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Joined: Aug 14, 2006 Posts: 103 Location: So. Calif.
Posted: Sun Nov 18, 2007 3:49 pm Post subject: MS, Tysabri, and the low risk of PML...
Hi everyone,
I have some information I would like to pass on to those here that are contemplating Tysabri therapy from a treating neurologist friend of mine regarding Tysabri and possible rare risk of PML (some of his patients are on Tysabri, and some of them are on the older generation ABCRs). Take good care now...Lauren
Without becoming too long-winded or using too many medical terms, he wanted me to try and explain to other MS patients that are afraid of PML, and informed me of the following:
"What are early symptoms of PML? I've seen PML 10-12 times, the last time in 2005.
Cortical blindness - a homonymous quadrantopsia or hemianopsia (rare but not impossible in MS) not to be confused with monocular blindness (or decreased vision) from optic neuritis (very common in MS);
Apathy/apraxia or other cognitive or personality changes referrable to frontal lobe dysfunction (assuming PML is located in that distribution).... rare to occur in MS in a short period of time.
Progressive weakness or progressive numbness/clumsiness - although numbness is extremely common in MS and weakness is fairly common, in PML these symptoms would be progressing over weeks vs. a rapid onset with stability or improvement in MS. This distinction may not seem clear but is, in reality, very clear in clinical practice.
Can progressive symptoms happen in MS? Certainly, if a person has several small exacerbations, an appearance of steady progression over weeks can be seen. Can PPMS look like PML? Generally no, as PPMS shows steady progression over months to years, not weeks.
Incontinence - seen as PML progresses....if this is occurring, mid to late PML is more likely. In MS, this is more likely to be in an urgency/frequency phase for years before progressing.
So, as can be seen, MS typically does not have symptoms overlapping with PML. However, now and then symptoms in MS could be worrisome for PML. 6% is as good a number as any.
When that occurs in my Tysabri patients I am immediately getting a MRI (I've ordered 3 - last one ordered Thursday and personally reviewed yesterday after a SPMS with relapses patient (with a history of Novantrone use in past) had 2 weeks of extreme fatigue coupled with apathy and very poor concentration). This one was the only one I was worried about, the other two were done more to allay patient fears that their mild sensory changes might represent PML.
All 3 MRIs have shown no new lesions (I've also done a half dozen 'one year' MRIs with no new lesions or 1 or 2 small new recent lesions only).
MRIs of MS and PML is usually very easy to differentiate.... but some radiologists and neurologists have never seen PML.
There is also plasmapheresis (plasma exchange) which, from the PLEX studies, could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation, should the need arise.
My case in 2005 of PML (HIV related) was read as 'subacute strokes or inflammatory lesions' and I had to straighten out the radiologist. I tapped (performed a spinal tap on) the patient the same day and got PCR confirmation 4 business days later (PCR confirmation is a very long and drawn out explanation, which I won't go into now). His symptoms were pure motor and sensory with no frontal lobe or vision loss signs, and it turns out he was having a relapse only, no signs of PML, which were easily treated with a short course of steroids."
Lastly, he said that if any MS patient currently on Tysabri has rapidly worsening symptoms, they should immediately contact their own neurologist, and he hoped that the above information would help other MS patients in overcoming fears of the very rare PML in MS. _________________ Feel free to visit my Blog and leave me a comment, I'd love to hear from you!
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Thu Jan 17, 2008 3:58 pm Post subject:
Thanks Lauren for this information - I read it a while ago as well when I first got on this site. Tell me are you on Tysabri & if so how do you feel? Its coming to Australia in April & I have to say the PML is what is really bothering me. Your post made me think although very bad if you get it, your Neuro friend seems very up to date with it all.
Is this drug ok to be on for ever????does anyone know that?
I know the long term effects are not known (obviously), but how long has it been in other countries for?
Joined: Aug 14, 2006 Posts: 103 Location: So. Calif.
Posted: Fri Jan 18, 2008 2:19 pm Post subject:
Hi Murph,
You are most welcome for the information. You stated:
Quote:
Tell me are you on Tysabri & if so how do you feel?
I have been on Tysabri therapy since October 16, 2006 - after it was reintroduced. I have had 16 infusions of Tysabri, with my 17th due on Wednesday the 23rd. My MS is now stable and I have not had a relapse in over a year, nor have I had any disease progression.
