Tysabri Information and Check In part 2
 

Part two, resume your conversation. :)

:I-Agree::Thanx::highfive::Bow:

Wheeeee!:yahoo:

We've come a LONG way! :grouphug:

Onwards and Upwards!

:rocket::BeamUp::Boy(angel-flying)::Girl(angel-flying):

Biogen reports another case of PML.

http://investor.biogenidec.com/phoen...82&p=irol-TPME

Click on view PDF.

31 infusions, not in US (ex US)

I haven't found any further info yet. I'll post when I know more.

o and polar, i am calling you right after school on monday to hear all about it! i hope it goes well! love you! :hug:

Latest PML case probably another German patient making them 4 of the 6 cases reported
 

Update from German blog of the husband of the Feb 10 PML case


Pit:, 02:30 ..am, (( for newbies: Pit`s wife is one of the pml cases - Feb 09 - ))

"Hello all,
Since the 15th of Apr., the 6 th case of pml - after 31 months - is listed in the Ty-update.
Again, ex-USA, and I bet , again a case in Germany..
Next week I shall clarify this.
If this is the case - then we would have 4 pml cases out of 6 being from Germany.
People, that is no coincidence, like they want to make us believe.

The federal committee has issued a drug policy with reference to Ty, in mid Oct 2008.

http://www.g-ba.de/downloads/39-261-...zumab_BAnz.pdf

Other reasons why this latest case is probably from Germany
 

The patient had been on Tysabri for 31 months (almost 3 years). Tysabri was not approved in the EU until Jul 2006. Most countries in the EU except Germany and the UK have long reimbursement application processes (6 months or longer). The UK has local reimbursement application processes. Therefore it is highly likely this latest case in the 4th PML case from a German patient.

As a US Tysabri patient, this sure makes me feel more confident that the TOUCH program is providing an extra measure of safety.

Sorry for the long post - thought some may appreciate the update on PML #5 patient from her husband who should be sainted as he's just gone through this PML experience, setting up/preparing for her rehabilitation, dealing with uncovered medical expenses, and he's worried about making sure other MS patients on Tysabri receive proper preventative measures. My important takeaway is that she had new symptoms which she wrote off as MS. TYsabri patients need to be cognizant of new sypmtoms and suspect PML first until confirmed as just new MS symptoms.

Infusion #1 done and history, no problems, no need for Benedryl or Epinephrine, drove home in nasty Twin Cities road construction traffic, stopped at Lil' Oscars for dinner on the way home..Everything went great (yay!)..Love you, too, SK!:hug:

Yeaaaaaaa, Polar, Congrats...I hope this is your magic bullet..:hug:

33rd Infusion
 

Just got back from my 33rd infusion:D YEA Ty!! Holding my improvements, progression halted and good MRIs. :D:D
Linda

I am new to this forum. I am here because I need some advice from other patients. I was diagnosed with MS in October of 1993. I still work full-time, and most people don't even know I have it, but I am having some problems that are really starting to affect my quality of life. My two major problems are double vision, and a weak right leg (I can walk about half a mile before it gives out). I have had double vision for 4 years now, and my only relief from it is prism glasses, but apparently if you wear those too long, the eyes shift and adapt, causing some additional problems, so I wear them as little as possible. The double vision has become worse lately, though, and I am now considering looking into eye surgery, or getting on Tysabri (I have been on everything else that's out there, and am currently on Rebif). I can't find enough information, though, that will let me know if Tysabri can help the double vision to go away. Did any Tysabri users on here have double vision before starting the treatment and, if so, did the double vision problem improve at all after starting the treatment? Thanks for any help you can provide!

I had a mild double vision from a prior relapse when I started Tysabri 2+ years ago. The double vision has improved to the point that it is almost gone.

I had ongoing double vision after a relapse that lasted until I was on Tysabri. I also had nystagmus and couldn't control my eye movement.

After 6 months of Tysabri I had an eye exam and my vision was back to pre-diagnosis level. The opthalmologist was amazed and asked what I was on for treatment.

It's been 25 infusions now and my vision has remained at pre-diagnosis level.

