Whoops, I put a Tysabri thread in the wrong place:o It's re my 37th infusion :D

Polar, what good news:D very happy for you!!

Wiz, sleeping always helps and hope you can get that exercise "thang" together;)

Linda

...and I answered in the wrong place...:p

Either place, congrats and glad to hear things are working out because you truly are OUR trailblazer! :)

I had #15 yesterday. It's hard to believe I've been on Ty. for this long but it seems to be working wonderfully. Nothing much to report. Still had the 2 hour infusion followed by 1 hour of saline. I felt really crummy for only 24 hours. I'm now back and functioning. Not too bad! :)

Natalie, working wonderfully, how great :D
Happy for you !!
Linda

Wow Natalie! 15 months already? It seems like yesterday!:)

So do you feel as if the steps you took, ie. slowing the infusion, premedicating, etc. helps with the aftereffects you were having?

Glad to hear that you are pleased with the results! :hug:

I know! I can't believe it is #15. Time flies by quickly. Yes, I definitely think slowing down the infusion has helped significantly. The worst effects I ever got were when the old nurse ran the infusion over 45 minutes. I was sick as a dog in bed for 4-5 days--headache, muscle aches, nausea, flu-like stuff. The whole thing is so strange because in the beginning I didn't always have intense side effects--or at least not every infusion. And then some infusions are more tolerable than others but overall they are better since it has been slowed down. This time I drank a LOT of water and went in very hydrated. I think over time you start to figure out your body and its reaction to the drug, just like you (RW) had the pinpoint itching for awhile and came up with a solution.

I think more doctors should suggest slowing down the infusion if people are having any side effects. I was looking through the Tysabri site on www.thisisms.com and I was amazed at the number of people who have had issues -- nothing overwhelming but enough such that I wouldn't say all people going on Ty. should expect a free ride. Nausea, headaches, and dizziness/cog. fog for a few days seemed to be a problem, especially in the beginning months.

I have always been hyper sensitive to medications of all kinds. If I feel crummy for 1 or 2 days a month then it is worth it to me. I certainly couldn't tolerate the Rebif or Copaxone.

Have a good weekend everyone! :)

Welcome to the Tysabri group Mary Ann! :) :hug:

Today I had my 30th infusion, it went off without a hitch as usual. :) I came home and worked in my office and puttered in the garden and I feel great! :)

Welcome to Tysabri Mary Ann! Looking forward to hearing how you do! :)



Wiz! 30 ROCKS! I am #30 Thursday! Hard to believe we are that far along, huh? :hug: Yay for coming home and having a normal day!:D

Welcome to Tysabri Maryann ! Hope you will be at least as pleased with it as I am.!! This month will be 3 yrs for me-38 infusions :D
Linda

Welcome to Ty, Maryann!!! I hope it works for you as well as it has me..Still feel the same, but had great results according to my last MRI & assorted Neuro tests..
My next infusion (#6) is tomorrow. The only thing I don't care for is driving thru Twin Cities traffic..;)

Today I opened my email and found the monthly newsletter from Trevis Gleason and Everyday Health. There's a post from a man- Jim Pattee is his posting name- who is the husband of the woman from the US who died from PML in December of 2008 http://www.everydayhealth.com/blog/t...ple-sclerosis/

His wife is patient # 6 (the 3rd patient post re-introduction) on the Tysabri PML chart) http://pietynorwit.com/Tytable.htm

He has indicated his willingness to answer questions. I have left a few of my questions and thought maybe folks might want to ask some of your own or follow his answers.

Words cannot express my appreciation to him for being willing to discuss something that must be very painful for him, and to give us some insight as to what they went through. I look forward to hearing from him and thank him in advance for any answers he can give us.

Riverwild, I tried every which way to find the post from Jim Pattee with no such luck :o Any suggestions ?
Thanks,
Linda

Just click here: http://www.everydayhealth.com/blog/t...t_sort=0&nkr=1

This is page 2 and his post is the first post on the page. :)

Hi Maryann -- welcome to the Tysabri group! We're glad you are here and hope the treatment goes well. :)

Drum Roll Please...:D

30 infusions down!

Noproblems, no concerns, all my blood work came back great except for my Vit D panel, while the numbers are up, I have to increase another 1000 units, he wants to see higher numbers. He says I am still dehydrated and said DRINK MORE WATER! (imma gonna start leaking from my pores like a sprinkler!)

We discussed the latest news from Biogen (NONE! :mad:) and even though there are rumors of another PML case emanating from overseas, he had no information for me. I asked why and he said he didn't get a call back from the info line. I immediately sent an email when I got home, chewing them out for not responding and suggesting that they get on the stick and DO what they are supposed to do. Their guidance is that all news will come from your physician now.

When the doc doesn't GET the info, they can't answer the patient's concerns and I want INFORMATION. I reminded Biogen that they make a LOT of money from us and that we are NOT mushrooms and I don't want to be fed **** and kept in the dark.

