Multiple Sclerosis (MS) Support Group
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Saw my neuro today. Repeat of MRI revealed three possibly 4 brain and C-spine lesions. Plus two really small areas in my Cerebrum next to the left midline ventrical that could be MS are could be normal for my age. One of the C-spine lesions cooled down and didn't enhance with our favorite gadolium. Another one showed up and enhanced. Another brain stem still enhanced. This is about 2 months after the first MRIs. Another, the biggest medulla lesion, still enhanced and crossed the mid-line, which as I understand it affects both sides of the body. It is also in the area where the cranial nerves originate. Another area lower down in the C-spine was just barely visible and may be another starting to form. My neuro reinforced the fact that MS that occurs after the late 50s progresses rapidly. I just loved hearing that.
They really got on go, as I'm to get 1000 mg a day IV of Solu-Medrol starting tomorrow for 5 days. They delivered the meds this afternoon. Then taper with oral Prednisone starting at 100 mg a day. A nurse is coming by in the morning to put the heparin lock in and show me how to administer it myself at home. I already checked the size of the cath. They are 22s and 24s. I hate big needles.
I'm to go back to the neuro in three weeks to have labs checked for JCV and the like and if all looks OK start Tysabri IV once a month. Apparently the JCV virus caused three people in clinical trials to develop progressive multifocal leukoencephalopathy that can cause death. in immune suppressed patients.
Anyone else take Tysabri?
They really got on go, as I'm to get 1000 mg a day IV of Solu-Medrol starting tomorrow for 5 days. They delivered the meds this afternoon. Then taper with oral Prednisone starting at 100 mg a day. A nurse is coming by in the morning to put the heparin lock in and show me how to administer it myself at home. I already checked the size of the cath. They are 22s and 24s. I hate big needles.
I'm to go back to the neuro in three weeks to have labs checked for JCV and the like and if all looks OK start Tysabri IV once a month. Apparently the JCV virus caused three people in clinical trials to develop progressive multifocal leukoencephalopathy that can cause death. in immune suppressed patients.
Anyone else take Tysabri?
the PMl cases associated with tysabri are now up to 82--its a little concerning that the most updated info the doc gives you about the pml is way back from the trials in 2003?. thats truly upsetting, a doc i wouldn't trust much after that
but thats me i demand a lot from my doc & she knows it.. but no one has gotten pml when tysabri was used to treat ms in the first 12 months. so that appears to be a safe pml time.
there is a tysabri users group you can look into.
http://www.dailystrength.org/groups/tysabri
http://www.foxbusiness.com/markets/2010/12/16/biogen-infections-death-tysabri-patients/
this is a site in germany that keeps track of cases before biogen announces them. first biogen reports to physicians-so apparently this german site has connections to those earlier reports--the new media follows soon after this is updated & it has been that way consistently for some time.
don't get me wrong i have used tysabri for 2&1/2 years now and i believe it was the right decision...but you really need to confront your doc with this info and demand some greater truthfulness out of him/her.
http://chefarztfrau.de/?page_id=716
Yep, you were right. chalk it up to a greenhorn MS patient, I'm catching up fast though. My guess is the 200 mg of Prednisone was more of a test to see how I would react as I can't remember but one time maybe 20+ years ago taking a 5 mg dose pak and remember not liking it but don't remember the reason. I did notice some improvement in fatigue while on the 200s and 100s of the taper.
I've always been a bit of a risk taker and the odds with Tysabri seem OK. I'm not going to stick my head in the sand but ready to get on with it.
What I've not completely gotten squared away is that 60-90 percent of the US population have been exposed (as per Wikipedia, not always perfect but informative). If Tysabri reactivates the virus, what good is a test that checks to see if you have had exposure in the past if up to 90% could test positive?
Biogen has applied the the FDA to get the JCV antibody test added to the black box label for tysabri. My guess is it will say something like this...'The risk of PML while using tysabri is about 1 in 1,000 for people using tysabri with a negative jcv antibody test but the risk of pml while using tysabri is greater with a positive jcv antibody test'
....
Biogen has said in reports that they have found a difference in pml rates for those who test positive and those who don't, but a negative test does not guarantee no pml.
the false negative rate for the test is 2.5% and the spontaneous reconversion of negative testing patients is 2% per year.