Tysabri and vision:

http://nationalmssociety.org/news/ne...x.aspx?nid=134

#25 down! :yahoo:

No problems, no concerns.:D

(i'm sooooo boring...:p )

sorry posted this in the wrong thread so yeah you are not seeing double if you read this elsewhere

hey folks, I am going to have a blood test or two and give it a try, i have read most of the pml's where in europe another factor that i was given by Nero the neuro is that 5 of them had chemo in the year or two prior to tys,

yeah im scare sh less keep reading this stuff and dont know what to make of it, but like he said with the way its progressing its tys or rebif he seriously thinks a b and c are just going to treat me the same, i have had 6 new lesions in 8 months and 2 that may of been hidden before or just not caught at last time and or 8 new lesions , either way copaxone isnt working or at least it kept my lesions to 6-8 instead of 15 ya know,

i am confused been reading a lot on line spent most of the day reading yesterday, sure wish i knew if this is right. Deb and I and nero the neuro sat in his office for an hour and half the other day, talking all aspects of this over and over finally deb said ok doc franks your son put him on meds he said without a doubt it would be tys if his kid had what i got going on, and he wont change the classification from rrms to spms cause of the insurance company. but he agreed its spms its going too fast losing left leg usage my eye my hand and now its attacking my right side too, so i am confused and as always the more i read the worse it gets lol

any advice would be greatly appreciated and i plan on reading this whole thread this weekend, i have been warned i also did a lot of soul searching and looking up reports of these pml or plm cases, just wish they could figure out why if its this bug that hides in, was it the kidneys? or if it is a fact of chemo treatments interacting with tys.... sorry if this turned into a hijack i figure this would be best place for this if ya want pm me or mail me your views i will read this to get some of your views, i know if i dont try something real soon i will be using a chair on a reg basis, and if there is a chance to halt this or stem the progress a yr or two b4 chair time guess thats good, not sure if risking this plm thing is worth it if i am gonna be in a chair anyway, thas my biggest question is the risk worth whats sort of gonna happen from MS or my degenerating spine, im just confused still, so got more reading to do and hey i may not even pass the blood test,


peace folks, sorry i went on so much

Thanks so much to komokozi and Riverwild for answering my question on double vision. You have given me some hope!!

I just thought I would share a bit of my story. Summer 2006 I saw myself going slowly downhill-no neuro said spms but I thought it. I was dx 1988, remission for 13 1/2yrs and now 6 1/2yrs of sx. I changed neuros after MRI she thought I should try Ty-the odds of pml were 1/1000. I considered this and the odds of my ms continuing to slowly, quietly take my QOL away.

I went with the odds of what ms was and could continue to do to me and started Ty in Oct 2006. I have never regretted this decision-only wish I could've started Ty 3 yrs earlier before my R leg got as bad as it is. I was off Copaxone 6 wks (due to timing) and saw myself go downhill. After first Ty infusion I was back to where I was on C and after 3-4 infusion I saw better balance, less fatigue and more stamina. At 7,20 and 29 mths of Ty my MRIs showed no new or active lesions and some old ones were better or gone :D My balance has gotten even better, no fatigue and I almost do any and everything I want. I had that eye thing nystamygus (sp) and now I don't:D Progression has halted! My QOL has been so improved !!!

I am a very grateful Tysabri user :D:D:D
I know it has not been wonderful or even good for some...I thank G-d this has been the med for me.

Best wishes,
Linda

Hi Frank (and Deb!) :D

Only you can decide what to do and what your personal risk tolerance is.

I know for me it was the right choice. I wasn't willing to lose any more brain or live with any further disability. The only other DMD I was on was Copaxone. It didn't work. I hadn't had any other treatments except for steroids. I looked at everything available, studied each one, weighed the risks and benefits and made my choice. For me, Tysabri's working.

It helps to be able to come here and share what we know, how things are going with our treatment, talk about it when we have a problem and support others who are in the same place. There's a lot of folks with a lot of infusions under their belts. Therre's folks who were in the original trials and folks who fought to get Tysabri returned to market. There's lots of good information in this thread.

If you have any questions, just ask! :)

Thank Ya Po! :D

I didn't get to comment on YOUR First infusion!
Glad to hear it was an uncomplicated day! :hug:
How did you feel when they started the infusion? Relief? Joy? Terror? :p
How are you feeling now??

