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159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Mon Oct 03, 2011 12:51 am
by MSUK
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
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Wed Oct 12, 2011 8:50 am
by Bender
How many people have taken it, the number of people affected by PML is not meaningful without the context.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Wed Oct 12, 2011 9:00 am
by euphoniaa
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.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Wed Oct 12, 2011 9:08 am
by euphoniaa
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.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Thu Oct 13, 2011 6:59 am
by HarryZ
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.
Harry
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Thu Oct 13, 2011 2:06 pm
by Bender
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.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Fri Oct 14, 2011 8:56 am
by HarryZ
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.
Harry
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Sun Nov 20, 2011 8:22 am
by HarryZ
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
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Sun Nov 20, 2011 1:28 pm
by RuSmolikova
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...
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Sun Nov 20, 2011 3:53 pm
by HarryZ
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!
Harry
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Wed Nov 23, 2011 5:15 pm
by numbness23
No offense but wheres the tradeoff? Watching yourself deteriorate or taking a drug that may kill you. Same diff
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Wed Nov 23, 2011 7:10 pm
by HarryZ
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.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Fri Dec 02, 2011 12:01 pm
by sou
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?
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Fri Dec 02, 2011 12:26 pm
by HarryZ
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.
Re: 159 cases of PML with 29 deaths for Tysabri MS patients
Posted: Fri Dec 16, 2011 6:48 am
by HarryZ
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.