tysabri pml update

• 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.

Good update Kyle. Glad your brain is PML free. Hope your CSF is JCV free too. Good luck with the MRI. Glad there are more DMD options available to you. Kinda cool how we RRMSers, SPMSers, etc. can have entire conversations in abbreviation and totally understand what we mean.

From all the information I have received from the Tysabri folks. No one on Tysabri for MS treatment has developed PML in the first 11 infusions. That gives a year to see how patients do on Gilenya.....I may decided at that time to switch.

There is an alogirthm for the chances of contracting PML while on tysabri. I believe it is on the tysabri website among other places. I will see if I can find it for you and report back.

Plasmorephis, blood filtering is already standard treatment to get Tysabri out of the body quickly if PML happens. I saw that a trial had been registered with the US FDA in clinicaltrials.gov when Tysabri was returned to market a trial was registered for Plasmorephis blood filtering to remove Trysabri from the body quickly whren it needed to be removed quickly. I was proud of myself for noticing when that trial was registed with the gov & watched it's successful completion.

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.

Data from the PLEX study suggest that plasma exchange may be an effective procedure for accelerating the removal of Tysabri from the blood if PML infection is suspected. A new warning has been added to Tysabri's label about possible liver injury, and two cases of melanoma (skin cancer) have also been reported in women taking Tysabri, but a connection has not yet been confirmed.

Last week when she went to the doctor, she was informed that patients who has been on the tysabri infustion for over two years have a greater chance of developing the brain infection PML. I believe she was told the odds went up to 1 in 800. However, she was also told that if she were to stop tysabri she was pretty much guaranteed to have an attack of the MS. She has an agressive form of MS and other medications don't seem to work.

Quix - I have wondered how someone without JCV acquired it. Is it airborne etc. Before starting Tysabri I tested JCV -. After 20 infusions I tested JCV +. Now I wonder if I had it earlier, at undetectable levels. It's a moot point for me, as at the same time it was determined that Tysabri was no longer working for me (fetuin-A CSF level). No point in risking PML if the Tysabri isn't working :-) I've moved on to rituximab.

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.

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.

Only people who have been exposed to the JC virus and developed antibodies (about 65% of the population) have contracted PML from taking Tysabri. PML is a disease of the brain, which is usually fatal or at least debilitating. There has not been a single case of PML in people who are JC negative. Being JC negative for me was great news. I had been on Copaxone for over three years and did well until late summer.

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.

But the neuro also talked about Natiluzamab (tysabri) and the PML problems associated with it. The take aways were: PML occurs with other drugs/diseases too, but doesn't occur spontaneously. People with JC Virus negatives NEVER develop PML according to the stats. Most interesting to me was the idea that that European incidence rate of PML is hypothesized to be significantly greater because of the cost constraints of health care.

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.

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.

Hi Kat - I will get my 11th infusion in about 10 days. I have had no issues of any kind in conjunction with Tysabri. From the follow up MRI's I've had Tysabri seems to be doing the trick. No new lesions or relapses since I started. You will be tested for the JC virus prior to starting.

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.

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?

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.

Tysabri pml update

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