Not that many years ago there were few options for the treatment of Multiple Sclerosis. When Betaserone was first approved for use, the demand was so high and the supply so limited, there was a lottery to see who the lucky patients would be who received this miracle drug.
Now, with the recent approval of Tecfidera, formerly known as BG-12, we have TEN choices of disease modifying drugs. What a difference a decade or two has made in our treatment options. Most of these are fairly easy treatment decisions to make based on personal preference and the willingness to do regular injections vs taking multiple pills.
But there is one drug that still should give serious pause before deciding to use it as the MS disease modifying drug of choice. I am talking about Tysabri – the monthly infusion drug that was once pulled off the market because of a possibly lethal side effect of PML (Progressive Multifocal Leukoencephalopathy). Tysabri is rarely offered as a first option for treating MS and is normally held in reserve for people who don’t respond well to the other disease modifying drugs.
Tysabri has a very high efficacy rate in reducing the number of relapses and slowing disability progression, but has the problem with the PML cases that once meant almost certain death, which is why it was pulled off the market. But Tysabri also has its fans, including patients and doctors, who felt the benefits of the drug were worth the risk. In response, Biogen Idec, the maker of Tysabri, revamped the control process for how Tysabri is distributed, and studied who was susceptible to PML – it was found it was pretty much limited to those people who tested positive for the JC Virus. (JC stands for John Cunningham, the first human who had the disease identified in).
The company then studied and got FDA approval for a test for the JC Virus, and all people beginning treatment with Tysabri are now given this simple blood test. If the person is found to test positive for the JC virus, that doesn’t mean they can’t receive Tysabri, it just means the risks are greater and should be discussed in depth with their doctor and their family.
The recommended period of time for Tysabri treatments is two years, but there are many people who do so well on this drug they continue to take it beyond the two years. If a person should contract PML while on Tysabri, the treatment is very aggressive and PML no longer means a fairly certain death but can still cause extreme disability. The PML treatment protocol includes hospitalization, and plasmapheresis, a complete cleansing of the person’s blood through plasma exchange.
It is also thought that to date, no person who is JC Virus negative has contracted PML, and these people are screened for the virus every six months (or more often if requested). The JC Virus is fairly common and it is not unusual for a once-negative person to become positive through exposure to this germ. Again, if that occurs, there needs to be a serious discussion of the benefits vs the risks of continuing on Tysabri.
Whether to take Tysabri or not is an important conversation to have with your neurologist – I know from first-hand experience because I have been on Tysabri for 14 months. Even though I tested and continue to test negative for the JC Virus, it was not a decision I took lightly. I have a good friend who initially tested positive for the JC Virus, but still chose to take Tysabri because she had not responded to any of the other DMD’s. She has now been on Tysabri for over 4 years and feels it is still her best option, even considering the risk she is taking.
Usually I include some levity in my writing because if we can’t laugh or smile at our situation, we can quickly find ourselves sinking down a hole, but in the case of discussing Tysabri, I can’t make light of the serious nature of this drug and the decision to take it for our treatment. In my thinking, it is a good drug, it works well, and it has risks – only you can decide if those risks are worth taking for yourself.
Wishing you well,