Initiation of febuxostat for acute gout flare does not prolong the current episode: a randomized clinical trial

Objective Our objective was to determine whether initiation of febuxostat during an acute gout flare prolongs the current episode. Methods In this randomized, placebo-controlled, single-blinded, multicentre trial, patients with acute gout flares within 72h were randomized (1:1) to the placebo and febuxostat (40mg/day) groups. All patients were administered diclofenac (150mg/day) for 7days and then open-labelled on the eighth day. Febuxostat 40mg daily and diclofenac 75mg daily were administered from day 8 through 28 for the remission period. The dose of diclofenac was 150mg/day before remission in both arms, and the original protocol was maintained until remission. The primary outcome was 'days to resolution'. Results We randomized 140 patients, 70 into each arm. The mean days to resolution was 5.98days [median 7.00, interquartile range (IQR) 2.45days] for the placebo and 6.50days (median 7.00, IQR 3.67days) for the febuxostat group (P = 0.578). The rate of resolution within 7days was 84.38% for the placebo group and 76.92% for the febuxostat group (P = 0.284). There were no statistically significant differences in joint pain, swelling, tenderness and erythema scores at days 1, 3, 5 and 7. The mean serum uric acid levels were 507.54 and 362.62 mu mol/l for the placebo and febuxostat group, respectively, on day 7 (P = 0.000). The rate of recurrent gout flares was 10.00% for the placebo group and 6.56% for the febuxostat group from day 8 through 28 (P = 0.492). Conclusion Initiation of febuxostat administration during an acute gout flare did not prolong the duration of acute flares. Trial registration Chinese Clinical Trial Registry, http://www.chictr.org.cn/, ChiCTR1800015962