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more tysabri scares
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magickalme posted:
Hi there group. I don't know if there are many here who are using Tysabri for MS. But I just read Dr. Julie's (she also has MS) blog about new issues surrounding this med and PML. Apparently, the issue at stake is the risk of long term usage in certain populations. Biogen et al is in the process of yet another study regarding risks to the long term population.

I had ONE weird experience, but we were able to trace it back to an incorrectly mixed solution- some genius used 1/2 normal saline rather than D5W, which is dextrose 5% in water. Aside from that, I am close now to Swampster, who tops the charts here at 44 doses. And NO side effects.

Question: Is anyone within the range of +24 doses considering quitting because of an increase in cases of PML? I know I am not, as I have stabilized quite nicely and, aside from MS, I just look so darn good!
Any response? Anyone want to kick this around?What do our MD's have to add to this latest report?
I'm interested.
Flapkat
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Rory26312 responded:
I got this from www.msrc.co.uk/ it basically shows the numbers as of Aug 4 th and states that the are within acceptable range , but the are compiled by Biogen and Elan.[a class="addthis_button_twitter at300b" title="Tweet This" target=_blank ost="1" at_titled="1" noh="1">
At this stage it is up to us the patient to decide we have all the figures available and should be left to make our own choices on this one.

Rory

5 more cases of PML brain infection in Tysabri MS patients Biogen Idec Inc. disclosed five more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. bringing the total number of cases to 63 as of Aug. 4.
The Cambridge, Mass., biotech company reported that the number of deaths among patients that have developed the infection--known as progressive multifocal leukoencephalopathy, or PML--remains at 12.
Sales of Tysabri are important to the future of both Elan and Biogen. The drug is considered a highly effective therapy for multiple sclerosis, but its growth has been slower than originally hoped due to concerns about the risk of PML that led to the drug's temporary withdrawal beginning in 2005.
The infection re-emerged among Tysabri patients in mid-2008, and Biogen provides monthly updates about the number cases.
The overall global PML rate is about 0.80 per 1,000 patients, the company said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.
As of June 30, 52,700 patients were using the drug around the world. In total, about 71,400 patients have use the drug since its launch.
Of the total PML cases, 25 were in the U.S., 34 were in the European Union and four were in other areas. The company doesn't disclose the distribution of the 12 patient deaths.
The number of cases is important because if the infection rate climbs too high, the drug's sales growth may drop. Regulators have said that they watch the cases, but have concluded that the benefits of the medicine to MS patients outweigh the risks.
Tysabri is usually used in MS patients who don't respond to earlier therapy or in patients with aggressive cases of the disease, and is distributed under a strict risk management plan that monitors patients for PML.
The risk of the infection increases with the number of monthly infusions that he or she receives.
The most recent data update translates to a rate of 1.35 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.76 per 1,000 for those on the drug for two years or longer.
Looked at another way, the rate is about 1.39 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.40 case per 1,000 patients in those using it for one to two years, and it is essentially nonexistent in patients using it for less than a year.
Source: Fox Business ©2010 FOX News Network(19/08/10)
 
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swampster1952 responded:
Good morning Flapkat,

I too have no intention of stopping my Tysabri treatment. I have had no new lesion formations since starting on it 43 months ago.

I am interested in the supposed increase risk we are under after being on the drug for well over two years. This idea that has been floating around the Tysabri users world about taking a so-called "holiday" from the drug to decrease a users risk of PML has no foundation in fact to support its use.

I hope you are doing well Flap,

Dave
 
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magickalme replied to Rory26312's response:
Hi, Rory...
See now, I thought either you, AL or Dave would pop up with more data. Dr. Julie just puts it out there and doesn't weigh in heavily either pro or con. She sort of just brings things to our attention.

BTW, She isthe author of 'The MS Manifesto', which has recently been classed as an award winning new MS publication. I recommend anyone either dealing with orhelping a lifemate get thru, as exceptional reading.

