Unique Tysabri risks?

[RockysMom]

Saw a new neuro yesterday who saw me right on time instead of having to wait up to two hours which is no longer possible. I liked my new neuro ok, she was pushing the Tysabri hard & I did get excited about it, with her saying that some people experience a dramatic improvement on symptoms they've been having, but after talking to the Tysabri company today, I am considerably less excited.

23% of all folks ever gone on it have developed PML which is either fatal or leaves you severely disabled? On top of this risk, you could also developed acute liver failure requiring a transplant?

And I have serious concerns about the fact that I have already had a previous serious nearly fatal brain infection and that was neuro Lyme's which could be lying dormant waiting to wake up along with the John Cunningham virus or JC virus associated with PML, the encephalopathy tha is usually fatal or leaves you seriously disabled if you happen to survive.

Since this was my first visit with this neuro, I really didn't even have time to get into the fact that there may be other risk factors for me involved including the fact that this PML is a type of Polyoma Virus which is associated with birds and I have 4 parrots all of whom have a borna virus which affects parrots like MS, they are being treated for it and are well but this is still something in my environment. Plus I have dogs, cats, and bunnies! And they are mostly all pretty old. So you can be sure I probably have the JC virus since I was told 50% of everyone has it and you can bet that it probably comes from animal contact.

I was unable to discuss this with her because it was the first appointment and she was trying to become familiar with my medical history, which is already complex, and there just isn't enough time for everything else. Plus there's the whole neurological history of problems in my fathers side of the family, which has often made me doubt that I am really even have MS. However I did have a spinal tap over 10 years ago which showed oligoclonal bands and neuro Lyme's, but I also have this family thing - nonspecific demyelinating neuropathy - which both my father and his brother have and their father have.

So this all just makes me think that Tysabri might be a terrible mistake for me to take? But then her saying about how some people have a dramatic improvement was just so tempting, so tempting, like something I've been fantasizing about. But I sure as hell don't want to die as a result, not like that.

Please anyone if you have thoughts about this, let me know, especially if you have animals as a big part of your life and know that it is a valid concern to be considering cross species things like this. So many people out there don't have pets or think that the ones who do are crazy to even consider them along with oneself, as opposed to just eliminating the animal from the equation. To me that would be like death itself.

I also got Zoloft for my depression which is now coming full force.

[DexterMorgan]

I actually didn't know that the PML virus might be from animals? I don't have any animals and I'm negative but my bf has a German Shepherd which I pet often enough So it might just be luck, no?

Personally I'd get the JC test first and see if you are positive or negative. If you are negative you could practically proceed to get Tysabri as the chances of getting PML are very small. However in your case if you were positive I'd think really hard about it especially considering your medical background.

And yes Tysabri has helped me a lot but I'll be honest with you, I noticed nothing the first 2 years I used it so definitely don't expect it will give you like immediate results.

I know this is a really hard situation especially in your situation... Oh and your pets, it's not even sure the JC virus is caused by animals, don't you think that if that was the case they would have found out by now?

And 1 other thing: I see you are a bit hesitant to believe that you indeed have MS. Ask for an extra test to make sure this is MS and not a **** up from 10 years ago. It would be really stupid to risk getting Tysabri when not even having MS. Or maybe ask your neuro why she thinks you do have MS and ask for prove.

Hope this helped a bit

[RockysMom]

Thanks Dexter. I have had five neuro's say I have MS. Two are really top notch but I moved from their practice area. I've had over ten MRIs too showing 13 lesions. Like I said, oligoclonal bands were in my spinal tap. So I think I have MS but I think I have an inherited demyelinating disease too. I did talk to someone at Johns Hopkins about having that identified from the 126 known familial neuropathies but when I mentioned also having had neuro Lyme's, I got this look of astonishment and an 'oh well.'

I've since found info from virology sites which say there isn't any evidence of animal reservoirs for the JC virus and other human polyoma viruses. And also found that the viruses namesake could possibly have contracted it in Asia during military service in either Korea or Vietnam. I'm married to a Korean War baby so I'm betting we both have it.

