12th case of PML from Tysabri posted today
 

3 from the trials + 9 cases confirmed in the last <11 months.

http://investor.biogenidec.com/phoen...82&p=irol-TPME

June 19, 2009, 34 doses, Ex-US

July 24/09 (when they are no longer going to be posting the cases publically on their website), is coming too soon though ... Not sure how we'll know about new cases then. :cool:

Cherie

we need transparency. I want honest figures about what is really going on with the brave folks that sit in that chair once a month. they are the soldiers that we are all looking towards for the long term results with this drug.

I want drugs that are more effective than the standard CRAB drugs, but when they start making things secret, it appears as if they have something to hide. That scares me.

When you sign on with Touch to take this stuff, you KNOW there are risks, and benefits. I dont understand what the issue is with being honest and up front.

Thanks for bringing this to our attention. God Bless those who do the research for us. I simply cant dig through every journal, article, and website looking for evidence.

Dej, probably with every PML case announced, I'm guessing, there are a 1000 people who either drop out or don't sign up.

With Biogen, it's all about the bottom line..:(. But, on the other hand, at least they came up with something that works a lot of the time.

It's all about the almighty dollar.

To keep the PML discussion in perspective:

European Doctors are not exactly shying away from using Tysabri in immunnosuppressed patients (which is identified as a potential risk factor for higher occurrence of PML)

Natalizumab treatment after autologous haematopoietic stem cell transplantation in patients with aggressive multiple sclerosis

http://registration.akm.ch/einsicht....NMASKEN_ID=900

Any wonder the PML case count is 2 in the US and 7 ex-US (Europe)

I agree with Komokazi.

The EU and ROW are much more aggressive. I also believe that they have prescribed Tysabri when the people who want it have no other choices, having tried all other options. There are reports out now that Tysabri will no longer be an option after mitoxantrone according to Tysabri website in Germany.

I also do not like being BIIB's mushroom. I want the information that allows me to make an informed decision. They ain't giving it to me. They are making me search everywhere under the sun for information besides where we SHOULD be getting it from.

I never forget that those of us who are actually ON Tysabri need to be vigilant for ANY adverse events, no matter how small. Changes in thinking, affect, speech, eyesight, etc. are all things we need to watch for.

Correction! The information did not come from Tysabri website. It was from http://chefarztfrau.de/?page_id=418#comment-34516 and was from one of the neuros who answer questions on that board in answer to a question from a patient, dated 16 June 2009

RW -- Do you know anything about the supposed JC virus antibody test that was supposedly going to come out at the end of this year? What help would that offer?

My neurologist has my blood checked every 3 months for the JC/BK viral DNA load. If there is anything funny they will yank you off Tysabri. I know some people who contracted PML did not test positive in their blood until well into the disease course and after clinical symptoms appeared (the best place to look of course is in the CSF) but I guess getting my blood tested is one more possible safety mechanism to put in place. They are making me get an MRI every 6 months too.

I wonder how many people were pulled off Tysabri because of a suspicious blood test or MRI but did not go on to develop PML? Those you would never hear about. Do you think that non-US people get fewer MRI's because of cost, socialized medicine, and long waits and that might also explain the higher PML rate too? Or perhaps it really is prescribing Tysabri on top of past immunosuppressant drug history.

I haven't heard anything further about that specific test lately, but you can be sure that when they do develop a reliable test, they will be trumpeting it everywhere.

It's my doctor's policy that tests will be done on the CSF because it's a much better indicator than blood, so MRI, LP and decision. He also says ANY relapses are suspicious when on Tysabri and that if there is any indication that a patient is starting a relapse he would follow the same procedure.

I've read on other boards about people who were taken off Tysabri due to relapse, increased inflammation or other adverse indications, including blood work.
Some of them weren't happy and some had the attitude that it was better than PML.

I am not sure if socialized medicine would preclude MRIs. I think that any doctor even if overseas would get the MRI approved and done immediately, because of the history of the drug.

There was an abstract at AAN 2009 in April about a bioenergetic assay that had good correlation with immune surveillance status.

How soon any sort of test might be available will depend on confirmation that the test theory works - confirmation in additional PML patients.

Chris

I didn't mean that socialized medicine would stop people from getting MRI's if there was a clinical suspicion of PML. I meant regular MRI's every 6 months like I get even though there is no suspicion--these might catch something earlier.

PML has a pretty rapid course. It starts affecting the brain before anyone usually notices what's happening. That's why you have to be vigilant to any changes. Confirming it on MRI means the damage has already started.

The doc asks the old man at every visit if I have had any changes in my thinking or odd behaviors and reminds him to watch for them too and not to wait, just call him, and not to argue with me over it...:D...like I wouldn't believe I'm sick or something!

