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bad news - hope they once will find out what exactly was the problem ...!

ursula wrote:bad news - hope they once will find out what exactly was the problem ...!

The problem is Tysabri prevents certain parts of one's immune system from operating normally with respect to protecting the brain. Nobody really knows what the future will bring to patients who use Tysabri in the long term.

Here is another article written in respect to more possible PML cases.

http://www.healthcentral.com/multiple-s ... 02/tysabri

Harry

sadly you are right: No one knows which and how many side effects will occur in the future.

Thanks for the interesting link:

"Have you encountered any Tysabri evangelists online? I have. Those patient advocates are key to the marketing efforts of promoting Tysabri. Funny thing is - patients are not bound by the same FDA regulations in drug promotion that companies are. How does that fit into the big picture?"

That´s my impression, too.

Ursula

The patient form Oct has died

http://www.boston.com/business/healthca ... tion_dies/

Did anyone know more about him or her?

I'm also taking Tysabri and try to find out more about the 4 patients. My knowleg about the two cases from Aug are pretty good, but form the US-patient and the latest EU-patient I'm knowing only how many infusions they have had.

Because I'm from germany, I hope you can read and understand me.

the concern is if you have been immune compromised.

The big questions:
- do you have advanced HIV disease?
- have you been treated with immune suppressant medications long term (o.e chronic steroids, novantrone, ect...)

the best bet to make sure you are ok is have you had bloodwork done to test your immune competence (quantitative immunoglobulins, CBC with diff)

I wouldn't worry. Tysabri is a fantastic drug. I have been on it now for over 2 years now....Its benefits far outweigh potential risks for me.

I wouldn't worry. Tysabri is a fantastic drug. I have been on it now for over 2 years now....Its benefits far outweigh potential risks for me.

While worrying about something doesn't change the situation, Tysabri isn't the kind of drug that users should ever drop their guard. I read the other day that one particular neuro in the US insists that his patients get spinal fluid tests often. This is because he had discovered several (and I don't know what his definition of "several" is) of his MS patients on Tysabri have shown an active level of the JCV virus in their spinal fluid. He has stopped using Tysabri on these patients because of this situation.

Now one would think that this information has been reported to Biogen but that was not mentioned in the post. Again, it is important for Tysabri patients to be followed closely by their neuros.

Harry

it has been reported to Biogen. Those patients were all high risk and now off treatment, obvously. Additionally, the main reason why the neuro is not giving his patients Tysabri, at least at that point was because he was disenrolled from the TOUCH program. As I am sure you know all patients on Tysabri in the US are to be enrolled in thisTOUCH program. This program is non existent outside of he US, another reason for the cases in Euro.

Another thing to remember the two people in this country who developed PML were both treated and recovering.

For me the potential risks to an immune competent patient are far far far outweighed by its benefits, especially given the side effects to meds that are being used for MS that have similar efficacy (Novantrone/Citoxan,ect...).

yeb4432 wrote:it has been reported to Biogen. Those patients were all high risk and now off treatment, obvously.

Do you know why they were all high risk?

Harry

HarryZ wrote:

I wouldn't worry. Tysabri is a fantastic drug. I have been on it now for over 2 years now....Its benefits far outweigh potential risks for me.

While worrying about something doesn't change the situation, Tysabri isn't the kind of drug that users should ever drop their guard. I read the other day that one particular neuro in the US insists that his patients get spinal fluid tests often. This is because he had discovered several (and I don't know what his definition of "several" is) of his MS patients on Tysabri have shown an active level of the JCV virus in their spinal fluid. He has stopped using Tysabri on these patients because of this situation.

Now one would think that this information has been reported to Biogen but that was not mentioned in the post. Again, it is important for Tysabri patients to be followed closely by their neuros.

Harry

I am a patient of the neurologist in question. He requires all of his Tysabri treated patients to undergo twice yearly spinal taps in order to test their cerebral spinal fluid for activated JC or BK virus. If active levels of the viruses are found, the patient is pulled off of Tysabri. This, of course, is to head off any potential cases of PML or other dire infections. According to his findings, approximately 3.5% of his patients receiving Tysabri do test positive for active levels of virus in their CFS.

Here's a link to a PDF detailing his findings in regard to these efforts. The report was presented at the 2008 meeting of the American Academy of Neurology. Biogen is very aware of this information.

http://msrcny.org/pdfs/JC-BK_virus_in_MS_4-08.pdf

Full Disclosure: I did four doses of Tysabri between September and December of 2006. I stopped receiving the drug because I was experiencing no benefit from it, and have recently started Rituxan therapy.

Marcstck,

Whatever you do, don't ever give up the care from your neuro. You normally don't find someone like that who is so detailed.

While only a group of 200 were in the trial, a 3.5% virus detection rate seems to be quite high. If that number were applied to the approx 43,000 patients who are now using Tysabri....well, do the math and it's alarming.

Two other points in that excellent trial summary caught my eye....none of the active virus patients showed anything on their MRI and it doesn't seem to matter what the past medication history of the patient may have been.

It kind of makes me wonder why it took your neuro to discover this kind of data about Tysabri. Was Biogen again asleep at the wheel or have they known about this all along? Hmmm.

Harry

HarryZ wrote:Marcstck,

It kind of makes me wonder why it took your neuro to discover this kind of data about Tysabri. Was Biogen again asleep at the wheel or have they known about this all along? Hmmm.

Harry

Either way, Biogen wouldn´t be keen on publishing figures like these..
3,5 % JCV positive patients - doesn´t sound really calming.

