8 WEEK INFUSIONS-1st. Exacerbation

[regi girl]

HELLO ALL, MY INDEX NUMBER FOR THE JCV IS 3.93 SO MY NUERO MOVED MY TY INFUSIONS TO EVERY 8 WEEKS.

OK, SO I HAD MY LAST "4 WEEK" INFUSION IN SEPTEMBER, THEN STARTED MY FIRST "8 WEEK" INFUSION WHICH WAS NOVEMBER 18, 2013. FROM SEPTEMBER TO NOVEMBER ALL WAS WELL.

SO THAT MADE MY NEXT "8 WEEK" INFUSION JANUARY 13, 2014. UNFORTUNATELY ON JANUARY 8TH, 5 DAYS BEFORE MY INFUSION, I BEGAN A PRETTY BAD EXACERBATION, THE FIRST SINCE I HAVE STARTED TAKING TY. THREE DAYS OF IV STERIODS.

I HAVE EXPERIENCED NEW SYMPTOMS WITH THIS FLARE THAT I HAVE NEVER EXPERIENCED BEFORE, SO VERY SCAREY.

FRIDAY WAS MY FIRST DAY BACK AT WORK, WE WERE OFF YESTERDAY FOR MLK DAY, AT WORK TODAY. I FEEL THAT I HAVE RECOVERED COMPLETELY FROM THE FLARE AND HAVE RETURNED TO MY ORIGINAL STATE AS FAR AS SUSTAINING ANY PERMINANT DISABILITY FROM THE FLARE. I STILL FEEL WEAK FROM IT ALL, BUT I'M WALKING WITHOUT ASSISTANCE AND I AM NOT LIMPING, MY OPTIC NEURITIS IS GONE, BUT GETTING HEADACHES AROUND 3:00 UNTIL BEDTIME AND EYE PAIN. BUT THAT IS NOT UNCOMMON FOR ME SINCE I'M ON THE COMPUTER AT WORK THE MAJORITY OF THE TIME. (CAN'T DO THIS MUCH LONGER)

I GO TO MY NUERO THIS THURSDAY TO DISCUSS WHAT HAPPENED, IF THERE WERE CHANGES IN MY MRI AND TO GET ANOTHER BLOOD TEST TO CHECK MY INDEX NUMBER.I WILL POST MY NEW# AS SOON AS I KNOW IT.

MY DOCTOR WAS GOING TO SWITCH ME TO LEMTRADA WHEN IT WAS APPROVED, HOWEVER WE ALL KNOW THAT THAT DIDN'T HAPPEN. SO WHAT TO DO?

TY HAS BEEN SOOO GOOD TO ME. NO SIDE EFFECTS THAT I AM AWARE OF AND IT HAS GIVEN ME A MORE MANAGABLE AND NORMAL LIFE. I AM LEAVING WORK MARCH 29TH BECAUSE EVEN WITH TY I JUST CAN'T DO THIS ANYMORE.

SO MY FELLOW TY USERS WITH HIGH JCV NUMBERS, WHAT DO WE DO? I THINK THIS FLARE PROVES THAT I WOULD DEFINATELY HAVE THE REBOUND EFFECT IF I GET OFF. HAVEN'T TALK TO NUERO ABOUT THAT BUT I THINK THIS FLARE INDICATES THAT I WOULD SUFFER FROM THE REBOUND EFFECT.

HE MAY DECIDE TO MOVE TO EVERY 6 WEEKS, WON'T KNOW ANY OF THAT UNTIL I TALK WITH HIM THURSDAY.

I'M SOOO SCARED AND I KNOW I'M NOT THE ONLY ONE IN THIS BOAT. SO MY DEAR SHIPMATES HOW ARE YOU AND YOUR NUEROS PLANNING ON HANDLING THIS SITUATION?

[DebbieB]

Regi Girl,

You are definitely not alone.

