I don't get it!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[NickyOz]

I am thinking of starting Ty but don't get something and need it explained REALLY SIMPLY. If you are JCV negative is there and chance of getting PML

[KarenR]

Hi Nicky,

I believe the not-so-simple answer is they just don't know!

Your chances are certainly less. But I don't believe they're zero.

Unfortunately, there are no absolutes with MS.

Be well,

[Myoak]

I am thinking of starting Ty but don't get something and need it explained REALLY SIMPLY. If you are JCV negative is there and chance of getting PML

There have been no reported cases of PML in anyone JCV negative. The belief is that JC virus causes PML.

Is it possible to go from neg to pos while on Tysabri? Yes, it is possible. That is being studied. It appears that JCV is latent in many people (55%-80%) and that Tysabri may allow it to become active. Again, it is being studied so we can't rush to judgement in how many, if any, convert from - to + but it is possible to do so.

My wife is JCV pos, she has taken Tysabri since 2002 except for one year. Since she has no history of taking immunosuppresant drugs her risk of developing PML is 2.8 out of 1,000. That means she has 997 chances out of 1,000 of not getting PML. As she continues on Tysabri it would not surprise us to if the risk continues to climb. That is being studied, also.

If my wife had a history of taking immunosuppressants at any time in her life, having been on Tysabri over 2 years, and being JCV pos, her risk factor would be 8 out of 1,000. Since Tysabri has been so effective she would still opt to take it. 8 out of 1,000 is a lot but the 992 number deserves attention, also. Depends entirely on the individual. My wife believes not taking Tysabri increases the risk of damage from MS.

Good luck Nicky, hope this helps, treatment decisions in MS never easy.

[D_HOLLAND]

I am thinking of starting Ty but don't get something and need it explained REALLY SIMPLY. If you are JCV negative is there and chance of getting PML

My son's neuro told us that everyone who has developed PML were positive for the JVC virus.

[hexed]

There have been no reported cases of PML in anyone JCV negative. The belief is that JC virus causes PML.

Is it possible to go from neg to pos while on Tysabri? Yes, it is possible. That is being studied. It appears that JCV is latent in many people (55%-80%) and that Tysabri may allow it to become active. Again, it is being studied so we can't rush to judgement in how many, if any, convert from - to + but it is possible to do so.

My wife is JCV pos, she has taken Tysabri since 2002 except for one year. Since she has no history of taking immunosuppresant drugs her risk of developing PML is 2.8 out of 1,000. That means she has 997 chances out of 1,000 of not getting PML. As she continues on Tysabri it would not surprise us to if the risk continues to climb. That is being studied, also.

If my wife had a history of taking immunosuppressants at any time in her life, having been on Tysabri over 2 years, and being JCV pos, her risk factor would be 8 out of 1,000. Since Tysabri has been so effective she would still opt to take it. 8 out of 1,000 is a lot but the 992 number deserves attention, also. Depends entirely on the individual. My wife believes not taking Tysabri increases the risk of damage from MS.

Good luck Nicky, hope this helps, treatment decisions in MS never easy.

I just want to start off by saying I'm not trying to be a "Debby Downer" here and I'm definitely reponding just for arguments sake..

2.8 out of 1000 chance does not mean there are 997 out of 1000 that she will "not" get PML.. because the math would mean that that statistic would have to be a 1 in 998 chance. A 2.8 out of 1000 chance means she has a 1 in 357.14 chance of getting PML. Conversely it means she has a 356.14 in 357.14 chance of "not" getting PML.

But on the better side of things, congrats that she has not developed PML after 2 years!

I recently was dx'd last month with MS and was going to start rebif but my jcv test came back negative so I am neck deep in stats and visiting the far corners of the interwebs to make an educated decision on whether I start Tysabri.

To me, a 1 in ~400 chance of developing PML just can't be trusted. That is just for "me" though since my sx's are sensory (numb hands, feet, MS Hug, and MS zaps). I might be singing a different tune though if my QOL was bad enough.

In Vegas odds, if I had a 356 in 357 chance of winning, I'd play all day with my life savings AND the deed to my house. In life/death odds, I just wouldn't be able to risk it. I'll be honest though, even if it was 1/1000 odds, I still wouldn't.

