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Julie  Stachowiak, Ph.D.

UPDATED: PML in Gilenya User with Previous Tysabri Exposure

By April 23, 2012

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Just ran across this article in the April 13, 2012 Wall Street Journal (a little late): Novartis Gilenya Patient Gets Rare Brain Disease.

Turns out that someone who was using Gilenya got diagnosed with progressive multifocal leukoencephalopathy (PML), the brain disease most associated with use of Tysabri in MS patients (or in people with AIDS). The person had previously been treated with Tysabri.

I have always been under the impression that the PML risk associated with Tysabri went away after stopping the drug, as the immune system returned to normal levels. However, maybe it is possible that it retains some sort of "memory" and certain cells are easily affected again on another drug. I just don't know.

I have not yet been able to find out any details, such as how long the person had taken Tysabri and how long it had been since they had stopped. Nor do I know how many doses of Gilenya this person has taken or what their status is today. This is definitely something to keep an eye on. I would appreciate it if anybody with more details could write into the comments section and share what you know.

UPDATED: I did receive communication from Novartis today that the person who was diagnosed with PML had been taking Tysabri for 3.5 years prior to beginning Gilenya and was JC virus antibody-positive. The risk for PML goes up drastically after a person has been on Tysabri for 2 years (24 infusions) and is JC virus antibody-positive.

I do feel like i need to add a comment of my own about Novartis' conduct in this matter. I do not feel like they are being at all reluctant to share information. From what I can tell, there is simply not that much information to share at this point. I think pretty much anyone would say that the main contributing factor for PML here is Tysabri, but if and how subsequent Gilenya doses somehow interacted with a Tysabri-exposed immune system is the question. It could only benefit Novartis to figure this out as soon as possible and communicate their findings.

Read more about PML:

April 23, 2012 at 3:23 pm
(1) Sherri says:

It’s no surprise that you haven’t been able to get any answers about this. Novartis is being tight-lipped about a number of things, including the actual death toll from Gilenya. I spoke with a neurologist in the SF Bay Area, and there have been two more cardiac-related deaths in this area.

According to the Cafepharma board, it seems that more information will be coming out about infections. More PML cases? Perhaps, but I hope not. Of course, I can’t post to ask any questions on that board to get any answers, so if you do, let us all know.

April 23, 2012 at 5:48 pm
(2) Ben says:

I am about to start my 19th infusion of Tysabri. That being said, my nuerologist (a leader and chairman of neurology at a large university), and I just had a meeting about my on going treatment with Tysabri. He said since I am JC negative, I was the perfect candidate to continue on Tysabri indefinately and I have no risk of developing PML. I have previously taken other MS therapies (Avonex & Copaxone) before my start of Tysabri. I believe that to be the original thought of cause to a person to develope PML. I took the risk. After about 6 months of treatment, they said that was a wash and that a person would have to be JC positive to develope PML. Now I am reading the news that you can be JC negative and still develope PML. What the $&?! is going on? Should I be nervous? Should I consult a different nuerologist? Will I never be able to switch to a new/different therapy in fear of developing PML? Can I/should I stay on Tysabri? Thoughts please.

April 24, 2012 at 10:17 am
(3) Steve says:

Julie, I’m surprised Novartis gave you as much information as they did, given the US health privacy laws.

That the Gilenya patient had been on Tysabri does not mean the Tysabri caused or contributed to the PML. It may have, it may not have. We didn’t know Tysabri increased risk for PML until we did. Maybe we’re learning Gilenya also increases risk of PML.

The amount of time Tysabri (and other drugs, too) remain in the body is affected by several factors. The drug itself breaks down over time. The body flushes foreign substances (such as drugs) out of the system over time. Tysabri attaches to certain cells in the body that have a limited lifetime and are then flushed from the body. Each of these factors, as well as others, very by person and environment, so it’s tough to say with certainty what the rules are for switching medications. The safest bet would be to choose the most conservative time estimate, and overshoot even that. But, the longer one’s off therapy, the more likely another flare-up becomes. Gotta weigh the risks and rewards.

Ben, I don’t think you should be nervous. I was on Avonex for four years before switching to Tysabri. I’ve been on Tysabri for five years. I am JCV positive. I’m happy with Tysabri and intend to stick with it until something else proves significantly safer. I’ve not heard that people that are JCV negative and on Tysabri are developing PML.

April 25, 2012 at 7:50 am
(4) Ben says:


Thank you for your thoughts. I really appreciate that. I certainly have a lot to think about. I wish you all the best.

