MSNews updates are on hold until further notice. Sign-up on our mailing list here to be notified when we are back.
Tysabri Label Update
Submitted by art on Mon, 2008-09-15 05:53.
Here's some more info on the FDA response to the two new cases of PML with Tysabri. Not sure what this does beyond all the warnings you get when enrolling in the TOUCH program, but hey, somebody needed to do something I guess. A PDF of the new prescribing info is here.
On the flip side, here's a study modeling the long-term risks and benefits of natalizumab in individuals with relapsing multiple sclerosis that concludes that a more than sevenfold increase in actual risk of progressive multifocal leukoencephalopathy was required to decrease natalizumab's health gain below that of interferon beta-1a.
Does this mean that Tysabri
Does this mean that Tysabri is less effective on the long run? (and even interferon is more effective)
Or does this mean the change on PML is 7 times bigger after a period of time?
(sorry but english is not my native language)
They're saying that (based
They're saying that (based on their model) that Tysabri is so much more effective than Interferon, that the risk of PML with Tysabri would need to be 7 times higher to out weigh the benefits.
***
Art Mellor, Accelerated Cure Project for MS, art-msnews -at- acceleratedcure.com
They're saying that they
They're saying that they created a mathematical model for "Quality of Life" for those with MS.
Those getting TYSABRI have so much fewer relapses and disease progression than those on Interferons.
(Note- there is no effect on MS disease progression disabilities for those on interferons or glatiramer acetate- per FDA. )
The risk of getting PML from TYSABRI is so small that even if it were SEVEN TIMES HIGHER than what the FDA says it is (1:1000) that the benefits still outweigh the risks.
Note that there are presently over 35,000 MSers on TYSABRI.
There should be 35 cases of PML per the FDA's 1:1000 risk ratio.....but it's NOT HAPPENING!
There has been a total of 5 cases of PML with Tysabri.
Two cases of PML occurred with patients taking a combo of Avonex & Tysabri.
Two cases have been associated with patients that took azathioprine (aka Imuran) - known to have lots of PML AERs.
Only 1 of these cases of PML were for a patient with MS and not another drug! And that patient is alive & well, thanks to Elan scientists coming up with a plasmapheresis therapy!