Results of blood work for JCV 'index" risk

[regi girl]

THANKS

THANK YOU MYOAK FOR YOUR WISE INFO AND YOUR KIND ENCOURAGEMENT. AND THANK YOU TO EVERYONE ELSE WHO RESPONDED TO MY POST.

RIGHT NOW, I HAVE SOME "SAFE" SPACE TO WORK WITH, LIKE MYOAK STATED, I'M BELOW THAT 18-24 MONTH MARK. SO FOR NOW I AM GOING TO STAY ON TY, NEXT WEEK WILL BE MY 14TH INFUSION.

TO ANSWER ONE QUESTION THAT WAS ASKED, NO, MY NUERO HAS NOT TAKEN ME OFF TY AT THIS POINT SINCE I'M STILL BELOW THE 18 MONTH MARK.

OVER THE PHONE LAST THURSDAY, MY NUERO'S SUGGESTION, WAS THAT WE CHANGE TY TO EVERY 8 WEEKS INSTEAD OF 4 WEEKS UNTIL LEMTRADA IS APPROVED.

HOWEVER I HAVE AN APPOINTMENT WITH HIM NEXT MONTH SO HE SAID WE WILL DISCUSS IT IN MORE DETAIL AT THAT TIME.

BEFORE WE KNEW MY NUMBER, BUT KNEW I WAS JCV+, HE SAID HE WOULD HONOR MY DECISION IF I DECIDED TO STAY ON TY. HE ALSO SAID THAT THE 4 YEAR MARK ON TY IS KIND OF THE HIGHEST PEAK FOR DEVELOPING PML, HE SAID THIS BECAUSE I BROUGHT UP A PATIENT WHO DEVELOPED PML WHO HAD BEEN ON TY FOR A LITTLE OVER 4 YEARS.

I TOOK HIS STATEMENT ABOUT THE 4 YEAR MARK TO MEAN THAT YOUR PROBABLY SAVER ON THE DRUG FOR A LITTLE LONGER THAN YOU THINK, ALTHOUGH THAT'S MY INTERPRETATION AND I KNOW HE WOULD NEVER TRY TO INFLUENCE ME ONE WAY OR THE OTHER. BUT I THINK HE DOES OPT ON THE SIDE THAT FOR THE BENEFIT THE ODDS ARE PRETTY LOW EVEN THOUGH HE DOESN'T COME OUT AND SAY THAT.

SO WHAT HIS RESPONSE WILL BE WITH AN ACTUAL NUMBER, I DON'T KNOW, OTHER THAN WHAT WE DISCUSSED ON THE PHONE.

THIS IS A VERY PERSONAL DECISION FOR ALL OF US AS WE RECEIVE OUR INDEX NUMBERS. NO ONES DECISION ABOUT THEIR THERAPY IS A WRONG DECISION. EITHER WAY, STAY ON TY OR TO DISCONTINUE TY, YOU ARE MAKING THE RIGHT DECISION FOR YOU AND YOUR SITUATION.

I THINK IF YOU DO YOUR RESEARCH, DISCUSS IT WITH THE PEOPLE WHO TRULY LOVE YOU, KNOW YOUR ODDS AND I THINK SOMETIMES YOU HAVE TO LISTEN TO YOUR GUT, THAT'S THE MOST YOU CAN DO TO MAKE THE MOST INFORMED DECISION.

THANKS TO ALL OF YOU WHO RESPONDED, YOU ALL HAVE TRULY BECOME LIKE FAMILY. SO MANY OF YOU, ESPECIALLY, MYOAK, I HAVE READ YOUR POST IN OTHER THREADS AND I HAVE HEEDED YOUR OPINIONS AND KNOWLEDGE EVEN THOUGH I MAY NOT HAVE RESPONDED TO THE POST.

I STILL DON'T KNOW WHAT MY ANSWER IS YET, I'M STUDYING MORE ABOUT LEMTRADA. BUT I'M LEANING TOWARD THE SUGGESTION OF MY NUERO.

THANKS YOU MY SWEET MS FAMILY!!!

[Myoak]

Regi girl and everyone, thank you for your kind words.

Regi, your doctor mentioned the possibility of extending your dose as far as 8 weeks. I urge you to read an article which explains the idea behind dose extension. The article’s headline may appear alarming but there is some good news behind it which will clarify why your doctor may advise dose extension. There is a basis for doing so.

Essentially, researchers reviewed data and found that MSers who were “low-weight” were more likely to get PML than heavier MSers. Data shows that Tysabri builds up faster in lower weight individuals. Researchers talk about serum concentrations as much as 95% when the goal is only 85%.

