Abstract:
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.