MS patient formerly on Tysabri develops PML while on Gilenya

[agate]

According to the Boston Globe and a couple of other news sources, an MS patient on Gilenya who had taken Tysabri previously has developed PML.

“The current assessment is that Tysabri is the drug most likely associated with this case of PML,’’ Novartis said in the statement. “However, a contribution of Gilenya to the evolution of this case cannot be excluded.’’

“At this stage, we cannot comment on any role Gilenya might have had in this PML case,’’ an Elan spokeswoman said.
A spokeswoman for Weston, Mass.-based Biogen Idec said, “PML is an infrequent, but serious side effect in Tysabri-treated patients.’’ Shannon Altimari, the spokeswoman, said, “We cannot rule out the involvement of Gilenya as a contributing factor.’’

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[agate]

Additional information here. It seems the patient had been on Tysabri for more than 3 years:

Case of PML reported in patient taking fingolimod (Gilenya®) following natalizumab for multiple sclerosis

Source: Reuters Health
Date published: 16/04/2012 13:06



Summary
by: Nicola Pocock
According to Reuters, Novartis has reported that a patient taking fingolimod (Gilenya®) for multiple sclerosis was diagnosed with progressive multifocal leukoencephalopathy (PML). The patient had been taking natalizumab (Tysabri®) for more than three years and the current assessment is that this is the drug most likely associated with this case of PML; however a contribution of fingolimod to its evolution cannot be excluded.

The European Medicines Agency (EMA) is conducting a review of the benefits and risks of fingolimod following reports of cardiac problems, and is expected to report its conclusions next week.

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It isn't known how long Tysabri lingers in the body after a person stops taking it?

The PML figures that Biogen issues are always for the total number of people who have ever taken Tysabri. Does this mean that they don't really know just when person might no longer be affected by Tysabri after stopping it?

[agate]

From the MS Foundation's MSFYi Newsletter, May 1:

A man who was taking Gilenya® and had a history of Tysabri® treatment has been diagnosed with progressive multifocal leukoencephalopathy (PML), a serious brain disease caused by an infection from the JC Virus (JCV). The man, who lives outside the U.S., is now “clinically stable”, according to Gilenya drug maker Novartis.

Novartis said the PML diagnosis was confirmed in mid-March, approximately three and a half months after the man started on Gilenya. He had been off Tysabri for six weeks. Duration of Tysabri treatment had been 3.5 years and he had tested JCV antibody positive.

And:

Symptoms signaling a relapse began a few weeks after starting on Gilenya, according to Novartis. No MRI was taken then, and the man received high dose steroids for five days with no improvement. When symptoms worsened about two months later, he received a MRI that showed lesions suspicious of PML. Further testing confirmed the PML diagnosis, Novartis said.

"The current assessment is that Tysabri is the drug most likely associated with this case of PML," Novartis said in a statement. "However, a contribution of Gilenya to the evolution of this case can't be excluded."

This is the first known case of PML in a person taking Gilenya, according to Novartis. No change in protocol is anticipated. Gilenya, which is currently the only oral MS drug on the market, has so far been approved in more than 55 countries, with more than 36,000 people receiving treatment.

For more information contact 1-888-Now-Nova (452-0051).

[Cherie]

There were some folks on the mSF Cruise last week who said Gilenya was now associated with PML and the doc on Board said, "Absolutely Not!" when asked about it. I was not going to argue because I had only a sketchy memory of hearing about this. At least 6 people on the cruise had gone from Tysabri to Gilenya and were concerned.

[agate]

Somewhere on the Elan Website it is stated that Tysabri remains in the blood for 12 weeks after the last dose. (Sorry I'm unable to find the exact reference just now.)

This person had been off Tysabri only 6 weeks.

[Cherie]

One of the people on the Cruise started it the day they should have gotten their next Tysabri infusion, another 3 months after stopping Tysabri and I don't know about the rest.

[Gary]

I am over due for an appt with the neuro. I need to do something different and am considering G since I have done the ABC route I think in my case anyway that they loose their effectiveness after a while and besides I am sick of the shots. At least the insulin ones are tiny and they don't hurt. For me Avonex was probably the worst. The IM shots were painful.

In addition the C ones are causing dimpling and I am running out of spots that are not effected. A pill would be a big improvement.

[Cherie]

Just today, the FDA issued new warnings on the use of Gilenya with anyone who has any cardiovascular disease. Here is a link to the new warnings.

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[stillstANNding]

Says, among other things, that ekg should be monitored continuously for 24 hours. That would make this an admission or at least a short stay. That will change how insurance pays for it, I think.

[Cherie]

Or they might opt to do a Holter Monitor at home for 24 hours. Less costly and effective.

[stillstANNding]

Cherie, a holter would not save anyone in those hours. They would need to be actively monitored for intervention.
ANN

[Cherie]

I agree. But the wording is cardiac monitoring for the first 24 hours (instead of the first 6). I suggest that some doc's offices might choose to do the monitor at home rather than admitting. Again, this would have to be repeated if someone missed several doses of Gilenya (as on vacation and forgot their meds). This could make things a bit cumbersome and would require a conscious commitment to never miss a dose on the part of the person taking Gilenya.