Everybody gets the same amount or dose of Tysabri; it doesn’t matter if you weigh 100 lbs. or 250 pounds, both get the same amount of Tysabri. Each person receives the identical FDA approved dose. People who raise livestock know the vet doses meds according to the weight of the animal, unfortunately our doctors don’t get that option. Normally, the same amount of medicine will produce a higher concentration in a smaller person than a larger one.

The reason why you don’t want a higher concentration of Tysabri than the ideal 85% is because Tysabri is an immunosuppressant and you don’t want to disrupt the immune system to the point where it is incapable of doing its job, one of which is keeping JCV at bay so PML does not develop.

If a MSer extends the time between doses, the serum concentration of Tysabri becomes less (that’s why you have to get another infusion every few weeks) and even a low weight person should be able to keep serum concentration of Tysabri down to a better level.

Selected quote… “At 60 kg or less, "there is a striking elevation in PML cases. [The] incidence definitely trends towards patients with lower body weights," said Dr. Foley.

"We think there’s a link between serum concentration and saturation of lymphocytes in general, and that excessive saturation leads to near-complete stoppage of [lymphocyte] trafficking from blood vessels into brain parenchyma."

Perhaps "we reach a threshold where we not only impede the cells that are programmed to cause MS, but also the trafficking of the cells that are programmed to kill viruses. We need to figure out what the optimal balance is," he said in an interview.

For now, "how we are approaching this is [by] dose-extending high-risk, JC virus antibody–positive populations out to 5-6 weeks, instead of dosing every 4 weeks," as the natalizumab label indicates. It "reduces concentrations in the last few weeks, and saturations decline. It may well be a viable approach for PML risk reduction," Dr. Foley said.

The good news is that dose extension appears to be a reasonable method to bend the curve in our favor. Be sure to check out this article!

Low weight may contribute to risk for natalizumab-induced PML

http://www.clinicalneurologynews.com...duced-pml.html

Valuable article. Best to ya

[regi girl]

MYOAK, THANK YOU FOR THAT VERY IMPORTANT INFO.

WHILE I AM NOT AT TH WEIGHT I WAS WHEN I WAS A RUNNER, WHEN ALL THESE SX STARTED AND HAVEN'T LET UP, I DID GAIN ALOT WHILE DRS HAD ME ON MEDS BEFORE MY DX THAT CAUSED ME TO GAIN QUITE A BIT OF WEIGHT. WITHOUT RUNNING IT'S TAKEN ME A WHILE TO GET IT OFF.

ALTHOUGH I'M NOT WHERE I WANT TO BE WEIGHT WISE, I WOULD LIKE TO DROP 15 MORE POUNDS, PEOPLE AROUND ME SAY I SHOULDN'T. I'M AROUND 145 AND 5'6", SO IT MAKES SO MUCH SENSE WHAT YOU ARE SAYING. MY DOCTOR, WHO I LOVE AND TRUST SO MUCH, MAYBE TAKING THAT INTO CONSIDERATION. HE HAD MENTIONED THIS EVEN BEFORE WE NEW MY NUMBER.

I WILL GO OVER ALL OF THIS WITH HIM NEXT MONTH. I HAVEN'T READ ALL THE LINKS YET SO THE ANSWER TO MY QUESTION MAYBE IN THE INFO, BUT IF HE MOVES ME TO 8 WEEKS FOR EACH INFUSION IS IT POSSIBLE THE JCV # COULD GO DOWN? DO YOU KNOW ANY INFO ON THAT?

YOUR SUCH A BIG HELP THANKS SO MUCH, MAYBE SOME NEW HOPE.

[Myoak]

Really a great question… BUT IF HE MOVES ME TO 8 WEEKS FOR EACH INFUSION IS IT POSSIBLE THE JCV # COULD GO DOWN? DO YOU KNOW ANY INFO ON THAT?

I have not read any articles on the issue of JCV decreasing after dose extension. There has not been time to collect and examine that kind of data, IMO. The JCV index test has only been used since the first of 2013.

From what I’ve read about JCV the viral load tends to remain fairly constant. How dose extension may influence the JCV index is difficult to guess. It will take time to get that answer. Just hasn’t been enough data generated to do anything but guess at this point, IMO. But anything is possible and we can hope for the best.

Dose extension should decrease serum concentration of Tysabri in latter weeks resulting in a less suppressed immune system according to proponents. A majority of the population has JC virus but normally the immune system prevents it from becoming a problem.

Good question Regi but too early for a good answer at this point in time, IMO.