I bet I get a response...:rolleyes: We shall seeeee...

Hope everyone is doing well! I am on the last few days of my vacation and plan to take advantage of my time and fix my leaking toilet! :p

Riverwild, great news on #30 :D As for Vit-D maybe try 10 min of sun evryday. How much you drinkin girl ?
As for Biogen :mad: and your e-mail...you go girl:hug:
Fixing a toilet doesn't sound like a vacation to me but hey-whatever "floats" your boat ;)
Linda

Yay for # 6!!! :)
Funny how you have to give permission to release info to you!
Don't you hate it when they say..."dismal"? My personal "dismal" was "too many to count" AAACK!

Glad it's going well for you!:hug:


"...Fixing a toilet doesn't sound like a vacation to me but hey-whatever "floats" your boat ;) Linda "

It wasn't. It still isn't fixed... everything is replaced, water gets turned on and oh looky! It leaks from EVERY bolt and gasket now! :mad:
I am nothing if not determined and I am GOING to repair this stoopid thing without paying someone if it takes me a month! Fortunately, toilets flush with buckets of water too! :p
( pre-Tysabri I would have had to pay someone! Now I have strength and energy, so I have to do it myself! :rolleyes:)

Twitter comments from an attendee at ECTRIMS PML Plenary Session
 

A few twitter comments from yesterdays ECTRIMS PML Plenary Session

http://twitter.com/neurologique

Plenary: Natalizumab treated patients who get PML have very low CD 4+ T cells and dendritic cells. Antigen presenting cells are depleted.

Plenary: The MRIs from the first post-marketing German PML patient was released yesterday and shown at plenary on PML.

Plenary:… Reduced iATP is more sensitive for detecting those at risk for PML and opportunistic infections (better than CD4).

Plenary:..Question was: iATP (intracellular ATP) is nonspecific and wide dispersion even in healthy individuals.

Plenary:…Answer:Agrees-doesn’t explain PML but is independant of CD4 count.

RW-- thanks for given Biogen hell!!! Maybe if we stay on them we will get info but it is shameless they blew off your doctor. I have an appointment with my neuro next week so I will ask her what she has heard, if anything. How much Vitamin D are you taking? Just curious. I am taking 4,000 a day (for about 5 months now) and plan to ask for a Vitamin D test when I go in just to see where I am at now.

Does anyone know anything about this CD4 T cell testing? Someone on another forum recently was talking about neuros doing this test now to watch for PML, and if the numbers got too low they were yanking the people off of Tysabri. I had never heard of this.

Based on the plenary info I linked to above, iATP was identified as a more sensitive test for identifying those most at risk for PML.

Right, I get that the latter test is more sensitive but i wanted to know if this is something neuros are testing for in their office now or is this only preliminary scientific testing? Someone on this other forum claimed it was even part of the Touch protocol which I know isn't true. But are neuros starting to do this test in their practice ?

Natalie,

I would call your neuro and make sure that he/she knows you want the info when you see him/her, to give them time to get the info. I called my neuro a week previous to my appointment and still didn't get it, so more time may help you to get the info.

I don't know much about the testing, since this just came out at ECTRIMS and I haven't had a chance to read yet. Once I digest the info I will write down my questions for my neuro and call back for answers to that AND the other info on new cases of PML.

(I REALLY hate this sutdown on info from Biogen...:mad: I hate that it's entirely possible that the only info we may get may come from their quarterly report to their freakin' investors!)

There is a test for iATP available commercially called ImmuKnow. As far as guidance on what to test for, etc, I think Biogen wants to provide the info to the scientific community for info/feedback before recommending what should be tested/how often, etc.

After being off Tysabri for 14 weeks due to shingles, colds and sore throats I was finally able to receive my infusion last Friday. I can't remember if it was my 25th or 26th....LOL While I was off Tysabri I noticed that I was getting weaker and beginning to lose my sense of balance. But, I must admit I have mixed emotions about being on Tysabri. I love what it has done to improve my quality of life. But, I do worry about PML......especially now that Biogen is less co-operative about disclosing new cases.

According to the Wall Street Journal this morning there have been 2 new cases of PML in the EU since Biogen stopped posting new cases in July. Biogen will not comment or confirm the new cases. I think it would be in Biogen's best interest to keep patients informed. Obviously, Biogen does not agree.

Ignorance is not bliss!!!!!!!! The stress of worrying about PML is not in the best interest of any MSer who is taking Tysabri. I wish I wasn't such a worry wart. Tysabri has gotten me out of a wheelchair and walking again. I'm able to play and run with my grandchildren again. Although I've never been athletic I'm able to participate in sports with them....they know to be careful because Grandma gets injured easily ;) But, PML is always in my mind.

Thamks for updating Shayna! :) It sounds like you have had a bad go of it lately and I hope that all the garbage is cleared up and you can go forward without any more illness!