I know for me, the whole process of fighting for Tysabri came down to when I signed the paperwork with the doctor. I heard a song on the radio out in the office- David Bowie~ "Grounds Control to Major Tom" I told the doc that the song said it perfectly...commencing countdown, engines ON!

A month later I heard the song again and it raised every hair on my body when the nurse turned on the pump and I watched that first drop. It had been 26 months of waiting and fighting. I had tears in my eyes and the nurse was blown away when I told her about what had happened during the previous 26 months.

I still think of those moments at the start of every infusion!

and yes...boring is VERY GOOD!:)

"...Take your protein pill and put your helmet on.." :D LOVE that song..
I spent some time calming my mind before I went. I wasn't nervous, wasn't even a spaz (:eek:), just curious..Watched them hook me up and the med dripping into the tube..Thinking how ridiculous it is to make someone jump thru so many hoops and wait so long for such a simple thing. Mostly, I was relieved that I didn't need any Benadryl..:rolleyes:
I felt remarkably good the first couple of days. Now, I'm pretty much back to my old, old feeling self. Oh well, at least I know I have something to look forward to!

Weegot- I am dxed ms sever 2-16-08. My desion to go on Ty was made in less then 5 min. I am not afraid of the so called risks. It is my understanding many died when other drugs were 1st brought on also. But this has nothing to do w/my desion. I do not wish to be in a chair ....I refususe to live like that or worse. My choice! I want the most agressive possible.

Bottom line is it it a personal choice as River said. I here u're words & u seem to be willing to take more from this disese then I am. We are all different! All I can can say is search u're heart. I also do not think the risk of a problem r high at all. Ty is just the newest drug so there r minor risks IMO.


I wish u the very best

BTW all - my cog is bad & forget typing - sp... I do not see a ck on here but prob is. So sorry 4 mistakes - I just give up on that - least of my probs - hope u understand.

Hi Frank,

I thought a long time before choosing Tysabri. Now I'm glad I did. I feel much better than I did on any of the shots, and so far my symptoms have let up, I have more energy and more strength too. No more shots either which is just a nice convenience.

From what I recall, you have a good neuro too so I'm sure he'll keep a close watch on you for any signs of PML.

If you decide to take Tysabri I hope you'll get good results. :hug:

I had my 2nd infusion yesterday. I feel the same. Don't get me wrong, I wasn't expecting a miracle, but I guess I was hoping. I don't feel worse, so I know that's all I can ask for. How long did it take for people to feel better? I've heard a lot of 3 or 5-7. Is this accurate?

Hi Stacer,

It was almost a year for me before I knew for sure I was feeling better. I actually felt a lot more tired much of the time for the first several months. It's been a very gradual change for me though.

Hi Stacer,

It took a few months before I thought I was seeing results. I was afraid to post about them until I had clinical proof.

My 6 month MRI confirmed no new lesions, no enhancing lesions and some large lesions smaller or gone.

My vision test showed no damage, vision back to pre-diagnosis levels, I had control of my eye again! ( previous to Tysabri I had dizziness, balance issues, double vision, and an eye that did what it wanted to when it wanted to.)

My fatigue was down to half of what it was .I went from 400 mg a day of Provigil to 200 or less.

Spasticity cut by 2/3rds. Went from 80 mg+ of Baclofen to 20-40 mg a day. Tizanidine cut to 4 mg at night from 8 mg.

Cognitively, I wasn't as tired, so my thinking was more clear. I could balance my checkbook again, read a newspaper or a book and actually get through a page without having to go back.

Best of all, I haven't had a relapse since I started Tysabri after going through one every three months or so before Tysabri.

It took a while, and the change was subtle, but there was improvement!

I'm still stiff, and I still have spasticity and fatigue, but it's nowhere near as bad as it was and I don't feel as if I have progressed any further. Each successive MRI has shown improvement.

Tysabri is designed to slow progression and reduce the number of relapses and in my case, that has happened. The rest is the gravy, the whipped cream on the pie, the cherry on the sundae!!

Thanks for your replies! I guess I'm looking for the gravy, the whipped cream on the pie, the cherry on the sundae. I'm trying to be patient. Like you all said, I'm just hoping to slow this progression. I'll keep you posted! Thanks again.

