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AR882 treatment resulted in lowering serum uric acid, dissolution of crystals, and resolution of tophi after 6 months for patients with gout.
AR882, a novel URAT1 inhibitor, decreased serum uric acid (sUA), dissolution of crystals, and resolution of tophi after 6 months of treatment in participants with gout. The drug may offer better efficacy and safety than existing therapies for gout, according to research presented at ACR Convergence 2023. Study results showed that it was well-tolerated and easy to use as a once-daily therapy that does not require titration.
A proof-of-concept phase 2 trial evaluated the effect of AR882 compared with allopurinol on the clinically visible tophi in participants with gout.1 The trial recruited 42 participants with subcutaneous tophi, who were randomized to receive once-daily AR882 75 mg, once-daily AR882 50 mg + allopurinol, or once-daily allopurinol up to 300 mg. Researchers measured tophi every 4 weeks for 6 months with a caliper. Participants also underwent imaging with Dual Energy Computer Tomography (DECT) at baseline and after 6 months. The primary efficacy endpoint was sUA change after 3 months. The study team collected safety data throughout the study.
Robert Keenan, MD, MPH, MBA (Duke University School of Medicine) presented the study results. The mean baseline sUA level was 9.4 mg/dL. After 3 months, these levels were reduced to 4.5±1.2 mg/dL, 4.7±1.4 mg/dL, and 6.1±2.0 mg/dL in the AR882 75 mg, AR882 50 mg + allopurinol, and allopurinol groups, respectively. After 6 months, at least 1 tophus had completely resolved in 4 participants (29%) in the AR882 75 mg group, compared with 1 participant (8%) in the AR882 50 mg + allopurinol group and 1 participant (8%) in the allopurinol group. The absolute change in crystal volume on DECT was -8.3 cm3, -0.9 cm3, and -1,2 cm3 in the 3 groups, respectively. Dr. Keenan said the complete resolution is “practically unheard of” after 6 months of therapy, especially with an oral agent. He added that AR882 treatment was not associated with any serious adverse events. The most frequent adverse event was gout flare, which had a lower rate in the AR882 treatment groups than in the allopurinol group. There were no cardiovascular, renal, or hepatic safety signals.
Dr. Keenan concluded that AR882 could potentially treat the entire spectrum of gout patients.
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