This second page about new gout drugs was last reviewed or update on 12 May 2014.
GEVOKIZUMAB (Previously called XOMA 052)
The developers of gevokizumab (Xoma Corp) announced in April 2014 that gevokizumab is now in a proof-of-concept programme (program). This one acts as an anti-inflammatory, and anti pain, by attaching itself to IL-1, a cause of inflammation. More about how his works in the arcalyst paragraph below.
It is also being investigated for use in treatment of type-2 diabetes, rheumatoid arthritis, cardiovascular disease and others. It did reduce the neutrophils attack on gout's MSU crystals in mice and the inflammation caused by this attack.
Gevokizumab has a half life of 22 days which ultimately could mean less frequent dosing (by its injections) for gout patients. Any new gout drug that's an improvement on colchicine is more than welcome.
Arcalyst, also called Rilonacept (or IL-1 trap) is not a tablet. It is injected.
Why do gout attacks occur when uric acid levels are falling and the MSU gout crystals are being dissolved? This very pertinent question is one of many at the heart of the whole gout puzzle. There are others, but this is the one that arcalyst addresses.
You would need to be a biochemist, and know a lot about cell behaviour, to understand it at a root level, and so would I. Simply put, the theory arcalyst works on is that a protein called Interleukin-1 (IL-1) is a leading cause of inflammation. The problem during attacks and falling uric acid levels, is that excess IL-1 is excreted from some cells. IL-1 enters the bloodstream before connecting itself to cell surfaces where it causes pain and inflammation. Arcalyst inhibits its attachment to cell surfaces by joining itself to IL-1 in the blood. Both are excreted from the body.
Arcalyst has not worked for everyone who took it in a phase two trial. But in this trial, among patients treated with arcalyst, only about 15% suffered attacks in a 12 week period. No patient had more than one attack during this time. Serious arcalyst related adverse effects did not occur.
In another phase 2 study of it with patients who also mainly took
allopurinol at 300 mg.(The standard allopurinol dose). The number of
patients suffering a gout flare during this 16 weeks trial who took
rilonacept and allopurinol was much lower than those on allopurinol and a
placebo (dummy drug). And their gout attacks' frequency was reduced. It
also seemed to be sufficiently safe. But a small number on rilonacept
did withdraw from the trial.
The main hope seems to be that arcalyst will work better than colchicine and NSAIDs in reducing the inflammation and pain of gout attacks, and during falling uric acid levels. The medical world calls this prophylaxis. And work for those who can't tolerate colchicine and NSAIDs. If it's successfully developed and approved, it is likely to be used in tandem with medications like allopurinol or febuxostat.
So it may be able to help people through the period of gout attacks, during which many are discouraged from continuing a medication, because of the pain. And help too, perhaps, those gout patients who eventually end up with pain for longer periods than usual in gout. .
However, in May 2012 an Arthritis Advisory Committee of the FDA decided by an 11 – 0 vote they would not recommend the FDA approves it.
THE BOTTOM LINE
All these new gout drugs offer the possibility of improved gout treatment for more people. No gout drug offers a complete solution for all gout sufferers. The drug which cures all gout cases, permanently, with certainty and completely, has still to be discovered. But there has been better news in the past few years, better in fact than there has ever been in 2,000 years of trying to deal with gout, at least from a drug cure perspective. Both Febuxostat and Pegloticase (Krystexxa), offer more likelihood of maintaining uric acid at the important 6.0 mg/dL level. And thus there is at least, more chance of halting gout's progression in the body.
Lesinurad (RDEA594) sounds very promising, but it has hurdles to cross. Perhaps Ilaris and Arcalyst wil be resurrected. Gevokizumab (Xoma-052) is still a few years from possible approval. Ulodesine is currently stalled.
A NEW GOUT DRUG TAKES A LONG TIME
It takes a long time for gout research to be done, new gout drugs developed and finally, approved by government regulatory agencies. The usual period quoted is 10 years, from the early stages of development
to final approval. But from conception to U.S. FDA approval for Krystexxa (pegloticase) in September 2010 took 17 years, said its lead inventor.