PML

[rsinger]

No matter how much research I do I can't quite understand how the neurologists can be so certain about Tecfidera being safe for patients who are JC positive. It seems that many patients who test positive for the virus are not being taken off Tysabri and being placed on Tecfidera. Are we going from one frying pan to another. Maybe they work very differently in the body. However both drugs seem to suppress the immune system which opens you up for infection. I would appreciate some clarification.

[rsinger]

PML

Not sure how to edit a post. In my previous post I had a typo. I meant to write "now" instead of "not". This is in reference to patients being taken off tysabri and placed on tecfidera.

[Marco]

No one is being forced to take Tysabri or Tecfidera. The known working mechanisms and risk factors for Tecfidera and Tysabri are entirely different. Based on the limited information available, Tecfidera just doesn't pose the same PML risk that Tysabri is known for. The patient is given a choice between the known PML risk of Tysabri and the unknown Tecfidera risk(s). As Tecfidera gets more real-world experience the long-term risks will become more apparent. If a patient believes the risk factors of a new drug are too high they shouldn't take the drug. There are a number of people here at MSWorld that do not trust the drug companies and have never taken a MS drug.

Fumaderm, the forerunner to Tecfidera, had 180,000+ patient-years of experience with a total of 4 PML cases(that I know of). When you research the handful of PML cases and/or deaths of Fumaderm, Gilenya or Tecfidera patients you'll find those patients had pre-existing conditions that should have probably precluded their use of the drugs. The Tecfidera patient was battling pneumonia and probably never should have started Tecfidera (according to the prescribing information).

[Marco]

Let me first apologize for the bluntness of this "soap box" response. I recently read where a Tysabri patient decided to sue Biogen after contracting PML. As someone who is JCV+ and received a sub-par CBC report, I'll relate it to Tecfidera.


Prior to beginning any new drug, physicians and patients should discuss risk factors and potential risks. Progressive multifocal leukoencephalopathy (PML) remains a rare opportunistic infection to individuals with compromised immune systems. There are certain known risk factors you and your doctor should consider to help evaluate your risk of PML. For some medications the risk factor may be considered ZERO. To date, the presence of JCV is the single most important known risk factor in the development of PML. Up to 85% of the population has been exposed to the JCV so it's important for everyone to understand their potential risks.

Patients need to be responsible for educating themselves on their medical conditions and the medications they take. Physicians and patients need to explore and discuss drug risks together. Patients need to read drug inserts instead of simply tossing them in the trash can.

The prescribing information for Tecfidera clearly covers much of your concerns without explicitly mentioning PML. Prior to taken Tecfidera, a recent (< 6 months) CBC is recommended and then repeated on an annual basis. The CBC serves as a safety check for both neurologists and patients identifying patients with pre-existing low lymphocyte counts. Tecfidera may also decrease lymphocyte counts by roughly 30% during the first year of therapy. Biogen further states that patients with serious infections should consider withholding treatment until the infection clears. If a patient is identified with "low lymphocytes" that should be discussed prior to ever beginning therapy, especially since Tecfidera has not been tested on patients with low lymphocytes. I am JCV+ and have a CBC scheduled every 2 months to monitor my blood for this very reason.

Every month prior to getting my Tecfidera shipment I am required to speak with a pharmacist about the medication, side effects and any concerns that I have. This is similar to Tysabri patients signing waivers to acknowledge their risks of contracting PML. Tysabri poses a known PML risk to patients, yet they still line up every 4 weeks for their infusion. I believe Biogen does a great job (now, not in 2004) of making patients aware of their PML risks and no patient can plead "ignorance" without them being "actively ignorant."

I recall getting gasoline on my hands and I did not look for Exxon or Shell to tell me to avoid fires.

[KatieAgain]

All the DMDs have risks. That it why it is such a personal decision.

I ended up in the Hospital, ready to meet my maker on one of the Interferons. 2 years ago PML scared the heck out of me. After 7 months of back to back flares MS scares me a whole lot more. I am now on Tysabri. I am going for Quality not Quantity.