For anyone considering Tysabri

[hch]

I know there are a lot of questions from people considering taking Tysabri, and I wanted to share my story. I took the Tysabri for a short time several years ago, and I'm of two minds about the drug.

First: A cautionary tale on Tysabri v. other drugs. (And I know everyone responds differently, but this is my history.)

I took Tysabri about three years ago for 10 months (knowing it would be temporary because I'm JC positive and have young children). Those were the best months of my MS life, and I've been diagnosed for 18 years. Alas, the nine to 10 months after going off the drug I was worse than when I had gone on it -- foggy cognition, lower body weakness, scuffing walk....

While I have gradually improved in the ensuing years, I'm not sure I'm back to where I was before I needed to go on Tysabri in the first place. That, of course, may have something to do with the course of the disease, but I do believe Tysabri contributed. (I was aware that there may be some minor setbacks after having quit Tysabri, but I was under the impression the setbacks would be minor and fleeting. They were neither in my opinion.)

Second:
I didn't have kids, I'd still be getting my monthly infusions. Tysabri made me feel great again.

[pennstater]

Thanks for sharing. One of the the things I find so frustrating is sometimes, there are no answers. Is it the disease, the meds, or something secondary to MS?

I am sorry you have had such a rough time since coming off of Ty. I hope there are answers soon for both you and your children's benefit.

[lindaincolorado]

For years I've known Drs are concerned about the rebound possibility when getting off Tysabri. My neuro believes you must get on another DMD almost immediately.. the last I knew he put his people on Copaxone.

Ty blocks T-cells from getting into the blood brain barrier-I'm pretty sure So, when one gets of Ty I worry about those T-cells

[DexterMorgan]

For years I've known Drs are concerned about the rebound possibility when getting off Tysabri. My neuro believes you must get on another DMD almost immediately.. the last I knew he put his people on Copaxone.

Ty blocks T-cells from getting into the blood brain barrier-I'm pretty sure So, when one gets of Ty I worry about those T-cells

That's the thing, you can't go on another DMD immediately. For Tysabri you have to wait at least 3 months for it to get out of your body and only then you can start taking something else... When I went from Avonex to Ty I had to wait 3 months as well.

[snowballs mom]

That's the thing, you can't go on another DMD immediately. For Tysabri you have to wait at least 3 months for it to get out of your body and only then you can start taking something else... When I went from Avonex to Ty I had to wait 3 months as well.

That is not the case in all neurology practices. Current thinking is that a washout period is not necessary and is actually harmful. My daughter was on Ty for five years and switched to Rituxan this past June. Her Rituxan infusion was one month after her last Ty infusion.

[Myoak]

"Current thinking is that a washout period is not necessary and is actually harmful. My daughter was on Ty for five years and switched to Rituxan this past June. Her Rituxan infusion was one month after her last Ty infusion."[/QUOTE]

So true, you can Google, "Shorter washout reduces MS relapse switching off natalizumab". Studies began appearing in 2013 about the benefit of reducing time between therapies and numerous articles have appeared since.

The idea is that you don't want a lapse in coverage. You need Tysabri to be protecting against MS while giving the new med you are switching to time to achieve effectiveness.

Some meds take weeks or months to achieve effectiveness. If you allow tysabri to wash out almost completely during 3 months and your new med takes 2 months to become effective MS has more opportunity to rebound.

It's not rocket science but nervous-nelly neuros who feel they risk patient health if they don't washout tysabri completely are actually risking patient health by doing just that.

It takes time for guidelines to change. Some neuros are early adopters and some are not. In the face of numerous published trials over the last 3 years I would hope that most neuros would take enough time to consider the detrimental effect a long tysabri washout period is having on their patients. But then again, with many neuros you might have better luck talking to a fence post.

For those who have an early adopter neuro, congratulations, you are envied!

[DexterMorgan]

Thanks guys! I have to stop with Tysabri and I have an appointment next month to discuss my options which in my eyes is way too late? I told the doc that I won't have any coverage now and that I'm afraid for the rebound effect and she told me I shouldn't because there is still Tysabri in me which should cover me. What on earth do I do? I'm in uni I can't have a relapse, let alone a full rebound effect...

[Myoak]

"I told the doc that I won't have any coverage now and that I'm afraid for the rebound effect and she told me I shouldn't because there is still Tysabri in me which should cover me. What on earth do I do?"

Here, in this forum, we can only offer discussion, thoughts and opinions, not treatment advice. Treatment decisions are the domain of patient and doctor alone.

My first thought is that your doctor is right, Tysabri does last a long time and dose extension studies prove that. By the same token that is why washout takes longer.

Often the reason neuros favor a long washout period with Tysabri is to make certain a patient does not have asymptomatic PML. Giving someone with asymptomatic PML a new DMT could make the situation much worse than it already is with PML… costly to a patient’s health but costly to a doctor’s time, too. Sometimes I wonder if the latter isn’t why some doctors insist a patient switch from Tysabri… so they can avoid any chance of having to treat a case of PML which would consume so much more of their time than not having one, beside all the stress involved.

Perhaps, I’m being too harsh, nevertheless, it is surprising to me how many give up on a treatment like Tysabri which is keeping MS in check and opt for a lesser effective treatment without trying dose extension. Tysabri has notable risk but let's not forget MS has notable risk, also. There is a link to more about dose extension at the bottom.

