Tysabri

[Owenh]

Does anybody have any experience with Tysabri? I just tested positive for the JC virus and my doc still wants to put me on it for 6 months. He says that the risk of getting the brain infection is very low since I will only be on it for a short period of time. My other option is to go on Gilenya, I am not sure what to do.

[Lulu54]

Gilenya has good points too - the most important thing is you are on a therapy and doing something to slow down your MS.  Making a decision has to feel good, L

[Owenh]

Thank you all so much for your feedback, it was really helpful. I decided to go with Gilenya for now. I am not ruling out Tysabri but right now I am just not ready to take the risk even if it is minor. I know I would be constantly worrying and driving myself my nuts if I woke up feeling slightly different.

[rendean]

Sorry for all the typos! My vision is blurry and I did  a poor job proof -reading. If there are any questions regarding what I wrote please feel free to ask.

Laura's print-out is very informative. My clinic tests for the JC virus every 3 months due to the chance of sero-conversion due to the lowered immune system caued by Tysabri. The remaining MRI recommendations are similar at my facility.

Ren

[kwarendorf]

My doc is pretty serious when it comes to PML. I have annual JCV antibody tests, plus LP and MRI monitoring. Had the blood test last week (results unknown) and the LP and MRI in 2 weeks, I had my 15th infusion yesterday.

Kyle

[JJLL]

My wife tested JCV+ at about the time of her 48th infusion.  We discussed her options with her neuro and decided to stay with Tysabri because she had done so well with it.  The neuro had one patient who had developed PML.  He admitted her to the hospital and had plasmapheresis done on her.  She recovered with minimal neurological damage.  My wife will have her 64th infusion tomorrow.

[Lulu54]

No firestorm, Sarah, just trying to get all the facts straight so the decision made can be an informed one.  The information I shared here is directly from the printout I got from the Neurologist. The decision to start Tysabri can be a scarey one, whether we are JC postive or negative, there is something intimidating about starting a black-box drug. I know most of us here who are taking tysabri wrestled with these same questions and concerns.

-L

[SarahL2491]

I certainly did not intend to create a "firestorm" with my comments but do hope the one asking the original question obtained some useful information among our exchanges!

[Lulu54]

Sorry, I have to jump in and correct something - PML is no longer always fatal but it used to be that way.  There are now treatments for PML but contracting it will almost always leave the person with new neurological deficits.

I am on Tysabri and each time I see my doctor or the MS nurse, they include the latest PML statistics - here is what I had from the last time I saw the neuro in October and is full of good information to base your decision upon -

" it might be of interest for you to see in entirety what I get from my MSologist each checkup regarding Tysabri-

"1. We reviewed the risks of Tysabri, including a potentially fatal infection (PML). We discussed recent data suggesting the risk of PML is likely increased with:

1) exposure to JC virus
2 time on drug (longer than 2 years)
3) prior exposure to immunosuppression

As of 10/2012 there have been a total of ~305 cased of PML to date and about ~108,300 patients exposed to Tysabri to date.  Only 54 cases occurred during the 1st twelve infusions.  Roughly 21% of the cases were fatal.  Only ~20% were able to return to work after treatment. The current PML estimated risk stratification is as follows:

Patient with JCV antibody NEGATIVE status: _<0.11/1000

Patient with JCV antibody positive status: (my note this is in a boxed table - which I can't do in this program)

JCV antibody positive              Months 1-24                              Months 25-48

NO prior
immunosuppression                    <1/1000                                         4/1000

YES prior
immunosuppresion                         2/1000                                      11/1000

she expresses understanding of these risks and is JCV antibody NEGATIVE

2. For patients on Natalizumab, I will depend on her referring doctors to facilitate a yearly skin exam

3.  We will moniotor LFTs with biyearly labs

4. In all JHCV antibody negative patients, we will montor for seroconversion with biyearly JCV
antibody testing.  All patients that seroconvert will meet with us in clinic to discuss the change in risk profile BEFORE their next Natalizumab infusions.

5. In JCV antibody negative patients, we will obtain annual MRI scans.

6. In JCV antibody positive patients, we will obtain biyearly MRI scans.

7.  If symptoms of PML were identified I will recommend:

    1. Stopping Natalizumab
    2.  Sending CSF for JCV PCR
    3. Rechecking an MRI scan for concerning lesions.

8.  If she were to be found to have PML I would reccomend inpatient hospital admission for 7 total plasma exchanges (done every other day) and high dose steroids to help stave off IRIS."