However, my neuro did order a blood test for the JC titer which I will have on Monday.

Biogen says one third of people on Tysabri experience the dramatic recovery effect. I'm 50, so I'd guess it's the younger set who experience this. My neuro said I could take it for a year or so and then switch to something else.

Still, it's a very scary thought to take this with an almost 1 in 4 chance of getting PML, which is invariably fatal. I'm having less panic attacks about it now.

[RockysMom]

Talked to Tysabri

I called them because that I was interested in a mathematical/statistical analysis of the issues regarding taking this.

I got a lot of dates and numbers and I have a lot number so I still wanted to know but was not provided to me. As those are public information, I can obtain them but I think the more interesting gave it would be to compare recent versus early and the improvement since then. Recent patient reaction versus early patient reaction is what I mean.

I know I should probably just take it easy and take it and I will do that but it's not happening immediately anyway. Because I can't go get tested for JC until it's not raining anymore. And then the transportation back-and-forth for the actual treatment is going to be my usual huge consideration's for transportation.

So I'm cautiously guarded but I'm also seriously considering going ahead and taking this medicine. At least at this point.

[GGritz]

The percentage you quoted was much too high. That would be 20 out of 100. The number who get PML is determined by many factors. It's worth it for at least first 2 years. Their is also an index that is specific to each individual. Ask for the blood test!

[Remy9111]

You have your statistics messed up. 23% of people who get PML die (and you only get PML if you are JC virus positive). If 23% of people on Tysabri got PML they wouldn't let the drug stay on the market!

Get tested to see whether you are positive or negative for the JC virus. If you are negative you have a 1 in 10,000 chance of getting PML (if even). If you are positive ask you doctor about the other risk factors and the statistics.

Good luck.

[RockysMom]

Remy9111

I will call the company back and verify this statistic's label.

Wikipedia and many other sources say PML is invariably fatal.

I copied this from the official drug sheet from their website:

"TYSABRI increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems."

"usually leads to death or severe disability" is an either/or statement, either you die or you're severely disabled. It goes on to say there is no known cure or treatment for PML.

I'm going to have the titre, then we'll see. Even if I'm positive, I'm not ruling it out but I'll talk to the neuro more if that happens.

[KatieAgain]

I am the daughter of a Korean War Veteran. I am also retired military myself. I served in Korea and had the unfortunate experience of being knee-deep in human waste...twice!

If anyone could have gotten JCV from Military Service in Korea...it would be me. I am JCV-

Additionally, I went on Tysabri at the age of 50 a year ago and am one of those folks who have had a dramatic improvement. So age is not a factor. I did not react to any of the other drugs like I did Tysabri.

I have been around animals of all sorts my entire life...and one of them sleeps in bed with me. Still JCV-.

With all that said, PML is a very serious concern. It is something I personally would not want to survive and I have advanced medical orders in place in case I would get it.

Additionally...no drug is worth not being able to sleep at night. If you are significantly worried, there is a reason. I myself had to put the TY card in my back pocket and save it for another time because I was too scared. Nothing wrong with that.

TY is an exceptionally personal choice because of the dangers involved. It's a choice that only you can make, and hopefully you will be able to make a more informed decision based on some of the posts here.

Best of luck to you...I know you will do what is best for you.

[RockysMom]

Thank you katieagain. I don't want to think about this now, I'm going to have to think first about taking another exciting bumpy ride to the lab for the JC titer.

Today was bad with bad news of different kinds and I'm too depressed to think about dying from a killer cure. But thank you.

[Mable]

Additionally, I went on Tysabri at the age of 50 a year ago and am one of those folks who have had a dramatic improvement. So age is not a factor. I did not react to any of the other drugs like I did Tysabri.

Wow Katie, thanks for sharing this. I'm nearly 53 and doing okay but always a little off. I wondered if taking one of the highly aggressive therapies might ratchet me back to feeling closer to normal. I was guessing it would not because of my age. But maybe I was wrong.

