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Tysabri Information and Check In part 2

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Old 05-06-2010, 10:05 PM #1
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Hi Linda! I will keep my fingers crossed for you! Peace of mind would be nice.

Does anyone know, then, if the JC virus antibody assay is available to everyone? I'm still a little confused about this.

I hope everyone is enjoying spring!
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Old 05-07-2010, 09:44 AM #2
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Quote:
Originally Posted by Natalie8 View Post
Does anyone know, then, if the JC virus antibody assay is available to everyone? I'm still a little confused about this.

I hope everyone is enjoying spring!
The assay is not available commercially only through the two Stratify trials. My understanding is that they are trying to make the assay available to as many Touch patients as possible but your Doctor will have to register with the trial - Bottom line check with your Doctor (Neurologist enrolled in Touch)
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Old 05-15-2010, 11:58 AM #3
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Default 49 PML cases as of May 6 (Wall St. Journal)
If anyone is interested, the Wall Street Journal (May 14) reports a new total of 49 cases of PML associated with Tysabri as of May 6. The number of deaths is unchanged (11) since the last reporting a month ago.

http://online.wsj.com/article/BT-CO-...eadlinesEurope

(You need to be a subscriber to read the entire article.)
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Old 05-16-2010, 11:51 AM #4
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Agate, if you could give the highlights of the article, such as where, how many infusions etc I would really appreciate it. This, of course, is me ***-u-ming you are a subscriber !!
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Old 05-16-2010, 12:30 PM #5
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Hi Linda,

I'm not a subscriber and so can't read the entire article. However, I found the Nasdaq article that the Wall Street Journal seems to have got its information from. I hope it's all right to post excerpts from it here:

Quote:
Biogen: Total PML Cases At 49, Deaths At 11 As Of May 6



By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 49 as of May 6.

The Cambridge, Mass., biotech company reported no additional deaths in patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 11.

Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped due to concerns about the risk of PML that led to its temporary withdrawal beginning in 2005.
The overall global rate is about 0.7 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.

Shares of Biogen recently traded down 2.9% to $49.92, while Elan shares dropped 1.4% to $6.26.
Of the total cases, 19 were in the U.S., 27 were in the European Union and three were in other areas. ...

The most recent update translates to a rate of 1.14 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.62 per 1,000 for those on the drug for two years or longer.

A patient's risk of getting PML increases with the number of monthly infusion that he or she receives, something that the Food and Drug administration highlighted in a January safety update. The agency concluded that the benefits of the medicine continue to outweigh the risks.

The rate is about 1.38 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.32 case per 1,000 patients in those using it for one to two years, and it is almost nonexistent in patients using it for less than a year.

...

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
http://www.nasdaq.com/aspx/stock-mar...11-as-of-may-6

Comparing the totals with last month's totals, I'd say that of the 3 new cases, 2 were in the US and 1 in the EU.

Sorry I don't know about the number of infusions but there's an informal Website where they are being recorded. The number of infusions apparently isn't yet known for the last 7 PML cases.
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Last edited by agate; 05-16-2010 at 06:09 PM.
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Old 05-17-2010, 11:46 AM #6
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Thanks agate
I do know about the informal website and go there daily to see if they have more info on the last cases of pml. So doggone frustrating
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Old 05-17-2010, 12:24 PM #7
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Well I'm sitting here getting infusion #21! It's hard to believe it's been almost 2 years. I'm still on the every 8 week cycle and I haven't noticed any difference except maybe the vision in my left eye gets a little blurrier by the end of the 8 weeks. They renovated the infusion room and added new chairs which aren't as comfortable . But I'm settled in with my pillow and blanket and looking forward to a nap. I kept the box and look forward to reading the new insert to see what exactly has changed. Hope everyone else is doing well.
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