He's said it enough that I listen to my body closely. He also stresses that anything that looks or feels even mildly like a relapse is a reason to call. Those will be the first symptoms.

He's not big on MRIs unless they are necessary, and I've only had two since I started. Those were at yearly intervals to see what's happening in my flip top head. They were excellent.

I agree, RW. I wish they would keep supplying this information to patients. We (the communal "we") fought for this drug, AND the PML monitoring process ... so I think they owe us ongong transparency.

It seems they should have patterns established by July 24th though... since they see that as the reason to no longer supply this PML incident information to patients ... then those who are at more risk can weigh up their decision on that basis.

That appears to be a "study" of some sort, possibly sanctioned by Biogen. I'm quite sure that the majority of EX-US patients have NOT used stem cell treatments, and/or that there are no US patients who've used other strong immunosuppressants at some point before Tysabri. :cool:

If immunosuppression is a potential risk factor though, can you link to a definition of how long people are supposed to wait/dependant on what drug, before going on Tysabri, Chris? I haven't (personally) seen that criteria detailed even for US patients yet.

It was just a small study, but it is interesting that the results show that THOSE strong immunosuppressants didn't seem to affect the outcome.

I hope they are undergoing bigger (and longer) studies, that might give them more conclusive evidence that immunsuppression either does or doesn't influence the development of PML. Maybe they are waiting on those results as we speak, and that this may be why they think they are getting closer to answers ...

Cherie

Cherie,

The study was an example of what European Docs are trying relative to Tysabri. I've also seen discussion of German Docs liberally using heavy immunosuppressants as well. I'm personally glad patients with no other alternatives are being given the option (Versus here in the US where Tysabri can't be used off-label.) to take Tysabri. Clearly this can have an effect on the rate of PML seen with Tysabri usage in Europe.

I have seen no formal documents listing wash-out periods for various drugs. My doc made me go through a 6 week wash-out for Rebif. I've heard others with ABCR wash-out periods of 4 weeks. I've seen some other posts about a 6 month wash-out for Novantrone. The trouble with wash-outs for these more powerful drugs is that they sometimes have residual effects for very long periods - example being Novantrone patients developing Leukemia 18 months after the last dose of the drug.

Chris

Chris, your link, which led to the study yesterday, does not seem to have an article associated to it any more. I'm linking to a "no page available" now, are you? If so, do you have another link to that study?

NIAID seems to have a similar stem cell trial going on out of various places in the USA.

The purpose is:

Purpose
The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system. The participant's own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.

And one of the inclusion criterias is:

Criteria
Inclusion Criteria:

•Two or more relapses in 18 months time on interferon (IFN), glatiramer acetate (GA), natalizumab or cytotoxic therapy with EDSS increase of 1.0 or greater for participants with EDSS at screening of 3.0 to 3.5 (0.5 or greater for participants with EDSS at screening of 4.0 to 5.5) sustained at least 4 weeks after at least one of these relapses OR one relapse on IFN, GA, natalizumab or cytotoxic therapy with EDSS increase of 1.5 or greater (1.0 for subjects with EDSS at screening of 5.5) sustained at least 4 weeks, together with MRI changes consistent with poor prognosis. More information on this criterion can be found in the protocol.

http://clinicaltrials.gov/ct2/show/NCT00288626

I don't remember the particulars about the small study you linked, but it seems that there are people willing to try some back-to-back serious heavy-duty drugs everywhere around the world.

Cherie

Thanks Chris.

Well it looks like they were quite careful in waiting a mean of 18 months before administering Tysabri, whereas the US trial seems to only require 3 months of no prior immunosuppressants (if Tysabri would be even considered an immunosuppressant ...?) before the experimental stem cell treatment. :confused:

Anyway, so far, so good ... as far as we know!!

Cherie

I need to correct this statement. PML actually starts out slowly. It is under the radar for a long time if not detected before it reaches the brain. It is when it reaches the brain that it starts to do the rapid damage that gets noticed, leading to MRI and diagnosis.

This is a link to another board where a person with PML has posted:
http://forums.wrongdiagnosis.com/showthread.php?t=49456

This person's experience is VERY compelling and a good warning for all of us on Tysabri AND for people searching for diagnosis because their signs and symptoms don't fit the norm.

If you are on Tysabri, be vigilant. Changes in vision, thinking and behavior are signs that something is wrong. You may be in relapse, but relapse isn't seen very often in people on Tysabri and the protocol is RULE OUT PML first before treating relapses with steroids.

I wonder if perhaps it starts out slowly in some instances ... but can go a lot quicker if "induced" by certain meds ...?

Thanks for the clarification.

Cherie