Me again...

I was looking through the excessive list of files in my laptop and found some things that may help folks to understand where we have come from the time the drug was pulled and where they started looking at PML and Tysabri.

The first is the conference call from Biogen Idec the day Tysabri was pulled from market Feb 28, 2005. It's LONG but there's a LOT of info in there.

http://siliconinvestor.advfn.com/rea...msgid=21088871

The second is Lauren Roberts' blog and there's a WEALTH of info there too. I found one patient who sent her a letter who has been on Tysabri since July of 2002 with an 18 month break while Tysabri was off market. That means the poster has been on Ty for a total of 66 doses+-.

"As a study patient, I have been taking Tysabri since July of 2002...That's almost six years. I had to take a 18 month hiatus when the drug was connected to the deaths of two subjects in my study pool. That said, as soon as it was offered again, I jumped at the chance. When I started the Tysabri, I was having difficulty walking. After 8 Tysabri treatments, I was back to running. Only a half a mile at a time, but I slowly worked my way back and played competive (over 35 league) soccer for a summer!
I know that people are worried about side effects. All I can add is that my fellow subjects, if they were going to have side effects, they had them right away...within the first few treatments.
I hate the pernicious nature of this disease--going to bed not knowing how your health will be when you wake. This treatment has cured me of that nightmare."

http://lauren-livingwithms-aolcomlgl....blogspot.com/

Lauren is very careful and checks and re-checks her facts before posting.. She's been involved with Tysabri for a long time and her blog is one of the places I go when I need more info about past info on Tysabri! Thanks to her for her VERY comprehensive blog!

Just FYI...

Does anyone know if Vic ended up getting back on Tysabri, or if he evenually moved onto something else? I know his mind is on his wife right now, but I don't know if he ever mentioned a resolution to the $$ situation he ran into with T.

Cherie

I don't know if he ever got back on Tysabri, Cherie. I've heard as much as everyone else has from Vic, that he is busy with his wife's recovery and that's about it. I am sure when he can update us he will.

This is a great blog, thanks for the link. I like the quote she has on there (from someone on a message board) that basically sums up what I've been feeling about the CRAB drugs:

As far as the PML risks go, even though I'm not in a place where I'd consider Tysabri, I still think that the issue is blown a little bit out of perspective. To compare, I know that this is another thorny issue, but compare to childhood vaccinations. Statistically there are higher risks of "adverse events" from those yet most of us still vaccinate our children, even though the risk of contracting those diseases is relatively small. With MS there is a sure decline in one's health vs. a low risk of a major complication. Given how well the drug works for most people I totally understand why people choose it. Being new to this disease I also really appreciate the fact that this type of drug even exists!

Thanks PL!

I am not sure what your experience is with your neuro, but most of us were handed a bag of literature and tapes and told to go home and call back when we chose a drug. I don't know of any other disease where they do that.

Many folks are on one or another of the "CRABs" For some, their choice works very well. For others, they run through all of the choices. Obviously, on this Tysabri thread, there are people who Tysabri is working for, so we can be called "Tysabri cheerleaders" There are also a lot of folks who have been here who, for one reason or another, have chosen to stop Tysabri and moved on to another therapy, or chosen to go "naked" and not choose anything for now.

One of our objectives when we fought to get Tysabri returned to market was to allow us the opportunity to make an informed decision and choose the drug we wanted.

This board exists to support people and give them all the information we have to help them make an informed choice. They can talk to people who are on each of the drugs and assess the risks involved for each of them, the ease of use, the side effects, and hear others' stories on the good and the bad.

Each time a new report of PML comes out, folks who are on Tysabri each have to make the decision all over again in their head, to continue taking Tysabri or to make another choice.

Regardless of what anyone's personal choice is, we support them in their decision.

I for one, have chosen to stay on Tysabri once again, after the latest case of PML that was reported, with the information I have received here and from other sources.

Let us know how you are doing and we will support you in whatever therapy you choose!

