate target below 0.30mmol/L, more intensive serum urate-lowering is difficult to achieve with oral ULT, leads to high medication burden, and does not improve bone erosion scores in erosive gout.

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