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09/02/2017 John Cozzarelli, DPM, RPh
Treatment for Severe and Painful Gouty Tophi (Elliot Udell, DPM)
I have had the opportunity to treat over 30 patients with multiple IV infusions of Krsyrtexxa at the Gout Institute of America in Belleville, NJ. I agree with Dr. Udell that the efficacy of pegloticase is tremendous. In each patient I have infused the patient's serum uric acid levels have dropped after the first infusion to almost undetectable levels and the process of dissolving the tophi begins.
This is due to the fact that pegloticase is the enzyme that turns uric acid into allantoin, a water soluble end product that is excreted via the kidneys. Pegloticase also mobilizes crystals out of the joints, kidneys and wherever else the tophi is present. This is best visualized with a DECT scan before and after treatment.
Where I disagree with Dr. Udell is with the safety profile. In my experience, when infusing a patient I have always adhered to the protocol of premedicating the patient with Tylenol, Solumedrol and Benadryl. It is also mandatory that serum uric acid levels be checked between every infusion. The reason being that FDA clinical trials have shown that 99% of all infusion reactions can be avoided in patients where antibodies do not develop.
What is known is that when uric acid levels are low antibodies are not formed. When serum uric acid levels rise above 6 for two consecutive infusions treatment is halted. In regards to surgical management of gouty tophi in the foot, it becomes questionable if surgery should be performed when this drug is available and can liquefy the tophus.
I have personally witnessed in multiple patients the dissolution of tophi from joints. In 2008, in the Journal of Rheumatology there is an article written by Kirshman illustrating that there were 973 million visits to doctors that year. Of those visits four million were for gout. The demographics showed that 60% were male. 70% went to the primary care doctor. 10% went to cardiologists. 16% went to other doctors (podiatrists, nephrologists). That 16% is 640,000 visits nationwide for gout. Less than 3% went to rheumatologists.
When looking at uricolytic therapy, 8 million suffer from gout yearly and is rising. As podiatrists we don’t realize we are seeing refractory gout on a daily basis far more than a rheumatologist. In an article written by Becker, MA, et al. N Engl J Med. 2005;353:2450-2461 is 79% of patients (n=251) on 300 mg allopurinol/day did not meet target sUA <6.0 mg/dL. 47% of patients (n=255) on 80 mg febuxostat/day for 52 weeks did not meet target sUA<6.0 mg/dL.
My point is that patients even on uricolytic therapy may not be able to achieve control of gout and Krystexxa is a safe option.
John Cozzarelli, DPM, RPh, Belleville, NJ
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