Stratisfy I and Stratisfy II trials.....
http://clinicaltrials.gov/ct2/show/NCT01070823?term=PML+and+Tysabri&rank=3
http://clinicaltrials.gov/ct2/show/NCT01070836?term=PML+and+Tysabri&rank=1
http://www.medscape.com/viewarticle/730736
so the jcv antibody test will not be a one shot deal but will be required periodically while using tysabri.
first they tried to test for jcv dna in a persons spinal fluid. that did not turn out to consistently define PML risk. also not a test tysabri users would want to submit to routinely while using tysabri..
then 3- 4(?) people who got pml( i can look up my notes--you better believe i take notes on everything!!!)
just happened to have blood samples saved before they got pml...and they all had jcv antibodies....100% . if the jcv anti body was incidental in pml development while using tysabri, at least one would not have had the jcv antibody.
from that very small data set researchers began developing and researching jcv anti bodies: devolping a test to find them..
they theorized, the jcv can lie harmlessly dormant in the throat, bones,spleen, kidney's and other organs.
but if it gets into the blood stream & then mutates into a virus that is active in the brain pml can occur.
it has been theorized that tysabri helps to dislodge wherever the jcv is lying dormant and gets it into the blood stream---but nothing has been able to prove it does that & there where many trials attempting to show that it does. lots of cometitive $'s in pharma.
normally a persons immune system takes care of a mutated JCV virus that gets into the brain--but the immune system can't when tysabri is blocking the immune system from getting into the brain....
I read that it actually was a long shot for people with the virus lying dormant somewhere to cause PML---first the JCV had to get into the blood stream and then it had to mutate into a virus able to get into the brain...its a long shot,but it happens obviously.
the biggest risk factor found for it to happen is if a person has used an immune suppressant in the past, like novatrone,cellcept ...so the order of MS treatment has to be tysabri BEFORE an immune suppressant not the reverse. the reverse has a greater risk. that relationship has been consistent thoughout the 5-6 years i've been following tysabri-pml
not that a previous use of an immunesuppresant will always cause pml, it just places a person at a much greater risk of pml when using tysabri.
http://www.tysabri.com/tysbProject/tysb.portal/_baseurl/threeColLayout/SCSRepository/en_US/tysb/home/about-tysabri/how-tysabri-works.xml
JCV virus dna, was found to increase in the urine after 12 month of ty use and it increases in the plasma after 18 month of using tysabri---but this trial didn't seem to go anywhere--maybe it shows tysabri disloges jc virus from where it is lying dormant?
it also appeared to drop between 6-12 months?
like i said it didn't go anywhere, but perhaps was used to develop the anti body test?
New England Journal Article on it:
http://www.nejm.org/doi/full/10.1056/NEJMoa0904267
Article of biogen was beginning to develop the JCV anti body test.....
http://www.forbes.com/2009/10/27/ms-crohn-elan-business-healthcare-tysabri.html?feed=rss_news
Thanks for the info. I'll check it out tomorrow. Had to take our mini schnauzers to groomer (they have hair instead of fur), pay bills, mop and sweep the kitchen, sweep out the garage, etc. Took 3 hours today for the IV solu-medrol. Took all my free time.
The nurse put a heparin lock in place and showed me how to hook up tomorrows bag. It was some kind of very net. It worked kind of like those old baby food formula bags that collapsed inside of a container. The inside part was pressurized by th pharmacy and had a flow regulator set at 100cc an hour. No IV pole, could do it while walking, shopping or watching TV. It was about the size of an orange. I found a fanny pack it would fit in a strapped it to my waste. The nurse had to stay with me for the first dose and gave me a 24 hour call number if I have any problems.
My only complaint is that she used a 24 gauge angio, less pain but more likely to clot off. A 20 would have been better but our only choice was 22 or 24. Hope it makes it to Tuesday.
On the request for coverage by my neuro to the insurance company, he described my case as aggressive relapsing-remitting with cord and brainstem active lesions.
I'm jealous. we do not have at home steroid infusions here. I have to go to the hospital outpatient every day to get them when I had to get them. it suck in winter sometimes when i would really prefer to stay off the roads.