First of all, I'm so sorry your titer # is "high"; sorry you had to go to 8 weeks when you were doing so well at 4; and sorry you had a relapse most recently.

I too am pondering my future - currently in a double-blind study for Tysabri for the use in SPSS patients. Although I don't know for certain if I'm on the drug, my guess is I am (for many reasons, one being I haven't felt so good for years).

Like you, my titer is "high" at 3.34; first test was 3.38. I have an appointment to discuss with Neuro/Study Doc on 1/31....have no clue what to do - do I stay in the study??? (another year).

Anxious to hear other's responses. I'll be thinking of you - if you have an epiphany, let us know.

[regi girl]

DEBBIE, THANK YOU SO MUCH FOR YOUR CONCERN. I DON'T KNOW WHAT I WOULD DO IF I WERE IN YOUR SITUATION EITHER. THAT'S A TOUGH ONE.

YOU KNOW WE JUST HAVE TO GET THE BEST ADVICE FROM THE DOCTORS WE TRUST, GET THE INPUT AND FEELINGS FROM OUR FAMILY AND FRIENDS WHO TRULY LOVE US AND WITH THAT GO WITH THE DECISION THAT WE FEEL IS RIGHT FOR US.

THE REBOUND EFFECT SCARES ME SOOO BAD. i JUST CAN'T STAND THE THOUGHT THAT I COULD BE WORSE THEN THE DAY I STARTED THIS DRUG. I PRAY THAT THEY COME UP WITH SOMETHING THAT MAY RID OUR BODIES OF THE VIRUS OR FIND SOME MARKER THAT WOULD ACCURATELY SHOW WHO WOULD AQUIRE PML AND THOSE THAT WOULD NOT. THAT SOUNDS LIKE A SCI-FI, BUT WOULDN'T THAT BE GREAT.

I HOPE OTHERS WHO ARE IN THIS SAME OR VERY SIMILAR SITUATION WILL POST THEIR CONCERNS AND THEIR VIEWS. I KNOW MY NUERO IS VERY CONCERNED ABOUT THIS AND IS VERY INVOLVED IN THE RESEARCH TO SOLVE THIS PROBLEM. WE JUST HAVE TO HAVE FAITH THAT ALL THESE GREAT MINDS THAT HAVE DEDICATED THEIR LIVES TO THE RESEARCH AND CURE FOR MS WILL COME UP WITH A TIMELY ANSWER.

GOOD LUCK TO YOU AND YOUR DECISION.

[LL60]

I too fear the rebound effect more than the risk of PML. I am so sorry that stretching out your infusions brought on an attack.

We all keep getting these titer tests and getting "our numbers" and I just think that they really don't know what it all means. There is so much grey area. Most of the graphs stop at 1.5. Well what does a 4.1 mean? Or a 3.1. Or a 9.1? How high do they even go?

I just am going to continue taking a drug that I know for a fact is helping me, and just try to keep up with the changing research.

[regi girl]

LL60 I HAVE WONDERED ABOUT THOSE SAME QUESTIONS!! I HAVEN'T BEEN ABLE TO FIND ANYTHING ABOUT WHAT THOSE NUMBERS REALLY MEAN BEYOND 1.5.

I DO KNOW THAT BEFORE THE BLOOD TEST THAT GIVES US "THE NUMBER" MY NUERO FELT LIKE I WAS DOING SO WELL ON TY THAT THE RISK WAS UP TO ME AND IF I WANTED TO TAKE THE ODDS AND STAY ON IT IN SPITE OF BEING JCV+ HE WOULD KEEP ORDERING THE TY FOR ME. I COULD TELL THAT HE FELT THE ODDS WERE IN MY FAVOR AND MY QUALITY OF LIFE HAD IMPROVED SOO MUCH. HOWEVER ONCE A NUMBER WAS PUT TO IT AS A MEASUREMENT HE SEEMED TO HAVE CHANGED HIS MIND.