Quote:
I have to say the PML is what is really bothering me.
Why? All drugs come with risks, including aspirin. Tysabri as a monotherapy (by itself) has not been linked to PML (see all posts referencing the New England Journal of Medicine which attributes PML to "diminished immunosurveillance") and the minimal risk has been placed at 0.1%. Furthermore, the Touch program screens out any MS patients that are severely immune compromised (a very low immune system), and prohibits Tysabri from being administered to such a patient until their immune system is strong again.
Actually, if you think about it, MS patients normally have a very high immune system which is why relapses occur. Also, Tysabri was just recently approved by the FDA on January 14, Monday, for moderate to severe Crohn's disease.
Quote:
Is this drug ok to be on for ever????does anyone know that?
The safety data for Tysabri only goes up to three years because the FDA halted the trial's temporarily. I have a friend that has had 60 infusions of Tysabri (she has been in the trials since April 2002), and has no intention of stopping the medication. She absolutely loves Tysabri, and so do I. Additionally, there are over 20,000 MS patients currently on Tysabri therapy, with more and more being added weekly. All interested MS patients should discuss Tysabri with their neurologist after researching information about it, and pose their questions to them.
Quote:
I know the long term effects are not known (obviously), but how long has it been in other countries for?
Tysabri has been available in the US since it was relaunched here in July, 2006. For information as to other countries, you could research that information by going to:
Joined: May 26, 2004 Posts: 1359 Location: London, ON, Canada
Posted: Sun Jan 20, 2008 9:57 am Post subject:
Quote:
Furthermore, the Touch program screens out any MS patients that are severely immune compromised (a very low immune system), and prohibits Tysabri from being administered to such a patient until their immune system is strong again.
Actually, if you think about it, MS patients normally have a very high immune system which is why relapses occur.
In theory, a patient who has an actively low immune system, should not suffer from as many MS exacerbations as one who has a highly active immune system. But nobody wants immune system activity to drop so low that the opportunistic JCV virus is allowed to multiply and attack the brain.
So the Touch program will not allow very low active immune system MS patients to use Tysabri until the patient's immune system is allowed to get much higher so we can possibly give them Tysabri and lower their immune system activity again.
And Drs Prineas and Barrett make a discovery a couple of years ago while performing an autopsy on a young MS patient who died from a very severe MS exacerbation and find no evidence of immune system activity in the damage to the patient's myelin. So the question now becomes what caused this severe MS attack. This of course has fueled the possibility that the root cause of MS attacking the myelin is not immune system related but the very attack on the patient's myelin causes the immune system to erroneously come to the myelin's aid and cause even further damage.
Makes you wonder if having a normal immune system (not too low or not too high) is better for the MS patient. Perhaps this is why LDN, which supposedly regulates the immune system, appears to stabilize the MS in many MS patients. As always, far too many questions and not enough answers when it comes to MS.
Joined: Aug 14, 2006 Posts: 103 Location: So. Calif.
Posted: Mon Jan 21, 2008 7:56 pm Post subject:
Hi Murph,
You asked:
Quote:
Does that mean the Touch Program or your Neuro will do tests on your immune system before you start Tysabri?...Did anyone who is on it - have tests for that before starting?
The Touch program here in the US requires MS patients have a baseline gadolinium (with dye) MRI of the brain prior to starting Tysabri therapy which is used as a reference to compare to any subsequent MRIs that the patient may require in the event their neurologist subsequently suspects PML in that patient.
For example: if a MS patient was previously on Novantrone, CellCept, Azathioprine, etc., the neurologist will probably wish to run a baseline blood test to make sure the patient's immune system is adequate enough (strong enough), including a brain MRI (The FDA indicates that a washout time from these drugs is approximately 3 to six months; with the ABCRs requiring an approximate washout time from two to four weeks).
I only had a baseline MRI of the brain prior to starting Tysabri therapy.
Hope this information helps,
Lauren _________________ Feel free to visit my Blog and leave me a comment, I'd love to hear from you!
Joined: Jul 12, 2005 Posts: 10 Location: Sydney, Australia
Posted: Wed Feb 06, 2008 4:23 pm Post subject:
Hi Murph
I am also in Australia - my neuro wants me to start Tysabri ASAP as my ability to walk is diminishing at a great speed. In addition to MRI's of brain & spine my neuro has me getting all sorts of bloods tests and a chest xray. I believe he is checking for any possible existing or previous virus that may be in my system ?
