Can anyone explain to me what the Tysabri rash, and/or PML rash?

[GladImSaved]

I would like some information/details from anyone who has had (or seen) the rash you can get from Tysabril and/or PML??  I have been on Tysabri 10 years so far without any major issues. I was outside after my treatment for 10 minutes or so.  After taking my shirt off, my husband gasped and asked what was wrong with my back.  I had no clue, checked in the mirror, and I had approx 20 bumps across my back that are big enough for bug bites, but my shirt was on, so why wouldn't my exposed skin have these instead of my back??

Thank you for any help you can give!!!!!!!  :-)

[AMO]

thanks   you both     for finding thiis link and posting.

it is very concise and esy to understand,  It makes it very clear.  I like the one slide reading at a time! Too many of the articles can be difficult    dissecting them .

I  encourage anyone looking for the up to this date statis and numbers  on Tysabri tto take time to copy, paste and read!
amo

[Cosmobirdy]

That's the slide presentation I was referring to ... :-).  I think it's great because it is concise and very informative.  I found it through my Google Alert too!  I've found some great sites with that.

Rita

[0485c10]

Hi All,

My tysabri alerts picked up this post of Tysabri and Rash, so i stopped by to read thread and as always with tysabri threads risk comes into the discussion.
My tysabri alerts also picked up this presentation on risk stratification--so i thought its a match, i was suppose to put a link to this presentation here.

Enjoy..

Duration of Tysasbri before PML diagnosis range from 8 to 71 doses
July 2012 shown at Barts Health NHS Trust(London,Britian)

http://www.slideshare.net/gavingiovannoni/tysabri-safety-and-pml-risk-stratification-ty-pan0463q-august

[Cosmobirdy]

Actually, the deaths I'm referring to are not necessarily new.  I am referring to the total deaths that have occurred among the confirmed cases of PML in patients who have used Tysabri since it became available for prescription in July 2006.

The National Multiple Sclerosis Society website has an Update on Tysabri and PML as of August 15, 2012.  This gives the total number of confirmed PML cases since July 2006, as well as how many of these patients have died.  (In truth, these are actually the numbers as of July 3, 2012.)

This update also states that on August 15, 2012 the prescribing information for Tysabri was changed, recommending that patients who have tested negative for the JC virus should be retested every 6 months.

The Multiple Sclerosis Resource Centre website ( a British site) has the number of PML cases and deaths as of August 1, 2012.  I have found that this site and a German site seem to always have the most current information.

Bear in mind, these are the confirmed cases of PML and deaths among everyone who has used Tysabri since July 2006.  There are cases from the United States, the European Economic Area and the rest of the world.  

Rita

[SarahL2491]

thanks Rita, well done, I did not know about the new deaths, will talk to Tysabri at next dinner in my state!  I also plan on staying on it as long as my neuro will allow it.

[Lulu54]

thanks, Rita, for jumping in here and sharing your knowledge and personal experience with Tysabri  - so much of this can be confusing and as always you do a great job of making it make sense.

hugs, L

[rendean]

Well done Rita, thank you!!!

Ren

[Cosmobirdy]

When Tysabri first came on the market after clinical trials, there were 3 deaths from PML and it was pulled from the market.  All 3 patients had been on one of the first line DMDs while they were also taking Tysabri.  The thought at the time was that if patients took Tysabri alone, PML would not be an issue.  Tysabri was re-released to the market, but with strict conditions and monitoring requirements, known as the TOUCH program.

Unfortunately, that has not proven to be true.  There have since been cases of PML as well as some deaths in patients who were taking only Tysabri at the time.  When I started Tysabri in 2008, the estimated risk of PML was 1 in 1000.  They knew being JC positive was a risk factor, but there was no test for it at the time.  Most estimates I've seen are that approx. 50-60% of ALL people carry the JC virus, as it is actually very common.

In the time I have been taking Tysabri, they have obtained much more data, as more and more people began taking Tysabri and staying on it longer.  The JC virus test has been very helpful, allowing people who are negative to go on Tysabri with much less worry of PML, as well as giving people who test positive a better idea of the risks and allowing them to make more informed choices and decisions.

At this time, they have identified 3 main risk factors for PML while on Tysabri:
1.  Being positive for the JC virus
2.  Being on Tysabri longer than 24 months
3.  Use of immunosuppressant meds prior to starting Tysabri -
this does NOT include the prior use of any of the DMDs/CRAB meds, such as Copaxone, Rebif, Avonex, and Betaseron.  These meds are immunomodulators, not immunosuppressants.  The meds that increase the risk of PML are things like methotrexate, mitoxantrone, azathioprine, cyclophosphamide and micophenolate.  I'm sure there may be others as well.

Knowing these risk factors has enabled doctors to better stratify the risk of PML, based on which, if any, risk factors they have.  For people who are JC negative, the current risk assessment is less than 1 in 11,000.  The risks jump up from there, depending on the circumstances.  It is recommended that people who test negative for the JC virus should be re-tested - some say every 6 months while on Tysabri, some say yearly.  This is because a person who is negative can later be exposed to the JC virus since it is so common, and then become JC positive.

