Current treatments for gout include use of drugs such as allopurinol and probenecid, which reduce blood levels of uric acid. However, some people with difficult-to-treat gout cannot tolerate medications or are not helped by drugs. Pegloticase is more soluble in blood and easier to excrete.
John Sundy, a rheumatologist at Duke and the lead author of the study studied the use of the drug in 41 patients who were randomly assigned to one of four treatment groups. Participants received either 4 or 8 milligrams of the injectable drug every two weeks, or 8 or 12 milligrams every four weeks, for a 12- or 14-week period.
Pegloticase normalized uric acid levels within six hours for participants in all dosage groups, and those levels were sustained throughout the treatment period in the two groups at the higher dosage levels. The most effective dose was found to be eight milligrams every two weeks, the study found.
Nearly 88 percent of the patients experienced gout flares during the phase II trials and some also experienced mild to moderate side effects, including reactions to the infusion and joint pain, researchers at Duke University Medical Center said.
Five million Americans suffer from gout, a disease that develops from an excess of uric acid in the blood. This build-up may be because of increased production of uric acid or problems in ridding it from the body causing the excess uric acid to get deposited in joints. This can cause painful inflammation in the big toe, foot, ankle, or knee.
The findings were published online and were to be in the September issue of the journal Arthritis and Rheumatism. The experimental drug is manufactured as Arcalyst by Regeneron Pharmaceuticals Inc. T
The results of the phase three trial of pegloticase will be presented at the annual meeting of the American College of Rheumatology in October 2008. A patent is pending on the drug.
