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I hope the fallout from this doesn't get too ugly...


http://tinyurl.com/tys-pml

Ick. Still a minuscule percentage. Hope it doesn't go back to the fda.

Can anyone on this board report a clinical benefit of taking Tysabri?

I certainly hope that PML with Tysabri isn't just a matter of time... WHEN, not IF...

And don't forget:

1: Mult Scler. 2008 Jun;14(5):708-10. Links
Paradoxically aggressive multiple sclerosis in the face of natalizumab therapy.Berger JR.
Department of Neurology, University of Kentucky College of Medicine, 740 S. Limestone Street, Lexington, KY 40536, USA. jrbneuro@uky.edu

In the pivotal trials of natalizumab in the treatment of relapsing-remitting multiple sclerosis (AFFIRM and SENTINEL), a dramatic reduction in relapse rate, new or enlarging T2-hyperintense lesions, and mean number of gadolinium-enhancing lesions was observed. While both relapses and new MRI lesions were observed in these trials, there has been no comment on the presence of aggressive disease in the face of natalizumab treatment. I report a 31-year-old woman with relapsing remitting MS of 12 years duration who developed aggressive demyelinating disease four months after the initiation of natalizumab. The clinical worsening was accompanied by a significant increase in new large T2-hyperintense signal abnormalities and in both solid and C-shaped contrast-enhancing lesions. Neither the clinical severity nor the striking MRI abnormalities had been noted earlier in her disease course. Neutralizing antibodies to natalizumab were not detected. She subsequently responded to combination therapy of pulsed methylprednisolone and daily glatiramer acetate.

, link

OK, just 'cause I wanted to understand this a bit better, and thought maybe some on the boards didn't know what PML was all about (we already have too many acronyms in MS!)

PML (Progressive multifocal leukoencephalopathy) occurs because of a deadly virus...an activation of the JC virus (named for the poor soul, John Cunningham, who was detected to have it in 1971.)

The JC virus is very common, in 80% of the population, and it remains dormant in most. Tsyabri blocks the immune system so radically, that this virus is allowed to replicate.

The virus has been found in spinal fluid of MS patients (before drugs):
http://www.ncbi.nlm.nih.gov/pubmed/9599333
and it uses Seratonin receptors to infect cells in the brain:
http://www.sciencemag.org/cgi/content/a ... 380?ck=nck

I just don't understand how a drug company can continue to test Tysabri on an unsuspecting population of folks who may very well have the JC virus in their bodies activated to PML!!!!

eek,
AC

cheerleader wrote: The virus has been found in spinal fluid of MS patients (before drugs):
http://www.ncbi.nlm.nih.gov/pubmed/9599333
and it uses Seratonin receptors to infect cells in the brain:
http://www.sciencemag.org/cgi/content/a ... 380?ck=nck

I just don't understand how a drug company can continue to test Tysabri on an unsuspecting population of folks who may very well have the JC virus in their bodies activated to PML!!!!

eek,
AC

The people who take Tysarbi are well aware of the PML dangers and choose to take it any way. It has been widely publicized as a potential hazard of the drug.

The fact that the CEO and other top Biogen bigwigs sold their stock last year would also be a primary consideration for me not to take the drug.


To each his own.

gwa

Yeah, Paul-
My husband's neuro said the PML was caused by an interaction of interferon + tysabri. She was considering it for him, but we went with copax. She did not mention the JC virus, or the fact that it is common in MS patients, or that tysabri allowed a replication of the virus in the brain.

As Alex (Gibbledygook's) post shows, a continuation of neurodegeneration happened in one patient. It may have developed into PML, had her neuro not caught it in time!!! But the was NO COMMENT on this fact from the study. Were there other cases? Was this related to JC viral replication?
from Dr. Berger at the Un. of Kentucky....

"there has been no comment on the presence of aggressive disease in the face of natalizumab treatment. I report a 31-year-old woman with relapsing remitting MS of 12 years duration who developed aggressive demyelinating disease four months after the initiation of natalizumab"

So, my question is, are patients told about and tested for the JC virus before beginning treatment?

AC

cheerleader wrote:
So, my question is, are patients told about and tested for the JC virus before beginning treatment?

AC

Excellent question. Hopefully a Tysarbi patient will have your answer.

gwa

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paul2008 wrote:just in time.....was about to start the drug but have now definitely changed my mind. It's not been around long enough and as they say themselves expect more cases of PML. Think I'll stick with Rebif and steroids for the moment.

I'm with you! When I had to stop Copaxone, the Neuro wanted to get my on Tysabri - I did some net checking and decided to try Rebif. So far (now 8 weeks on rebif) I don't regret NOT going to Tysabri.

NOT treating multiple sclerosis, or not treating MS effectively carries it's own risks, which seems to carry more risk than Tysabri use.

Bob,

The problem with MS medications and when to treat is as unpredictable as the disease itself.

We have "experts" telling the patients they should begin treatment with one of the DMD's as soon as possible. Yet we have other "experts" (Mayo Clinic) saying that the patients should wait and see the course of the disease before making such a decision. As usual with MS, the patients are caught in the middle trying to figure out which "expert" is more reliable.

My wife didn't take anything for 20 years after her first attack. Not that there was anything to take back in 1971. But if there had been, that particular drug company would have stated that their drug delayed the onset of the disease for 20 years!

Bottom line....the very relapsing/remitting nature of MS pretty much makes it extremely difficult to determine whether these drugs do much if anything to alter the course of the disease and make the treatment "effective". I know that Biogen has testimonials from some people using Tysabri stating how much it has changed their life. What we don't see them post are the comments from users who have no change or become sicker when using the drug. One only needs to read comments from some of the other MS forums where you would see these postings.

The same kind of comments have been made on the CRAB drugs for many years and we all know the controversy about what they may or may not do for MS patients.

As for the latest two cases of PML that are receiving a lot of attention in the media....Biogen has only themselves to blame for the type of coverage that Tysabri gets. I'm not going to repeat the reasons for this because they have been posted many times in the past. The concern now is the very problem that some "experts" predicted would happen to Tysabri is indeed taking place...and that obviously is not the kind of news that MS patients want to hear.

Take care.

Harry

Thought I would post this link to show the large activity of Biogen insider stock trading since July 21. Was it a co-incidence that this activity happened before the recent news of the 2 new cases of PML?

http://www.secform4.com/insider-trading/875045.htm


Harry

PS....Ian, I don't understand why my name wasn't on this list

I am with you Harry, I guess I am a henchman

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