- Volume 26 - Issue 1 - January 2013
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For further reading, see the DPM Blog “How To Solve The Dilemma Of The Jumbo Bunion” at http://tinyurl.com/3xq5bus , “Why The Lapidus Bunionectomy Is The Best Procedure For Severe Bunions” in the December 2011 issue of Podiatry Today or “Mastering The Technical Approach To The Scarf Bunionectomy” on page 22 of this month’s issue. To access the archives, visit www.podiatrytoday.com.
Could Pegloticase Be Effective For Refractory Chronic Gout?
By Danielle Chicano, Editorial Associate
Two new poster abstracts, presented at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/ARHP) Annual Meeting, support the long-term efficacy of pegloticase (Krystexxa, Savient Pharmaceuticals) for the treatment of refractory chronic gout.
Obtaining new data from an open-label extension study, researchers concluded that treatment with Krystexxa for up to three years can benefit patients with refractory chronic gout. The study also identified no new safety signals of long-term pegloticase treatment.
Among the 149 study participants, 110 received pegloticase and 39 received a placebo. The mean baseline uric acid level of the patients was 10 mg/dL, according to the study. After one year of treatment with pegloticase in the open-label extension study, 59 percent of patients remaining in the study (62 out of 105) had uric acid levels below 6 mg/dL. Researchers saw a reduction in gout flare incidence over the course of the study. During the first three months of the study, 52 percent of patients had flares. In the 22nd to 24th months of the study, 17 percent of patients experienced gout flares.
“(The study outcomes) did not identify new classes of adverse reactions and showed that the patients who sustained urate-lowering responses to treatment with (pegloticase) for the six months of the randomized trial continued to do so for up to two years or more. Sustained urate-lowering with pegloticase was accompanied by progressive improvement in patient clinical outcomes that verified the findings in the six month RCTs,” explains Michael Becker, MD, the study’s principal investigator.
“Pegloticase should be considered in patients with clinically advanced active gout (often with many tophi and sometimes with chronic drainage or infection) and the need for rapid reversal of signs and symptoms that cannot wait years to achieve as with oral agents. I would not consider pegloticase for use unless both these criteria are met (i.e. not for cosmetic purposes alone).”
Patients with refractory chronic gout previously had few alternatives to prevent worsening of the disease, explains Dr. Becker, a Professor Emeritus of Medicine at the University of Chicago.
When comparing Krystexxa to other treatments for patients with refractory chronic gout, Dr. Becker notes that cost, time spent in treatment, gout attacks early in treatment and infusion reactions may be concerns to some practitioners. He adds, however, that one must keep in mind the disadvantages already present in other treatments.
“The early gout attacks occur with allopurinol or other urate-lowering agents but perhaps not as frequently because they don’t lower urate nearly as much as pegloticase,” notes Dr. Becker. “Allopurinol is generic and cheap, but sometimes causes hypersensitivity that can be severe or fatal. Febuxostat is 10 to 20 times the cost of allopurinol and the range of adverse events is not yet entirely known after only three years of limited use.” He adds that febuxostat inhibits the same enzyme (xanthine oxidase) as allopurinol so some patients may expect ineffectiveness or intolerance of the medication.
Dr. Becker says the outcomes of this study argue for a disease-modifying role for pegloticase in approximately 40 to 50 percent of patients treated for refractory, chronic gout.
Are Biodegradable Ankle Implants Better Than Metallic Implants?
By Brian McCurdy, Senior Editor