More PML, another death

[LL60]

My fellow Tysabri users.......talk to me a little here okay.

I must say I started out never giving PML a thought. As the months passed and I had such great results with few side effects, I always said I didn't care about PML I would always stay with Ty.

111 people probably felt the same way. As did the 22 who have died trying to fight their MS.

I can not take the CRABS. They are out. Why go off of Tysabri when it is working? Not only working, but working great. Why try something new that is not tested over time either. My doctor brought up chemo. But there is a limit on the infusions, and so then what? She said well maybe my then there will be something else. "MAYBE!" Why live with a maybe when I am for sure being helped by this drug.

Only now I seem to be living with the maybe of getting PML.

Karen, how are doing. Are you worried that you may have it? Do you feel you are still fighting the persoanlity changes?

After 3 years, the risk goes down. I am in that higher number of 2 - 3 years. So do I just hold my breath for a year?

How are you guys coping with these new numbers? Life is a risk I know. I do my mediation, "I may die today" and it brings me comfort that this day may be last to do a kind deed or to help someone. So, I don't usually live worrying about death. And I don't. PML brings the chance of something worse than death - severe disability. And isn't that why we are taking this drug, so we won't have disability?
Sort seems ironic doesn't it?

Can you guys just share with me, what is going though your minds right now. I don't really have anyone else to talk to this about.

[Sequoia]

Where did you hear that the risk goes down after 3 years?

I have had several online friends who were past the 3 year mark and struggling with whether or not to continue treatment because they were under the impression that the risk continues to rise the longer you stay on the drug.

[KarenR]

Karen, how are doing. Are you worried that you may have it? Do you feel you are still fighting the personality changes?

Hi LL,
I'm doing well. I'm always worried that I may get PML but at least the personality changes seem to be getting better (according to my dear & patient husband ).

Where did you hear that the risk goes down after 3 years?

Biogen recently applied for and received permission from the FDA to update the Tysabri label. They they cited that the included data showed the risk of getting the infection is
0.3 patients per 1,000 when using the drug for less than two years.
That rate rises to 1.5 per 1,000 when using the drug for two to three years,
but notably drops to 0.9 cases for the period of three to four years.
The data is current as of January, and Biogen said the label will be updated as needed.

You can google Tysabri label update to read the most recent news.

I would caution, however, that there is not as much data for patients using Ty for longer than 36 months.

Be well,

[0485c10]

Where did you hear that the risk goes down after 3 years?

I have had several online friends who were past the 3 year mark and struggling with whether or not to continue treatment because they were under the impression that the risk continues to rise the longer you stay on the drug.

the fda put in right on the label in it's recent label update. on page 4 of the label it says

0-24 months Risk is 0.3
25-36 months Risk is 1.5
37-48 months and risk is 0.9(below the risk gaurenteed on the label when Ty was re approved to go top market)

LL66- don't you think you are being a little melodramatic? you haven't used immune-suppressants in the past and as of 3-8-2011 you posted you had not been tested for the jcv anti bodies, so you don't know if you have that risk.

it strikes me, that sometime when stress is released it can cause me to over react emotionally & your stress was reduced by the release by biogen of the risk factors found during the ANN conference...you don't know if you are jcv positive so you don't know if you have that risk yet, probably you will know in a few more months.

you know you haven't used an immune-suppresant in the past--its pretty likely you are at much less risk than you thought? perhaps that caused tight kept emotions to be released? ....nothing was as bad as it was imagined it could be.

Not the MS, or the PML risk--that stress reduction will cause an emotions to swing. I experienced that when i was approved for disability--it just seems i kept my emotions so tightly in check during the uncertainty of applying, then i had an outbust finally after it was completed successfully.(go figure?)

now that you have more info, of course you need to logically, with a clear mind re-evaluate your Risk-Benifit profile again given this new info, but not go all emotional about it. I suggest you put off your re-evaluation until after you get your JCV anti body test results

deep breaths, calm now. I wonder if this has anything to do with the fact that you get your TY infusion at a cancer center with people getting chemo? i think that is what i thought i read? With the pml risk, you had some solidarity with the people being treated for cancer, but now that you know your risk is likely to be the same as the risk of being in a airplane crash, perhaps its the infusion center that is causing this emotional swing?

I didn't like my 1st infusion center for a variety of reasons, but the biggest reason was when a nurse told me this infusion center was for really sick people who had insurance that would not pay for them to be admitted, so they had to get their infusions in the infusion center, but they really should be admitted. like i don't have a disorder that needs an infusion? my dad said she should shut her mouth & just do her job.

i left that infusion center and found one where people are getting an infusion as an outpatient & don't need to be admitted. I'm happier there, but still frustrated at times.

could any of your emotion swings be caused in part from you infusion center? my infusion center causes me issues at time--makes me miss self injectibles done privately at home.

[0485c10]

You can google Tysabri label update to read the most recent news.

I would caution, however, that there is not as much data for patients using Ty for longer than 36 months.

Be well,

I made a post about the label change and included links to it in this thread....
http://www.msworld.org/forum/showthread.php?t=110410

[lindaincolorado]

First I am going to answer Sequoia's question. Go to the thread FDA approves label change. The table of pml is listed there plus the site where you can read the info yourself.

LL60, wow I couldn't have said all that you did any better.
I have had 54 infusions, am jc virus positive and WANT to continue Tysabri. Yes, I am concerned and for the past few months think more about pml Hate that the med I love has this worry/scare hanging over my head. I think about my "thinking", personality changes-if, G-d forbid, I see changes in me (tell my family to keep an I on me) I want to acknowledge this and get to my Dr ASAP! I will be starting at the RMmsC end of May and don't know what they will want me to do.

