Another Case Of PML

[ru4cats]

I'm on Tysabri, but this came into my email this morning. I thought this forum might be interested.

http://www.medpagetoday.com/Neurolog...ews_2015-07-16

[REG53]

Thanks ru4cats for the infor.

[Marco]

I heard about this, but did not have any real details to discuss. I am saddened and angered that another seemingly preventable case of PML has occurred. I want to refrain from posting unsubstantiated information, but from the posted article the following information is noteworthy (imo):

• The patient has Primary Progressive MS. Tecfidera is not indicated for PPMS patients so the neurologist was using this "off-label" in attempt to help the patient.
• The patient had prolonged severe lymphopenia.

Again, we have a situation where a patient had lymphopenia, an uncommon, but well-known side effect of Tecfidera. The current Tecfidera prescribing information has warnings of PML (Section 5.2) and Lymphopenia (Section 5.3).


Lymphopenia is diagnosed by blood test where lymphocyte counts are reduced below a certain range. MS patients WANT our lymphocyte count reduced, but if lymphocyte counts go too low it makes us susceptible to opportunistic infections like the John Cunningham virus (JCV). Patients should get a complete blood count (CBC) before starting Tecfidera and periodically afterwards. If a patient's lymphocyte count goes too low, blood monitoring should be increased and Tecfidera potentially withheld. A patient is at increased risk of PML if they develop lymphopenia and lymphocyte counts remain too low for a period of time (think months and not hours). To date, Tysabri, Tecfidera and Gilenya have all been associated with the development of PML. Any drug that suppresses your lymphocyte count can increase your PML risk factors. Again, as MS patients we want this, but we need to have regular blood screenings to ensure our lymphocyte counts remain in an acceptably safe range.


I personally believe the risk versus reward of Tecfidera remains extremely favorable. Patients should talk to their neurologists about the frequency of blood work, their latest blood work results and their individual risk factors for PML. In the majority of cases, PML risk factors will be close to zero.

Patients PLEASE become your own health advocate. As a patient if you develop lymphopenia:

• At some point, your neurologist should be taking you off Tecfidera until your lymphocyte count rebounds into a safer range.
• At some point, you as a patient should refuse to take Tecfidera until your lymphocyte count rebounds. Do not go 18 months or several years with lymphopenia and blindly continue to take Tecfidera. Demand answers from your neurologist, your primary care physician or someone. If you cannot talk to your neurologist about PML, please consider finding a new neurologist.

For patients on Tecfidera with normal lymphocyte counts. If you become seriously ill (think shingles, pneumonia, etc) or have another health crisis (think severe loss of blood due to injury) inform your neurologist. They may ask you to withhold Tecfidera treatment until you are able to receive new blood work or your other health concern is resolved.


Please understand I am not denying Tecfidera's role in the development of PML. Obviously, using Tecfidera, and other medications, can increase your PML risk. I am just upset that we have routine blood monitoring capabilities to greatly reduce your risk of developing PML. Generally speaking, the more potent our MS medications are the greater potential risk(s) are as well. Ideally you are on a medication with a great potential upside, but you are alert to the risk factors and submit yourself to the appropriate level of monitoring. Please assume an active role in your medical decisions.

I wish you all well ... and I mean that!

[ru4cats]

Well said, Marco. The most important lesson I've learned since diagnosis 6 years ago was that I HAD be my own advocate because only I knew what was in my best interest. Everyone else seems to have an "agenda" that may not fit with my needs and desires. I've learned that "NO!" can be a powerful response that gets everyone else's attention.