Having set my goal as giving you the type of information that I would be interested in, I will start with my “bottom line,” summarizing my take on Tysabri. I have then compiled more detailed information, which follows.
Bottom Line: Tysabri has been shown in trials to be twice as effective as the CRABs in preventing relapses, without the flu-like symptoms of the interferons or potential disfiguration due to lipoatrophy from Copaxone. It is given only once a month by infusion in an infusion center, or in your doctor’s office (in other words, you don’t have to inject yourself).
The catch? PML (progressive multifocal leukoencephalopathy) which has occurred in three people taking Tysabri, resulting in two deaths and one case of severe brain damage. The estimated risk of PML is 1/1000, but is probably lower than that, as the people who had PML were also taking other immunosuppressants or modulators. Because of the risk of PML, Tysabri is recommended for people who are not responding to their first-line CRAB treatment, cannot tolerate the side effects of the treatments or have aggressive forms of relapsing MS. You may find yourself in a position to decide if Tysabri is a good choice for you. In my opinion, the real “bottom line” is how you feel about the 1/1000 statistic. Clearly, the odds are hugely in anyone’s favor that they will not get PML from taking Tysabri. However, anxiety and worry are side effects, too. If you think that even this tiny risk of PML will cause stress for you, take that seriously into your equation when deciding whether or not to start on Tysabri.
More Detailed Information on TysabriType of MS and Severity: Tysabri is for people with relapsing forms of MS, who have tried other disease-modifying therapies but have not had good response (meaning increasing numbers of relapses), as well as those who are unable to tolerate the other treatments (meaning they have side effects which effect quality of life or have experienced problems with liver function, thyroid, blood counts or depression).
Doctor’s Opinion: You will have to work closely with your doctor to decide if Tysabri is the right thing for you to try, as the prescribing indications of "inadequate response" or "unable to tolerate" the older CRAB drugs is a subjective decision. Also, it is not indicated specifically for relapsing-remitting MS, but for "relapsing forms of MS," meaning that some people with progressive forms of MS who still experience relapses may be candidates for Tysabri. Again, only you and your doctor can make these decisions.
Necessary Monitoring: Tysabri can only be given at an infusion center that is registered through the "TOUCH" program. "TOUCH" stands for "Tysabri Outreach: Unified Commitment to Health" and is the program that was put in place in an attempt to catch any potential cases of PML in early stages, as well as prevent them. You will be examined by a doctor or nurse and get an MRI before starting Tysabri, then examined every 3 to 6 months for neurologic changes. You will be asked to review patient safety information and fill out a short survey before each infusion.
Side Effects: Tysabri is not associated with flu-like symptoms or depression (side effects linked to interferon drugs). The side effects associated with Tysabri are:
- PML: The most serious (but rarest) risk is PML (progressive multifocal leukoencephalopathy), which can happen in people with weakened immune systems. PML can cause death or severe disability, but is rare – estimated at 1/1,000 patients.
- Common Side Effects: These include infusion-site reactions, fatigue, headaches, joint pain.
- Severe Allergic Reactions: There have been cases of allergic reactions in about 4% of patients, some requiring treatment (even hospitalization). The symptoms of this include: hives/itching, chills, dizziness, chest pain, flushing, trouble breathing and low blood pressure.
- Increased Susceptibility to Infections: People on Tysabri may be more susceptible to infections, and should take measures to avoid them, including good hand washing habits and avoiding people who are sick, when possible.