I've been waiting for Lemtrada, but lately I've been thinking I can at least go find out what my JCV status is. Maybe I'll call my neuro next week. Thanks again.

[RockysMom]

Thank you KatieAgain

I didn't thank you enough for your input. I really do appreciate it, I just had some shocking bad news today and that plus the fact that I've only been out of the house a handful of times this year make me extremely sensitive to things. Negative things impact me so much more these days.

But frankly, Tysabri sounds just like something I've been dreaming about, fantasizing about being almost normal again.

I'm also concerned about the veil of misunderstanding there seems to be about this treatment. I will call the company again and ask them again the same questions that I asked before. I did poke around on the FDA website for info but there's so much on there, it would monopolize my time researching it. And then there's this other stuff I'm supposed to do in life besides be an MS patient.

My isolation from society is getting so hard. And yet, people usually cause me nothing but stress, and sadness. I have so much sadness all the time, I hope this Zoloft starts working soon.

[Myoak]

Tysabri Safety Information

http://www.tysabri.com/about/safety

Risk of PML
JCV negative PML risk is less than 1 in 1,000

JCV+ w/o prior immunosuppressant use:
1-24 months PML risk is <1/1,000
25-48 months PML risk is <3/1,000
49-72 months PML risk is <7/1,000

JCV+ with prior immunosuppressant use:
1-24 months PML risk is 1/1,000
25-48 months PML risk is 13/1,000
49-72 months PML risk is 7/1,000

Overall the risk of PML is far under 1%; not 23%. We really have to be careful that new people are not misinformed and alter treatment decisions based on incorrect information.

The JC virus has nothing to do with animals other than it is not found in plants. Between the ages of 1 and 5 approximately 10% of children are JCV+. By age 10 JCV can be observed in 40-60% of the population. It doesn’t matter if they are Korean, have pets, or are over age 50.

How well Tysabri works has nothing to do with age. Absolutely nothing.

Much of the information and speculation in this thread is tragically unfortunate. It is so wrong and misguided that it has been difficult to know where to begin in correcting it.

RockysMom, I would love to sit down with you and talk over these issues. You are inquisitive, searching and trying to find answers to inform your treatment decisions; that is all good. I hope you will sense my sincere concern for you, personally. I trust you will as I type this praying for your good health and well-being. I care about you. Because I care for you and other MSers I felt I should speak up about the PML issue on Tysabri.

You mentioned “an almost 1 in 4 chance of getting PML, which is invariably fatal”. No, you have nowhere near that risk. Please look at the info I copied above for your actual risk. Also, PML is not invariably fatal. If 23% die, 77% don’t, so it is not invariably fatal.

There have been approximately 114 people die from PML while on Tysabri out of over 120,000 who have taken it. Usually, Tysabri is infused every 4 weeks. So far, there have been no deaths from PML in those taking Tysabri at 5, 6, 7, or 8 week intervals.

Over 600 JCV+ MSers are being monitored at 6 MS Centers taking Tysabri between 4 weeks and 3 days to 8.5 weeks. So far, none have gotten PML. It is hoped that this technique, called dose extension, will diminish risk of PML. A few more months are need for this study to be confident of achieving statistical significance.

Advancements are being made in several areas… reducing PML risk, diagnosing PML earlier so it can be treated with good results, and techniques to discontinue Tysabri and not experience MS rebound.

Katie and I probably need to have a conversation about some of these. You are a dear, Katie. I appreciate you and you know that. There is no way I am not going to do everything I know to keep you healthy and well.

And, Mable, there are so many people on this site I would love to meet but you among the first. Your logic and demeanor are always beautiful.

But right now my concern is for you, RockysMom. I would not have you feel criticized or hurt by my response. All this will work out to everyone’s benefit so you have done a good thing by posting. I’m sure you are a remarkable person and a wonderful person to have a cup of coffee with. Thank you for posting. There are many, many people who care for you, girl, and deeply. Be encouraged, you are a delightful person.