Did you read the thread about the 2011 AAN (American Academy of Neurology)Conference on Tysabri. It states that
if you have 3 risk factors the risk of pml is 1/100 The risk factors are: being on Ty over 2 years, being on an immunosuppressant previously and being jcv positive.
I have 2 of those risk factors and I don't want to give up my Tysabri . I remember what ms was doing to me before starting Ty...

This just sucks!!

Best wishes and good luck (for all of us)
Linda

[LL60]

Yes - my first reaction at seeing the new numbers this morning freaked me out. And not being a freaking out sort of person, it was very emotional for me. And I came right here.

Yes - I have never taken the immuninesurpressents.

Yes - I do not even know if I am JCV + or -.

Yes - I do get my infusions at the outpatient treatment center where people get chemo, blood transfusions, and other med by IV. It makes me thankful for "only" having MS.

Yes - Tysabri works well for me, with few or not side effects each month.

Sooooooo......I took a deep breath and I am in a much better place now. But.....from all your responses am I to take that most of you don't worry about PML?

Karen, glad to hear you are doing better.

Linda, thanks for your reply. I trust information coming out of the RMMSC. I get their magazine. I hope you can stay on Ty and continue to do well.

Thanks everyone. I'm okay. Just had a moment there. Maybe I should stop checking Alex's web site.

[Scooter24]

I think what we need to do is look at this in relation to other chances of dying for example, 3 : 1000 of dying in a car accident, better chance of getting alot of types of cancer, similar risk of dying from flying in a plane, etc etc etc.

At least with Ty we make the decision not some drunk coming the other way or some idiot putting a bomb on a plane or a controller falling asleep,

I am getting ready to take # 12 in 2 weeks, it works for me, I feel better on it, I am jc virus antibody pos or at least that is what the test shows ( still being trialed). I am also a 2 yr cancer survivor so I have had my life scare which makes you look at things from a completely different point of view. I have said elsewhere and will say again give me quality of life rather than quantity.

[REG53]

Hello LL60,

I will be taking #50 next wk. I am jcv positive and I am concerned about PML. Every time I heard of another case I start considering should I or shouldn't I continue.

I start reading all the post and weighing the benefits versus the risk.

I always talk to my Dr. about my concerns and so far he recommends me staying on TY.

So for now I will be taking #50.

[LL60]

Scooter, you are so right.

I went skydiving for my 60th birthday, I never gave it a thought. If I had been scared, I would have missed a wonderful experience.

I'm very glad you beat cancer.

Just the emotions are going back and forth today. I can't really talk to my family. Don't want to worry them. One of my close friends just put her dad in hospice, so don't want to bother her either. I know you guys think I am over reacting. And I am. Just have not worried about it. I know my body well and watch every little thing.

I am so sorry for all those who have gotten PML. How unfair. To just trying to help yourself and be on the right meds for you, to now have to deal with this.

Quality of life means a lot to me too. To go back to the way things were before Tysabri would not be good for me. So I guess it is worth one day of freaking out now and then.

I want to thank everyone again for helping me put things in focus. With starting infusion #24 - 36 I may worry a bit more. But that's okay, maybe it will mean if something happens, we will catch it soon.

Everyone have a great Easter and nice weekend.

[Lendi]

I think that all of us probably have some thoughts about "what if" where Ty is involved. It's kind of scarey, death. For me, it's kind of scarey however it comes to me.

My thoughts though, if it's time death is going to come to me whether I'm on Ty or not. One way or another. So, I want to enjoy life each day while I have it.

Now, I also have to say that I'm only on my 18th infusion and I tested negative for antibodies. That might make this whole decision and process easier. A year from now I might be saying something very, very differently.

[LL60]

Death doesn't scare me as bad as "severe disabilities" of PML does.

I know what you mean about being on #18. I use to think I will think more about PML when the number reaches 100. Then when it hit 102 I thought about it for a short while. Jumping to 111 seemed to have really hit me.

But.....that is still a whole ton of people who are on Tysabri and did NOT get PML. A ton of people. And as the day is coming to a close, that is what I am focusing on. Not who got it, but who did not get it. Right now, me being one of those who have not.

I guess I will go get the JCV test when it is out for everyone. Although I work with ill children and have for well over 20 years, would be strange if I have never come into contact with it.

I think all we can do is have the very best day we can have each and every day.

Reg - wow, I think that is great that you are going for #50.

See....thanks to all of you, I can come along way today.

[Tomjadg]

I am only at #4 next week, and although I feel no different yet, I understand I need to give it at least 6 months.

If it turns out that it does help, I will continue to take it.

I don't fear death, as it would be a relief from this misery.
I've had a good life, and I would feel bad for my wife if I would leave her.
I would take that chance to continue.

[kbloom2]

I have never in my years thought I would say this, but I read up on my meds when they are mention to me before I try them. Tysabri was not my cup of tea at all. I mean all meds can cause a side effect, but when it is life threaten I opt out even if it shows great results.
So I did chemo Cytoxin which there is no life time to having it. Nyvantrone was mention and that to can be life threatening to the heart. So with Tysabri I chose not because with my luck I would get PML. I mean I already have Ms I dont need anything else.
great thread
Kari

[ru4cats]

Tomjadg, hang in there! It wasn't until my 6th infusion that I began to feel any changes at all, and it took at least 8 before the changes were noticeable. For me, the changes have been gradual but definite, and each infusion brings me positive results. Like you, I have no fear of death; for me, Tysabri is worth "playing the odds." I honestly don't think about PML, but I do keep close tabs on my physical self. I have a great infusion center (after a switch), and my nurse also keeps tabs on how I'm doing.