Gout tophi may be cleared up with pegloticase, if its approved.This page on gout tophi and pegloticase was last reviewed on 20 June 2010. Pegloticase, (generic name), previously called PEG/Uricase, may be used as gout tophi treatment. Its developers applied to the US FDA for approval in 2009. The application did not succeed, but the reasons for this were not really connected to the drug's efficacy or safety. The developers have reapplied and an FDA decision is expected in September 2010. It has been given the brand name Krystexxa. It completed its phase 3 trials and went through an extension trial (OLE trial). If the developers, Savient Pharmaceuticals Inc., get approval in September 2010, expect them to move quickly for approval in other countries, beginning with member nations of the European Union. Pegloticase is not a xanthine oxidase inhibitor, unlike febuxostat or allopurinol, and it does not encourage the kidneys to excrete uric acid as does probenecid. It works in a subtle way by converting uric acid into a substance called allantoin. Allantoin is more soluble than uric acid and better excreted. Hence uric acid levels fall. Most animals don't get gout because they can convert uric acid to allantoin, but we humans can't.
What Savient have said so far is very encouraging. In December 2007 the company said: "We believe that the most clinically important of the secondary efficacy outcomes assessed in these studies was the effect of pegloticase on gout tophi. The every two week dose arm (i.e. the group of patients taking pegloticase every two weeks) attained statistical significance in the pre-specified pooled analysis for the elimination of gout tophi (complete elimination of at least one tophus and no new tophi), whereas the every four week dose group did not attain statistical significance." In May 2008 the company said: "31% of the patients who were non-responders for the resolution of gout tophi at the end of Phase 3, showed a complete response in the OLE, with additional patients showing a partial response for tophus resolution." There appears to be a similar pattern to febuxostat. The longer you take it, the more likely it is that you will clear tophi gout up. And you'll probably need to be on an every two week course. In June 2008 the CEO of its developing company, in a regular presentation about pegloticase's progress to financial analysts, made upbeat statements about the medication. In his remarks about pegloticase and tophi, there was a definite delight in his voice when he described one case of how a multi-tophi sufferer, after 25 weeks of pegloticase treatment during the phase three trials, had cleared them up. And some of the tophi had been "weeping." i.e. exuding pus, which makes their disappearance even more welcome, necessary and encouraging. But pegloticase is for certain categories of gout sufferers, among whom are treatment failure gout sufferers i.e. if other drugs simply don't work, pegloticase (if it's approved) may be prescribed. For most gout sufferers it won't be the first drug prescribed. However, for long-term tophi sufferers for whom other medications haven't worked, there's hope here.
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