To close my little post, I wanted to make sure I'm not coming off as condesending or a jerk. When someone has wrong info, ESPECIALLY when it comes to their loved ones I want to make sure they are aware. If any math wizz wants to make a correction in my math please do, cause I could be wrong too

[lindaincolorado]

Hi Nicky, from what I understand there has only been one case of pml for someone who was jcv- BUT that was after being diagnosed with pml and undergoing plasmapheresis. If he had been tested before the plasmapheresis he (or she, can't remember) probably would have been jcv+.

The odds of being jcv- and getting pml almost do not exist from what I've read/heard. Also, there was only one case of pml in under 14 months on Tysabri and may be the only one in 2yrs and under-there might be another-I can't remember-but, odds are 1/1000 or better for 2 yrs and under.

I have had 68 infusions-some being under the info I was jcv+ and then a few months ago-after being retested twice-finding out I am jcv-

Best wishes

[ru4cats]

There was a recent post from the New England Journal of Medicine, I believe, that said your chance of developing PMl if JC- is .09/1000. The odds are definitely in your favor.

[Thinkimjob]

Then the odds of getting MS in the first place are 1 in 750. Feeling lucky?

[Myoak]

Ms Hexed,

“2.8 out of 1000 chance does not mean there are 997 out of 1000 that she will "not" get PML..”
If 3 out of 1000 got PML then how many people out of 1000 did not get PML according to your math?
Please consider your math more carefully, try again and take your time.

But there is a far more important point, my post was a year old and anyone considering Tysabri should base risk assessment on the most current numbers available.

For those who are JCV neg you may want to remember that the JC virus causes PML and if you don’t have JC virus it is next to impossible to get PML. So if the Las Vegas analogy is used the question becomes would you take a risk in which it is next to impossible to lose? Perhaps not when your life is on the line.

But there is another critical factor often overlooked. And that is the fact that if you don’t take the ‘next to impossible to lose risk’ (being JCV neg) you are left with the statistical probability that your health will suffer because you didn’t take that risk. Why?

Because the statistic you must compare is the efficacy of the various MS treatments you would be on if not taking Tysabri. If Tysabri is twice as effective as Copaxone in preventing new lesions and you chose Copaxone, you accept the far greater risk of new lesions that goes with it. And, if you chose no treatment, you accept an even greater risk of new lesions.

Keep in mind that as lesions accumulate the brain has more difficulty doing the workarounds of the lesion areas and disability becomes more likely.

Each person has a unique risk tolerance with which they must be comfortable. But IMHO risk assessment should not be an emotional exercise but an intellectual one, as much as possible.

Ms hexed, please forgive me if I have offended you in any way, won’t you? We are always limited by time and opportunity in fully understanding one another. However, I’m thankful for this forum which is a place to share in a meaningful way. You are a delightful and wonderful person and I wish you the best, truly!

PS Thank you for being so kind as evidenced by your effort not to give offence, I’m trying to be more like you. Someone has said that kindness is the highest form of intelligence.

[Myoak]

Risk of PML

For the sake of clarity about PML risk here is a quote and source from Bruce A Cohen, MD
Professor
Davee Department of Neurology
Feinberg School of Medicine
Northwestern University
Chicago, Illinois

It has recently been estimated that the risk of PML in a person who has a negative JCV antibody result is less than 0.11/1000, compared with 2.8/1000 after 2 years of infusions for someone who is antibody positive. Prior immunosuppressive treatment also increases the risk of PML for patients taking natalizumab, and the risk for someone who is JCV-antibody positive and who also had prior exposure to an immunosuppressive agent is estimated at 8.1/1000 after 2 years of infusions.

Dr. Cohen's source... Sandrock A, Hotermans C, Richman S, et al. Risk stratification for progressive multifocal leukoencephalopathy (PML) in MS patients: role of prior immunosuppressant use, natalizumab-treatment duration, and anti-JCV antibody. Abstract P03.248. Presented at: 63rd annual meeting of AAN; April 9-16, 2011; Honolulu, Hawaii.

Also, another quote from an interview given during the AAN annual meeting April, 2011… “Robert Fox, MD, a multiple sclerosis specialist at the Cleveland Clinic, told MedPage Today that the likelihood of PML in the lowest-risk group was similar to the lifetime risk of dying in a plane crash.

But for the highest-risk patients, he said, it's more like the risk of a fatal car wreck.”

I quoted the Fox statement from a MedPage Today article published April, 17, 2011.

Hope it will be helpful to risk assessment in those considering treatment options. I don't know if more current data is available but if so, I would be surprised if the stats were significantly different from these published in spring last year since they would be averaged over time.

