Arhalofenate at an 800 mg dosage seems safe and well tolerated
MONDAY, Aug. 15, 2016 (HealthDay News) — Arhalofenate (800 mg) is safe and significantly decreases gout flares compared to allopurinol (300 mg), according to a study published online July 27 in Arthritis & Rheumatology.
Jeffrey Poiley, M.D., from Arthritis Associates in Orlando, Fla., and colleagues from the Arhalofenate Flare Study conducted a randomized controlled phase IIb trial in which patients were randomly assigned (2:2:2:2:1) to receive 600 mg of arhalofenate, 800 mg of arhalofenate, 300 mg of allopurinol, 300 mg of allopurinol plus 0.6 mg of colchicine, or placebo once a day. To qualify, patients (239) had had at least three flares of gout during the previous year, had discontinued urate-lowering therapy and colchicine, and had a serum uric acid level of 7.5 to 12 mg/dL.
The researchers observed a 46 percent decrease in flare incidence in the 800 mg arhalofenate group versus the 300 mg allopurinol group (P = 0.0056); 800 mg arhalofenate was also significantly better than placebo (P = 0.049). However, 800 mg arhalofenate was not significantly different from treatment with 300 mg allopurinol plus 0.6 mg colchicine (P = 0.091). Mean changes in serum uric acid level were −12.5 percent with 600 mg arhalofenate and −16.5 percent with 800 mg arhalofenate (P = 0.001 and 0.0001, respectively), compared to −0.9 percent with placebo. The groups showed no meaningful differences in adverse events between groups, and there were no serious adverse events tied to arhalofenate.
“Arhalofenate is the first urate-lowering antiflare therapy,” the authors write.
Several authors disclosed financial ties to CymaBay Therapeutics, which manufactures arhalofenate and funded the study.
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