I go back to see him 14 Feb. He said he will time my walking without an aid .... I only have 2 speeds ..... snail & turtle !!!!!
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Fri Feb 08, 2008 10:48 pm Post subject:
Hi Smyelin,
I thought I responded to your post but cant seem to find it...oh well at the risk of repeating myslef...would love to here how you go on the 14th & do you know when exactly your Neuro will start you. I think they are still in the setting up satges here in Aus, waiting for Cabinet to sign off on the pricing etc.
My Neuro said to come back in March & see him and then we will get going with it, I was under the belief that it will be available in April for us Aussies!
Let me know how you go - good luck with it all.
Murph
Joined: Jul 12, 2005 Posts: 10 Location: Sydney, Australia
Posted: Sun Feb 10, 2008 4:23 pm Post subject:
Hi Murph
According to my neuro April 1st is the day (not sure if we should be worried about it being April Fools Day !!). A neuro has to complete a programme and be specially 'trained' in order to administer it, which many have already done.
I have sent you a pm, let me know if you don't get it because my pc was doing some strange things at the time
Smyelin
Last edited by smyelin on Tue Feb 12, 2008 8:52 pm; edited 2 times in total
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Mon Feb 11, 2008 8:06 pm Post subject:
Hi ya Smylin,
I did get your Pm and have replied - hope it worked cause did not even realise you could do that - bit slow on the uptake!!!!!
Best of luck & to all who are on/starting Tysbari, because I am sure there are many of us here in Australia who are a tadd concerned about going into a new area of treatment.
Lets keep updating & hopefully sharing support for all of us!
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Mon Feb 11, 2008 8:08 pm Post subject:
What makes it worse is there is the PM tabb down the bottom of every message you post...dahhhh. Oh dear, I am going to have some lunch and hope to grow some brain cells!!!!!!!
Joined: Jul 12, 2005 Posts: 10 Location: Sydney, Australia
Posted: Wed Mar 12, 2008 10:05 pm Post subject:
Hi Murph
I had my first infusion 6 Mar and it was very non eventful -I wish I had taken a good book to read ! I feel no different not worse, not better. The week before I had another relapse and now need my walking stick all the time - and the fatigue, sheesh well all I can say is it's exhausting being exhausted !
My neuro did tell me that whilst tysabri has been approved for PBS lisitng by the TGA the govt and biogen still need to reach agreement on $ - so the April date isn't set in concrete.
Joined: Dec 27, 2007 Posts: 29 Location: Australia
Posted: Sun Mar 16, 2008 5:23 pm Post subject:
Hi Smyelin,
Glad you got through your infusion ok, but sorry to hear about having another another relapse Its so frustrating this MS, so many things to think about with it.
Last week I went to an information session in Footscray, Victoria that the MS Society organised. They had a guest speaker, Professor Elliot Frohman, he is currently Professor of Neurology & Ophthamology and Director of the MS program at the University of Texas, USA. WOW he was awsome to listen to and I really found him to be one of the most interesting speaker's on MS I have ever heard. He was just such a wealth of information - too much to talk about now but he really gave some interesting insight to the research they are doing and how they are thinking that MS isnt something we have just got in our twenties - that we may have infact had it since chidlhood. Anyway thought if anyone is interestes they can Google him.
My Neuro appointment is on the 1st of April - so I will let you know what my Neuro say's about Tysabri and the costing side as well.
Take care and I hope after your next infusion you are feeling some benefit - do they say that it takes a few? I know it's different for everybody!
I just have to now concentrate on giving up smoking not just for obvious reasons, but I want to be free of any other crap in my body before I start with the Tysabri. Just hope I can do it, I am really gearing up to it but don't really trust myself because my moods are so bad at times that I just grab another cig! I wonder if they have any data on alcohol also with Tysabri. NOT that I drink all the time but I do like a few wines on a Friday night, and have wondered if they say you can drink with this medication????? Does anyone know?????
Anyway Smyelin take care and good luck with your next infusion - DON'T FORGET TO TAKE A BOOK!
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The week before I had another relapse and now need my walking stick all the time 
- and the fatigue, sheesh well all I can say is it's exhausting being exhausted !
Its so frustrating this MS, so many things to think about with it.