Confused - Tysabri or Gilenya? Help!

[Curious1]

I am in the process of changing my DMD treatment, which was supposed to be from Avonex to Tysabri, but since I'm JCV+ the MS Doc wants me to use Gilenya due to the increased risk of PML (I'm not interested in using Tysabri for just under 24 mos, then changing treatments again). So...I go to my usual monthly MS Support Group hoping for feedback on Gilenya and I find out that most of the folks there have been on Tysabri, some for many years - and these folks are also JCV+ !! WTH?! Is Tysabri still a long term option for me?? I've got to decide soon which treatment to go on now, I'm having some progression (reason I'm changing DMD now) and I want to slow it down or stop it and I don't want to have too much time lapse between treatments. Steroids haven't been mentioned, but I can't spare the time for the usual '5 day inpatient IV Spa' at the hospital.

And those of you already on Tysabri, does that 'Touch Prescribing Program' really monitor patients for PML on a regular basis as much as I've been lead to believe?

[Redwings]

does that 'Touch Prescribing Program' really monitor patients for PML on a regular basis as much as I've been lead to believe?

No. The TOUCH program does NOTHING to monitor patients for PML. The TOUCH program is a risk-managment program instituted to appease the FDA. The purpose is to educate doctors of risks and recommended procedures, and to try to ensure that only appropriate patients are put on Tysabri.

NO ONE but your treating doctor, and to a limited extent your infusion nurse, is responsible for monitoring you for PML.

[ru4cats]

At each infusion the TOUCH program mandates that three questions be asked that are directly related to the possible development of PML. If you have a good infusion nurse, that individual will also ask general questions that relate to "How are you doing?" "Any changes during the month?" etc. However, as a Tysabri patient, you are responsible for recognizing changes in your body that could be linked to PML.

During each infusion, the nurse is required to contact the TOUCH unit and provide specific information on you. They also keep a close eye on each individual. I wasn't aware of this until after my last infusion, #27!

From what I've heard, it actually takes several months for PML to develop. The yearly MRI is actually used to see any changes in the brain that could be related to PML, not to look at MS lesion activity; this is just added benefit.

[gshea]

No. The TOUCH program does NOTHING to monitor patients for PML. The TOUCH program is a risk-managment program instituted to appease the FDA. The purpose is to educate doctors of risks and recommended procedures, and to try to ensure that only appropriate patients are put on Tysabri.

NO ONE but your treating doctor, and to a limited extent your infusion nurse, is responsible for monitoring you for PML.

This thread came up in my daily Google alert and I'm a few days late to this thread.

However, I have to correct your note about the Touch program. On one hand you say that it does nothing to monitor patients for PML and then, in the next sentence, you say it's a risk-management program. I've been on Tysabri for six years and feel pretty familiar with the Touch program. It's a risk-management program to monitor patients on Tysabri for safety issues, but PML is the main safety issue that they focus on. Of course, if I developed skin cancer or had some other issue, they would report that, but PML is the main focus.

My experience with the Touch program encompasses a lot more than people are noting here. Yes, the infusion nurse asks me questions about whether I've experienced any new symptoms, but that's just an infusion procedure. Where the Touch program really works is that my doctor sends me for MRIs every three months (yes, more than what Touch requires) and sends for blood work every six months. The MRI will notice anything abnormal that signifies PML. The blood work includes CD4 and CD8 counts which signify the strength of your immune system and can determine your risk for something like PML. I am also required to see my neurologist every six months and a nurse practitioner every six months.

By my count, that's at least four people that are monitoring me for PML. (My neurologist, an infusion nurse, a radiologist that is the first to look at my MRI, and a blood lab technician who would notice an abnormality in my blood work)

You may take issue with the safety procedures and that's your prerogative, but I think it's unfair to say it does nothing to monitor patients for PML. Tysabri is a very effective drug and it has some safety issues, but the Touch program is one way they are trying to manage that risk and prevent people from being affected by PML. It's not perfect and won't end PML, but I'm thankful that it exists.

[BrianH]

I have to say I have been on Tysabri for over 4 years now. Tysabri is by far the best drug for me. I have not had a single relapse in those 4 years and I have no real side effects.

