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Patients with gout may benefit from arhalofenate
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Gout flares were significantly decreased in patients who received 800-mg arhalofenate compared with 300-mg allopurinol, according to recently published data.
Researchers studied data from 239 patients with gout who received at least one dose of study medication. Of the patients, 95.8% were male. Investigators found the mean baseline serum uric acid level was 9.1 mg/dL. Tophi was found in 20.1% of patients.
Patients were randomly assigned 2:2:2:2:1 to one of the following five treatment groups: 600-mg arhalofenate; 800-mg arhalofenate; 300-mg allopurinol; 300-mg allopurinol plus colchicine; or placebo for 12 weeks. Flares were reported by patients using a hand-held electronic device following training.
During the 12-week period, 32 patients discontinued participation in the study, with eight patients reporting a treatment-emergent adverse event.
A 41% decrease in flare activity was reported in the 800-mg arhalofenate treatment group compared with the allopurinol monotherapy group. Flare incidence in the patients who received allopurinol plus colchicine was 0.4, which was lower than the allopurinol monotherapy group but not statistically different from patients who received 800-mg arhalofenate. A 16% lower incidence of flares was found for the group of patients who received 600-mg arhalofenate compared to the 300-mg allopurinol monotherapy group. No flares were experienced by 65% of patients in the 800-mg arhalofenate group compared with 39% in the allopurinol monotherapy group.
The mean change in serum uric acid levels from baseline to week 12 was a decrease of 12.5% in the 600-mg arhalofenate group and 16.5% in the arhalofenate 800-mg group, while the reduction was 28.8% in the group that received allopurinol and 24.9% in patients who received allopurinol plus colchicine. However, a greater proportion of patients achieved serum uric acid levels of 6 mg/dL or less in the 600-mg and 800-mg arhalofenate groups. No serious adverse events were reported in the treatment groups. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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N. Lawrence Edwards, MD
Arhalofenate was originally brought into the gout world because of its uric acid lowering property. This phase 2 study looked at arhalofenate’s anti-inflammatory, pain relieving properties and prevention of flares in gout. The study was relatively short — 12 weeks — but it showed what it needed to show compared to placebo. It cut down the number of flares, which supports the contention that it has anti-inflammatory properties as far as the prevention of gout flares. That was good.
The uric acid lowering properties were stated to be 12% to 16%, depending on the dose of arhalofenate used. This is not overwhelming, but the drug was designed to be used as a combination with febuxostat. I think we knew it was not going to be a “barn burner” as far as uric acid lowering itself.
The company is on track to do what they want to do, which is to have, in combination with febuxostat, a drug that has few adverse events and will get most patients to the target uric acid levels that all the guidelines tout — less than 6 mg per dL, few symptoms and the prevention of the flares that occur early when patients are started on uric acid lowering therapy. That is one of the big reasons why patients do not stay on allopurinol or febuxostat. They have an uptick for the first few months of therapy of the background flare rate. This appears to be a drug that would help both in getting patients to the target uric acid levels and block the increases in flares.
Like all of these medications, the proof will be in how well it does in the larger phase 3 trials, which are planned to start later this year. Researchers are anticipating more than 1,000 patients in the phase 3 trials, and we are anxious for that. The “holy grail” we have been looking for all along is a drug, or in this case a combination of drugs, we can give to most every patient with gout to reproducibly get them to target without a great deal of dose titration or other adjustments needed.
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