Tophaceous gout treatment... In trials febuxostat has a quite good success rate, but it takes time





This page about febuxostat and tophaceous gout, was last reviewed or updated on 4 December 2011.

Febuxostat has been tested against tophi gout. First approved in the U.S., it is now approved in the European Union, (brand name: Adenuric) and for many countries in Asia. 

Febuxostat went through two major phase 3 trial-studies (called APEX and FACT). They involved a large number of participants. What was the effect of febuxostat on tophaceous gout in these studies? 

Make sure you read to the end of this page to get a better understanding. The story gets more encouraging as you read further down.

APEX TRIAL 

In the 28 week APEX trial patients were given either placebo, febuxostat at 80 mg, 120 mg and 240 mg daily amounts, or that old standby of gout treatment, allopurinol at 100mg/300 mg. Febuxostat showed the most success in reducing uric acid levels. But after 28 weeks, although there was a reduction in tophus area, there wasn't much difference between any of the five groups in tophus size changes and no change in the number of patients with tophi.

It seems 28 weeks (just over 6 months) of febuxostat or allopurinol may reduce tophus area but not clear up tophi.

FACT TRIAL

In the 52 week FACT trial the results appear to be more encouraging. Note that this was a longer study than the APEX one.

The median per cent reduction in tophus area for participants on 80 mg febuxostat was 83% and those on 120 mg febuxostat was 66%.That is after 52 weeks (one year). Quite why those on a lower dosage appeared to do better was not clear. There seemed to be more reduction in the febuxostat group than in the allopurinol group. The EMEA assessors highlighted tophus area measurement difficulties.

As far as the number of tophi is concerned there was hardly any change, at any dosage of febuxostat and allopurinol, during the year of the trial, among all participants. 

So it seemed that tophus area was going down, but tophaceous gout was not being cleared up.

EXTENSION STUDY 

Read on, it gets better! After the phase 3 trials febuxostat went into an extension study with the name of Cxx-021. 

The results were much better. After two years of the Cxx-021 study just over half the patients with gout tophi at the beginning of the phase 3 trials showed, what was described by the EMEA's assessors as <i> complete resolution. </i> 

CONCLUSION 

The meaning of the extension studies is crystal clear (pun intended!). If tophi reduction and removal is your objective, the longer you take febuxostat the more likely it is that it will cure tophaceous gout. After two years of the Cxx-021 extension trial 54% had completely cleared up tophi. 

It depends a great deal of course on the number of tophi you have, and their size. The smaller of both the better. And in the FACT trial an approximate average starting point of uric acid levels for all participants was between UA levels of 9 mg/dL – 10 mg/dL. Yours may be higher or lower. And much depends too on how well you stay the course. You can see from the trials that a satisfactory outcome is not guaranteed because after the extension trial 46% had not shown complete resolution. That is the tough part. 

If you notice tophi shrinking in size, that's good news. From these study-trials the more likely outcome is that tophi removal will take up to four years and it is unlikely to occur in the first year. The febuxostat extension trial is still ongoing and we shall learn more about its results later. When available, they will be on this website.

A note about natural gout remedies  Water drinking is imperative in all gout treatment. The effect of drinking lots of water, and a more alkaline body (higher pH), whilst on these drugs in the trials was not assessed. They could not be included because they would have skewed the results of what febuxostat and allopurinol are capable of achieving in gout treatment. 

Results could have been better because both water and a higher pH assist in removing uric acid. In addition, diets to reduce uric acid levels and other natural remedies were not part of the trials.

Always discuss using natural remedies with your doctor if you consider using them in combination with tophi-lowering drug medications.

Read more about tophaceous gout - from toes to tophi

Read about Krystexxa (pegloticase) for tophaceous gout.

Read about a new gout drug that may become the most successful at clearing up tophi.


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