NeuroTalk Support Groups - View Single Post - 12th case of PML from Tysabri posted today

lady_express_44 · 06-21-2009, 03:21 PM

Quote:

Originally Posted by Riverwild

I also do not like being BIIB's mushroom. I want the information that allows me to make an informed decision. They ain't giving it to me. They are making me search everywhere under the sun for information besides where we SHOULD be getting it from.

I agree, RW. I wish they would keep supplying this information to patients. We (the communal "we") fought for this drug, AND the PML monitoring process ... so I think they owe us ongong transparency.

It seems they should have patterns established by July 24th though... since they see that as the reason to no longer supply this PML incident information to patients ... then those who are at more risk can weigh up their decision on that basis.

Quote:

Originally Posted by komokazi

To keep the PML discussion in perspective:

European Doctors are not exactly shying away from using Tysabri in immunnosuppressed patients (which is identified as a potential risk factor for higher occurrence of PML)

Natalizumab treatment after autologous haematopoietic stem cell transplantation in patients with aggressive multiple sclerosis

http://registration.akm.ch/einsicht....NMASKEN_ID=900

Any wonder the PML case count is 2 in the US and 7 ex-US (Europe)

That appears to be a "study" of some sort, possibly sanctioned by Biogen. I'm quite sure that the majority of EX-US patients have NOT used stem cell treatments, and/or that there are no US patients who've used other strong immunosuppressants at some point before Tysabri.

If immunosuppression is a potential risk factor though, can you link to a definition of how long people are supposed to wait/dependant on what drug, before going on Tysabri, Chris? I haven't (personally) seen that criteria detailed even for US patients yet.

It was just a small study, but it is interesting that the results show that THOSE strong immunosuppressants didn't seem to affect the outcome.

I hope they are undergoing bigger (and longer) studies, that might give them more conclusive evidence that immunsuppression either does or doesn't influence the development of PML. Maybe they are waiting on those results as we speak, and that this may be why they think they are getting closer to answers ...

Cherie