We are all learning together.

Best.

[RockysMom]

Myoak

Thanks for your reply & no offense taken.

The numbers given to me by Tysabri over the phone are as follows:

129,291 worldwide taking Tysabri as of June 30, 2014

They could not find a total for the US or would not give it to me.

486 total worldwide had developed PML as of 8-5-14

154 of those PML cases were in the US.

23% as of 8-5-14 of cases (result in fatal PML)

8-92 doses received before PML developed.

So that means 77% of PML survivors are left severely disabled.

"TYSABRI increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability."

I wonder how many of those taking Tysabri had previously had neuro Lyme's.

Myoak I hope you don't mind my finding the numbers given to me over the phone by the manufacturer more informative than less than/greater than breakdowns which start making some people into fractions of a whole.

[Myoak]

Thank you, RockysMom.

You have included some good numbers to work with.
1% of the 129,291 people who have taken Tysabri equal 1292 people.

So if 1292 had gotten PML we could say the PML rate is 1%. But only 486 have gotten PML, therefore we can say the PML rate is far less than 1%, just as Biogen presents in their info.

I hope everyone understands that the PML rate is not 23%. If the rate was 23% then about 30,000 of the 129,291 would have PML, not 486.

The death rate from PML is 23%. So 486 PML cases x 23% = 112. In my post above I used Oct 2014 numbers of 495 PML cases worldwide and multiplied by 23% to arrive at 114 deaths.

I would like to address this statement… “So that means 77% of PML survivors are left severely disabled”. No, that is not correct. Some who had PML have recovered and have gone back to work. That is one of the points I felt important for Katie to understand. If someone gets PML all is not lost.

New methods of treatment are having success.
For example, at the recent MS conference in Boston a study was presented titled “Fifteen Non-Fatal Outcomes in Natalizumab-Associated PML/IRIS: The Effects of Early Diagnosis and Evolving Novel Therapies”.

Here are some of the points made…

MRI discovered asymptomatic PML in 4 patients. The other 11 were symptomatic. Different combinations of filgrastim, maraviroc, mitazepine, mefloquine, and corticords were used for treatment.

Patients #1 through 6 recovered in 5 to 9 weeks and all 6 have gone back to employment.

Patient #7 recovered in 8 weeks and went back to the same volunteer work as pre-PML.

Patient #8 is somewhat worse but is currently attending school.

Patients #9 through 15 are markedly worse; all are at home, 6 are listed as semi-dependent and 1 as dependent.

It remains true many die and many are severely disabled by PML; that is tragic. But it is not true that those who do not die are all severely disabled.

New diagnostic/treatment approaches to treating PML are making good progress as evidenced above. I am not trying to talk anyone into making a treatment decision. I am merely presenting science as information to those interested. We need good information and good understanding of that information to be helpful.

We all have learned there are no easy decisions with this disease. Each person is unique. Personalized medicine has arrived in MS, particularly.

You truly have my best wishes in whatever you and your doctor chose, RockysMom. I often say we assemble our information, consult our doctor and then make the best guess possible.

We will be traveling during the next week and I may not post until we return so if I fail to respond I trust you will understand.

Thanks again for posting.

[pennstater]

I just want to thank everyone for posting. Myoak, I really appreciate the numbers clarification. These are really close to what my neuro told me last time we had this discussion.

I started Tysabri at 48. I did not have, nor do I have a lot of physical disability now ay 51. I have the "invisible symptoms" problem. My MRIs were stable, but I was having relapses and starting to progress into more physical symptoms. Ty did stop the progression, which I am grateful for. But the sensory symptoms remain. I have decided to stay on Ty despite frequent infections as I feel it gives me the best shot.

It is a very personal decision for everyone. But it is really important to make sure we fully understand the risks of any drug, and then decide if those risks are tolerable for ourselves and our family.

Good luck to anyone considering any new therapy.