April 25, 2012 at 11:34 am
(5) Beth says:

Great piece. Though it’s just the tip of the iceberg for Gilenya. As with any new meds, just b/c it’s seen massive amounts of clinical trial data, doesn’t mean it’s going to react the same way in the general population. Clinical trials as a rule are always more exclusive than inclusive. You’re missing many co-morbidities that exist in the real world. So in essence it takes two, three, four years to see what the drug really does. IMO as time marches on it seems this drug will be segmented into certain pwMS. Already in Europe it’s only allowed as a second line treatment, which from what I’ve heard in speaking with neuros here in the US is the way they trend towards using it as well. What also isn’t widely published are respiratory issues. If you have any type of respiratory disease such as asthma, it’s not recommended. I too am surprised they spoke with you at all Julie, but they were also reading from a well crafted, multi-layered senior management approved Q&A. It’s great to have more choices, as with anything else read, read, read, to make informed healthcare choices. And ask LOADS of questions!

April 25, 2012 at 12:13 pm
(6) bhorsoft says:

As my docs have said, most of the new drugs have been fast-tracked. The trials are small and are more exclusive than inclusive. When you dramatically increase the population of a drugs users, you will start to see more complications. In a sense, the first couple of years on the market for a new drug are really an extension of the clinical trials.

My understanding about the Gilenya heart deaths is that the two patients were also cardiac patients and were taking heart drugs that also slowed their heart rate. It could have been communication deficits between doctors and pharmacists as they were probably not good candidates for Gilenya while taking the heart meds.

I’ve been on Copaxone, Rebif, had 3 infusions of Tysabri and I’m now on Gilenya since January. Happy with it (except for cost) – no infection issues (had them badly on Tysabri) and it may be working (hard to tell with all MS drugs). BTW, diagnosed in ’86, so I’m a longtime patient – was one of the first folks diagnosed with the then new-fangled MRI.

April 25, 2012 at 4:20 pm
(7) Colleen says:

I’ve been on Gilyena for 2 mos now after being on Avonex for 3 yrs. I can say I feel great. (I’m also on Ampirya and it has made a very noticeable, positive, difference in my walking and mobility).

Since Gilyena restrains the white blood cells from floating around (and getting into the brain), maybe that had something to do with the PML–the body couldn’t fight the infection off.

April 25, 2012 at 8:45 pm
(8) May says:

My husband was wheelchair bound, diagnosed late in life 2009 but has been suffering from MS since he retired in 1994 with optic neuritis. After taking morphine and opiod tablets as prescribed by specialists, he still could not walk and the said pain relievers after over a year or two of taking them, would not work on him anymore. Just like another MS patient who we know, my husband tried the CCSVI theory . He had venous angioplasty February of this year and lo and behold, he came to the hospital as a cripple and the same evening we came home, he was walking. I have never given up researching and I shall make sure he would take the safest medicine. Whatever it is that made him walk and free from all MS pain, I will not question anymore.

May 1, 2012 at 2:16 pm
(9) sandra says:

I have just had my 9th infusion of Tysabri,working okay but still have problems with the balanceand dizziness.I am JC positive so will only be able to stay on Tysabri until September then hopefully onto Gilenya,heard and read some very promising results.

May 1, 2012 at 7:37 pm
(10) kristin says:

May, can i ask you where your husband went for this ccsvi theory and venous angioplasty? i have never heard of this and am very interested. i have taken my 54th tysabri infusion and am jc positive. i feel as if i’m playing russian roulette and need to change therapies asap….

May 7, 2012 at 7:23 pm
(11) Lisa says:

I’ve taken Novantrone previously, and my doctor tells me that THAT puts me at greater risk for developing PML. I took Tysabri for just under a year, but I don’t believe he would let me have it now, with the knowledge that he has. It’s my understanding that my risk is permanent, that is, it doesn’t go away with the passage of time.

June 15, 2012 at 9:02 pm
(12) Tabatha says:

I am currently on Tysabri and was originally negative for the JC virus. After about 2.5 years, I was just tested last week again and am now JC positive. Now my neuri wants me to decide to stay on the Tysabri or switch to Gilenya. Has anyone else, had this happen

August 26, 2012 at 11:54 am
(13) todd hewitt says:

I am just greatful that awareness is being increased about the mere existence of PML. Three years ago my daughter’s own Infectious Disease Specialist had never even heard of it; unfortunately for my daughter it was too late!

September 14, 2012 at 1:12 pm
(14) Lyman Foster says:

I am a current MS patient on Tysabri the risk of PML is on everyone’s mind who takes it. My neurologist warned me about the risk and performed the test to make sure I was not previously exposed to the JVC virus. From what I was told is that most people can only be on Tysabri for 2 years. The risk for PML increases exponentially after those two years. If prescribed Tysabri make sure that your neurologist is well informed on the matter.

January 28, 2013 at 7:31 pm
(15) todd hewitt says:

This site is for and about PML Awareness.

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