The efficacy and tolerability of febuxostat treatment in a cohort of Chinese Han population with history of gout

Objective To measure the effect of febuxostat on the serum levels of uric acid (sUA) and the proinflammatory cytokines interleukin (IL)-6, IL-17 and tumour necrosis factor-alpha (TNF-alpha) in Chinese Han patients with gout and hyperuricaemia. Methods This randomized, double-blind, placebo-controlled pilot study enrolled patients with gout and hyperuricaemia (sUA >= 8 mg/dl). Patients were randomized to receive either febuxostat 80 mg or placebo once daily for 24 weeks. The serum levels of sUA, IL-6, IL-17 and TNF-alpha were measured at weeks 0 (baseline), 2, 4, 8, 12, 16 and 24. Baseline clinical and demographic characteristics were recorded for all patients. Results A total of 156 patients were randomized: placebo group (n = 78) and febuxostat group (n = 78). The febuxostat group showed a significantly greater reduction in sUA compared with the placebo group. Serum uric acid concentration was reduced below 8 mg/dl in 46 of 61 patients (75.4%) by week 24. There were also reductions in the serum levels IL-6, IL-17 and TNF-alpha in the febuxostat group. In the febuxostat group, 10 of 78 patients (12.82%) discontinued treatment due to adverse drug reactions. Conclusion Febuxostat reduced the levels of sUA, TNF-alpha, IL-6 and IL-17, but there were some side-effects.