Flare of ON early in Ty

[salamandertom]

I have my third dose on Friday. About 2 weeks ago I started another ON flare. My doctor was pretty concerned about this. She is doing an MRI and if that is stable we will discuss what to do about Ty.

I want to keep trying until 6 doses, but also want more information about how many people just are not helped by this drug? I want to be realistic.....Thanks!

[nursejan]

TYSABRI HELPING?

I HAVE JUST HAD MY 11TH INFUSION OF TYSABRI AND TO TELL YOU THE TRUTH I DON'T KNOW IF IT HELPING ME. I HAVE FELT WORSE OVER THE MONTHS. HAD TO GET THE SOLUMEDROL A COUPLE OF TIME SINCE MAY 2011. MY DOCTOR REMINDS ME THAT JUST BECAUSE I DON'T NOTICE ANYTHING, WHEN WE REPEAT THE MRI IF THERE IS LESS LESIONS THEN ITS WORKING. GOING FOR REPEAT MRI IN FEW WEEKS. I PROBABLY DIDN'T HELP MUCH BUT I AM KINDA STRUGGLING WITH THE SAME KIND OF QUESTION I GUESS. GOOD LUCK

[Redwings]

I'm so sorry to hear about your turn of events.

I think you are being realistic about giving Tysabri an adequate trial of 6 doses. Things may not change after 6 doses, but 2 doses isn't really enough time to see what's going to happen. But even the Tysabri prescribing information used to (I'll have to defer to someone else to see if it still does) say that Tysabri shouldn't be continued past 6 doses if there isn't any evidence that it's being effective. (Again, that may have changed with the increased knowledge of occurrence of PML.)

The fundamental place to go back to effectivity information about Tysabri is the original studies. This is the information summarized in the prescribing information. Again, bear in mind that the studies evaluated 2 years' worth of data, not 2 months. But it's a starting point.

In the original data, 67% of subjects were relapse-free at the end of 2 years. That means that 33% -- one third -- had at least one relapse during that time. Also, 17% had sustained increase in disability during that time.

I appreciate that that doesn't help you much, since you're trying to figure out what may happen after 6 months and decide whether you should stay on Tysabri after that point or move on. (I've had to discontinue Novantrone and Rituxan when neither worked for me as they seem to for most other folks.) Maybe your doctors have access to short-term reports through their medical data bases, and hopefully other posters have quicker access to the same kinds of short-term information. Even though the original clinical data doesn't contain outcome information, it does give you an idea that about one-third of Tysabri patients had relapses, so it doesn't work for everyone.

There was a recent thread here about second guessing oneself. Second guessing -- based on emotion and guessing -- is different than a deliberate, systematic review based on evidence and milestones. A relapse after 2 months of Tysabri is time for a systematic review with one's doctors, so it sounds like you're on the right track in looking for realism rather than reacting and second guessing out of fear. I hope you start getting a benefit in a couple more months.

[0485c10]

I had a relapse of ON after 11 months on Tysabri--it actually relived me somewhat--i'll explain.

the first relapse on tysabri for those that have them is attributed to damage done during the washout time-when MS was untreated. Not damage while on tysabri but damage done before tysabri, specifically during the time ones ms was untreated.(washout time) Remember TY does not claim to reverse damage, it claims to slow damage more than any other ms med on the market.

then there is the most serious risk of using tysabri, pml.
pml is a virus of the BRAIN not optic nerve, so a relapse of ON was rather reassuring, its not pml.

then pml happens because there is no immune surveillance of the brain while using ty-i was kind of proud of my immune system for getting around ty..kind of like i imagine guys feel having caused an unintended pregnancy, both dismayed that it has happened but at the same time kind of proud of their "swimmers"---worked in engineering, male dominated when i was there--i heard some of their bragging-comments. (they can swear better than us too, i was challenged, i lost. i thought i had a chance of winning when i started?)[(my strategy was most swear words are of bodily function and the female gender has the most care taking responsibility so bodily functions are not shocking to them..i thought i would win for sure because of that but the guys can get into soda-maschic terms, wasn't long before i had to concede defeat)]

in the 2006 FDA advisory transcripts, biogen reported that it takes 6-9 month for ty to achieve a stable baseline concentration..I was lucky it was 6 months for me then i noticed a difference. I would actually encourage you to give it 9 months in case you are on the later side of the range. You can find links to the transcripts on my home page. I think it was in the briefing notes they said it.

[0485c10]

say that Tysabri shouldn't be continued past 6 doses if there isn't any evidence that it's being effective. (Again, that may have changed with the increased knowledge of occurrence of PML.).

that needs some clarification--an IF& ORIF in parathesis

say that Tysabri shouldn't be continued past 6 doses(IF there has been a past use of an immunesuppresant OR IF ty is being used to treat crohns disease) if there isn't any evidence that it's being effective. (Again, that may have changed with the increased knowledge of occurrence of PML.)

it does take 6-9 months to establish a consistent base line concentration.

btw--ty is only approved to treat crohns disease in the US, the rest of the world has decided the risk of ty are too great for crohns disease. makes them somewhat more cautious because of being approved in only 1 country.

the US and the rest of the world have declined to approve ty to treat arthritis--risk versus benefit. There is a benefit in both disease, but not enough to overcome the risks.

[0485c10]

Just making sure you saw this post & replies about antibodies ..i'm sure you did but just in case still need more than 3 months but just in case..

http://www.msworld.org/forum/showthread.php?t=118562

[salamandertom]

Thank you. I am aware of the antibody issues, but my doctor insisted as she was so confused as to why I would have the ON with ty.
I had my third dose friday and I am feeling very yucky. I have a sinus thing going on, but my eyes have been hurting and my legs are not great.
I am starting to feel like this isn't going to work either...... Trying not to get down about it. Trying to remember that I cannot control this disease and I need to just keep trying to find something that may help slow it down.

[Redwings]

I am aware of the antibody issues, but my doctor insisted as she was so confused as to why I would have the ON with ty.

When things don't make sense, it pays to go back to the beginning and review the evidence again for anything that might have been missed or misinterpreted. If the ON isn't an expected occurrence on Ty, then it may be beneficial to go back and reconsider the remote possibility that the ON isn't being caused by MS, and could be why MS treatments aren't slowing down the recurrence rate.

Nota bene: I'm NOT saying or suggesting that you don't have MS. What I'm saying is that, if your ON is acting in an unexpected or uncharacteristic manner, it could be beneficial to get an opinion on it by a neuro-ophthalmologist -- or a different neuro-opthalmologist -- who is skilled in neuroimmunology, no matter what that opinion turns out to be.