tysabri risk of pml

There have since been cases of PML as well as some deaths in patients who were taking only Tysabri at the time. When I started Tysabri in 2008, the estimated risk of PML was 1 in 1000. They knew being JC positive was a risk factor, but there was no test for it at the time. Most estimates I've seen are that approx. 50-60% of ALL people carry the JC virus, as it is actually very common.

• Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the U.S. FDA and the company have released data suggesting that the risk increases with increasing time on therapy. • The company changed the label of Tysabri to indicate that the risk of PML is increased in patients who have been treated with an immunosuppressant (such as mitoxantrone, and less commonly, azathioprine and methotrexate) prior to receiving Tysabri.

9 (11/1000) Patients taking tysabri risk of PML with positive JC antibody and asecond risk factor (i.e. being on tysabri 24-48 months) 1/250 (4/1000) that does not mean you can not develope PML before the mmagic 24 mark. The risk just in creases at that point.

I have a different take on the risk of Tysabri. What I see as a big risk is the near certainly that your mother will go downhill - possibly rapidly - if she stops the Tysabri. Lets call this a 1 in 2 chance or worsening severely. Then you look at the slightly increased risk of PML after more than two years on Tysabri. The initial risk was 1 in 1000 and now it has increased to about 1 in 800 according to her neurologist.

When the risk of PML was stratified according to three risk factors, the risk of PML was lowest among the patients who were negative for anti–JC virus antibodies, with the incidence estimated to be 0.09 cases or less per 1000 patients (95% confidence interval [CI], 0 to 0.48).

The test tells if the person has been exposed to the JC Virus or not. PML on tysabri has only occured in people who are JC positive. There has not been a single case of PML in JC negative people. You can read the release here- http://www.medpagetoday.

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.

Just an update on PML, for anyone who is currently considering Tysabri, or who may need to look at it in the future...the original 3 cases of PML were indeed initially considered to be due to the use of Tysabri in conjunction with other treatments for MS, particularly interferon.

I had no adverse reaction of any kind to either med. The risk of developing PML, a rather nasty brain infection, is remote with both meds, but higher with Tysabri. Other considerations include insurance coverage. The use uf Rituxaqn for the treatment is "off label". This means that even though it has been used successfuly for years, the manufacturer did not submit Rituxan for FDA approval specifically for MS treatment.

Apparently PML is a demyelinating infection, too- to add an extra level of irony. My chances of developing PML are higher, because of the chemo. My other option is to keep doing steroids once a month- letting my body deteriorate. I am pretty sure that I am going to try the Tysabri. Does anyone have any thoughts or experiences to share with me about any of this? Thank you all so very much, and keep your chins up.

re negative the chance of you getting PML are about as close to zero as you can get, without it actually being zero :-) Prior steroid treatment alone does not increase you risk for developing PML. Prior immunosuppressant drug therapies, like those for treating HIV/AIDS, do. But even if you have had prior immunosuppressant therapies you still need to be JC Virus positive. Rebif is an immunomodulator not an immunosuppressant.

The risk associated with being JCV + and getting Tysabri is PML. PML is a rather nasty little brain infection. In addition to monitoring my blood for JCV, my doc also used MRI to watch for signs of PML. My MS dod not advance, nor did I have any relapses while on Tysabri. I stopped for 2 reasons. The first was that after initially being JCV -, I converted to JCV +. At the same time my doc was able to determine that Tysabri was no loger working.

t necessarily have to stop Tysabri at two years, dpeending on what his doctor says and what level of risk he is willing to assume. We have one member here, Cosmobirdy, who just had her 42nd infusion, without a break, and is doing very well. If I were to continue past the two year mark I would be sure that the infusion center is doing a thorough screening each visit. There are interventions that can be done is PML is suspected early enough. Also, has your friend had the JC Virus test?

And even if Tecfidera ultimately was directly connected to PML, know that Tysabri is too, and yet the vast majority of patients use it safely every month. It's something to be aware of, but no reason to throw out the Tecfidera yet. http://www.foxbusiness.

Deb, I am certainly no expert, but this is what I understand from reading as much as I can and from discussing the issue frequently with my neuro ... if anyone has any more or different information, please speak up, so we can all keep learning more.... :-) The JC virus test detects antibodies to the virus - so if you are positive, it just means that you have been exposed to the virus at some point in your life.

then you have to decide if you accept the risk (1 out of 1000) of Tysabri or the much more certain risk of severe disability. Also remember that one third of people who develop PML appear to recover, as I told you before. Another third develop neurologic damage and the last third die. I understand how much Dr. C has hurt you, but I think you need to try to put that behind you and focus on someone who can give you a new opinion. My heart goes out to you.

m not actually sure you would be a good candidate, not only because of being JCV positive putting you in the higher risk category but because of the higher rate of urinary track infections and your history of infections. See below the linc from the national MS society for the doctors prescribing information to get a full picture of the known issues and if it is worth trying or not. http://www.tysabri.

I truly feel that as more and more people start to take Tysabri, there will be more and more cases of PML, as well as other serious complications and side effects. It just stands to reason... There's still also the risks for serious liver damage, as well as the FDA now having Tysabri on it's watch list because of melanoma. There have been at least 2 cases of that this year, both after only being on Tysabri a very short time.

Tysabri risk of pml

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