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.


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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.

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Reference

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.