FDA investigates multifocal leukoencephalopathy (PML) in patient on Novartis multiple sclerosis drug Gilenya

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Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri

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Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri

MSers STOPPING TYSABRI DO IT BECAUSE THEY ARE AT HIGH-RISK OF DEVELOPING PML....

BUT STOPPING TYSABRI LEADS TO REBOUND IN MS DISEASE ACTIVITY

GILENYA APPEARS TO PREVENT THIS REBOUND IF IT'S STARTED WITHIN 4 WEEKS AFTER THE LAST TYSABRI INFUSION



"The study below confirms what we already know; stopping Tysabri/natalizumab leads to rebound in MS disease activity.

Switching to a DMT on a lower-tier of efficacy, i.e. interferon-beta or glatiramer acetate, or taking steroids does not prevent this rebound.

Dr Gavin Giovannoni

In comparison, a higher-efficacy drug such as Gilenya/fingolimod appears to prevent this rebound provided it is started within 4 weeks after the last Tysabri/natalizumab infusion."

"Most MSers stopping Tysabri/natalizumab are doing it because they are at high-risk of developing PML. The major safety concern we have is so called carry-over PML; i.e. PML that presents in the first few months after starting fingolimod.

I am aware of two cases of carry-over PML on fingolimod. Carry-over PML is a problem in that we rely on the immune response to clear you of PML; it takes about 6-8 weeks for fingolimod to wash-out of your system and during this time PML can cause devastating damage. Our practice, to prevent carry-over PML and rebound disease activity, is to do a MRI and lumbar puncture shortly after the last natalizumab infusion. If the spinal fluid analysis shows no JC virus DNA and the MRI shows no evidence of asymptomatic PML we start fingolimod within 4 weeks of the last natalizumab infusion. So far this practice seems to be  working; touch wood we have had no cases of carry-over PML."
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Labels: 100 MOST POPULAR, 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri

Hi Stan,

As for the PML case on Gilenya: Here is Part 1 for my column on MSnewsChannel.com

There are over 60,000 MS patients on Gilenya world wide.  There have been other cases of PML in patients started on Gilenya, but in all cases until this one it was in patients that had just stopped Tysabri, and the PML was felt to be due to the Tysabri, not the Gilenya.

This case is different in that the patient was never on Tysabri.  But the patient was exposed to high dose steroids repeatedly and, briefly, to azathioprine, both known causes of PML.  Also, the clinical characteristics of the disease in this patient is quite unusual in MS.

So, the bottom line is that we must wait for more information on this case and continue to monitor safety reports world wide on Gilenya along with all the other new meds.

I do not think patients should be stopping Gilenya to start other therapies because, of the newer more highly effective therapies, there are none that are clearly safer than Gilenya at this time.  This may change in the future, but even if this case of PML is directly due to the use of Gilenya, we need to consider how best to approach the issue and this will take a few more months as the MS neurologists around the world discuss this case.

Next month, we have a large international meeting on MS in Copenhagen.  I would suggest patients on Gilenya wait for that meeting to end before consulting their doctors about changing their MS therapy.

I will start writing Part 2 for my column 'The PML case on Gilenya" for your MSnewsChannel.com after my international meeting on MS in Copenhagen next month.

Thanks for everything.  Feel free to call any time.

Best
tim
Timothy Vollmer, MD

Co-Director, Rocky Mountain MS Center at Anschutz
Medical Director, Rocky Mountain MS Center
Director, Neurology Clinical Research
Professor, Department of Neurology
University of Colorado

CURRICULUM VITAE

Rocky Mountain MS Center

Click to learn about Dr. Vollmer's Research

Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri

CLICK TO GET DR VOLLMERS'S UPDATE ON THE GILENYA-PML PROBLEM PLUS ANY PROBLEMS ON ALL OF THE OTHER MS TREATMENTS IN THE FUTURE!

WE POSTED EVERYTHING BELOW THIS SENTENCE LAST WEEK WITHIN A FEW HOURS OF THE BREAKING NEWS ABOUT THE GILENYA-PLM PROBLEM:

BREAKING NEWS: FDA Warns of PML Case With Gilenya 

"The FDA advised clinicians to report side effects involving fingolimod to its adverse-event reporting system. It also told patients currently taking the drug not to stop it without talking first with their physicians"

READ DR. VOLLMER'S & DR. APATOFF'S ADVICE ON THE GILENYA-PML PROBLEM BY CLICKING ON THE PURPLE Read More BELOW:

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Labels: 500 Best PML Stories & Studies, Dr. Timothy Vollmer, PML (Progressive Multifocal Leukoencephalopathy)

Novartis has been informed of a progressive multifocal leukoencephalopathy (PML) diagnosis in a JCV antibody positive MS patient who had previously been treated with Tysabri® (natalizumab) for approximately three and a half years prior to initiating treatment with Gilenya (fingolimod).
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Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri