Patient taking oral MS medication Gilenya developed PML

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

Patient taking oral MS medication Gilenya developed PML

Postby MSUK » Tue Jul 30, 2013 4:42 am

A patient taking Novartis' multiple sclerosis pill Gilenya developed a rare and potentially fatal viral disease, the Swiss drugmaker said on Tuesday, an unexpected setback as it faces growing competition from new oral treatments.

Gilenya is one of Novartis' big new drug hopes, growing 66 percent in the second quarter to $468 million. But the drug faces competition from new medicines such as Biogen Idec's Tecfidera....... Read More -
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Re: Patient taking oral MS medication Gilenya developed PML

Postby CaliReader » Tue Jul 30, 2013 7:39 am

Thanks for the news.

I will be following this story closely. I feel better on Gilenya than I have in years, but this is worth watching.

I have never taken Tysabri or any other immune depletor. I want the details of the case. The article said there were unusual
aspects to the health history. PML is not a risk I'm comfortable taking.

"By the time there was a similar level of patient experience with Tysabri there had been 298 cases reported." So far 71000 patients on Gilenya. Up to now, the only one with PML had already taken Tysabri.

I'll watch for now, and report back when I know more/ make a decision.
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Re: Patient taking oral MS medication Gilenya developed PML

Postby cheerleader » Thu Aug 01, 2013 3:17 pm

Gilenya is a very stong "immune depletor"--like Tysabri and Tecfidera. Fingolimod (Gilenya) is a sphingosine 1-phosphate receptor modulator, which keeps lymphocytes in the lymph nodes, preventing them from fighting a virus or bacteria in the central nervous system. Depleting lymphocytes, or sequestering them, allows for fatal infections in the brain.

This has been noted before the recent PML case, in two fatal brain infections (herpes and zoster)

Serious herpes infections are the major risk seen in the fingolimod trials. Fatal herpes infections (herpes encephalitis and disseminated zoster) occurred in two patients with MS on fingolimod 1.25mg/day who also received high dose IV corticosteroids for relapses. An additional four patients receiving fingolimod in the controlled trials experienced a herpes infection requiring hospitalization (two on 1.25mg/day and two on 0.5mg/day). ... Update.asp
Keep your eye on your lymphocyte levels, CaliReader--and talk to your doctor about any concerns.
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Re: Patient taking oral MS medication Gilenya developed PML

Postby CaliReader » Thu Aug 01, 2013 7:30 pm

Cheerleader, thanks for the advice. I appreciate it.

I'm still processing this and waiting for more information and the chance to talk to my doctor.
At minimum, I will monitor my lymphocyte levels, paying out of pocket if need be.
Also, thanks for the snippet. I had read the articles detailing the clinical trials, but had
forgotten that steroids were linked to the fatal herpes infections. I can avoid steroids.
I can ask to be checked for the JC virus.

Beyond that I'm not sure. I'm still fairly new to all of this. Not to having the disease unfortunately, but to knowing I have it and
to weighing these kind of complex health risks and benefits. I'm going to sit with the information for a while,
protect myself as best I can, and think through whether I want to change treatment.

If I'm going to use an immune depleting therapy, I have a narrow window while I'm still
young enough to believe that I can beat back infection if needed and while I'm still
RRMS. If I can gain a few years better health, that should be worth it... or at least
that was the theory. PML is possibly a risk too far.

Thanks for all the research re endothelial health. I'm following that track too.
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Re: Patient taking oral MS medication Gilenya developed PML

Postby CaliReader » Thu Aug 01, 2013 8:33 pm

Also, re-reading this, reading nuances in your email that I missed the first time,
suggests to me that I've already got some real cognitive decline from where I was 5 yrs ago.

That cuts both ways re the risk benefit ratio. I won't whine about issues, hopes and fears we all share here, especially when I'm doing better than many.

Re immune depletion, I meant that Gilenya was my first. I have no history of immune depletion.