Hi Stacer, I found the gravy, whipped cream, cherry (whatever you'd like to call it) in 3-5 mths. I started noticing I wasn't leaning so much on the shower wall with my elbow (balance), that I could now do dishes (husband likes this)' could socialize longer and more and no longer dozing off in front of the tv :) Now all of these have held-even more so of each- I've had 33 infusions. A few months ago I noticed that the jumping of my right eye (nystamygus) -sp- is now not happening after first having the issue for a few years and my bladder may be a bit better. :D:D:D
Ty has also done for me what it claims to do ;)
Best wishes,
Linda

It's been vewwy quietttt in here. :lookaround:

Hopefully it's because everyone is out enjoying spring weather!! :grin:
:sunchair: :rain: :sunchair: :rain:

Lots of rain here.

I had infusion #11 today and it was so infuriating! :mad: I don't want to go into the whole long story but suffice it to say that 1) my infusion started one hour late 2) I was forced to sit on a tiny couch because they "overbooked" (???) and there was no room for me in an infusion chair 3) I spent almost 5 hours in the infusion clinic 4) the usual clueless and unhygienic nurse messed up my infusion. I lost it at the beginning with the nurse and my husband lost it at the end. I rarely raise my voice or lose it in public but I was mad!!!!

One example of many: the nurse put on rubber gloves before a patient's IV (normal, right) but then put his hands in his pockets to fish out keys to open a cabinet and went on to use the same gloves to work on someone's IV! He also forgot to start my saline flush after the slowed down 90 minute infusion. Then he remembered much later (but I wasn't sure what was going on...I kept asking questions and he was dismissive).

I don't trust this place anymore. I think I have to go somewhere else even though it will probably cost me much more. Just so everyone knows, I reported this clinic to Biogen months ago for not asking the 4 questions or following protocol. Biogen sent me a personal letter telling me the clinic had to go through TOUCH retraining again. But the MS infusion clinic still is ridiculously screwed up.

In addition, my neuro apparently wants to do a Tysabri antibody test again (I got the order today by paper) since I may have had some mild optic neuritis a few weeks ago...I think in conjunction with feeling somewhat crappy after the infusions it is probably a good idea. Of course I am speculating this is the reason why. But now I am extremely worried. I have to wait 2 weeks before I go in to get the blood drawn (not sure why the nurse told me this) and then of course 2 weeks to get the results.

It has been a long frustrating day.

Good news. Maybe getting mad yesterday worked. Out of the blue I get a call from a nurse at my clinic wanting to check in. He said my neuro heard that I was unhappy with my experience with the tysabri infusion because of overcrowding and they had an alternative. The general neurology dept. has it's own infusion clinic and they could move me there permanently. I know the infusion nurse who works there and she is awesome!!!!!!

Yay Natalie! :) The squeaky wheel gets the oil!!

Natalie, I'm so happy for you :D After reading your first post I felt really bad/sad for you-I'm having my own issues :mad: and then I saw the 2nd YEA!!! I hope mine works out as well!!
Linda

Congrats on the progress, Natalie! Ty infusions are no small thing ~ you need to have confidence in the people who are administrating it..
My next infusion is coming up Monday. I'm thinking positive thoughts, especially since the first one went so well.

Thanks Wiz!

Linda, I'm sorry to hear you are having problems too. Hope it gets resolved. Keep us posted.

Polar, good luck with the next infusion. You are so right about having confidence in the people who administer it. That is so important -- it is stressful enough being on this drug.

The best news of all that I forgot to report is that the cost will stay the same (still a $30 co-pay visit for the infusion instead of 20% of the total infusion cost). Yea!! :)

Thanks Natalie-I think it's resolved AND the way I wanted it :D
Another YEA for your best news:D:D

statistics on PML and Tysabri
 

According to the VP of Drug Safety at Biogen the chance of getting PML on Tysabri are lower than initially suspected based on the clinical trials. Maybe someone posted this article already.

http://www.medscape.com/viewarticle/702373

The incidence of PML in patients taking natalizumab for 1 year or more is 2.4 per 10,000 patients, 1.4 per 10,000 in patients treated for 18 months or more, and 3 per 10,000 in patients treated for 2 years or more, with confidence intervals "that are overlapping," said Dr. Bozic.

I'm not sure what "confidence intervals overlapping" means.