BUT HE WANTS ME TO STAY ON IT UNTIL HE SEES WHAT HAPPENS WITH THE LEMTRADA APPEAL, HE WAS ONE OF THE DOCTORS THAT PARTICIPATED IN THE STUDY AND HE IS DEVISTATED THAT IT WAS NOT APPROVED BECAUSE SOME OF THE STATEMENTS BY THE FDA HE SAID WERE JUST NOT TRUE. WON'T GET INTO THAT HERE.

I JUST HAD MY 17TH INFUSION SO I'M SUPPOSE TO BE "SAFE" UNTIL WHAT? THE 21ST OR 22ND?

I'M HOPING & WISHING FOR A MIRACLE, THERE HAS TO BE AN ANSWER. I WANT TO STAY ON TY UNTIL SOMETHING AS GOOD OR BETTER AS TY COMES OUT THAT DOES NOT HAVE THE THREAT OF PML. BUT AS MY MOTHER USED TO SAY "IF WISHES WERE HORSES, BEGGERS WOULD HAVE RIDES"

[DebbieB]

Speaking of mothers....

Regi Girl, speaking of mothers, mine always says "if it's too good to be true, it is". Which is exactly how I feel about Ty.

I'm very frightened about the "rebound effect" as well...and what's worse, PML? Rebound? Who knows.

Also, to address LL60's Q, I know my doc classifies my titer index (3.34) as "extremely high" and "troubling" (thus "the talk" scheduled for 1/31).

Google "Anti-JCV antibody index further defines PML risk in natalizumab-treated MS patients". This is the most recent info I've found re: risk of PML. I am not a believer in the often-cited Rocky Mountain MS data where the most is 1:181 (I personally think this is now outdated with the indexing). Check out the latest.

I find folks are either so engrained in the TY and their positive response to it, or folks are too scared to even try it. I don't think there's alot of "us" out there, Regi Girl.

Sending positive thoughts your way. Hopefully others will weigh in...

[regi girl]

THANKS DEBBIE I WENT TO SOME OF THESE WEB SITES, (IT DIDN'T PULL UP TOO MANY) AND SEARCHED THAT INFO. I FOUND SOME INTERESTING INFO BUT STILL NO REAL INFORMATION ON EXACTLY WHAT THESE NUMBERS MEAN TO US AS FAR AS OUR IMMEDIATE ODDS AND RISKS TO PML.

I WOULD JUST LIKE SOME CLARIFICATION, LIKE I'M SURE EVERYONE ELSE WOULD.

[DebbieB]

I'm sorry if I confused you more, or led you down a road of searching without finding anything....There's a good article entitled "Plavina_Tysabri JCV AB Index_2013 CMSC Poster_Final.pdf" that I intend on speaking to my Neuro about this coming Friday. Can't find a link online - it keeps converting directly to the PDF.

I feel it's the first thing that I've found that (I believe) links the index # (and higher the number) to greater the risk for PML. If I have any great enlightenment after my visit on Friday, I'll post.

[Myoak]

This may help; it may not. I will not provide sources so everyone may want to disregard this info as hearsay. Better yet, IMO, copy it and take it with you to your next appointment with your neurologist. Hopefully he/she is a MS specialist because if you are not seeing one you are likely not getting the expertise a disease like MS demands. If your MS specialist cannot verify the following information, he/she is not up to date.

For those who want to know what JCV titer numbers over 1.5 indicate, sorry, but data are insufficient. I doubt if more complete data exists anywhere with the possible exception of within Biogen and I personally doubt if they have sufficient data to make more available at this time. Speaking to Regi, Deb, and LL60 this is what I have to say, others may ignore it:

JCV negative, risk of PML is 1 in 10,000.

JCV positive and previously taken immunosuppressants…
On Tysabri 1-24 months risk of PML is 1 in 556.
On Tysabri 25-48 months risk of PML is 1 in 89.
On Tysabri 49-72 months risk of PML lacks sufficient data.