[Remy9111]

That is a fascinating article with useful info. I weigh 125 pounds. I get Tysabri every 8 weeks and have been doing that for the last 3 1/2 years because of too many infections. The first 1 1/2 years my immune system got too suppressed and toward the end of my 4 week trial I would get a bad UTI with every 4 week infusion.

So perhaps being a lightweight led to more drug concentration in my body and therefore more immune suppression and more infections? Now with infusions every 8 weeks I don't get the UTI's.

It is so true that size often matters in drug dosing. And there are even differences in how women and men metabolize the same medication. For example, just recently they began to advocate that women take a lower dose of Ambien (5 mg instead of the usual 10 mg) for sleep. Too much heavy drug fog was leading more women to sleep walk and talk, sleep eat, and sleep drive.

My spouse is 6' 7" and 250 lbs. the same amount of medication often affects him much differently than me.

[MSW1963]

There was a discussion by the nurses at my last infusion about one patient who is very petite, low body weight who's dose of Ty was reduced after experiencing intolerance problems. If I remember the discussion correctly, Biogen was involved in approving the lower dose, at the suggestion of the MS doc. The patient is doing well on the lower TY dose according to the infusion center nurses.

The infusion center is located in the same medical center complex as my MS neuro, and while I don't know if the infusion center only treats my MS doc's patients, the nurses are very informed/familiar with the MS center doc's, patients and routines.

My MS doc also showed me MS brain MRI compared to a PML brain MRI during my visit last week. It's available at WebMD.

There is one patient in the practice who developed PML about a year ago. According to my MS doc, the PML patient was PML sx free, PML discovered during routine MRIs.

[Remy9111]

Okay, we'll that's pretty scary that the patient was symptom free but they caught the PML on an MRI. I mean it's great they caught it early but what an insidious disease. Did catching it early mean the patient recovered well?

[MSW1963]

My doc stressed that the patient experienced significant loss. Also mentioned that the patient is on lifetime IVS, the only treatement option for a PML infection.

I can only imagine the concern and panic it caused at the MS center, the hospital nurses and staff who handled regular infusions, blood draws, etc.

According to my doc, the patient's recovery is beyond what doc's in the practice expected.

[golfore]

Re-starting Tysabri

I just started Ty after missing 5 doses because of surgery.

I'm 120lbs. I had about 75 tysabri infusions before I stopped due to the surgery.

I was tested at the first infusion in 5 months and my number is 1.8.

I will discuss stretching out my infusions to 5-6 weeks when I see my neuro in a couple of weeks.

[alanpgh]

Myoak, thanks for posting an interesting and relevant article from the CMSC Annual Meeting!

Everyone:
Here are some interesting videos about Tysabri:
http://resourcecenter.msworld.org/ed...ion-videos/#ms

What do you think about these videos in general, useful or not?

Do you have any suggestions as to where to post these to maximize the right people seeing them?
The video on Understanding MS and Tysabri provides an interesting animation on the MS Mechanism and why be on a DMT.

Let us know what you think.

Thanks Much!
Alan

[LL60]

Alan,
I just watched the two videos. I have seen one like the first one before. Telling just how they think Tysabri works. I think this is an excellent video. Everyone on Tysabri should watch it. I am a person who needs to know just how a drug works. This tells in a very simple way that is easy to understand.

I think this would be good to post at the top of the Tysabri thread.

The second video on PML - I didn't think was a good. It was like in trying to be simple and to the point, it was too simple. I felt it left out a lot of information. I didn't learn anything from it. But then again, I didn't start this medication until I had read everything I could find on it, and I try to keep up as this information changes. Someone who is just starting the journey may find this just perfect for them.

To have one place where you can come for everything is a great need. Doing these videos was a wonderful step in this direction. Thank you very much.

[alanpgh]

LL60,

We just stickied the Tysabri videos at the top of this forum, as you suggested.

Great idea. Hope this helps others!

Alan

[missykay75]

Perplexed

Hi,
I know these post were put up in May, but I'm hoping someone will still respond out there. I received a call yesterday from my Dr. about my JCV index being too high as well, and he now wants me to stop the Tysabri. I just had my 73rd infusion on 8/30. He told me that being JC+ put me at a 4-5/1000 risk of developing PML, but now with this new information, that number doubles, and that is too much of a risk for him.

He would like to switch me to one of the oral meds. My problem is I would have to go 3mo without anything if I start Gilenya (the other one is way too new), and it 50% efficient compared to Tysabri at 70%. I've also read that there is a high incidence of relapse when stopping the Tysabri, even when switching.

