medwireNews: Patients with early gout who are treated with febuxostat are less likely to experience flares and have a reduction in synovitis compared with placebo-treated patients, but the drug does not reduce joint erosion, researchers report.
These findings are based on the results of a phase II trial in which 314 patients with hyperuricemia and early gout, defined as serum uric acid (sUA) levels of at least 7.0 mg/dL and one or two gout flares, were randomly assigned to receive the urate-lowering therapy febuxostat at a dose of 40 mg once daily or placebo. Febuxostat-treated patients with sUA levels of 6.0 mg/dL or higher at day 14 had their dose increased to 80 mg after 1 month of treatment.
As reported in Arthritis & Rheumatology, the 157 participants receiving febuxostat experienced a reduction in mean sUA levels from 8.7 mg/dL to 5.7 mg/dL after 2 years of treatment, whereas the 157 patients in the placebo group had corresponding levels of 8.8 mg/dL and 8.2 mg/dL.
The researchers observed no “notable changes in joint erosion” between the two groups over 2 years of treatment, with mean changes in modified Sharp/van der Heijde erosion scores from single affected joint X-rays of 0.01 points in both groups.
However, participants in the febuxostat group had significantly greater improvements in rheumatoid arthritis magnetic resonance imaging scoring (RAMRIS) synovitis from baseline to the 2-year follow-up, with corresponding reductions of 0.43 versus 0.07 points.
And consistent with this reduction in synovitis, patients treated with febuxostat were also significantly less likely to experience gout flares over the duration of the study than those in the placebo group, with rates of 29.3% versus 41.4%.
“This flare reduction has particular timely significance since the recent American College of Physicians guidelines cite a lack of [randomized controlled trial] evidence on the benefit of [urate-lowering therapy] on improvements in symptoms such as flares,” say Nicola Dalbeth (University of Auckland, New Zealand) and study co-authors.
A comparable proportion of patients in the febuxostat and placebo groups experienced treatment-emergent adverse events (TEAEs) and serious TEAEs over the study period (56.7 vs 48.4% and 8.3 vs 7.0%, respectively). The most frequently reported TEAEs were upper respiratory tract infection and musculoskeletal and connective tissue pain and discomfort.
Together, these findings suggest that febuxostat “can reduce synovitis, prevent future gout flares, and improve sUA control without outstanding safety concerns,” write the researchers.
And they conclude that “reducing serum urate in early gout may provide treatment benefits to the patients.”
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