Sad news

[MrsBones]

A case of PML has been diagnosed in someone taking Gilenya without prior use of Tysabri. The patient has been using Gilenya about 8 months. Of course, investigation will be done, but Novartis doesn't believe it was caused by the Gilenya.

http://www.medpagetoday.com/Neurolog...ews_2013-08-29

[tspaulding]

[QUOTE=MrsBones;1424447]A case of PML has been diagnosed in someone taking Gilenya without prior use of Tysabri. The patient has been using Gilenya about 8 months. Of course, investigation will be done, but Novartis doesn't believe it was caused by the Gilenya.


I just looked up another medication that this patient was taking, an autoimmune med, Imuran, for chrohns, lupus, RA. That medication has a .89% chance of getting PML.

I would definitely encourage all patients taking gilenya to speak to their neurologists.

[Dreams008]

According to the FDA, who just released a statement yesterday, this client received numerous corticosteroid treatments. The patient was also on other immune-suppressing drugs. Their statement today said that Gilenya did NOT cause the PML, but it was factors before she started taking it. They encouraged people to not stop taking Gilenya without consulting your doctor. Hopefully, by 2015, we'll have a cure for the JC virus, as a company is currently working on that (google JC virus cure), and we will no longer have to worry about the dreaded PML.

[MrsBones]

Yes, the one month's exposure the Imuran is in that link I posted.

Unfortunately, this has not been the only case of PML in a person taking Gilenya. Like most of us, people have tried more than one drug. At least one other person developed PML after taking Tysabri , then Gilenya. Many immediately blamed the Tysabri, which we know is involved with the development of PML, as are many drugs that suppress the immune system. As this patient didn't take Tysabri, but an immune suppressant, we may be looking at another Tysabri situation, in which you have to consider not only the drug's inherent risks and side effects, but if you're JCV+ and what you've previously taken, as well.

It isn't so much a specific drug used previously that may be involved, but that it was a drug that sufficiently effected the immune system.

The same thing happens with Tysabri. The greatest risk is when you are JCV+, have taken IS previously and have long term exposure. Sadly in this case, the person was only exposed to Gilenya 7-8 months after one month's exposure of Imuran. We don't know enough yet to have an idea of how much Gilenya is too much after IS, like we do with Tysabri.

This is a mighty big flash back to the early days of Tysabri and PML. First, it was taking it with another drug, like the people in the trials who took it with Avonex. Then other people started getting it and we figured out JCV was involved and now we know that prior use of IS, a certain exposure to Tysabri and being JCV+ are all factors.

We can apply that to Gilenya. Sadly, unless others develop it and there's more data, we just don't know what the risk is. In light of this latest case, people taking Gilenya should definitely talk to their dr about their JCV status, history of medications and what it might mean to them.

[Kuda]

How bad was the PML? Did the subject die or...?

Thank you,
Kuda

[22cyclist]

PML is pretty bad. If they catch it early, sometimes they can treat it and it works. Otherwise the patient dies. It is something you want to know about if a PML case has been found. Read up on the Ty site. I take Tysabri and am tested for JC virus every 3 months. MRI every 6 months now. It depends on your JCV index and your other risk factors. Like in Ty, how long you have been on it. Never hurts to be informed.

Lisa
Moderation Team

[Scooter24]

Just a little clarification on 22cyclist's comment

PML is pretty bad. If they catch it early, sometimes they can treat it and it works. Otherwise the patient dies.

The current mortality rate for PML tysabri patients is approx. 23% Though many do have more issues afterwards.