Tysabri - 9th case of PML
 

The 9th case of confirmed PML (or 6th, Post-marketing), was revealed on the Biogen site on Friday . . . .

http://arthritis.about.com/gi/dynami...e%2F019_2.html

So that brings the total ratio of confirmed cases (for those who've used it for 18+ mo, including trial patients), to 9:24,400:

14,400 – used it for 18 mo (post-marketing)
6,800 – used it for 24 mo (post-marketing)
1,800 – were on 18 mo (during trials)
1,400 – were on 24 mo (during trials)
24,400

Or a current ratio of 1:2711.

Cherie

Please stop mixing apples and oranges by including the original trial data with the post marketing experience. Patients deserve honest information about their potential risks. 6 PML cases in the post marketing setting with almost 25,000 at 12 months or greater and 14,400 at 18 months as of the end of Mar 31, 2009. It is also important to note that 4 of the 6 PML cases appear to be in German patients which begs the question of whether the German usage of Tysabri is outside the US TOUCH procedures. I'll leave the calculation of the PML risk to the biostatisticians.

Personally, I really don't think it makes any difference to the number of PML cases as whether it happened during the trials or afterwards. The bottom line is that the patient being treated with Tysabri ended up getting PML and that IS the concern.

I also don't think that it makes any difference that the German cases happened outside the Touch program. The German medical system, the last time I heard, was excellent. I read on another MS forum that the German's were being very honest when it came to reporting problems with Tysabri use.

I fear that the PML count for Tysabri users will continue to climb and make the MS patient's decision to try the drug even harder to make.

Harry

I am pretty sure that all Ty users including those from the trials is approx 52,000. So using this number with total pml cases would make the odds a little less than 1/5800. The number post trial is appox 40,000 Ty users with 6 pml cases making these odds around 1/6700. My mind just can't remember where I read the numbers on Ty. I hate when this happens and I just read it recently...sorry:o
Linda

That's sad for those who passed however the odds are too great. Every drug we take can have bad side effects. For the good I have seen Tysabri do I say the risks are too small to not give it a try. Olhipie was on it for 7 months in 2007. Actually made him sick after each dose. :(

Calculate it however you choose, Chris . . . the numbers are all there, so if reducing it by three (or taking out the German cases) makes YOU feel better, go ahead. Whatever floats your boat. :rolleyes:

The original risk ratio of 1:1000 was calculated on the basis of how many had used it for 18+ months. They calculated the mean amount of time that everyone in the trials had been on it, and there were 3 cases of PML, so that gave a ratio of 3:3000, or 1:1000.

We don't have a 'mean' of 18 months on the market yet, so the best numbers we can use for comparison is how many have simply been on for 18+ months. I provided those numbers, which is 24,400 people with 9 cases of PML to date, or 1:2711.

Cherie

ummmmmm

careful with the tone of these responses please

"apples and oranges" and "deserve honest information" and "whatever floats your boat" are bordering flaming each other and not conducive to an intelligent discussion of the topic, but reduce it to a spat.

if you must disagree, please do so agreeably

we really dont want to have to intervene here but if the guidelines are broken we have to

thanks

[QUOTE=lady_express_44;498927]Calculate it however you choose, Chris . . . the numbers are all there, so if reducing it by three (or taking out the German cases) makes YOU feel better, go ahead. Whatever floats your boat. :rolleyes:


The apples and oranges comparison is easily supportable. In the original trials ,which drove the 1:1000 label (3 pml cases:3000 patients), the PML cases occurred in patients who were on other immunosuppressants (Avonex/1 recently had Remicade and Imuran). In the post-marketing setting, concommittant immunnosuppressants are specifically contraindicated i.e. shouldn't be being given. Different usages (apples vs oranges) can clearly affect the relative risks of an opportunistic infection.

In no way do I exclude the 4 PML cases from the 6 post-marketing cases confirmed. It does suggest given the patient numbers in the US and other countries excluding Germany and only 2 confirmed cases versus the patient numbers in Germany and the 4 confirmed cases that this isn't just random chance and normal distribution. I don't know how the Germans are using this drug compared to US Touch (although the husband of PML patient #5 postmarketing said that Germany had no periodic MRI monitoring) but I would certainly investigate to see if there are any identifiable differences that may explain this.

All I know is that those numbers don't mean squat to most of us...my eyes cross when I see ratios, etc. I truly get brain fog...
What the discussion needs, as far as I'm concerned, is how those who are on Ty feel about the risk/benefit ratio...
I have talked to a few people who are on Ty, and they feel it's worth the risk...they feel so much better as far as their quality of life is concerned. So many of us on DMDs have side effects or do not get relief from our sxs.

If a patient feels that the quality of life is worth the risk, and is fully informed, then that is the barometer I wish to go by.

While I have no doubt that Germany's medical system is good, the husband of PML patient #5 (post marketing in Germany) just posted that Germany just instituted periodic MRI monitoring for Tysabri patients in response to the first 2 PML cases. All systems clearly have their weaknesses.

Chris