Kelly, I think MdotDdot is a visiting MD?

Welcome MD, please do introduce yourself. I have read some of your posts and you seem to be knowledgable about Meds, Sides and symptoms.

Are you also ill and need support? We are here for you, as all others, and welcome your special kind of support, as well.

Again, Welcome..

Hello MdotDdot and welcome to the Tysabri thread.

I have to disagree with some of your post.

The data since Tysabri's return to market shows that PML is NOT necessarily fatal anymore. PML CAN be treated. When caught early, there may be little damage. The key to preventing damage due to PML is VIGILANCE, and those of us on Tysabri are pretty vigilant by now, and so are the neurologists prescribing Tysabri, and the infusion centers administering Tysabri.

As to traditional therapies, who should choose? We get sent home with a pack of info from the drugmakers, and told to come back when we pick a therapy. It's OUR choice. It should BE our choice no matter what. I planned to go on Tysabri and was scheduled for my first infusion when it was pulled from market in 2005. I hadn't taken any other therapy prior to that and the ONLY reason I agreed to do Copaxone was because MY CHOICE was no longer available and Copaxone seemed to be the least obnoxious of the drugs available.

I waited and worked to get Tysabri back on the market, while suffering from relapse after relapse on Copaxone. Copaxone obviously wasn't working for me, so it would be considered inadequate. When Tysabri returned to market, I went on it as soon as I could get on it. I haven't looked back since.

It's my brain. It's my body. I am an intelligent person and I can weigh the risks and benefits using the available information. I would still make the same choice today, to use the most efficacious therapy available to prevent relapses and slow the progression of disability.

Tysabri is prescribed as both first and second line therapy. The FDA clarified that back in 2006. Tysabri is generally recommended for patients who have had an inadequate response to or are unable to tolerate alternate MS therapies. I cannot tolerate losing my brain to this disease, nor can I tolerate drugs marketed to people with MS that, at best, give the patient a 34% efficacy rate.

I haven't had a relapse since I started Tysabri and it's been over two years now. My MRIs are tremendous. Not only do I have no new lesions and no enhancing lesions, many lesions seen previously are reduced in size or gone completely. My vision is back to pre-diagnosis levels, my spasticity and fatigue have been cut to 1/3 or better than where they were before Tysabri. My thinking is clear and I can read a book again without having to re-read every paragraph I previously read. I can retain information again. I'm not dizzy or walking like someone who is intoxicated. I can drive. I can work full time and work more than one job. Time is brain. So far, I'm holding on to mine in what I consider to be the best way that I can.

So, do you have MS? What therapy are you on? How's it working for you?

I'm just stopping in to say "Hi" and hope everyone is still doing well on their Ty journey.

I was so bummed when I got NABs with Ty. I have now been on Copaxone since March 22nd, and the fatigue is horrible! That was the one thing on Ty I noticed the most, I just wasn't so dang tired all of the time!

I don't have a lot of hope that when I have an MRI next March that I won't have many more lesions. But I've run out of drug options for the time being, and hopefully the C will get me by until the orals come out.

The good news is that I have such a good layer of fat all around I'm not having any skin problems with the C ! And no relapses, but then again, I didn't really on any of the drugs, just more lesions.

I feel a little bad because I went to a meeting with a doc from an MS center in Colorado, and he said he would have never changed me off of Avonex just because the MRI showed new lesions. He made the comment that you treat the patient, not the MRI! An interesting way of looking at things.

But it is what it is. Just wishing you all the best with Ty, and know I'm jealous!

Hi Mom!

Good to see you again. Glad to hear you aren't having any skin problems with Copaxone. I think the lumps and itching were the worst for me when I was on it.

Are you treating the fatigue? Provigil worked miracles for me, and it still does when I need it to.

Good Luck with your treatment and let us know how you are doing!

Hi 4boysmom - -Nice of you to stop in and say hi. We miss having you around! I hope the Copaxone works for you.

I had #13 yesterday. It got delayed a couple of days because I had the chance to be interviewed on the radio for my profession at the last minute and the only time they could do it was during the Tysabri appointment on Monday. So I thought it was worth it to delay!! I will go back to the regular schedule next time (25 days from now).

This was my second time at the new facility and it is a dream to be here. Once again they ordered lunch for me at Subway and delivered it right to the chair. The infusion was slowed down even more -- to 2 hours. Whoohoo! I feel even more able to recover afterward (just fewer side effects). Everyone is so friendly and caring at this place -- I guess I'm just not used to that given the horrible experience I had at my MS clinic's infusion room.