People that are immune suppressed have a higher risk of developing PML , and you can tell by history and by bloodwork should not be on Tysabri period. Potentially immune compromised patients are the only ones I would ever do twice yearly LPs on, if they insisted. I dont think TOUCH program would enrol these pateints to begin with, beccause they are too much of a risk.

Twice yearly LPs are overkill on non immune suppressed patients. PML is not something that develops overnight or even over a week or five. The signs of PML can easily be picked up on careful exam. I commend the neuro that does that, but feel for the patients that must undergo 2LPs a year because of t he neuro's understandable fear, because most will be for naught and many people who have positive JC or BK will be taken off an amzingly effective drug. JC, BK levels in sera or CSF DO NOT EQUAL PML. We would be surprised to see how many people would test positive for these viruses if screened.

that 3.5% risk of PML on Tysabri will change when new figures are published in coming year when the TYGRIS data is published. That 3.5% number is based on a study with under 5,000 patients and many of them where on immune the immune suppressive therapies at the same time.

yeb4432 wrote:People that are immune suppressed have a higher risk of developing PML , and you can tell by history and by bloodwork should not be on Tysabri period. Potentially immune compromised patients are the only ones I would ever do twice yearly LPs on, if they insisted. I dont think TOUCH program would enrol these pateints to begin with, beccause they are too much of a risk.

I believe if you read the PDF file, the neuro stated it didn't matter whether the patients were immune suppressed or not prior to starting on Tysabri and ended up with an active virus situation. That's the disturbing part.

Twice yearly LPs are overkill on non immune suppressed patients

But according to this neuro, there were non immune suppressed patients in the 3.5% group of 7 that ended up with virus activity.

because most will be for naught and many people who have positive JC or BK will be taken off an amzingly effective drug.

Obviously you have not read the many comments on other MS Forums where Tysabri has not been so "amazing" for patients who are on it. It seems to be turning out like the other MS drugs...some patients benefit, others stay the same and others become sicker. What IS becoming amazing is the amount of extra care Tysabri patients require in being followed to try and ensure they don't become very sick.

that 3.5% risk of PML on Tysabri will change when new figures are published in coming year when the TYGRIS data is published. That 3.5% number is based on a study with under 5,000 patients and many of them where on immune the immune suppressive therapies at the same time.

The 3.5% figure in the small trial done by the neuro indicated an active JCV and another virus activity in the spinal fluid of those patients. Again, according to the neuro, it didn't matter whether they were on immune suppressive drugs or not...and that is disturbing. Let's not forget Biogen telling us that the first two PML patients got that way because they were on Avonex. A monotherapy course of Tysabri was OK.....but now we very differently!

Harry

yeb4432 wrote:People that are immune suppressed have a higher risk of developing PML , and you can tell by history and by bloodwork should not be on Tysabri period. Potentially immune compromised patients are the only ones I would ever do twice yearly LPs on, if they insisted. I dont think TOUCH program would enrol these pateints to begin with, beccause they are too much of a risk.

Twice yearly LPs are overkill on non immune suppressed patients. PML is not something that develops overnight or even over a week or five. The signs of PML can easily be picked up on careful exam. I commend the neuro that does that, but feel for the patients that must undergo 2LPs a year because of t he neuro's understandable fear, because most will be for naught and many people who have positive JC or BK will be taken off an amzingly effective drug. JC, BK levels in sera or CSF DO NOT EQUAL PML. We would be surprised to see how many people would test positive for these viruses if screened.

that 3.5% risk of PML on Tysabri will change when new figures are published in coming year when the TYGRIS data is published. That 3.5% number is based on a study with under 5,000 patients and many of them where on immune the immune suppressive therapies at the same time.

I'm sorry, but much of the information contained in the above statement is misinformed.

To begin with, if you define "immune suppressed" patients as those who have ever undergone immunosuppressive treatment in their multiple sclerosis history, you would be excluding patients that the TOUCH program specifically includes. TOUCH (and TYGRIS in Europe) requires a washout period for patients who had previously been on immunosuppressive or immunomodulating therapies, but specifically does not exclude them from Tysabri treatment.

Tysabri has been approved for use in relapsing multiple sclerosis patients who have failed other front-line therapies. That, by definition, means that patients should not be using Tysabri as a first attempt to treat their MS, and therefore all Tysabri patients should have been on some sort of immunosuppressive or immuno modulating therapy before attempting Tysabri. The fact is that all cases of Tysabri related PML reported since the drugs' reintroduction have been in cases of patients using Tysabri as a monotherapy.

Furthermore, the TOUCH program does nothing to stop patients from getting PML. By design, is an attempt to catch PML in its early stages, so that it might be treated before the disease becomes devastating. The damage done by PML is by and large irreversible, therefore nobody ever truly recovers from the disease, and the hope of TOUCH is that the damage done might be minimized.

My neurologist is doing spinal fluid analysis on his Tysabri patients in an attempt to keep them from developing PML. If active levels of virus are detected in the CFS, the patient is pulled off of Tysabri therapy. This gives the immune system a chance to reconstitute and fight off the virus attacker, thereby potentially saving the patient from developing full-blown viral infection. This proactive approach is an attempt to keep patients from ever contracting PML, and as such is far more aggressive and potentially beneficial to the patient than the TOUCH program is or was ever intended to be.

The 3.5% figure that has been discussed is derived from research my neurologist has done, and has nothing to do with the TOUCH or TYGRIS programs. If you take the time to read the PDF, I think that will become obvious.

Tysabri has indeed proven to be a very effective drug for many patients. That said, it has also failed many patients, and there are patients who claim that it worsened their condition.as with all pharmaceuticals, Tysabri carries with it risks as well as rewards. Patients need to be armed with as much information as possible in order to make a reasoned decision about their course of treatment.