159 cases of PML with 29 deaths for Tysabri MS patients

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159 cases of PML with 29 deaths for Tysabri MS patients

Postby MSUK » Mon Oct 03, 2011 1:51 am

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According to information released by Biogen Idec, as of September 1, 2011 there have been 159 confirmed cases of progressive multifocal leukoencephalopathy (PML, a viral infection of the brain that usually leads to death or severe disability) among people who have used Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) after it became available for prescription in July 2006.

Eighteen percent of those who have developed PML have died (29 out of 159). The degree of disability in the survivors is a wide spectrum: at the milder end, some have recovered enough to return to work, and at the other extreme, some are confined to bed, requiring extensive assistance with activities of daily living, and others were in between this range.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905
MS-UK - http://www.ms-uk.org/
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby Bender » Wed Oct 12, 2011 9:50 am

How many people have taken it, the number of people affected by PML is not meaningful without the context.
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby euphoniaa » Wed Oct 12, 2011 10:00 am

Bender wrote:How many people have taken it, the number of people affected by PML is not meaningful without the context.

If you click on the link for more info, you get a whole row of Tysabri articles with all the stats - the number who have taken it, and the percentages of PML for the length they've taken it, etc.

Example:
As of June 30, 2011, approximately 88,100 people worldwide have used Tysabri since it was marketed.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby euphoniaa » Wed Oct 12, 2011 10:08 am

And more stats from July:

The overall global PML rate is now at 1.62 per 1,000 patients. Of the total PML cases, 57 were in the U.S., 81 were in the European Union and seven were in other areas.

The company believes that the best way to assess the pool of PML data shows all patients over a fixed duration range of treatment.

According to that method, the rate is about 1.94 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.54 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.

For patients on the drug for three to four years, the rate drops to 1.34 patients per 1,000, but Biogen doesn't believe there is enough data to conclude that incidence of the infection drops after a certain amount of time.

Looked at another way, the rate is 2.41 cases per 1,000 patients on the drug for a year or longer, rising to 3.03 per 1,000 for those on the drug for two years or longer, and dropping to 1.85 for more than three years.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Thu Oct 13, 2011 7:59 am

Looked at another way, the rate is 2.41 cases per 1,000 patients on the drug for a year or longer, rising to 3.03 per 1,000 for those on the drug for two years or longer, and dropping to 1.85 for more than three years.


I guess the bottom line is the PML risk rate has jumped significantly from the original 1:1000 rate that Biogen gave us. There have been a lot of MS patients stopping the use of Tysabri after 24 infusions for various reasons.....side-effects, lack of efficacy, fear of PML after two years of use. You wonder if the drop in risk after 3 years has to do with fewer patients using the drug at that point or simply better tolerance by the patients.

Regardless, viewing data like this adds one more difficulty for MS patients in trying to choose which drug to use should they go that route.

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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby Bender » Thu Oct 13, 2011 3:06 pm

But it looks like the 2% estimate my doctor gave me is pretty close to accurate.

Sorry my doctor is looking at switching me too this and the bulk of the what I'm seeing is not providing me with what feels like complete info. Also I would point out the 2-3 year+ rate drop is (IMO) probably due to people more likely to get PML either getting it and therefore not counting towards the later samples or being removed because their viral exposure is detected.
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Fri Oct 14, 2011 9:56 am

There have been 11 new cases of PML reported, bringing the new total to 170. How many additional deaths isn't known at this time nor is the number of infusions each patient had before contracting the PML.

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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Sun Nov 20, 2011 9:22 am

Latest figures show the number of PML cases has risen to 181. It isn't known if any more deaths are included in the recent increase.

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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby RuSmolikova » Sun Nov 20, 2011 2:28 pm

HarryZ wrote:Latest figures show the number of PML cases has risen to 181. It isn't known if any more deaths are included in the recent increase.

Harry


11 new cases of PML and 5 more deaths (since the beginning of October 2011).
Total November numbers: 181 PML patients and 38 PML deaths...
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Sun Nov 20, 2011 4:53 pm

11 new cases of PML and 5 more deaths (since the beginning of October 2011).
Total November numbers: 181 PML patients and 38 PML deaths...


The monthly increases appear to be on the rise and I can only assume it's because more patients are getting into the 2-3 year use category. Not good!

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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby numbness23 » Wed Nov 23, 2011 6:15 pm

No offense but wheres the tradeoff? Watching yourself deteriorate or taking a drug that may kill you. Same diff
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Wed Nov 23, 2011 8:10 pm

numbness23 wrote:No offense but wheres the tradeoff? Watching yourself deteriorate or taking a drug that may kill you. Same diff


This has always been the big question for MS patients ever since the CRAB drugs appeared back in the 90's although the CRABs weren't possibly fatal. As they develop more powerful immunosuppressive drugs, the risks become even greater. My wife,who had MS for over 35 years, chose not to take any of these powerful drugs due to the possible side effects. Others choose differently.
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby sou » Fri Dec 02, 2011 1:01 pm

What would you choose?

Watch you deteriorate or watch you deteriorate and take a drug that might kill you or ruin what's left of your life with its side effects?

The answer is simple, isn't it?
Shortest joke: "We may not be able to cure MS but we can manage its symptoms."
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Fri Dec 02, 2011 1:26 pm

The answer is simple, isn't it?


For some people yes, but for those who trust everything their MS doc tells them, they will likely end up on one of the immunosuppressive therapies.
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Re: 159 cases of PML with 29 deaths for Tysabri MS patients

Postby HarryZ » Fri Dec 16, 2011 7:48 am

12 more cases of PML bringing the total to 193! Despite all the precautions supposedly being taken these days, the number of cases doesn't appear to be slowing down any. Don't know if there are any more deaths included in this new number.
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