Good luck in making this decision.
Laura

[debgen]

Hi Owen,

Welcome to our forum!

About 6 months ago I needed to be taken off of Copaxone and it was suggested that I switch to Tysabri but when I tested JC+ I decided not to go on it. I did a lot of research, discussed it on this forum an ultimately decided that it was too risky for me. I have decided to use Gilenya instead which I finally stated about 3 weeks ago.

It is always a personal decision between you, your doctor and your family to choose the DMD. I wish you good luck and good health!

Deb

[rendean]

Dear Owenh,

Hi and welcome! You've reached a great site with lots of info and plenty of experience from MS  sufferers.

I am currently using Tysabri and and had dose 16, 2 days ago. There was confusion about my JC status for a while because of the number of false negatives associated with the test, however, unfortunately that isn't the same with positive results. If you test positive you will always remain postive. Negeative results can change upon exposure to the virus due to community contact and/or the decrease in the immune system allowing the JC virus to becme active.

Taing Tysabri whie positive is a risk but so is having  a devastting relapse. I am on oit due rough relapses and still had a rough rleapse in October with a 7 day stay in the ICU and remaing defiects tht are solwly improving(yay!!!).

I may be switched to BG-!@ in the spring when it is release since i has a different mechanism of action than any other of the DMDs at this point.

The Tysabri website has an excllent presentation on the risks and facts associtated with Tysabari.  The link is :

http://www.tysabri.com/pml-risk.xml#test-results

I wish you luck wit this difficult decisin. to me, the trust in my doctor would play a important factor in my decision. yysabri does have the highest rate %  on average of.stopping relapses with it's average at 67% compared to 30% with the other DMDs.

each case of MS is different just like each snowflake is different. If you have trust in your doctor and he thinks this is the best for you for now, then go with it AFTER you read the facts. The  link I gave you is pretty straight forward.Unfortunately this  is a personal decision.

I do believe we have a JC poitive member who has had many infusions with Tysabari and has done well . Hopefully, she'll pop i and comment for you.

Good luck! Come back with ANY questions you may have and we will do our best to get you an answer!!!

Cordially,
Ren

[SarahL2491]

I have sent you a PM with details concerning the site you referenced!

[SarahL2491]

yes, PML is fatal, always.

I got my information from the Tysabri official website.

Although those numbers may/may not be correct, you need to look at what these people were on, medication wise.  This is important.

My theory is that "there is no free ride" regardless of what drug you go on for what condition you might have.  You can also call Tysabri at their toll free number and talk with them without being a patient.  Their number is on the webside.

Hope this helps

[Owenh]

Thanks for you feedback, I think I am probably going to try it.
The plan is to have me on Tysabri for 6 months and then hopefully switch to BG12 if it is released. By the way, where did you get your info about the number of PML cases? The website I found had the information below.

http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/3563

"August 2012 Tysabri PML update that was made available to physicians:

As of August 1, 2012, there have been 271 PML cases, of which 162 have been in the European Economic Area (EEA), 97 in the US and 12 in rest of world (ROW).

As of August 1, 2012, 59 of the 271 patients with PML have died"

[SarahL2491]

I have been on Tysabri since last February and I tested positive prior to going on it.  

Tysabri has a wonderful support service and is very, very tightly regulated.  They take it very seriously.  If you go to their website and look at the product information page, the rate of infection is so low its funny.

NO one has gotten PML from it since it has been brought back, IF they are only on ONE DMD drug.  In fact, if you are on another, they won't let you into the program.

Why is he only putting you on it for 6 months?  You need to stay on it for the protection.  I can't understand the "temporary" protection.  You should ask him for his rationale.

I was offered Gilenya when I had problems with Tysabri (which turned out to be something other than Tysabri that caused it) and after reading the cardiac warnings and other side effects, chose not to take it.

Tysabri has a wonderful financial support program.  They fully donated my first 4 months of Tysabri until I could get an insurance program in place.
Tysabri is considered an "outpatient" procedure and under my insurance, is paid for now at 100%.

Do give it a try, I think you will like only having to deal with it once eery 28 days!