JCV positive and not taken immunosuppressants…
On Tysabri 1-24 months…
JCV titer under 1.5 risk of PML is 1 in 10,000.
JCV titer over 1.5 risk of PML is 1 in 1,000.

JCV positive and not taken immunosuppressants…
On Tysabri 25-48 months…
JCV titer under .9 risk of PML is 1 in 3,333.
JCV titer under 1.1 risk of PML is 1 in 1,429.
JCV titer under 1.3 risk of PML is 1 in 1,000.
JCV titer under 1.5 risk of PML is 1 in 833.
JCV titer over 1.5 risk of PML is 1 in 123.

JCV positive and not taken immunosuppressants…
On Tysabri 49-72 months…
JCV titer under .9 risk of PML is 1 in 2,500.
JCV titer under 1.1 risk of PML is 1 in 1,429.
JCV titer under 1.3 risk of PML is 1 in 833.
JCV titer under 1.5 risk of PML is 1 in 769.
JCV titer over 1.5 risk of PML is 1 in 118.

Risk acceptance is individually unique. There is no right or wrong. It is a personal matter. No one can predict the course of MS. I have a friend who stopped Tysabri from fear of PML even though she was JCV negative. I have no criticism at all for her. I don’t live in her body. My privilege as a friend is to love her no matter what she chooses.

Same goes the other way. If someone chooses to take Tysabri (remember 34% of those on Tysabri are free of disease activity) I have no criticism at all no matter what the risk. MS has risk, also. And, lack of treating it in the most effective way possible can be disastrous for some. It is not difficult to understand someone relatively free of MS would want to continue that way.

Regi, I’m so sorry the Lemtrada didn’t work out, for now anyway. It certainly has issues of its own but may have worked well for many. Regi, 8 weeks may be too long between Tysabri infusions. Dose extension may be helpful (and it may not be) but 8 weeks appears to have been too long for you. You may want to discuss shortening that 8 week period with your neuro. Or, you may want to drop Tysabri and consider alternatives.

My own belief is that diet and supplements discussed at MS World have important value.

Keeping all of you… Deb, Regi, and LL60 in my thoughts for good health and inward peace. I trust God to give you strength and help for impossible decisions. We all face them. You are all mighty women of valor. You will do well.

[regi girl]

THANKS MY OAK, I APPRECIATE THE INFO. I HAVE READ ON ANOTHER POST THOSE STATS. I FIGURE YOU ARE RIGHT, FOR NOW I DOUBT THAT WE CAN FIND CONCLUSIVE INFORMATION ON EXACTLY WHAT THE DIFFERENCE IS BETWEEN 1.5 AND 2.3 OR 4.1.

BUT THERE MUST BE MORE RISK OF PML WITH A HIGHER INDEX NUMBER. MY NEURO IS AN MS SPECIALIST AND WAS OK WITH ME STAYING ON TY EVEN THOUGH I WAS JCV+, HE SAID THAT WAS MY DECISION TO MAKE AND HE WOULD HONOR WHATEVER I CHOOSE. BUT WHEN A HIGH NUMBER WAS ATTACHED TO IT, HE NOW WANTS ME TO COME OFF IT. HE IS STUDYING THE BEST ALTERNATIVE FOR ME.

HE FEELS I AM "SAFE" FOR THE NEXT FEW INFUSTIONS, MAYBE UP TO 22, JUST HAD #17. HE IS USING THIS TIME TO RESEARCH WHAT IS GOING TO BE THE SAFEST AND MOST EFFECTIVE DRUG FOR ME WHILE TRYING TO AVOID THE REBOUND EFFECT.

MYOAK ALWAYS HAS SOME OF THE BEST INFO AND ADVICE, I READ YOUR POSTS ON OTHER THREADS AND IT IS ALWAYS SPOT ON. THANK YOU