Tysabri Talk
 

Hi Lauren,

I hope you get great results from Tysabri. You deserve a break! Please keep us updated on your progress, I hope you get spectacular improvement.

I have a doctor appointment on Monday, and I'm going to ask my doctor about it.

I'm on Copaxone and not doing so great. I tried Avonex and Rebif too. He might want me to try one of those again, but I had bad side effects from Rebif... and not so great results from Avonex.

I sometimes think I might be better off on no treatment, then I might not need all these extra side effect meds.

I hope you will have renewed energy soon and too busy to update us.

Hello Lauren!

Good to see you here.

As always - I'm wishing you the very best with Tysabri.

Hi Ewizabeth, thank you.....and....

nooooo, dear....just because you "feel" better off meds, doesn't mean you won't have "silent" lesions forming...

The Tysabri label states in part: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

I pray your neuro is smart enough to see you are failing the older MS meds and gives you the opportunity to experience the best MS med in over a decade!

Best of luck tomorrow,
(((hugs)))
Lauren

Hi Lee Ann!

Small world! haha, thank you honey :)

((((((hugs)))))
Lauren

It doesn't always hold true, Lauren, There may be no lesions on MRI, with many symptoms and great disability, and then there may be many lesions with no disability.

But, if Tysabri does lower the risk of exacerbations, that has to be a good thing. It does have a (what did XO say) 10% better efficacy rate at reducing exacerbations, than the CRABS.

The Jury's still out on it being better than fried rice, though, since, just like the crabs, the majority of PWMS will not respond favorably to Tysabri.

Good luck and Best Wishes,

Am I close on that, XO?:rolleyes:

Wow Sally, not even close but, thank you for your post...
I did not say "are not" silent lesions forming, I said "does not mean there won't be", as anything is possible with MS, i.e., nothing is "concrete"....you are actually talking "apples and oranges"; when I was going by what Ewizabeth stated: which "implies" she is having more lesions causing more symptoms (lesions are the scarring that is interrupting the nerve signal due to myelin loss/damage", thus the disability.
http://www.nationalmssociety.org/What%20is%20MS.asp

Not sure if you are terribly misinformed or what Sally, but please, let me enlighten you re: Tysabri....there is no if when it comes to it's proven 68% superior efficacy...here is the New England Journal of Medicine's (where some of the most highly respected unbiased medical opinions in the worldopined: "Results Natalizumab reduced the risk of sustained progression of disability by 42 percent over two years (hazard ratio, 0.58; 95 percent confidence interval, 0.43 to 0.77; P<0.001)....Natalizumab reduced the rate of clinical relapse at one year by 68 percent (P<0.001) and led to an 83 percent reduction in the accumulation of new or enlarging hyperintense lesions, as detected by T2-weighted magnetic resonance imaging (MRI), over two years (mean numbers of lesions, 1.9 with natalizumab and 11.0 with placebo; P<0.001). There were 92 percent fewer lesions (as detected by gadolinium-enhanced MRI) in the natalizumab group than in the placebo group at both one and two years (P<0.001)." Volume 354:899-910 March 2, 2006 Number 9

Furthermore...Wrong again Sally, see the PROVEN DATA recently released: TYSABRI® Demonstrates Improvement in Cognitive Function (http://www.elan.com/News/full.asp?ID=910099); TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations (http://www.elan.com/News/full.asp?ID=913012; TYSABRI® Has Sustained Effect on Relapse Rate for up to Three Years (http://www.elan.com/News/full.asp?ID=910437); TYSABRI® Improves Quality of Life (http://www.elan.com/News/full.asp?ID=840112).

Kinda difficult to argue with proven data, Sally..plus I happen to like "fried rice" alot, and I'd venture a guess that alot of others do too! ;)

Best wishes to you also.

Lauren

I'm not as "Misinformed" as you think I am, Lauren.:rolleyes:

Read the thread link below, especially what XO, Our resident Trial Study Guru, and re-inform yourself.:)

http://neurotalk.psychcentral.com/showthread.php?t=2333

Been there, done that, and please don't roll your eyes at me or the published data (that borders on rudeness)..and I don't need to re-inform squat, you are more than welcome to believe whatever TRIAL guru opinions you want to, but if you start posting falsehoods, as in your ealier post, I won't hesitate to point them out for ALL to see.

Good evening to you.

Lauren

Lauren,

I saw my neuro today and he said I could have Tysabri if I wanted it, but he offered me other options too. I am going to test for the Tovaxin trial and hope to be accepted into it.

Another option he offered was double Copaxone, which has showed good results in a recent trial, so if I don't get into the trial I might take that route.

I hope you do really well with Tysabri, keep us posted!

Temper temper :)

Be careful about talking about Tysabri in such absolutes. The overall results of the trial were very good, but the best case will not be the experience of all patients.

This board is more for talking, less about arguing or stomping off indignantly, Lauren. Doing that eliminates the opportunity for dialogue.

