Quote:
Originally Posted by komokazi
Cherie,
If you really knew about Tysabri, you would know that it is twice as effective as our other choices. The unknown is the long term safety of using the drug (I'm at two years as of Monday, 22 Dec no problems to report) regarding PML and other opportunistic infections. The other unknown is the outcome of PML. It was assummed that the outcome would be death or severe disability. 3 of the 4 PML cases since relaunch of the drug under monitoring have resolutions. 1 of the 3 patients has died - cause of death is unknown but PML or IRIS from PML treatment is suspected. The other 2 patients are out of PML danger. One only had minor weakness.
While it is always good to have a balanced discussion, your assessment of risk/reward comes from your individual situation of MS risk in using a less efficacious MS treatment.
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Hi Chris,
This discussion was about the announced 7th case of PML, and the recent death that occurred. It was not intended to center around how effective Tysabri is, or whether some might think it is a risk worth taking ... so that’s why you didn’t run into many comments regarding those points in this thread.
As far as efficacy, although Tysabri claims to be twice as effective in reducing relapses, there has never been a head-to-head trial against the CRABs. It is really impossible to know if it is "more" effective, as results from these trials may be very skewed by any number of factors:
http://www.ncbi.nlm.nih.gov/pubmed/18437041
http://www.ncbi.nlm.nih.gov/pubmed/1...t=AbstractPlus
Tysabri claims to be about twice as effective in reducing relapses, however, IMHO, relapse rates aren’t a significant measurement of “efficacy” with this disease anyway. Even if Tysabri proved twice as effective in reducing relapses in a head-to-head trial, unfortunately that does not mean we are going to be any less disabled in the long-run.
While reducing relapses might be pleasurable, Tysabri proved to be only slightly more effective (in absolute terms) then the CRABs for short-term disease progression. There is no long-term efficacy measure of this drug for disease progression yet, so that is another “unknown” that people need to measure up against the risk, obviously.
http://www.neurology.org/cgi/content...916.38629.43v1
I am glad you are at two years with no problems to report, but that doesn’t mean there haven’t been any with others.
I agree that “the unknown is the long term safety of the using the drug regarding PML and other opportunistic infections”.
However, I disagree that:
- “the unknown is the outcome of PML”
- it was necessarily “assumed that the outcome would be death or severe disability”
- “3 of the 4 PML cases since relaunch of the drug under monitoring have resolutions”
We knew/know the current “potential” outcome of PML, at least at this moment in history. We know that people may die from PML ... since two out of three in the original trials did. We also know that even IF they initially seem to survive the PML (as the recent US patient did), they may succumb in weeks, months, or die from IRIS (used to treat the PML). We don’t have autopsy confirmation on the recent death, but I'm “speculating” that Biogen spokesperson would not be “announcing” her death in the same breath as the fact that she got PML from Tysabri . . . if her death was unlikely to be related to the drug.
We also know/knew patients might live through PML. . . since the third trial patient in the trials did, as have 3 people since. We don’t know precisely “how” disabled that ANY eventually became from PML as much of the details are deemed “patient confidential”. In fact, it was only a few weeks ago that we got “news” that the Florida woman who got PML in Oct, was home and “recovering” under her doctor’s care. Next we know, she’s died.
So, it’s probably going to take time, and perhaps even a court case before we ever find out EXACTLY how disabled ANY of the people who got PML have become, or what the long-term prognosis might be for them.
Quote:
Originally Posted by komokazi
While it is always good to have a balanced discussion, your assessment of risk/reward comes from your individual situation of MS risk in using a less efficacious MS treatment.
Chris
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I don’t know what that sentence means . . . ?
Quote:
Originally Posted by komokazi
I just wanted to post that I take Tysabri because of it's effectiveness - convenience and lack of side-effects for me are just bonuses. For me, the Tysabri risk/reward choice was easy - On rebif I was in a glider slowly/constantly losing altitude (slowly but still losing altitude) while also enduring the mental strain of fighting the flu like side effects for 4 days every week for week after week, month after month.
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As I said previously on this thread, Tysabri “is at least as effective as our other options, it is much more convenient, and there are less general side-effects.” I get why some people want to use it, and that they may be willing to take a risk . . . just as you would likely understand how others feel the opposite.
Quote:
Originally Posted by komokazi
I felt going into Tysabri that the risk of PML would ultimately be less than 1 in 1000 and that PML would not ultimately have to be fatal as I would treat any relapse like event as potential PML and stop taking the drug.
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Well, you were more wrong then right. . . at least so far. That is the reason we still talk about the risk though, as like you, some people did go on it thinking the risk would be much less then was predicted.
Currently the risk for PML is at about 1:1357, so we are not that far off. While there are many thousands of people on it now, the risk they estimated was 1:1000
for those who’ve been on it for 18+ months. Currently there are 9500 that have been on that long, or longer, and 7 cases of PML . . . so there estimation was pretty close ... SO FAR.
Cherie
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I am not a Neurologist, Physician, Nurse, or Hairdresser ... but I have learned that it is not such a great idea to give oneself a haircut after three margaritas
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