Re comparative risk to Tysabri, there are other sources of active immune cells besides the lymph nodes.
Blocking the sphingosine receptors keeps a large percentage of immune cells out of circulation and out of the central nervous system, but not all. Gilenya is still less risky statistically than Tysabri for PML, but not for other potentially fatal issues.

When I made my decision, I discounted the risk of death, as opposed to either slow or quick disability.
Now, my pain is nearly gone. I am doing much better. More strength, more energy, less depression. Mild balance
and mobility issues when I get tired. How much of that is due directly to Gilenya?

But, now, with the PML case, when I look at Gilenya, I have to know that there is also a small risk of quick and horrible neurological
disability. This could also be true of Tecfidera. It is too soon too tell.

Feedback is welcome. I will report back if I make a change, and as I learn more.
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Re: Patient taking oral MS medication Gilenya developed PML

Postby CaliReader » Thu Aug 29, 2013 7:24 am

This is from the fda website... I'm guessing it is the same patient as the July announcement by Novartis, as the announcement claims it is the first PML case for Gilenya, not to have been on Tysabri first. There was some other immune suppression done with Azathioprine and with multiple courses of steroids.

FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
Safety Announcement

[8/29/2013] The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.

Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems. Some medications, including Gilenya, can weaken the immune system.

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. MS is thought to affect more than 2 million people worldwide. The drug was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.

The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.

We urge health care professionals and patients to report side effects involving Gilenya to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

For more information about Gilenya, read the patient Medication Guide (PDF - 216KB) or the Risk Evaluation and Mitigation Strategy (REMS) (PDF - 473KB).
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Re: Patient taking oral MS medication Gilenya developed PML

Postby sruasonid » Sun Sep 08, 2013 1:09 pm

I just posted the following on another thread that was asking anyone if they got infections since taking Gilenya. (This is just part of my answer there):

"I've been on Gilenya for over 18 months now. About 8 months ago I started getting HORRIBLE herpes outbreaks. I contracted herpes in 77 but had not had a single outbreak since 1988 and only 3 or 4 mild ones between 77 and 88. Early this year (2013) after about a year on Gilenya, I got the first outbreak of herpes I'd had in 25 years. It was worse than the first one and lasted over 2 weeks. It was gone for maybe 3 days and the next one hit. Since then I've had them nonstop even though my OB/GYN put me on a high dose of Valtrex that I take every day. About the same time I got a bladder infection; same thing, after being treated for it and it went away, I kept getting another and another no matter what antibiotic I take." Hm. Yep, I'd say my poor little ravaged body is a prime target for infections.

I stopped taking Gilenya today on my own since my doctor ignores everything I say and insists I'm "getting better" no matter what I tell him about what's going on with me. I plan to see another doctor tomorrow and try something else - after waiting the two months to get rid of the effects of Gilenya. And I've already started fervently praying that I don't already have, or someday develop, PML.

A couple of thoughts I had re Novartis' reaction to the PML case: First, they imply that it's not a big deal because Tysabri gave more people PML faster than Gilenya - wow, how many dead people is too many? Second, it's always pointed out that this is only one person of many - gee, I wonder how YOU OR I would feel if we were that ONE person? But what strikes me as most egregious is that nearly every article mentions how Novartis is worried (my take) that this might impair their ability to compete with the newer oral MS drugs coming out (meaning cut into their Gilenya profits). I'm not angry about that, just sad. No matter that these are people's lives in the balance, people who have a nasty disease we didn't ask for, deserve, or expect, trying to cope as best we can and grasping onto the "miracle drugs" being developed for some little bit of hope. Nope, that's not what they're in it for; not enabling people to live or be healthy - it's all about PROFITING off unfortunate sick people. Lucky for them there's so many of us out there with MS hoping for the cure, or at least to feel better. I don't begrudge anyone profit, after all, who works for free? But it just struck me reading about something so horrible and their major worry about this guy with PML is that it might cause their stock to go down. Like he's just a fly in the ointment instead of a scared, sick human being. Made me want to cry. I don't usually feel sorry for myself for getting MS, and I haven't been scared before, but I'm sad and scared and beaten down now.
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