gout: what's new?

Improving Outcomes for Gout Patients

October 25, 2008 — Patients who have not had successful treatment for their gout may find new hope in pegloticase, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.

Gout is a painful and potentially disabling form of arthritis that has been recognized since ancient times. Initial symptoms usually consist of intense episodes of painful swelling in single joints, most often in the feet (especially the big toe). Treatments are available to control most cases of gout, but diagnosing this disorder can be difficult and treatment plans often have to be tailored for each person.

Researchers recently studied 212 patients with gout who were either treated intravenously with pegloticase (Puricase®) or placebo in duplicate six-month, double-blind, randomized studies. Researchers recently studied 212 patients with gout who were either treated intravenously with pegloticase (Puricase®) or placebo in duplicate six-month, double-blind, randomized studies. Participants were eligible to participate if they had been unsuccessfully treated – experiencing three or more gout arthritis flares in the previous 18 months, had one or more joints affected by chronic gout, or had tophi; a serum urate level greater than 8mg/dL; and either intolerance of allopurinol or no success taking the highest medically appropriate dose of allopurinol.

Participants in both studies were divided into three groups, and received 8mg of pegloticase every two weeks, 8mg of pegloticase every four weeks, or placebo. Researchers considered the treatment successful for a participant if he or she had uric acid readings within the normal range at least 80 percent of the time in months three and six of the studies. In addition to reviewing plasma uric acid levels, researchers looked at the size of tophi, which are chalky deposits of uric acid often found in gout patients, the incidence of gout flares, the tenderness and swelling of joints, quality of life, safety and disability.

Participants—mostly men with an average age of 55 years and many who had additional medical conditions including high blood pressure, chronic kidney disease, heart disease and diabetes—were found to have a significantly better response to pegloticase over placebo in both studies. The number of gout flares did not significantly differ between the two groups; however, complete resolution of tophi was noted in more patients taking pegloticase over placebo. These patients noticed improved physical function as well. Serious adverse reactions were more common with pegloticase than with placebo.

Overall, pegloticase was successful in treating 40 percent of the participants, with significant improvement in clinical outcomes.

“Patients with treatment failure gout suffer from severe pain, increased disability and reduced quality of life, explains John S. Sundy, MD, PhD; associate professor of medicine; Duke University Medical Center, Durham, N.C., and lead investigator in the study “Therefore, these findings are exciting because they show that pegloticase was able to reduce urate levels and improve clinical outcomes in subjects with gout who had exhausted all available treatment options.”

Patients should talk to their rheumatologists to determine their best course of treatment.