tysabri pml risk

• 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).

My doc told me that statistically people with a titer below a certain level have NO increased risk of PML. Above that level the risk of PML goes way up, possibly even higher than the 1 in 1000 which is the standard risk quoted. Interesting enough, it is not a linear risk, meaning that your risk does not seem to go up as your titer goes up from zero. These are the numbers that my neuro gave me, but I don't know the exact units.

Use of other immunosuppressants before Tysabri are a risk factor for PML, but this does not refer to the standard first line DMDs. Have you had any side effects in your time on Tysabri? It's great that your MRIs are stable! Have you talked to your neuro about remaining on Tysabri? Everybody is different, so there are a lot of factors that play into a decision to remain on it or stop. there is also the possibility of rebounding when stopping Tysabri that should be taken into account.

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.

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 just saw a MS neuro at OSU hospital. He asked me whether I was interested in being in the Tysabri study. I am only 37 and have only had one relapse. I know I will be deciding on a treatment and not sure what direction to go. This neuro is big in research and he spent a lot of time talking with me about MS. He mentioned a JC Virus and took my blood to look for it. If I don't, I would be a good candidate for Tysabri. It has 67% reduction in relapses but also risks getting PML.

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.

However, we have some good evidence that the TOUCH surveillance program is learning to pick out at least some of the people who may be at higher risk for PML, stopping the Tysabri and trying preemptive measures to get the Tysabri out of the system. Okay then. What is the worst thing that could happen if you don't do anything - except steroids - and what is the risk that it would happen?

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.

being on Tysabri longer than 24 months, being JC virus postive, and prior immunosuppressant treatment. Even though I have 2 out of the 3 risk factors (I have no prior immunosupressant usage), we are still sticking with Tysabri at this point. He watches me very closely, and I get MRI's every 6 months. Like LuLu mentioned, Gilenya is the newest alternative treatment to hit the market. It is an oral med, but it also has it's own risks.

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.

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.

The JC virus test was developed as part of a clinical trial to hopefully gather enough information from many people to be able to help stratify the risk for PML when on Tysabri. At this point, though, there are no hard and fast answers. The assumption is that if you are JC positive, you stand the CHANCE of developing PML - it certainly doesn't mean you will develop it.

The arguments you gave to me are not to be considered, as their are not true. the risk to develop PML with tysabri is 1/10000, not the risk you wrote, for example. So, your decisions concerning yourself do not meet my ethics. I do respect your decision, but I consider that my work does not consist to wait peacefully for the development of handicap of a patient. Yours decisions in the past (to stop copaxone) and now (not to treat you with the most efficient drug) are not reasonable.

com/prescribingInfo A lot is out there regarding the risks of PML but most is in regard to people already on Tysabri and then becoming JCV positive, not much actually discussed risk prior and choosing it. All i can surmise is possibly patients and doctors are not choosing Tysabri when they their is a high risk factor..... "For JCV antibody–positive patients with no prior immunosuppressant use, the risk for PML increased with longer natalizumab use.

t monitor as closely as we do. I think if we are on Tysabri, we just have to accept that this is a very real risk, and just be even more vigilant watching for any changes in our physical or mental status. The sooner it is identified, the better your chances are to not have so much permanent damage. 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...

Tysabri pml risk

Common Questions and Answers about Tysabri pml risk

tysabri