Well, it seems that despite the marketing/sales efforts of Biogen/Elan and the hype that is being created by some with this drug, the financial world (and that is what big pharma is all about) is being far more cautious as is demonstrated by this press release yesterday:


Like I've said many times, it will take about a year of general MS population use before we start to see any meaningful results from Tysabri.

Harry

And then there is this article found on Braintalk, to consider:

Reuters article of reluctance to use Tysabri

--------------------------------------------------------------------------------

By Toni Clarke

BOSTON, Oct 23 (Reuters) - Doctors are proving more leery than many had expected about prescribing the multiple sclerosis drug Tysabri, which was relaunched in July after being suspended because of safety concerns.

Over the past month or so, analysts have drawn down their 2006 sales forecasts as it becomes clear that doctors wary of the risk of the rare but potentially fatal brain disease PML are reserving the drug as a treatment of last resort.

The drug, which is made by Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) and Irish partner Elan Corp. Plc (ELN.I: Quote, Profile, Research) (ELN.N: Quote, Profile, Research), had been expected by some analysts to generate sales this year of more than $100 million, but those figures have dropped dramatically.

Ian Hunter, an analyst at Goodbody stockbrokers in Dublin, said on Monday that he has cut his full-year Tysabri forecast to $25.7 million from $78 million, in part because of continuing safety concerns and the complexity of reimbursement systems in Europe.

A survey of 63 neurologists conducted by Reuters Primary Research indicates that in 2006 Tysabri will be used in less than 1 percent of multiple sclerosis patients -- translating into revenue of under $30 million.

Since July, only 47 of more than 8,500 patients treated by the physicians surveyed by Reuters had used Tysabri, even though more than 700 patients had discussed using it, according to the report.

And more than 75 percent of the patients who had used Tysabri prior to its 2005 suspension have decided not to use it since its reintroduction, the survey showed.

In taking the rare decision to allow a withdrawn drug back onto the market, the U.S. Food and Drug Administration was partially influenced by calls from patients who said they were willing to take the risk of contracting progressive multifocal leukoencephalopathy, or PML, because of the potential benefits of the drug"It turns out in real life that a lot of patients and doctors are taking a wait-and-see attitude," said Ben Weintraub, author of the Reuters survey.

About 250,000 to 350,000 Americans have been diagnosed with MS, a degenerative disease of the nervous system that can lead to muscle weakness, blurred vision and, ultimately, disability. Many benefit only partially from current treatments, which include Biogen's drug Avonex.

Tysabri's ultimate sales potential will depend, to an acute degree, on whether there are any more cases of PML, analysts say. Most of the respondents to the Reuters survey said they would stop using Tysabri altogether if two new PML-related deaths were associated with Tysabri.

"Most people say its going to be a $1 billion drug eventually," said Steve Brozak, an analyst at WBB Securities. "But more time is needed. Time buys you information." (Additional reporting by Paul Hoskins in Dublin)

© Reuters 2006. All Rights Reserved.

Tysabri/Crohn's News
 

Good news, that is:
__________________________________________________ ______________________________

Biogen, Elan Drug Effective in Crohn's
Tuesday October 24, 9:12 am ET
Biogen Idec and Elan Present Data Showing Effectiveness of Tysabri in Crohn's Disease


NEW YORK (AP) -- Biogen Idec and Elan Corp. said Tuesday data from a long term study of their multiple sclerosis drug Tysabri maintained remission rates in Crohn's disease patients treated over a two-year period.

The study involved 90 patients and showed 86 percent were still in remission after two years of continuous treatment. Also, a subpopulation of 22 patients who had previously taken infliximab therapy showed an 82 percent remission rate after two years.

Rex,

I guess the only concern about Tysabri and Crohn's would again me the lack of long term safety data. The one patient who died from Tysabri monotherapy was a Crohn's patient and the PML started to appear only after a couple of infusions.

Again, it's benefit vs risk and as long as the patient, be it Crohn's or MS, is given all the information about this, the decision becomes that of the patient.

Harry

In all fairness, that patient was already severely immunosuppressed when Tysabri was started. So that's really not a fair case of monotherapy. Nobody has died from monotherapy to date.

Rex,

I know that is a statement that has been made before but in actual fact, this Crohn's patient had stopped using Infliximab 20 months earlier and had stopped Azathioprine 8 months before being hospitalized. Unless those drugs stay in one's system for that huge length of time, the only drug the patient was using at the time of getting PML was Tysabri.

Another note of interest...this patient was relatively healthy at the time of going on Tysabri, only suffering from the problems associated with Crohn's which had been with him for several years. He had been involved in the Tysabri trial earlier but was on the placebo.

Harry

I did not know that Harry Z.

And, let's all remember that Biogen has ethics that have been seen as questionable in th past, so we only know what Biogen tells us, and what they tell the FDA (which sometimes is not the full story).

