Adherence Report

Didn’t realize it had been so long since I posted!  Please also follow my twitter feed for more frequent but brief thoughts as well!

Came across some interesting comments from a recent call that BioCryst held to discuss clinical results from their clinical phase gout treatment, BCX4208 (See materials here), in combo treatment with current standard of care, allopurinol.  See specifically pages 23 and 30 for key analyses.

Of particular interest to me were the following comments, excerpted from the call transcript:

CHARLES DUNCAN: Another question that I have is why do you think the adherence to study drug is better than the adherence to allopurinol?

WILLIAM SHERIDAN: That’s a very interesting observation and I think we’re speculating but many of these patients have been familiar with allopurinol before, perhaps they’ve had in the past, out of their milieu, if you like, and they’re motivated by a variety of reasons to join a clinical trial and they’re interested in the study drug and perhaps they’re more interested to take the special pill rather than something they’ve had prescribed by their physician in the past.

I’m speculating, we don’t know for sure, but it is an interesting observation.

JON STONEHOUSE: Charles, this is Jon, I think this is another area where there’s real opportunity for better treatment as well. One of the things that we’re finding in digging into the adherence in gout in general is that about 50% of patients take their medication in the early days of treatment and it goes down to as low as 30% over two to three months. So a lot of this is just because gout still looks like something that you take Advil for when you have a flare versus chronically treating the high levels of serum uric acid.

So again, with the right partner doing the right education we think that we can get much better adherence and ultimately more like other chronic diseases like hypertension and hyperlipidaemia.

First, to me there’s a question whether there can be a documented “new trial drug” favorable adherence bias (sort of a clincial “placebo effect”).  Harder to determine given that normal practice is to drop out non-adherent patients.  I’ve not done the digging into trial design, but it is interesting that in this case they are able to measure clinical adherence.

Second, most gout sufferers have complex medication regimens anyway (see p 30 of slides for co-morbidities), and normal conventional FP/GP wisdom is to treat the pain/inflammation symptoms with Rx or OTC NSAIDS (e.g. acute) rather than long-term chronic treatments which inhibit the causes.  Similar to other classes of drugs without immediate self-observable physical effect, discontinuation rates are quite high.  I wonder how a bioerodable implant might fare in this disease state?

The audio of the call is also streamable here.