Researchers report that the drug febuxostat reduced gout flares in a double-blind, placebo-controlled study of 314 adults with early gout. Febuxostat treatment also reduced synovitis – or inflammation of the joint lining detected by MRI scanning – over a 2-year period compared with placebo.
Febuxostat treats high urate in the blood of patients with gout.
“Current clinical practice guidelines do not recommend routine use of urate-lowering therapy for people after the first gout flare. This study indicates that even for people who have had only 1 or 2 prior gout flares, urate-lowering therapy to reduce serum urate below 6mg/dL may have benefit in reducing future flares,” said Dr Nicola Dalbeth, at the University of Auckland, Auckland, New Zealand and lead author of the study.
Objectives: To assess the effect of treatment with febuxostat vs placebo on joint damage in hyperuricemic subjects with early gout (experienced ≤2 gout flares).
Methods: In this double-blind, placebo-controlled study, subjects (n = 314) with hyperuricemia (serum uric acid [sUA] ≥7.0 mg/dL) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if sUA ≥6.0 mg/dL at day 14) or placebo. The primary efficacy endpoint was mean change from baseline (CFB) to month 24 in the modified Sharp-van der Heijde (mSvdH) erosion score from the single affected joint X-rays. Additional efficacy endpoints included CFB to month 24 in the rheumatoid arthritis magnetic resonance imaging scoring (RAMRIS) scores for erosion, edema, and synovitis in the single affected joint, incidence of gout flares, and serum uric acid levels. Safety was assessed throughout the study.
Results: Treatment with febuxostat 40/80 mg once daily did not lead to any notable changes in joint erosion over two years. In both treatment groups, mean CFB to month 24 in mSvdH erosion scores of the single affected joint was minimal with no between-group differences. However, treatment with febuxostat 40/80 mg significantly improved the RAMRIS synovitis score at month 24 vs placebo (−0.43 vs −0.07; P <0.001), decreased the overall incidence of gout flares (29.3% vs 41.4%; P <0.05), and improved sUA control (62.8% vs 5.7%; P <0.001). No major safety concerns were reported.
Conclusions: ULT with febuxostat improved MRI synovitis and reduced gout flares in subjects with early gout.
Nicola Dalbeth, Kenneth G Saag, William E Palmer, Hyon K Choi, Barbara Hunt, Patricia A MacDonald, Ulrich Thienel, Lhanoo Gunawardhana