PML with Gilenya & past tysabri use

[0485c10]

First case of PML has occued with Gilenya but it was with a patient who had used tysabri in the past...the pml is thought to be caused more from past tysabri use than current gilenya....

for me to be considered is... it may be a first indication that pml risk may continue after tysabri is stopped

&

like prior use of an immune suppressant before using Tysabri increases the pml risk...a combination of tysabri followed by gilenya may also not be a good combination?

something to keep ears open about

http://www.boston.com/Boston/busines...24N/index.html

[0485c10]

I don't want to be guilty of trying in the media...i'm interested in more information being released on it first...

like...
jcv status, if known?
how long was tysabri used before gilenya?
how long was gilenya used before pml symptoms started and then pml confirmed?
how much wash out time was given between the two drugs?

i'd kind of like to know what the first symptoms of a tysabri-gilenya pml?

and how much damage was done & if they survived?

illness doesn't run on internet time, they may not know yet. i hope they publish when the do know.

[0485c10]

Fox news reports that a swiss analyst has said that the case has to be taken seriously but does not define a "trend" yet that a 2nd or even 3rd case coming up within the next few weeks?

http://www.foxnews.com/health/2012/0...brain-disease/

in same article it says that the EMA(European Medicine Agency) is expected to issue their decision on the safety of Gilenya on April 20th. Next Friday...the review started after the death of a US citizen within 24 hours after taken the first dose.

[Daisy Dead Petals]

scary. been on both.

[0485c10]

This article adds the information that the patient was jcv+ and had been on tysabri for 3 years. This article says that biogen/elan recommend 3 month washout period between the 2 meds, but it is not known how long of a dry out period was done.

This is the article from Ireland where Elan is(developers of Tysabri) swiss drugmaker Novartis is the manufacturer of gilenya...so i'm certain there will be some finger pointing, making it more difficult to get the facts.

http://www.irishtimes.com/newspaper/...314729546.html

[Scooter24]

Gee and everybody thought it was so safe, this is the exact reason I won't even think about BG12 until it has been out for more than a year. I'll stick with TY at least we know what to watch for.

[CougarMama]

I'm so glad you posted about this case! I haven't seen much in the news about it but it's certainly a concern for tysabri and Gilenya patients. please post if you learn anything kre abut ths case (or others.)

[Cindarelly]

I think the difference is when the first pml case came out with ty their was a reaction from the medical community. They did something and made changes.
With G, I see the need for changes and don't see anyone doing anything?? then again that is just my opinion.
I also think it is a good drug, that may get thrown by the wayside because of this NON reaction.

[HereIam]

First I feel such great sympathy for the family of the person affected by PML.

Second, I feel anger, frustration, and lots of it. And, fear for many people around the world on Gilenya.

Why? Because a lot of neuros who had JC+ patients on Tysabri were of the opinion "let's just keep going with the T until Gilenya is available." And, that's what they did. The affected patient was washed out for 6 weeks that's what I read. But, how many patients are out there on Gilenya because they are JC+ and needed to get off T? What percentage of those on G are in this group?

The science of working on MS is so shady, most of the meds, they don't even know why the heck they work. So, if they don't know how they work, how can they know what other effects they have on a body already blasted with other treatments?

As for me, I will do exactly what I've always done when offered a new med "talk to me about it in 1.5 years please," is what I say. And, I have SPMS so these meds aren't even designed for "me!" yet the neuros still want us to try them. It's difficult to not personalize these 1 out of 36,000 events, it's just to easy to believe "that one could have been me."

No thank you.

[0485c10]

@Cindarelly--your observation is good, i just want to add to it. The first few PML occurances with Tysabri were not identified as PML, thought to be from MS. Now they are much more alert to that side affect.

the aggressive reaction to tysabri, when it was actually taken off the market, occurred when a woman died after taking Tysabri from PML & on autopsy it was determined that she did not have ms.

she had sensory symptoms only, her MRI did not meet the McDonald criteria for ms...but she was frightened of what MS was going to do to her in the future so she jumped at the newest MS treatment available.

then she died from the treatment for a disease she did not have. it was clear that Tysabri PML killed her.

