Wednesday, February 17, 2016

Alefacept Reports on Phase-II Results

Alefacept is a drug that has been used to treat the skin condition, psoriasis. Psoriasis is generally considered to be an autoimmune disease, similar to type-1 diabetes, but with the body attacking it's own skin cells, rather than it's own beta cells. So trying a drug already approved for Psoriasis on type-1 diabetes seemed like a reasonable thing to do, and these researchers did it. You can read my previous blogging here:

This was a honeymoon trial. 33 people got the drug and were compared to 16 who did not. The treated group got a dose a week for 12 weeks, then a 12 week break, and then weekly doses for 12 more weeks.  This publication is the two year follow up; they have already published a one year follow up.  The graphs below summarize the main findings.

For me the "A" and "C" graphs are the important ones.  The "A" graph (upper left) shows that untreated people's C-peptide levels did not drop in the first year, and even in the second year,they dropped less than the placebo group.  Remember that generation of C-peptide measures how much insulin the body is naturally producing, so more is better.  The "C" graph (lower left) shows that untreated people used about 30% more insulin after two years, which is also a good result, especially when graph B shows that both groups had the same A1c numbers.


Cure Results
My reaction to this is the same "boilerplate" reaction that I've had recently to other honeymoon research where the untreated group got worse, and and the treated group held steady, so at the end of the study, there was a statistically significant difference between the two:

I think I was much more excited about them in the past.  Part of my lack of excitement now is that the treatments with these results that I saw a few years ago have not progressed. They don't give better results in more recent studies.  That might be because the research is taking longer than expected, or it might be that getting a small result is much easier than getting a useful (to patients) result.  But in any case: I haven't seen forward progress in other treatments with similar initial results, so I've become less excited about these kinds of results, in general.

So in general, these results go in my "good start, but more is needed" category of results.
I like them; I think they represent potential, but I'm not excited by them.

Treatment Results
If you look at chart D above you can see that the people who took Alefacept had half as many low blood glucose events, as those who were not treated, and this was statistically significant.  From a treatment point of view, this is an interesting finding.

Not Moving Forward
Unfortunately, in a certain sense, none of this matters.  The company that made Alefacept stopped production in 2011, so it has not been available for years.  I don't know of any planned clinical trials with Alefacept, nor any similar fusion proteins.

COMPare:  +16/16 (100%)
Primary outcome given less prominence than secondary.           

COMPare is an experimental methodology for reporting switched or misreported results.  As my own experiment, I'm going to report on COMPare metrics for all results that I blog about in 2016.  I will explain this methodology in a blog posting in a week or two.  So the text in green should make sense then.  For now: this study has a very good COMPare score.

Press Release:
Full Paper:

Joshua Levy 
publicjoshualevy at gmail dot com 
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

1 comment:

Bruno said...

We must all keep our fingers crossed and, where appropriate, perhaps pray.