Tysabri - 9th case of PML

lady_express_44 · 04-20-2009, 07:27 PM

Quote:

Originally Posted by komokazi

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.

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.

Quote:

Originally Posted by Grammie 2 2

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

Linda

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

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