MS patient on Gilenya for 4 years develops PML

[agate]

Novartis has put out a safety update in connection with an MS patient on Gilenya for 4 years who developed PML:

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The patient had not been on Tysabri previously.

[SuzE-Q]

Thanks, agate. Looks like this might not be the first PML case associated with use of Gilenya:

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[agate]

This newer case seems more significant because the person was on Gilenya for 4 years, compared to 7 or 8 months for the other one:

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More information about the 2013 case is on the MSAA Website:

... another woman with MS who was taking Only registered and activated users can see links., Click Here To Register... for seven months and was diagnosed with progressive multifocal leukoencephalopathy (PML). This serious infection of the brain has been associated with Only registered and activated users can see links., Click Here To Register..., another treatment for MS, although this individual did not take Tysabri in the past.
Novartis Pharmaceuticals (the makers of Gilenya) states that the patient had received interferon beta treatment for one month in combination with azathioprine prior to receiving Gilenya. (Azathioprine is an anti-cancer drug that has also been linked to PML.) In addition, she received repeated courses of high-dose corticosteroids over the brief course of her illness (she was diagnosed in May 2012). The company also notes that the course of this person's MS prior to starting Gilenya was considered to be "atypical," with unexpected findings on the magnetic resonance imaging (MRI) scans, a more rapid disease course, and unusual symptoms. No conclusions may be made at this time and Novartis is working with the reporting physician to learn more about this patient's history and any other contributing factors.

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One would like to know more about how these patients have been doing but that's probably confidential information that rarely reaches the public.

[Howie]

PML is pointing the way to a cure for MS. What is being affected in the body in these cases of PML by different drugs? And what component of the drugs causes it? The answer would be a significant step towards a cure.

[Cherie]

So now we have CellCept, Tysabri Tecfidera and Gilenya that have patients who have developed PML while on these meds.

[stillstANNding]

Also Rituxin although it is not specifically for MS.

ANN

[SuzE-Q]

Also Rituxin although it is not specifically for MS.

ANN

Yes, any of the monoclonal antibodies, or immune suppressors, would increase the risk of an opportunistic, but latent infectious agent proliferating.

I think this is why it's so important for researchers to address the reason for the demyelination as opposed to trying to dampen the reaction to it. Let's stop the cause of it.

[Cherie]

My neurologist told me that with Rituxan there have been no cases of PML in PWMS but have been in those with RA. When I researched Rituxan before agreeing to take it, I found the same information. Same with CellCept...no one with MS but folks with Lupus had gotten PML. (CellCept and Tecfidera and Gilenya are not monoclonal antibodies). The ONLY monoclonal antibody used in MS that is given to PWMS that has produced PML in a person with MS is Tysabri.

[SuzE-Q]

Cherie, I just don't think enough MSer's have taken the other mab's yet. I suspect (or fear) that cases will come up if more people take them.