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First Case of PML with a Gilenya Patient
I just saw this article - http://www.irishtimes.com/newspaper/finance/2012/0414/1224314729546.html. It seems there is now a case of PML with a Gilenya patient. This person was previously on Tysabri for 3 years, and was JC positive. There is no information yet as to how long of a wash out period they had before starting Gilenya, how long they were on Gilenya before getting PML, what kind of symptoms they were experiencing, or any info yet about the condition of the patient.
Novartis (the maker of Gilenya) at this point is attributing the PML to the prior Tysabri usage, but they acknowlege "that the contribution of Gilenya to this case can not be excluded."
I figured I'd post this just as a heads up ... not trying to freak anyone out, just something to be aware of and keep an eye on. It will be interesting to see if this will be an isolated incident, or if there will be more cases to follow. I had always figured I'd probably have to transition to Gilenya if I had to stop Tysabri for some reason, so I definitely will be watching how this plays out. Still hoping that BG-12 will live up to its hype when it hits the market.....
Rita
Novartis (the maker of Gilenya) at this point is attributing the PML to the prior Tysabri usage, but they acknowlege "that the contribution of Gilenya to this case can not be excluded."
I figured I'd post this just as a heads up ... not trying to freak anyone out, just something to be aware of and keep an eye on. It will be interesting to see if this will be an isolated incident, or if there will be more cases to follow. I had always figured I'd probably have to transition to Gilenya if I had to stop Tysabri for some reason, so I definitely will be watching how this plays out. Still hoping that BG-12 will live up to its hype when it hits the market.....
Rita
Hey Shell,
I am very fortunate, in that I truly am watched very closely, by my neuro as well as my family doc and my GI guy. My Tysabri treatments are done right in my neuro's office - he starts the IV himself each month.
He likes being able to physically see his Ty patients and talk to them briefly each month - he doesn't do a neuro exam each time or anything, (I have an actual office visit every 3-6 months) but by talking to us he is also watching for any subtle changes in speech or cognition, and paying attention to any physical differences as well. Because he sees each of us so often and regularly, he has a pretty good feel for what is "normal" for us, and he might pick up on something subtle that I had not noticed.
I like having those few minutes of face time with him each month as well. I can tell him anything that has been going on with me during the past month, and then he can decide if anything needs to be pursued or addressed. What may seem insignificant to me may not be to him.
I also am able to ask him any questions I have each month, and discuss anything that I have read in the past month that I found interesting or confusing or that I may have concerns about. He is totally comfortable with the fact that I do alot of reading and research on my own, and is always honest with me. He respects my thoughts and opinions, and all treatment decisions are made as a partnership.
I have told him that he is like a unicorn or bigfoot .... you always hear that there are good, caring neuros out there, but you hardly ever get to see one, lol. I wish I could clone him and send a copy to all the people who have had bad experiences with neuros...
Rita
I am very fortunate, in that I truly am watched very closely, by my neuro as well as my family doc and my GI guy. My Tysabri treatments are done right in my neuro's office - he starts the IV himself each month.
He likes being able to physically see his Ty patients and talk to them briefly each month - he doesn't do a neuro exam each time or anything, (I have an actual office visit every 3-6 months) but by talking to us he is also watching for any subtle changes in speech or cognition, and paying attention to any physical differences as well. Because he sees each of us so often and regularly, he has a pretty good feel for what is "normal" for us, and he might pick up on something subtle that I had not noticed.
I like having those few minutes of face time with him each month as well. I can tell him anything that has been going on with me during the past month, and then he can decide if anything needs to be pursued or addressed. What may seem insignificant to me may not be to him.
I also am able to ask him any questions I have each month, and discuss anything that I have read in the past month that I found interesting or confusing or that I may have concerns about. He is totally comfortable with the fact that I do alot of reading and research on my own, and is always honest with me. He respects my thoughts and opinions, and all treatment decisions are made as a partnership.
I have told him that he is like a unicorn or bigfoot .... you always hear that there are good, caring neuros out there, but you hardly ever get to see one, lol. I wish I could clone him and send a copy to all the people who have had bad experiences with neuros...
Rita
Hi Rita,
Thank you so much for keeping us up to date on this. It's concerning. We talk about benefits vs risk all the time, and I know you are our resident veteran where that is concerned.
I pray that you and others who face such risk and have to make decisions so you can have quality of life are monitored very closely :)
Thank you so much for keeping us up to date on this. It's concerning. We talk about benefits vs risk all the time, and I know you are our resident veteran where that is concerned.
I pray that you and others who face such risk and have to make decisions so you can have quality of life are monitored very closely :)
Hey Sho,
Thanks for posting that link! Very interesting article, and it's always helpful to see what some neuros are thinking about the situation. I'm sure there will be alot of different reactions/approaches among neuros regarding this, just like there are with so many aspects of treating MS.
I find it VERY interesting that some of the neuros had already been predicting and speaking out about this particular problem ... and that they feel this is not likely to be an isolated incident. I also did not know that fingolimod stayed in the system for much longer than Tysabri. I wonder how this will impact trying to treat PML in these cases?
Rita
Thanks for posting that link! Very interesting article, and it's always helpful to see what some neuros are thinking about the situation. I'm sure there will be alot of different reactions/approaches among neuros regarding this, just like there are with so many aspects of treating MS.
I find it VERY interesting that some of the neuros had already been predicting and speaking out about this particular problem ... and that they feel this is not likely to be an isolated incident. I also did not know that fingolimod stayed in the system for much longer than Tysabri. I wonder how this will impact trying to treat PML in these cases?
Rita
One neuro's take:
http://multiple-sclerosis-research.blogspot.com/2012/04/news-first-case-of-pml-on-fingolimod.html
sho
http://multiple-sclerosis-research.blogspot.com/2012/04/news-first-case-of-pml-on-fingolimod.html
sho
Hey Lulu,
Let me know if your paperwork mentions anything about the recommended washout period if switching from Tysabri to another med - don't just take my word for it, lol. The 12 weeks is just what the article said - not sure if that is what Biogen recommends or what.
I remember when I switched from Rebif to Tysabri, it was a 4 week washout, and I had several different things that were starting up or worsening in that time period. If I had to go 12 weeks without any treatment before I could start a different DMD, that would make me very nervous because of my previous experience.
Is there anyone here on the forum who has made the switch from Tysabri to Gilenya? It would be interesting to see what kind of a washout period they had in between. I wonder if it may be like so many other things with MS treatment, and vary depending on how a particular neuro feels about it. Still so many questions...
Rita
Let me know if your paperwork mentions anything about the recommended washout period if switching from Tysabri to another med - don't just take my word for it, lol. The 12 weeks is just what the article said - not sure if that is what Biogen recommends or what.
I remember when I switched from Rebif to Tysabri, it was a 4 week washout, and I had several different things that were starting up or worsening in that time period. If I had to go 12 weeks without any treatment before I could start a different DMD, that would make me very nervous because of my previous experience.
Is there anyone here on the forum who has made the switch from Tysabri to Gilenya? It would be interesting to see what kind of a washout period they had in between. I wonder if it may be like so many other things with MS treatment, and vary depending on how a particular neuro feels about it. Still so many questions...
Rita
Rita, you are the leader here when it comes to Tysabri and the risks. Thanks for staying on top of this and sharing what you find out. I know there is a washout period for the CRABS before starting tysabri, but I'll have to look at my papers to see about the washout period afterwards. In the meantime I'll take your word for it - you are a very informed consumer. thanks, L
I read this morning that the Gilenya patient is in Australia, and had been on Tysabri for 3 1/2 years, not 3 years. The article also says that the patient was started on Gilenya after only being off Tysabri for 6 weeks, when the recommended washout period is actually 12 weeks.
There are still alot more questions than answers about this situation - hopefully more specific information will continue to become available, so it can all be put into better perspective. And hopefully this will prove to be an isolated case ... time will tell.
Rita
There are still alot more questions than answers about this situation - hopefully more specific information will continue to become available, so it can all be put into better perspective. And hopefully this will prove to be an isolated case ... time will tell.
Rita
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