HealthDay News – Arhalofenate, a novel uricosuric investigational drug, appears to be well-tolerated and significantly decreased the number of gout flares compared to allopurinol (300 mg), according to a study published in Arthritis & Rheumatology.
Jeffrey Poiley, MD, from Arthritis Associates in Orlando, Fla., and colleagues from the Arhalofenate Flare Study conducted a randomized controlled phase IIb trial (ClinicalTrials.gov Identifier NCT02063997) 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 (n=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% decrease in flare incidence in the 800 mg arhalofenate group versus the 300 mg allopurinol group (P = .0056); 800 mg arhalofenate was also significantly better than placebo (P = .049). However, 800 mg arhalofenate was not significantly different from treatment with 300 mg allopurinol plus 0.6 mg colchicine (P = .091).
Mean changes in serum uric acid level were −12.5% with 600 mg arhalofenate and −16.5% with 800 mg arhalofenate (P = .001 and .0001, respectively), compared to −0.9%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 NCT02063997 clinical trial was supported by CymaBay Therapeutics. Several authors disclosed financial ties to CymaBay Therapeutics, which manufactures arhalofenate and funded the study.
Poiley J, Steinberg AS, Choi YJ, et al. A Randomized, Double-Blind, Active- and Placebo-Controlled Efficacy and Safety Study of Arhalofenate for Reducing Flare in Patients With Gout. Arthritis Rheumatol. 2016;68(8):2027-34.