Arhalofenate safely prevents gout flare
Gout is one of the most common cause of sudden burning pain, stiffness and swelling in a joint, usually a big toe and leads to painful joint attacks, also called flares. It is caused by too much uric acid in the blood. However, several urate lowering therapies are currently available for the gout, but these therapies are effective to decrease serum uric acid (sUA) and increases the possibility of having gout flare attack.
Now, a new drug "Arhalofenate" is available that decreases sUA and suppresses flares. This novel drug lowers serum uric acid (sUA) by blocking the reabsorption of uric acid in the proximal tubules of the kidney by inhibiting a renal uric acid transporter called URAT1. This leads to increased excretion of uric acid into the urine with concomitant lowering of sUA.
In this context, a randomized, double-blind controlled Phase IIb study was conducted for 12 weeks to demonstrate and evaluate the anti-flare activity of Arhalofenate, a new uricosuric agent. Patients are selected on the basis of sUA level who had ≥7.5 and ≤12 mg/dL and had not been using urate lowering therapy and colchicine for 2 weeks. In treatment plan, patients were administered in a ratio of 2:2:2:2:1 daily Arhalofenate 600 or 800 mg, Allopurinol 300 mg, Allopurinol 300 mg + 0.6 mg Colchicine or placebo. As the primary and secondary outcomes of the study were flare incidence and sUA.
Overall, the study randomized and dosed 239 gout patients.. Results of this study displayed a decrease of 46% of flare incidence, as 0.66 in Arhalofenate 800 mg group and 1.24 in Allopurinol 300 mg. In addition to this, Arhalofenate 800 mg was also significantly better than placebo with 41% decrease in flare incidence but not statiscally different from Allopurinol + Colchicine. Further, mean percent change for sUA was noticed i.e. -12.5% with Arhalofenate 600 mg and -16.5% with Arhalofenate 800 mg. During the study, no patient experienced adverse events related to arhalofenate.
In conclusion, Arhalofenate, however, was well tolerated and appeared safe. This phase II clinical study results indicates that the study met its primary outcomes, so Arhalofenate at 800 mg, can safely prevent flare as well as reduce serum urate levels in patients with gout. This dual mode of action of arhalofenate confers a substantial advantage over other urate-lowering therapies.