[hexed]

Ms Hexed,

“2.8 out of 1000 chance does not mean there are 997 out of 1000 that she will "not" get PML..”
If 3 out of 1000 got PML then how many people out of 1000 did not get PML according to your math?
Please consider your math more carefully, try again and take your time.

That would be Mr. Hexed... hehehe. But I won't take offense to that

Sorry, I really didn't re-read that comment by me before I posted. What I meant to say is to not focus on such a big number as 997 or 992, when it comes to one individual, which I continued to say unless it was 997 out of 998. It was said in the post I was replying to that 992 is a big number that deserves some attention and I just wanted to point out that those high numbers get much lower when you factor in the fact that it is not 1 out of XXX.

...but yes, you are 100% correct that there is without a doubt a 997/1000 chance she will not get PML. I need to re-read my posts before I hit "submit". Wish I could blame that on the MS

[hexed]

For those who are JCV neg you may want to remember that the JC virus causes PML and if you don’t have JC virus it is next to impossible to get PML. So if the Las Vegas analogy is used the question becomes would you take a risk in which it is next to impossible to lose? Perhaps not when your life is on the line.

But there is another critical factor often overlooked. And that is the fact that if you don’t take the ‘next to impossible to lose risk’ (being JCV neg) you are left with the statistical probability that your health will suffer because you didn’t take that risk. Why?

I agree 100% about the jcv- people and risk associated. I just found out 2 days ago that I am jcv- so I am switching from Rebif (haven't even started yet) to Tysabri. My Dr. said there is a 1 in 100,000 chance I will get PML, which basically means it is impossible as long as I am jcv-. With those type of odds, I will take that all day long.

I think it all boils down to quality of life as I had mentioned. If I had a more aggresive form of RRMS, and was told that I would most likely be disabled in any way in the near future, I think I would have to take that 1 out of ~357 chance. Just like so many people on these boards say, when your health is suffering, and you didn't take the risk, you just wonder what "could" have been. TBH, I wan't to make sure as this disease gets worse as time goes on, I can say I did everything I could possibly do.

One thing that gets me a little confused though when it comes to jcv- patients. My Dr. says you have a 1 in 100,000 chance of getting PML but others have said all kinds of different numbers. On this board alone I have seen 1 in 10,000, 1 in 30,000, 1 in 40,000. Why is it not 0 out of 100,000 or something like that? If jcv is the only thing that causes pml, then why is there even a 1? Is that because they are factoring in the slight chance that A) it may be a false negative/you may get jcv after you start treatment and B) if you get jcv+ result, that the possible maximum 6 months of treatment you had before your 6 month blood test is enough to give you the smallest possibilities of getting PML?

I dunno if you or anyone can answer that though, but I was just curious.

[BigA]

Hexed: You only have light symptoms and not having major events and you're considering Tysabri?

I would be surprised if your doctor would even let you. I think you have to have a very active disease even to be considered.

[Redwings]

You only have light symptoms and not having major events and you're considering Tysabri?

I would be surprised if your doctor would even let you. I think you have to have a very active disease even to be considered.

That is an excellent point. The original idea behind the TOUCH program was to prevent mild cases from being exposed to the risk of PML for possibly relatively little benefit. But it also became apparent pretty quickly that doctors were somehow able to bypass the TOUCH guidelines fairly easily, and get inappropriate cases right onto Tysabri.

Perhaps that might become more acceptable now, with the greater understanding of the risk factors. If the risk for PML is so low for certain patients (down around the risks of life in general ), their potential for benefit goes up. From that viewpoint, it might be appropriate to not deprive those patients of the potential benefits of Tysabri and, as with all other medications, let the chips fall where they may as far as other nonlethal, nondebilitating side effects.

[Mable]

...it might be appropriate to not deprive those patients of the potential benefits of Tysabri.

This is my big question right now. I've heard a couple different MS experts suggest that the aggressive therapies might be especially beneficial to us with "mild" disease (it doesn't feel mild, by the way, just means I pass all the neuro clinical exams).

In some cases, Tysabri and Lemtrada reverses symptoms. I heard one expert say those reversals might be especially helpful for those of us who struggle mostly with cog/depression symptoms.

That's why I keep asking, "am I missing out on a window of opportunity by continuing on a 20-year-old CRAB drug?" I'd consider exposing myself to the nasty side effects if it means a 70-100% reduction in disease activity now before I start gathering disability and getting closer to SPMS. And look at the brain atrophy numbers people are getting with Tysabri! They're practically normal!