I've been relapse free for 5 years. The other thing is, even with my risk of developing PML doubled (which who knows how long my levels have been that high), it is still less that 1%. I'm just not sure the risks outweigh the benifits of going of the Tysabri. Does anyone have any thoughts or advise on this? Thanks.

** Moderator's note - Post broken into paragraphs for easier reading. Many people with MS have visual difficulties that prevent them from reading large blocks of print. **

[LL60]

mussykay75,

This is my feeling and mine alone.
As long as you are informed and can make an informed consent, the choice should be yours with guidance from your doctor.

I hate the terms "high" "low" "normal".... Give me the numbers!

What are your numbers. ARE they high? And we just don't really know what the higher numbers mean. We are still at that stage where we know more what the lower numbers mean.

I have what they look at now as a high index: 4.1
I will be retested 6 months from the test. Think I had it in June. If it goes up, well then I will have to think about what that means. With the information I have at that time.

I am not a gambler. I know Tysabri works for me. It works great for me. I do not know if the pills will work for me and I can not take the injectables. So why would I switch from I know as fact to a maybe? I won't.

My risk of getting heart disease is 1 in 5. Cancer 1 in 7. Stroke 1 in 24. Dying from a hospital acquired infection 1 in
38. Risk of me getting PML stands at about 1 in 190.

For me, the choice is simple. At this time. With what I know.

But what you need to do is up to you. You have heard how your doctor feels. Would it possible to sit down and talk to more about why he feels this way. And it can't be all about the numbers. It has to be about quality of life too. And is it working for you and what sort of risks are you willing to take. Now, your doctor also needs to listen to you and how you feel.

[Myoak]

Hi Missykay,

Treatment decisions can be terribly difficult. There are great differences among individual patients; each decision is made on an individual basis. Your neurologist would be most familiar with you and your circumstances so my opinion should be secondary to the discussion between you and your neuro, obviously.

Each neuro has his or her personal viewpoint and biases, also. Different neurologists have differing views on risk. You said because your JCV index number is high PML is too much of a risk for your neuro. But you seem undecided if it is too much of a risk for you because PML isn’t the only risk to consider. The risk of losing your current state of health is at risk, also. You have been relapse free for 5 years, which is notable.

You mentioned that there is a high incidence of relapse when stopping Tysabri, even when switching. That is true. And apparently, the longer the delay between stopping Tysabri and starting Gilenya, the more probable it is that relapse will occur:

Switching therapy from natalizumab to fingolimod in relapsing-remitting multiple sclerosis: clinical and magnetic resonance imaging findings.
http://www.ncbi.nlm.nih.gov/pubmed/23100526

QUOTE, “Twenty-two relapsing remitting MS patients having JC virus antibodies (JCVAb+) in serum were shifted from natalizumab to fingolimod after a three-month washout period… Disease reactivation was observed in 11/22 (50%) patients: clinical relapses in six patients (four patients within the first month of therapy) and MRI activity in a further five patients (three patients within the first month of therapy). Clinical and/or MRI signs suggestive of disease rebound were observed in three patients. Our data indicate that fingolimod does not exert clinical activity quickly enough to stop MS reactivation after a break from natalizumab.” END QUOTE.

Waiting 3 months is counter-productive, apparently. If you decide to switch from Tysabri to Gilenya and your neuro wants to wait more than a month tell him there is good reason not to delay, according to this study and others which lead to the same conclusion, such as: http://www.ncbi.nlm.nih.gov/pubmed/?...er+natalizumab.

Please don’t be frightened, there is good news, also. This new study just out a few days ago will raise a few eyebrows, and possibly hopes too, I’m sure: Second line use of Fingolimod is as effective as Natalizumab in a German out-patient RRMS-cohort. http://www.ncbi.nlm.nih.gov/pubmed/24008757.

In Europe both Gilenya and Tysabri are “second line”, in other words a different DMT must be tried before either of these. Probably to save money because those governments pay the bills in most European healthcare systems.

Important point… neuros waiting 3 months to switch from Tysabri to Gilenya are not up-to-date, IMO. But be really wise about how you approach the topic because most neuros have egos which will not tolerate instruction from unschooled patients.

Maybe you could trade-off. Agree to switch if the washout is limited to one month, otherwise, no deal. That is one possibility. Please note this is my opinion, only.

Treatment decisions are complex. No one has a crystal ball. We all make the best guess possible and go with that. Your neuro will be a big help; talk it out until you reach a level of comfort that you can sleep with. Bottom line; your life, your decision. God Bless!