But, the choice,if you look at that data really closely, is, for me a no-brainer. Do I feel better on this drug. Yes. Are my SX more manageable on this drug. Yes. Have I had any of the SE's commonly associated or thought to be associated with, MS? Uh, no. Overall, do I personally believe I will take my chances? Oh hell yes!

But I thought perhaps we could get a good discussion going and cut to the chase. There's always something to learn from another's experiences.
Breathe, folks....
flapkat
 
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roberlyn replied to Rory26312's response:
very interesting ... i'll definitely be paying attention to this. hope all tysabri'ers are doing well!

robyn
 
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hackwriter responded:
Hi, Flap,

I just had my 6th Ty infusion and I will continue on the drug until I've been given a good reason to stop. I feel no better and no worse for the treatment and tolerate it well. However, I'm concerned about the increased risk of PML I've been hearing about, a small risk that rises with each passing year on the drug, and might consider switching to an oral therapy after year two if studies confirm this. That's IF...

I see my neuro next week and will ask for his two cents. Glad you're feeling well, Flap.

Kim
 
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myspitball responded:




Hi Flapkat.

I have been on Tysabri since June 2008 except for three months after I developed shingles which ultimately was due to a small dose of Depo-Medrol for a case of bronchitis and went in for my Tysabri infusion. My doctor thought it would be alright, but a week after my infusion I developed shingles and he took me off the Tysabri. I went for three months without any treatment and had a bad relapse from which I have not completely recovered from.

I went right back on the Tysabri and have no regrets and have no intention of going off the Tysabri even with the upcoming oral medication.

The increase chance of PML doesn't scare me off the Tysabri.

My doctor has made a decision to see his patients every three months now, i am assuming because of this report. I have complete confidence in him and his ARNP,
 
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magickalme replied to myspitball's response:
Hello all, Well that about tears it for me, too. I am not giving up this drug, they'll probably have to tear the TOUCH protocol from my cold, dead paws first. Nasty analogy, but look at it practically. l am better. In some ways. Say, loss of those ugly, short 230 pounds a few months ago. See, better. "Myspitball", above says it right: get your sources and go with the flow, just don't stop thinking. Gotta luv us.

And some not so better. great neighbors this time, but knees are shot. Can't even replace them, nothing to set the prosthesis into. Carpe diem? No carpe dog. Walks with me everywhere, and sucker ducked last time I was somewhat moving towards him, quickly. Imagine. LOL.

I have a new keyboard and have retrained all the mucslces in my left paw now, so my typing/spelling should improve.

And you all sound wonderful! I do miss the oild format, but oh well.

Kudos to all for making it through a long, hot summer. Stay well and....

breathe.......
flapkat
 
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swampster1952 responded:
Hey Flapkat,

I am flying to Seattle this morning to see my MS doc. I will be getting a MRI to see if I have any new lesions or PML.

I plan on stopping the Ampyra since I feel it has done nothing for me. I will let you all know what I find out.

Dave
 
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magickalme replied to swampster1952's response:
OK, Dave. Will be interested in hearing how it all goes. You are my touchstone for tysabri....there's a mouthful.

The newest scam in RELIV.

And some PPL never learn.

Tysabri tomorrow, and this time, donuts, just for fun. I get lots of warm hugs when I do the donut thing. I just say it's the agony of me getting up at 6 am, for a 9 am appointment. Takes a while these days to get the old gal up and moving. Sugar....my OTHER drug of choice.
blessings, and
breathe....
flap
 
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AuntyTess replied to swampster1952's response:
Hi Dave,

My Neuro took me off Ampyra too - apart from my euphoria at the beginning, it did not seem to help me. I am now trying to strengthen my bones myself.

I am staying on the Tysabri, I don't feel any different than when I first started it. I also had a full body and head MRI last week, hopefully there won't be any new lesions, we will see..

Tess


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