I did learn that all new people going on Tysabri in my MS clinic are having their blood sent to a doctor at the NIH who is working on a vaccine for JC virus. I guess the director of my clinic is helping out this researcher. I wish I could remember the name of the doctor/researcher but next time I will find out. I thought this was quite interesting. I guess it behooves Biogen/Elan,to do everything in their power to figure out how to eliminate the PML risk from their "blockbuster" drug Tysabri so they can keep the income flowing in. As it stands now they are way under the numbers of people they predicted would go on this drug by 2010.

Just to add in response to the conversation generated by MdotDdot: There are people who will choose Tysabri as a first line option. And there is nothing wrong with that. I was mostly treatment naive before I went on Tysabri. I tried Rebif for only 2 weeks. The depression was so severe in that short time I had to stop the drug given my long history of depression. I tried copaxone for 6 1/2 weeks and the anxiety, insomnia, fatigue, and general malaise I experienced was intolerable and I couldn't do my job. I suppose I could have stuck it out even longer on the copaxone to see if the side effects went away but I decided that my quality of life was important to me. The side effects of those CRABs really do suck!! I came to realize that I also wanted to be as aggressive as I could in the earliest stage possible so I chose Tysabri instead of toughing out the Copaxone. For me the benefit outweighs the risk. I can forget that I have MS. I do not have any MS symptoms nor have I had a relapse.

Thanks for the kind words, guys! I do try to take 100 mg of provigil most working days, but I don't notice a difference. Even when I first started, it did help me stay more alert, and it still does that, but my eyelids feel like they weigh 100 pounds most days.

I'm sure some of it now is just the heat. If I take more provigil, then I don't sleep at night, which I also figure contributes to my fatigue. I just didn't have these problems on Ty! I did on Avonex and Rebif, along with Copax now, but I don't recall that entire year on Ty complaining of fatigue so much.

Well, I've talked DH into taking me to dinner, so away I go! Then home to bed and it is only 6:00 p.m.!

Hiya Natalie,


Glad to hear that things are going well with the new infusion center. It sounds much better than what you posted about your previous place!

I'm happy to hear that slowing the infusion is working for you too! Sometimes they overlook the simplest things, and make everything more complicated than it is. I found that out when I had the pinpoint itches and we re-mixed the bag and voila!

Good to hear that there's some investigation going on to prevent PML. I've been watching for something like that to start being news'd around. I'd love to hear more when you get more information.

I'm no scientist but I still believe that it's not the Tysabri, per se, but the immune system and what the patient was exposed to before Tysabri, or the dose of Tysabri relative to size of patient. I still can't believe that the dose works the same for someone who is 5 feet tall and 90 lbs. and someone who is 6'2" and 220 lbs. and I haven't seen any stats on that yet. It could turn out to be something entirely different but like slowing the infusion or re-mixing the bag, everything should be investigated.

Biogen reported no newly diagnosed PML patients today on their minimal information release page.

No new PML cases is all the information I need.

Biogen reports earnings this week and maybe they will talk about their research efforts to detect PML earlier and to identify risk factors for PML.

Chris

I wonder about the weight too. I remember I read something about weight and clearance from the body in the insert. I went searching and found what I was looking for from Elan.

http://www.elan.com/Images/EMEA%20SPC_tcm3-14693.pdf

"Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition. Body weight was found to influence clearance in a less-than-proportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance."

And this from NIH.

http://www.pubmedcentral.nih.gov/art...?artid=1936307

"Analysis of pharmacokinetic data from Phase 2 trials and population modeling indicated that natalizumab clearance was only weakly correlated with body weight (over the range of 40 kg to 100 kg), but that natalizumab exposure (area under the plasma concentration-time curve and maximum plasma concentration), increased in proportion to weight despite the use of weight-based dosing (Bennett et al 2002; Rudick and Sandrock 2004; Biogen Idec Data on File). However, the effect of patient weight on natalizumab clearance and exposure was within the typical inter-patient range and was not considered clinically relevant. The 300 mg fixed dose selected to achieve maximum α4-integrin saturation was expected to produce acceptable pharmacokinetics in Phase 3 trials (Table 1)."


Essentially it sounds as if weight does make a difference but it is not "clinically relevant." If that's the case I have to wonder how they know with certainty it is not relevant?