Tigulixostat significantly reduces serum urate concentration in gout patients

A study by Robert Terkeltaub and peers found that Tigulixostat (nonpurine xanthine oxidase inhibitor) reduces serum urate (sUA) levels in gout patients with hyperuricemia. The findings were published in Arthritis and Rheumatology Journal.

The research team conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding phase II study. Following screening, gout patients with hyperuricemia were randomly assigned to receive 50 mg, 100 mg, or 200 mg of oral tigulixostat or placebo for 12 weeks after an appropriate washout. Also, all subjects were treated with colchicine to prevent any event of gout flares. The primary endpoint was the proportion of subjects with an sUA level of 5.0 mg/dL at week 12.

The highlights of the study were:

A total of 143 subjects were include randomly to receive 50 mg (n=34), 100 mg (n=38), 200 mg (n=37) or placebo (n=34) of tigulixostat.

Significantly greater proportion of subjects in the tigulixostat dose groups (47.1% in the 50 mg, 44.7% in the 100 mg, and 62.2% in the 200 mg group) achieved sUA levels <5.0 mg/dL at week 12 compared with the placebo group (2.9%).

The mean percent change from baseline in sUA levels was also significantly greater in the tigulixostat dose groups (-38.8% to -61.8%) than in the placebo group at all time points (P value < 0.0001).

The rate of gout flares requiring rescue treatment was 9.4% to 13.2% in the tigulixostat and placebo groups.

The incidence of adverse events in the group ranged from 50.0 to 56.8% and was mild to moderate in severity.

Thus, the authors of this study concluded that Tigulixostat significantly reduces sUA at all doses with an acceptable safety profile when compared to placebo.

Source:

Terkeltaub, R., Lee, J., Min, J., Shin, S., & Saag, K. G. (2023). Serum urate-lowering efficacy and safety of tigulixostat in gout patients with hyperuricemia: a randomized, double-blind, placebo-controlled, dose-finding trial (CLUE). Arthritis & Rheumatology. https://doi.org/10.1002/art.42447