As far as the PML rearing it's ugly head and no updates from Biogen, it seems that they cannot keep the news down even if they won't report to us, the patients who keep them going.

This is what a google on the subject brings up today. It seems there may have been one or two more cases since Biogen started treating us like mushrooms:

http://news.google.com/news?q=Two+ne...title&resnum=1

This is an updated chart from Pit (the husband of a PML patient overseas who blogs about his wife's experience): http://chefarztfrau.de/?page_id=716

I still haven't received any info as requested from my neuro yet, but I had a long day after working all night and did not call today like I was supposed to...(sorry for that-we're in winter prep mode here and had six cords of wood delivered and room had to be made in the yard to hold the pile! :(...it's too early!!! What happened to summer?)

I am still taking heart from the fact that despite whatever cases are rumored to have been found, that the rate of PML still appears to be below the 1:1000 threshold, and there are a LOT of us who have been on Tysabri for a long time without any signs of PML and that the benefit, for me, outweighs the risk.

Hope everyone's doing well!:grouphug:

Youtube video of a Dr reporting from ECTRIMS 2009 on the PML plenary session

http://www.youtube.com/watch?v=t7GkwSRXpXk

Riverwild, you are amazing with all the info you find :D Thank you !!!!

komokazi, I have tried to follow what you are posting but I just don't understand :o and I don't even know what plenary is :o:o

Linda

Grammie 2 3, plenary means comprehensive.....including all or everything....on a subject. I hope that helps a bit :)

Just scientific lingo for a big meeting to discuss. The good news is that the scientists are discussing the risk factor information compiled to date from the PML cases and appear to have two possible areas for testing - CD4 numbers and iATP. The key to these discussions is to test the ideas for scientific robustness so they don't end up with a test that's actually a red herring (produces false positives or doesn't identify those at risk).

I e-mailed the NIH (Dr Major's ofice (NEJM commentary) to ask about his 12 PML case article verus the Dow Jones 13 PML case article - Is Dow Jones incorrect? Will post what I find out.

Chris

Shayna, thank you :)
Chris you have now, along with Riverwild, become my hero !! I so appreciate how informed you are and how you try to keep us informed ;)
Thank you :hug:
Linda

FDA confirmed 13 PML cases today, 9 in Europe, 4 in US
 

Reiterated no changes to the label.

More on the FDA Update:

http://www.fda.gov/Drugs/DrugSafety/.../ucm107198.htm

The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease.
The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri.
The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.

Good link to save to favorites. Previous updates are listed here too.

I wonder why no one being treated for Crohns disease has gotten PML. Maybe the numbers are just lower in terms of total taking drug? I see my neurologist tomorrow. I have plenty of questions to ask about Ty and PML. I'll let you know what I find out. I'm curious to know what she thinks of the CCSVI theory. Enjoy the day! :)

RW: Thanks for the extremely useful information. I guess the aren't willing to or can't speculate on the risk above 24 months? What do you think?

I know of one Crohn's patient from Belgian that got PML while on Tysabri and unfortunately died.

He had been involved in the Tysabri clinical trials with Crohn's but was on the placebo. Months later, he was given the actual drug and within 6 infusions, became very sick and died quickly. His initial cause of death was attributed to a brain tumour but subsequent investigation changed that to PML.

Biogen stated that he got PML because he had taken two different kinds of immusuppressants prior to using Tysabri but his family stated that those drugs had been stopped 8 months earlier and the patient was in good health other than from the symptoms of Crohn's.

I'm not sure if there is any other recorded incident of PML with Crohn's patients using Tysabri since that time.

Harry

Harry, that case I am aware of. I should have been more specific and noted I was asking about cases that occured post clinical trials. I just assumed from the content of the article it was clear what we were talking about. Thanks anyway.

Sorry so late to answer this! I've been working...:rolleyes:

I think that I heard that Elan dismissed their Crohn's sales team. I do know that a lot of the gastro docs/rheumatologists are as conservative as a lot of neuros are.

In addition, many docs move to stronger drugs and a lot of those drugs may be contraindicated before Tysabri. They may feel the risk is not worth it when it comes to prescribing Tysabri. We may see more Tysabri use sooner (before stronger drugs used for Crohn's are used) as younger docs come up through the ranks.

I also think that as with any new drug, a lot of docs wait to see what happens with others using the new drugs before they prescribe.

I don't hear much news on Crohns disease and use of Tysabri, but I am not usually looking for it either. I am sure that it's out there, maybe they aren't as vocal as we are? :D

As far as the speculation on the risk above 24 months use, I believe they use data from studies being conducted on people who are enrolled in the STRATA and the TYGRIS trials, which follows people on Tysabri for MS. I didn't join the STRATA or TYGRIS trials because it wasn't offered to me, I think it had to do with where you go for treatment and I am in a very rural area without the researchers available, and there were certain requirements that had to be met to be in the trials.

Hope everyone is doing well! :)
I am as usual-working too much and trying to get ready for winter before it gets here to Maine!