AT THE ACR ANNUAL MEETING
WASHINGTON (FRONTLINE MEDICAL NEWS) – Putting patients on urate-lowering therapy after their first flare of gout and treating urate levels to target appeared to reduce risk for additional disease flares over a 2-year period, based on results from 314 patients in a randomized, double-blind, placebo-controlled trial.
Among patients with early gout – those experiencing their first gout flare or a second flare that occurred more than 1 year after their first flare – the risk for one or more gout flares during the course of the study was 41% in the placebo group and 29% in the group of patients given febuxostat, a statistically significant difference (P = .033).
The significant advantage for active therapy to prevent flares was seen at 6-12 months, 12-18 months, and 18-24 months.
The majority of patients (63%) treated with febuxostat achieved target serum uric acid levels of less than 6 mg/dL. Of those at target values, 94% did not have a flare between months 18 and 24 of the study.
“The reduction in flares with febuxostat is clinically important and statistically significant,” said lead author Nicola Dalbeth, MD, of the University of Auckland (New Zealand). “This is the first clinical trial of [urate-lowering therapy] in patients with early gout. These are patients who would not be treated under current [American College of Rheumatology] guidelines,” which call for urate-lowering therapy if patients are symptomatic and have experienced two or more flares per year.
Dr. Dalbeth presented the study results at a late-breaker session during the annual meeting of the American College of Rheumatology.
The 314 patients were initially randomized to febuxostat 40 mg or placebo. The febuxostat dosage was increased to 80 mg if serum uric acid levels were above target on day 14, and 60 patients had their febuxostat doses increased.
The study was completed by 57% of placebo patients and 59% of febuxostat patients. Baseline characteristics were similar across treatment arms. Mean baseline serum uric acid was about 8.7 mg/dL, mean age was around 50 years, and more than three-quarters of study participants were white. Mean body-mass index was about 32.5, and mild renal impairment was present in 73% of placebo patients and 67% of febuxostat-treated patients.
Based on imaging studies, febuxostat had no significant effect on joint erosion during the observation period, but it reduced synovitis, compared with placebo, she said.
Dr. Dalbeth disclosed relationships with a variety of drug companies, including serving as a consultant for Takeda, the maker of febuxostat (Uloric).