I'm certainly no expert on all this, I've just been reading about it for a long time, and trying to understand and sort out the information so I can make the best decisions for me.  Each of us is different, and there are no right or wrong choices.  If I've gotten any of this wrong, I apologize, and please feel free to correct me so I can learn more.  I am by no means trying to scare or alarm anyone - just trying to help others sort some of this out.  I remember how overwhelming it was when I was having to make the decision about Tysabri and figure out the most realistic risk/benefit scenario for my particular situation.

For those that are interested, there are a few sites that post the monthly stats on PML.  There is also a site I just found a couple of days ago, that is a slide presentation with a lot of tables and graphs and information regarding Tysabri and PML that is very good and concise.  

I am so grateful for this forum ... I have received so much support over the years, and I have learned so much ....:-)

Rita

[GladImSaved]

I hope you realize I wasn't trying to 'panic' anyone for any reason.  I simply said that I am at the 'highest risk' for PML, cause I've HAVE had other meds for MS than just Tysabri in the past.  I HAVE tested positive for JCV and I've been on Tysabri for over 3 years.  Those are the facts.

For someone who HAS been on other MS drugs in the past and now they're considering Tysabri, it'd be a good idea for them to get the blood test for JCV to see if it's positive or not.  If it's not, super.  If so, then they need to be aware of that in order to make an informed decision.  

I don't know what the statistics as to what 'highest risk' is, nor do I want to. I'm not going to stop taking Tysabri, and I'm not going to let 'risks' stop me from living my life.  I look at it as the 'highest risk' may be 3 in 10000, rather than 1 in 10000 for getting PML.  That's how I see it in my mind.

[SarahL2491]

and I will repeat AGAIN.........NO ONE has died who is on ONLY Tysabri......

all deaths were from people on multiple MS drugs.............so don't panic, guys........

My neuro and several other docs told me that more than 50% of people are JC+ and will never realize it because we are one of the few groups concerned with it.  I asked if I had picked it up in hospital work and they said probably not, you can get it from anywhere........

I asked then if JC+ was a really big issue and was told that as long as I was ONLY on ONE MS drug (Ty in this instance) my chances were low in getting PML...........

Tysabri, in my case, is my first MS drug......I have used no other....

I hope your rash goes away, to the poster of the original thread, I somehow don't think its Tysabri related, I'm leaning towards internal shingles or something on that order.  I agree with Rita, sun sensitivity seems to be an issue for some.....

Best of luck!

[GladImSaved]

Thank you all for your helpful information!!!  I got my treatment hours before the bumps were noticed.  Were they there before my treatment...I don't know (I don't look at my back!!LOL).  Were they there before I went out in that yard...I don't know!!!  It's a mystery!!!

I emailed my neuro, as he's an hour drive away, and I am not able to drive anymore.  He didn't seem too concerned, said he'd look into the rashes of Tysabri, and if they were still there on Monday, I need to see him.  I love my neuro, so I don't feel as if he were just blowing me off.

Tysabri's phone number...didn't even realize it!!!  I took pictures on my phone of it, but I can't find the right cord I use to load them onto the computer.  So...........I do not know.

Thank you all again for being so kind to me!!

Rita, when Tysabri first came onto the market it was on for a year, then they pulled it cause of the deaths of some people.  I went on it once it came back on the market for the second time.  That's heading towards 11 years I'm pretty sure!!!

A few months ago, I found out I DO have JCV.....swell!!!!! (ha ha)  So because of that, I've been on Tysabri for more than a few years, and I had taken Avonex before....he said I am now in the highest risk for getting PML.  

So to anyone who is THINKING about Tysabri, this should be your last resource of treatments to use.  Also, PLEASE get tested for JCV BEFORE yiou start on Tysabri, and THEN make your decision!!  :-)

[Cosmobirdy]

I have been on Tysabri since 2008, but have never experienced a rash like that.  I am MUCH more sensitive to the sun in general since I started Tysabri, and will usually get a rash on exposed skin after a very short time, even with strong sunscreen - but the rash I get is very small red bumps and very itchy.  

Have you ever had anything like this before?  Are you having any other signs of an allergic reaction?  When was your last infusion?  Sarah's suggestions to call your neuro, as well as Tysabri's 800 number are the same things I would start with.  Have you talked to anyone about this yet?  

So have you been on Ty since clinical trials?  Ten years is a very long time - do you know if you are JC positive or not?  As far as PML, I am not aware of an associated rash, but I'm certainly no expert ... :-).

Please let us know how you are doing, and if Tysabri caused this for you.  I hope you are feeling much better already...

Rita

[SarahL2491]

have you called Tysabri's 800 number?
I have found them to be a wealth of information about Tysabri
If you indeed have a rash that is related to the drug, then they have to
file a report with the FDA so it can be added to the collection of information
available to patients.

What does your neuro say?

[sllowe]

Hi there, so sorry you post slipped to the bottom of the page!

I have not seen it, but we do have Tysabri users on  the forum who have been on it for years. I'll bump this, and then hit up one of our veteran members to see if she can help!

-shell