Thanks to Komokazi for the heads up!

Info on the 10th PML case is now on Elan's site.

In brief:

On 23 June 2009, tenth confirmed post-marketing diagnosis of PML in a 27 year old male in the EU with a history of MS. The patient had previous exposure to interferon-beta, Copaxone, and IVIG. The patient received 30 TYSABRI doses between January
2007 and June 2009. Symptoms began with right hand weakness. MRI scans
revealed new lesions in the left motor and parietal cortex. PCR of CSF
returned 250-500 copies of JCV. Plasma exchanged started. Patient is
reported to be stable according to treating physician.


More good info: PML lesions do NOT enhance with contrast on MRI. I think I knew that but forgot it, and I may have posted it before. I just woke up and haven't finished coffee quart #1 yet!

thank you for the support.... nope, I got no information. Just a quick "debriefing" in his office and an ultimatum-of-sorts to call him in a week with my decision. I didn't really demand any info, partly b/c I was peeved at his attitude and didn't want to prolong the visit, but mainly because I figured all I would get is the same marketing info I can download directly from the manufacturer's online.

It's exciting to hear of people that are good responders to any drug, really.... a lot of times you just hear the stories of people who the med works only so-so for them, or not at all, which is unfortunate. It's reassuring that I have come across a few good positive stories for the ABCR/CRAB drugs (where the heck does that second acronym come from btw?)

A question on PML-- is it fair to say that this is a disease that comes about as a result of immune suppression or is the reason not very well understood yet?

Also, a question on Tysabri-- does it impair one's immune function in a general way, or is it more targeted to the MS? In other words, does one have a higher risk of coming down with common viruses/bacterial infections? And does one tend to stay sick longer?

Thanks!

Hi PL,

I've heard of other people having problems with infections, but I am one of those people who never gets sick. I've had a run in with salmonella and a ruptured appendix but the first was due to something I ate and the second was something that anyone could have!

When my doc does my bloodwork, I have slightly higher than normal WBCs, and he says that is from all the T cells milling around because they aren't getting into my brain anymore. He says all it does is block T cells from crossing the blood/brain barrier and damaging myelin, and that it doesn't block all of them but enough are blocked to stop damage.

I think that not enough is known to make a stand on what actually causes the JC virus to activate and cross the BBB. 80-85% of the population of the world carries the JC virus in their kidneys and it is usually dormant. PML has been seen in people with AIDS who are immune suppressed, in people who are treated with Rituxan, Tysabri, Raptiva, Cellcept, Methotrexate, Mitoxantrone, chemotherapeutic drugs, corticosteroids and some transplant drugs.

Because of the PML cases associated with Tysabri, more has been learned about PML than ever before. It was previously known as a fatal disease. Now, with plasma exchange along with treatment with mefloquine or mirtazepine, and steroids if IRIS develops, people are living after diagnosis of PML.

Reports on patients diagnosed with PML after Tysabri shows that most of the patients diagnosed so far are still alive. Some are doing well. Some of the earlier people are very disabled. The key seems to be increased vigilance and reporting ANY symptoms to your doctor. Since not many people are relapsing on Tysabri, when signs of relapse are seen, the new norm is to suspect PML first and vigorously test for it with blood tests, spinal taps, MRI, discontinuing Tysabri and further treatment if necessary. It COULD be just a relapse, but no one takes that chance now.

Sorry to be so long-winded but you did ask...

Thanks for the reply ... guess I'll wait till he comes back to this thread, if that's what he is on.

Great summary, RW.

Cherie

Tysabri works great for many of the people I know--which is about 10. The PML risk is there, and one should assume it fatal when it occcurs. The risk is higher for those who have received mutiple immune modulating therapies, especially when they have been given in close temporal proximity. If two immune modulating ("traditional") therapies fail to prevent flare ups then tysabri should be considered next along with other treatments--with the understanding of the risk of PML.