When a patient switches off Tysabri some MS clinics do an LP. If they find no JC virus in the CSF the patient does not have asymptomatic PML and can safely begin the new treatment. Doing an LP is how some clinics are shortening the washout window post-Tysabri.

BTW, studies have shown that headaches associated with a LP can be largely avoided by using an atraumatic needle such as a Sprotte. They only cost about $20. European doctors are notoriously slow in using these new, smaller needles so best to ask and request beforehand if you live there.

Bottom line… the safest way to initiate another DMT post-Tysabri is to have a LP establish there is no asymptomatic PML. The JC virus causes PML. If no JC virus is found in the CSF from the LP, you do not have PML and can begin the new treatment immediately.

The person who knows the details of why a particular treatment is most appropriate for a specific individual is the treating neuro. He/she ought to be able to explain why a treatment is, or is not, appropriate in a way that can be understood. I’m sure most are willing to do that.

Here is one article about dose extension. No one extending time between doses has gotten PML. The theory is that by extending time between infusions Tysabri concentration is diminished which allows sufficient immune surveillance against the JC virus thus preventing PML. This news came out of ECTRIMS this week:

http://journals.lww.com/neurotodayon....aspx?PostID=2

[Myoak]

Dexter, thank you for asking a question which is on the minds of so many facing the prospect of discontinuing Tysabri, even though they may have enjoyed good health on it.

May I share some of my thoughts about that situation? Many JCV+ MSers believe they must stop taking Tysabri after two years because their doctor said so. Actually, if you want to continue and your doctor refuses you would have to find another doctor. But many JCV+ do continue on Tysabri and far longer than two years. I’ll present some of the reasons.

First, they may be enjoying life relatively free from MS while on Tysabri. Only those who have suffered from MS can understand how much that means.

Some notes from ECTRIMS presentations last week include the 3 PML risk factors associated with Tysabri… treatment longer than 2 years, elevated JCV antibody titers, and prior treatment with immunosuppressants.

For those who have been on Tysabri between 49 to 72 months the PML risk is 6 in 1000 rising to 13 in 1000 in those with prior immunosuppression. Pretty sobering stats. We should understand in the first group 6 would get PML and 994 not.

What if there were a way to decrease the risk of PML in those who are JCV+? Let’s consider research into this question.

There is an ongoing study to find out if extending time between doses lessens PML risk. If it is safe to take Tysabri for 2 years why not longer?

Research has shown that certain receptors build-up saturation of Tysabri as the number of infusions increase. In the "regular" population and in MSers taking Tysabri less than two years the immune system has no problem taking care of JC virus which causes PML.

But it appears if the receptors affected by Tysabri become over-saturated and do not allow enough white blood cells (which fight JCV infection) to traffic into the CNS then immune surveillance of JCV is not sufficient to prevent PML in the ratios described above.

The theory being tested is that by extending time between doses would Tysabri saturation be diminished enough to allow enough white blood cells into the CNS to protect against JCV and PML.

So far, here are the results:

In the standard dosing (4 weeks plus or minus 2 days) group there are 1093 people and there has been 4 cases of PML.

In the extended dosing group (4weeks 3 days to 8 weeks 5 days) there are 905 people and there has been no cases of PML. In this group those JCV+ had a titer average of 2.03.

Did the extended dosing group have more disease activity? No, 62% of the standard dosing group had no evidence of disease activity (NEDA) and 61% of the extended dosing group experienced NEDA. So nearly identical. The standard dosing group had slightly more relapses and slightly less MRI activity than the extended dosing group but overall, they were nearly identical.

So far, extending time between doses appears just as effective in treating MS as standard 4 week dosing and, so far, there have been no cases of PML in the extended dosing group.

Extending time between doses may be an option worth discussing with your neuro.

Thank you, Dexter for expressing something on the minds of so many. Thank you, AMJ for your kind expression.

[lindaincolorado]

Hi all,
I just wanted to add my 2 cents here

I started Tysabri 10/2006, so I have started my 10th year Approximately a year ago I went to every 6 weeks and approx 8 months ago I went to every 8 weeks. My Dr at the RMmsC asked me to switch as all the data is at 8 weeks. My jcv is at .23 to .27 which is indeterminate all tho my Dr will refer to it as positive-.20 is neg and .40 is positive.

I have had neuros in the past that either for her ego/power trip, wanted to take me off Ty and another to cya (his) I fired/switched neurologists-Thank G-d. This med has been a blessing for me! I saw myself going downhill 8 1/2 years ago, was given Tysabri..progression halted, I recovered back to a healthier me, MRIs showed no new or active lesions. What a gift I was given!!

[KatieAgain]

Glad to see you back Myoak!

[Myoak]

Linda, you make a good point about treatment... that if you treat early, while still in the relapsing phase, recovery is more likely. Wait, and that opportunity may disappear.

You are so fortunate to have insisted on continuing with tysabri. I cringe at how many have been bullied off this med by neuros who insist. Tysabri is not 100% effective for halting MS in everyone but it does slow progression for the majority taking it and it has halted progression entirely for many.

Katie, thank you for your welcome; you are a doll! Don't worry about that gall bladder scar, its going to be tiny; just incorporate it with a smiley tattoo, or body art of some kind. Bikinis never made a girl beautiful, anyway; at least, not like kindness or qualities that make someone truly attractive and worthy of friendship.

Count me among all those who have kept you in thoughts and prayers with unfeigned affection for the delightful person you are. Thank you for walking with me/us. Yes, we need you, Katie, the real deal if ever one was. What a joy you are!