Biogen got their hands slapped by the FDA for running trials with people who did not have MRI confirmed MS by the McDonald criteria.

The fda took it off the market until further review. there was a groundswell of patients testifying that tysabri be returned to market, for those that had no other options.

the fda allowed its return under strict guidelines. it was to be a 2nd line drug, a person had to have MS confirmed by MRI under McDonald Criteria.

That hasn't happened with Gilenya yet..a person without MS but thought they did have MS has not yet died from Gilenya. From what i have read of the people who died while taking Gilenya they all has MS so they all had a justified reason to be taking Gilenya.

that was not the case with the strong FDA response to Tysabri causing PML.

[Alicious]

Gee and everybody thought it was so safe, this is the exact reason I won't even think about BG12 until it has been out for more than a year. I'll stick with TY at least we know what to watch for.

Not everyone. My neuro flat out said that he feels it was rushed to market, the safety profile is worse than expected and that % of reduction is almost certainly not as good as advertised over time, either--and he said this a year ago. He's not alone, either, thankfully. That's not to say it's not a good med for some people; no clue on that one, but I'm with you, I'll wait until a med is a bit more proven before jumping on board.

[0485c10]

Not everyone. My neuro flat out said that he feels it was rushed to market, the safety profile is worse than expected and that % of reduction is almost certainly not as good as advertised over time, either--and he said this a year ago. He's not alone, either, thankfully. That's not to say it's not a good med for some people; no clue on that one, but I'm with you, I'll wait until a med is a bit more proven before jumping on board.

I agree with your doc, i have always distrusted
FYT720 ->fingolimid-> finally renamed Gilenya.

there was intense pressure to get it out before another oral med came out. it was given away at no cost in the first year to get people on it before competition from another oral med came out.

it was developed in japan. the first of the trials were done by Japanes pharma company
Mitsubishi Tanabe Pharma Corporation

http://clinicaltrials.gov/ct2/show/N...=fty720&rank=4

then bought by swiss company Novartis.
who has since announced it wants to get out of neuro disease because not enough is known. it wants to focus on its cardiac(?) line of meds instead. Heard that on Good morning America, i do not have a confirming link about that, just my memory.


the fact that it was developed in Japan is the reason i think it is so big in australia, close ties between australia & japan i read. read many post from australians on it or were deciding to go on it.

[lindaincolorado]

I was at a RMmsC seminar yesterday. Dr Vollmer said 26 doses of Ty, off 3 months then Gilenya.

[Sequoia]

I agree with your doc, i have always distrusted
FYT720 ->fingolimid-> finally renamed Gilenya.

there was intense pressure to get it out before another oral med came out. it was given away at no cost in the first year to get people on it before competition from another oral med came out.

it was developed in japan. the first of the trials were done by Japanes pharma company
Mitsubishi Tanabe Pharma Corporation

http://clinicaltrials.gov/ct2/show/N...=fty720&rank=4

then bought by swiss company Novartis.
who has since announced it wants to get out of neuro disease because not enough is known. it wants to focus on its cardiac(?) line of meds instead. Heard that on Good morning America, i do not have a confirming link about that, just my memory.


the fact that it was developed in Japan is the reason i think it is so big in australia, close ties between australia & japan i read. read many post from australians on it or were deciding to go on it.

It was first tested in Japan probably because it's a development (synthetic) of a folk remedy popular in Japan & China for centuries. And they probably were expecting it to be safe because the natural folk remedy is so benign.

[meissie47]

wow!! this is very interesting. I was just in my neuro's ofice last month and he was trying to get me to try G. I have been off TY for a yr b/c of being JC+.Been off for a yr.

I had called the office on Friday to tell him I was ready to try G. They said he or nurse would call later that day,but I did not hear from them. Maybe this is why.

I know now I have 2 choices go back on Ty and be deligent watching my symptoms or go back to Copaxone. Although it takes 6-9 months for it to take effect and I relasped while on it a yr ago.

Think I'll take my chances with the copaxone

Meissie