Gilenya Patient Contracts PML

[Marco]

A Gilenya patient, without previous Tysabri exposure, has contracted progressive multifocal leukoencephalopathy (PML). Novartis has reported a case of PML in an individual who had received Gilenya®* (fingolimod) for more than 4 years for the treatment of relapsing-remitting multiple sclerosis (RRMS). Novartis has informed the regulatory authorities of this case, and is investigating whether treatment with Gilenya® contributed to the development of PML.

Details of the case: The following key medical details have been sent to Novartis based on the data currently available:

• 49 year old male who first experienced MS symptoms in Oct 2009 and was diagnosed with RRMS in Nov 2009.
• The individual began treatment with Rebif®, which was discontinued in September without the initiation of treatment with another therapy.
• In March 2010, the individual had another MS relapse.
• Treatment with Gilenya® began in Oct 2010 (he is currently participating in a Gilenya® non-interventional observational study).
• There were no reported co-existing conditions, nor was he taking any other medications during treatment with Gilenya®.
• He had never received treatment with Tysabri®.
• A routine MRI evaluation performed in January 2015 detected several lesions which were considered unusual for MS and compatible with a diagnosis of PML. The individual tested positive for JC virus, confirming the diagnosis.
• The patient is currently doing well. Gilenya® was discontinued.

http://www.novartis.com/newsroom/pro...y-update.shtml

[Waydwnsouth1]

What other medical problems might one have to contract PML? This is an eye opening post as I just started Gilenya 2 weeks ago and also tested positive for the JC Virus. What other medical problems might one have to contract PML? I would think it's not limited to MS and its treatments.

[Temagami]

Thanks for the heads up. If you run across the lymphocyte count for this patient, please post it. I´m creeping closer to the 4 year mark. Novartis talks about 138,000 patient treatment years with no cases of PML, BUT, what if it all hinges on the length of time a particular patient is taking the drug? What if the effect is cumulative? Then the patient years are less meaningful One more thing to worry about. Ugh.

[Marco]

What other medical problems might one have to contract PML? This is an eye opening post as I just started Gilenya 2 weeks ago and also tested positive for the JC Virus. What other medical problems might one have to contract PML? I would think it's not limited to MS and its treatments.

For people without a compromised immune system there is basically a zero chance of contracting PML. A healthy immune system can easily keep the JCV from reactivating and eventually morphing into PML. The metamorphosis from JCV to PML takes time and at any point can be interrupted by a healthy immune system. The problem for MS, HIV, organ recipients, etc is when they may take drugs that suppress their immune system allowing the reactivation of the JCV.

To mitigate the risk, doctors should have their patients on immunosuppressant therapy submit to regular blood work (CBC) to monitor their lymphocyte counts. For Tysabri patients, they can also receive the JCV stratify test at no charge. Patients also need to be aware of early warning signs and receive prompt medical attention. Unfortunately, symptoms of PML can often be confused with an increase in normal MS symptoms (visual problems, fatigue, balance issues, etc). This is one area where prudence and precaution should always be exercised.

I hope I answered your question, but I am not a medical professional. Neurologists should be doing more than writing a script and sending patients to their pre-approval person. Patients should be doing more than just accepting a script without understanding the pros and cons.

[Marco]

Novartis talks about 138,000 patient treatment years with no cases of PML, BUT, what if it all hinges on the length of time a particular patient is taking the drug? What if the effect is cumulative?

It stands to reason that the longer you artificially suppress the immune system the greater the PML risks. The precursor to Tecfidera had close to 190,000 patient years before the drug was ever approved and that went up in a cloud of smoke. Tecfidera is also considered an immunomodulator and not an outright immunosuppressant. I get quarterly CBCs to monitor my lymphocyte count -- not sure else what I can proactively do besides pay attention to my health and seek prompt medical attention when needed.

I would definitely save and ask your neurologist your questions.

[rsinger]

Gilenya PML case

It is my understanding that following a patient's WBC count is very important especially if a patient is JC virus positive. Paying close attention to the absolute lymphocyte count is crucial. I wonder if this patient was being followed closely. I would think so given that he was in a study but who knows. Hopefully in the next few days there will be more info on this case.

[allHailye2]

lymphocyte count IS important! (coming from someone whose count plummeted to 260)

[Temagami]

Am JVC+ and have a consistently low lymphocyte count- between 200 and 240. Ugh, worry is a nasty companion.

[allHailye2]

Am JVC+ and have a consistently low lymphocyte count- between 200 and 240. Ugh, worry is a nasty companion.

what does your dr say about that?!?!

[tspaulding]

I would think so given that he was in a study but who knows. Hopefully in the next few days there will be more info on this case.[/QUOTE]


I looked up an observational study and its just that, one does not have to be tested on a regular basis for WBC so we do not know how often his counts were tested.

The good thing is he is alive and off gilenya. I hope the best for this individual.

[Temagami]

Got a WBC panel and my lymphocyte count came close to doubling- still below normal, but the highest it has been since starting DMTs. The variables between checks (Sept. and March) are: taking magnesium via a cream that is absorbed in the skin- was taking oral supplements prior, taking vitamin B3, doing daily ocean breathing several times a day(google for the how to) which calms the entire body. It was a dramatic increase and it pulls me far above the scary Gilenya cut off mark.

[TaoWarrior]

5.5 years on Gilenya and no issues yet. So far all blood work has been good. So not sure if this individual just got unlucky or what. Keeping my fingers crossed Gilenya has been good to me so far and would hate to have to find another DMD.