Confirmed PML

[rsinger]

Just read that Biogen has comfirmed its first case of PML in a patient who recently died of complications form pneumonia. Anyone else hear of this? Apparently this person had been taking tecfidera for 41/2. The article states that the patient had severe lymphopenia for 31/2 years. Hard to believe that a doctor would allow any patient to continue therapy for that long with severe low WBC.
Any opinions?

[agate]

I've seen several very recent articles about it. Apparently it's shaking up Biogen considerably.

I don't have any more information than you've already provided. Sorry!

[Myoak]

There were several articles about this yesterday in investment media. I'll link one of them: http://www.bloomberg.com/news/2014-1...estimates.html

Of course, you can Google the topic and read more of the same. Since a few PML cases were experienced with Fumaderm, the forerunner of Tecfidera, it was not unexpected for PML to show up in Tecfidera.

One thought is that fumaderm, given for psoriasis, is mostly given for short periods and some theorize if given for longer periods more cases of PML may have surfaced.

Some have theorized if Tecfidera is taken for a long period then some cases of PML would occur. However, if patients are monitored for lymphopenia, or white blood count suppression and taken off when appropriate then PML should not become an issue.

So far, 1 out of about 100,000 taking Tecfidera has gotten PML. With proper monitoring that rate may not increase. Only time will tell.

[REG53]

Thank you for the infor. We should all make sure we get our blood tested and know our wbc level so we can make our own decisions. I also can't believe the dr. kept his patient on tec.

Very sad.

[JerryD]

I just called the Biogen phone number listed in their Tecfidera brochure. The rep told me to discuss the issue wih my prescribing doctor. There is no mention of PML in the paperwork that I have been given by the doctor's office.

[agate]

There had been a couple of PML cases in patients being treated with Fumeric Acid for dermatologic problems. One of them is described here:

http://www.nejm.org/doi/full/10.1056/NEJMc1211805

[nosrepmodnar]

I asked my doctor about pml on my last visit and he said there is no indication from the drug company indicating a JC virus connection and that all they can do is monitor WBC which should be getting done every 3-6 months depending on what the last results looked like.

[Myoak]

We should keep in mind that JC virus causes PML and well over 50% of the population carries the JC virus. The work of white blood cells is to keep JC virus in check. When those WBC’s are diminished to the point where they cannot adequately control JC virus then there is possibility for PML to develop.

The connection between Tecfidera and JCV is lymphopenia (low level of lymphocytes, a kind of white blood cells). Tecfidera can cause lymphopenia and lymphopenia can allow JC virus infection to cause PML. That is the connection Tecfidera has to JCV and PML.

The link Agate provided of a previous case of PML is worth reading. Here is the last sentence in that article, “Similar to treatment with natalizumab, long-term treatment with fumaric acid and prior treatment with other immunosuppressants may have increased this patient's risk of PML”.

Possibly, Biogen will change their literature to reflex a slight risk of PML with Tecfidera.

[rsinger]

confirmed PML

So happy to see so many responses. Still concerned to hear of this and will probably discuss this with my neurologist. I happen to be positive for the JC Virus as many people are. I know that patients on tysabri who are JC positive are being asked to take tecfidera instead. I wonder how this incident will impact this.

Thanks for all your comments.

[Pipes123]

I would want to know what they call previous treatment with immune suppressants. Which drugs qualify? Hopefully not simple iv steroids for flares.

The pml case from Gilenya involved previously taking azathioprine, which is a potent immune suppressant.

Very sad for the person who got PML. I hope they get excellent treatment and do as well as possible. IMHO, that treatment should be paid for by Biogen, since they marketed Tecfidera as so much safer than other highly effective drugs.

[RingpOP]

Some Clarification

I just wanted to touch base with everyone about a recent news release in regards to Tecfidera and PML, like the article here:
http://www.mstrust.org.uk/news/article.jsp?id=6542

Now - as we all know - some people write articles just to receive ratings/clicks/$$… so there isn’t always the ‘full truth’ included in articles, from non-trustworthy resources.

I spoke to one of Biogen’s PR Reps this afternoon, because I wanted some clarification on this story that is spreading like wildfire - so that I can share with others speaking about the case of PML & Tecfidera.

The patient who had been on Tecfidera for 4 years, was experiencing lymphopenia for about 3 & 1/2 years. If you are on Tecfidera, or know some info about it… Tecfidera does have a notice on it’s label and it is told to the consumers of Tecfidera - that it can lower your white blood cell count.

Since this patient had severely low counts - that was then classified as lymphopenia. Lymphopenia, is a risk factor for contracting PML. So this patient did get PML due to a Tecfidera side effect & not the drug ingredients by itself, if that makes sense.

The patient’s death was due to pneumonia, not PML directly.

It’s very sad to hear this happen to someone in the MS community… But unfortunately, there aren’t many medications out there, without a risk involved, some higher than others.

I hope this gives more insight to everyone.

[RingpOP]

There had been a couple of PML cases in patients being treated with Tecfidera for dermatologic problems. One of them is described here:

http://www.nejm.org/doi/full/10.1056/NEJMc1211805

This is contributed with Fumaric Acid - and not the total make up of Tecfidera - keep that in mind.

[Temagami]

Anybody know how low the WBC lymphocyte count was? Mine is depressed due to Gilenya and I do wonder about long term low WBC count.

[agate]

I would want to know what they call previous treatment with immune suppressants. Which drugs qualify? Hopefully not simple iv steroids for flares.

The pml case from Gilenya involved previously taking azathioprine, which is a potent immune suppressant.

Very sad for the person who got PML. I hope they get excellent treatment and do as well as possible. IMHO, that treatment should be paid for by Biogen, since they marketed Tecfidera as so much safer than other highly effective drugs.

Tecfidera still may prove to be safer. Biogen is not overly perturbed about this one case. There are so many variables in this particular case that it's hard to say whether Tecfidera should be held responsible for the PML. The patient's white blood cell count ought to have been monitored regularly. It probably was, and the patient may have decided to take the risk.

Immunosuppressants used in MS are mitoxantrone (Novantrone), Cytoxan (cyclophosphamide), methotrexate (Rheumatrex, Trexall), and, as you mentioned, azathioprine (Imuran), according to the eMedicine Website:

http://http://www.emedicinehealth.co...s/page5_em.htm

[agate]

Anybody know how low the WBC lymphocyte count was? Mine is depressed due to Gilenya and I do wonder about long term low WBC count.

Temagami, I haven't found that information yet. Usually specific details like lab test results don't come along till later but maybe someone here will have that information.