This Is MS Multiple Sclerosis Community: Knowledge & Support

This is MS has established a wonderful contact at Elan who is an MD researcher there. He has graciously offered to at least entertain, if not answer, our questions about Antegren (because they are a public company, there are certain questions that they simply cannot answer at this point...)

So.... please post questions you would like to ask Elan about Antegren in this thread, and when we have a critical mass, I will pass them on and hopefully get you answers. Also encourage friends from other boards to chime in here-- this is a GREAT opportunity to get information on this new therapy straight from the source!

One question...

Whilst it's too early to have disabilty data from the Antegren trials, did Elan measure parenchymal volume changes amongst recipients and controls? If so what were the results?

This is probably a 'can't answer for commercial reasons' question, but thought I'd ask anyway.

Robin

Another questions....I have heard that Antegren is not effective after 18 months. Is this true?

Antegren supposedly causes NABs in approx 6% of the users and they must come off the drug if this takes place. I've also heard that coming off the drug can cause some kind of "rebound" effect with the patient suffering exacerbations. What do you know about this situation? Thanks.

Harry

Difficult to decipher the announcement.

66% reduction tysabri vs placebo
54% reduction tysabri+avonex vs placebo+avonex

.66 * .54 = .37 relative relapse rate for tysabri+avonex

1 - .66 = .33 relative relapse rate for tysabri alone

Is tysabri+avonex even less effective than tysabri alone?
Or would this not be statistically significant? It would after
all be from different patients.

Or am I flunking this story problem?

The NAB issue is of concern (no Avonex NABs for me after 6 years, but Avonex isn't doing a good enough job either). When you have a NAB test done, just make sure you pay the $199 "liability limitation" policy from the testing company, so you are not liable for the entire $995 bill after the
insurance company pays only $260 like mine did (which would have
left me liable for the other $735)! If tysabri antibodies did develop,
could one go back to Avonex?

batpere,
IF the difference is significant, then I suspect it may be due to the different populations used.

"In the SENTINEL trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen. "

So the relevant question may be: were the patients in the Avonex+Tysabri trial already having more disease activity than the patients in the Tysabri alone trial? If so, then the baseline for comparison is different between the two trials.

I haven't looked into it enough to know the answer to that question, but ElanMike or someone else might know.

carolsue

The Sentinel trial participants were reputedly chosen for their higher disease activity.

Arron,

Is there an expectation that the "Biogen rep" will be answering the questions posted? Haven't seen any replies as yet

Harry

Is it known if there was any difference in the NAB rate between
the two trials? Or any correlation between having Avonex NAB
and having Tysabri NAB?

I was told a week ago at my MS Clinic.... that we have to remember these are early data that the FDA approved the drug on.As part of the approval, the manufacturer has committed to continuing its trials of this product for another year. 66% WOW

Further testing still needs to be done...on the CRAB's and Antigren/Tysabri. Also the Avonex Antegren study is still going on for another year in some clinic's.

I was also told it will be an infusion that will cost 20,000. What about our Caps?? I do think this is what we have all been waiting for. My specialist told me in Europe they only did studys on Antegren alone.

I would like to know about the percent of heart attacks that were caused by the drug. I was told this is why this has to be given in a hospital setting because of the risk...although slight... of antaphalactic shock. This is my question.

Also I was told they only pretty much chose progressing RR patients for these trials. Good to talk..been awhile...Kim

iI was told by my nuro that it is about $2000 an infusion. Has anyone heard if there is any improvement with this drug( by means of better functioning)? I'm wondering if it's worth the risks and expence.

antegrin, $1800 per monthly infusion.
what is NAB?
also has anyone seen "The Lancet" from europe, stating that Avonex or Rebif (interferons) are only effective approx 1 year?
Dr Braziella Filippini...Feb 2003

NAB ....= Neuteralizing antibodies....If you have them them ...supposedly the med you are on becomes less effective. ........Kim

Skimming through the Lancet article (full text is free), it appears that Filippini's results are questionnable:
Filippini and co-workers artificially inflate the available number of trials by including two trials with interferon alfa...

and so on. Numerous objections follow. Those who understand this better could (and probably will) answer more completely, but in short I wouldn't put too much stock in Filippini's findings.