They are finding a correlation between the JC Virus and PML. So if I was you would ask for a JC Virus antibody test to see if you are JC Virus negative I would absolutely go with Tysabri myself as I don't believe anyone who got PML was JC Virus antibody negative... at least that's the last thing I heard so I could be wrong.

I am JC Virus antibody positive which puts me in the higher risk category but I still take it. I find the benefits outweigh the risk currently for me. I may switch in the next year or 2 depending on how BG-12 does, but the only reason is my wife is expecting so that risk is a lot more meaningful now I guess.

[ru4cats]

gshea,

I couldn't have said it better myself! I agree with everything you said. The only difference for me, JC-, at 27 infusions is I've moved to blood work once every three months and an MRI once a year. If there is a change, we'll go a different route. 6 years! Wow! Great news for me as I love Ty.

[Redwings]

Posters ru4cats and gshea brought up some good points, so I'm going to clarify my last response.

The TOUCH program is a risk-management program with some very good guidelines for how medical personnel are supposed to monitor for PML. Even though the Tysabri website says, "How we [emphasis mine] monitor your safety and manage your risks," it doesn't say that anyone involved with the program actually performs any medical or monitoring services.

The TOUCH program does not and cannot supersede doctors' judgement or authority to treat their patients as they deem appropriate. That also means that the TOUCH program has no authority to force medical personnel to comply with program recommendations/requirements or "punish" them for not following them.

As an example, the TOUCH guidelines, at least in the early days, recommended that other, lower-risk, DMDs be tried before Tysabri. Yet MS forums have contained numerous posts by people whose doctors put them on Tysabri as a first drug just because they didn't want to do injections. Those doctors didn't follow the guidelines for patient selection, but the TOUCH program had/has no authority to prevent it from happening.

Likewise, the actions of monitoring for PML are performed by patients' medical personnel. All of the responsibility lies with those personnel. The TOUCH program itself doesn't do any of the patient monitoring, the program has no authority to ensure that medical personnel do, nor does the program bear any responsibility for medical personnel's failure to monitor according to guidelines.

Poster gshea counts at least four people that are monitoring for PML. And prudently following program guidelines is the way it's supposed to be. But none of them are TOUCH program personnel. And if none of those doctors properly monitored, if a neuro doesn't do a timely MRI, if an office doesn't promptly follow up on a report of symptoms that might indicate PML, if an infusion nurse fails to ask the required questions, if a patient doesn't keep up with their neuro appointments, the TOUCH program doesn't actually do anything about it.

This might appear to be semantics, but the actual difference is important. The TOUCH program does have "requirements" for how Tysabri patients should be monitored. But the program itself doesn't do or participate in the actual monitoring, and has no authority over doctors. Medical personnel monitor for PML. The TOUCH program itself doesn't.

So, Curious1, if your question is whether the TOUCH Prescribing Program has good "requirements" for regular monitoring for PML, the answer is yes. But if your question is whether the TOUCH program itself actually monitors you and/or supersedes your doctors/nurses in ensuring that you are properly monitored, the answer is no. The program is only as strong as the weakest link.

[ru4cats]

I agree, Redwings, but isn't this where personal responsibility kicks in? Since my diagnosis, and since this was my 1st excursion into the medical field, the most important thing I've learned is I need to advocate for myself. At my 3rd infusion at a hospital, after a switch in nurses, I was told I could leave after the Ty was infused. I said "What?" Turns out they also "lost" a vial of blood, and I had to return for another blood draw. At that time, I told the nurses of my experience, and they agreed it was wrong and blamed it on a new nurse. Of course, after the 3rd $11,000 bill, I took it upon myself to find a new infusion center at less than half the cost! I also speak up anytime I have questions and push for answers. Especially with Ty, no way do I rely only on the medical professionals!

[BigA]

It depends. Is your disease particularly active? I think Gelenya is preferable to Tysabri, if it's the appropriate level of treatment. Plus, you'll always worry.

You should know - do you need to be on Tysabri, or can you get by with Gilenya?