I'd be interested in seeing a link to that timetable and to the assertion that he had not been immunosuppressed for 8 months prior to being started on Tysabri. I've never read that anywhere.

Hi Elizabeth, glad to hear that your Neuro is looking at Tovaxin for you. I am personally very excited about this new treatment option, and wish you all the best with getting into the trial.

Hi Lauren, and welcome aboard.

I think you are going to like NeuroTalk, and I am sure you will find it very refreshing to meet such a fine group of astute and well informed members to interact with.

When I read your first two identical postings on this forum, my first thought was that you were a sales rep for Biogen. IMO, most of your posts read like some sort of over-the-top advertising campaign, with hugely broad-sweeping statements about a yet very controversial & unproven drug (in the l/t). Given that you too are a PwMS, I can see you are just very excited about having another treatment option available to you.

Please know that I wish you continued health and success from using Tysabri . . . however, I am concerned about some of your statements, assumptions, and a seemingly biased viewpoint about this drug. While I agree that none of us should have to defend our chosen treatment, we may very well be challenged on our ‘perception’ of the “facts”.

If I were in your shoes, this would have had ME questioning whether Tysabri might have actually caused the relapse, since this "severe relapse" occurred so shortly after the infusion. :confused:

Of course that is HIGHLY unlikely, but it just goes to shows that we can not jump to conclusions when we try new meds, especially after only one treatment.

Didn’t you only have the one infusion in 2005, then experienced another attack within a few months of it? (I understand that you have recently had another infusion, about a week ago too).

If this is your only experiences to date with this drug, how have you have already come to the conclusion that this is the “only MS therapy that has stopped my attacks”?

How do you know that Tysabri is going to work for stopping YOUR relapses with so little history to base your opinion on?

There are many choices of therapy available to us, not just those that are currently endorsed by the pharma companies and/or supported by the NMSS. Your comment, that you 'support people’s right to choose', does not seem represented by such points (above).

This is getting to be very OLD news now, but thank you for sharing your tape.

What does that sentence mean; "68% superior efficacy”. 68 percent superior to what?

Are you aware that the PRIMARY, and most important measure for a drugs effectiveness is it's influence on disease PROGRESSION? Tysabri did NOT fair significantly better in this regard, with the following reported/comparative results:

"In the AFFIRM monotherapy trial, 29% of placebo patients but 17% of Tysabri patients progressed in a two year period (based on a statistical model), a difference of 12%.

In the PRISMS Rebif trial, 37% of placebo patients but 26% of Rebif (44mg) progressed in a two year period, a difference of 11%.

In the phase III Avonex trial, 35% of placebo patients but 22% of Avonex patients progressed in a two year period, a difference of 13%."

QUOTE: XO++, Mark

Relapse rates, for which you have quoted the efficacy rate of 68% is simply a SECONDARY measure of a drug’s effectiveness. Although I agree it’s kinda’ nice if we happen to be one of the lucky ones to experience less relapses due to a drug, if it doesn’t significantly impact disability accumulation, quite frankly I’m not getting all that excited.

The “reduced relapses” stats that are presented to us, i.e. the 68% that you are advertising for Tysabri, are RELATIVE TO PLACEBO, not absolute. This is NOT very a forthright representation of how effective they are, IMHO. The same holds true for the “enhancing lesions” reduction stat, and a correlation between the reduced # of enhanced lesions' effect on disease progression.

The link that Sally provided for your reference is extremely relevant to the efficacy of these drugs, and may influence our decisions. Therefore, I encourage you to “point out the falsehoods for everyone to see” by providing specific details about where there is misinformation being presented.

Again, welcome to the board, Lauren. Hope you enjoy it here. :)

Cherie

I did see the NEJM report today...however, even though the patient had stopped immunosuppressants 8 mos. previous, he had been on that therapy for 5 years, and there is no way to demonstrate that his immune system was functioning normally when he began Tysabri infusion. In fact, his immune system may well have been very abnormal after such protracted immunosuppressant therapy.

The best evidence I know of is that there have been no cases since, and while we must wait and see, every day which passes without incident makes everyone a little more confident in the safety of Tysabri in monotherapy. So, time wil tell; but I'm not holding my breath at this point.

Hi Rex,

I had saved this graph from a conversation we had last yr on OBT, which shows which drugs he was on, etc.:

http://i12.photobucket.com/albums/a2...sab_crohns.jpg

There is no doubt that his immune system was compromised, but the problem is that many of ours are, from steroids, chemo, CRABs, etc. However, he was on Tysabri as a monotherapy at the time of his death.

You are right, time will tell.

Cherie

Thanks, Cheryl for your post and for the chart. I had not seen that until now...Wow, Poor guy.

I'm also interested in how the Lawsuit against Biogen and Elan, by Anita Smith's Husband, goes. She is the first person to die from PML and was on Avonex and Tysabri.

Well, first off, has Biogen taken responsibility for the PML?

After getting all of my slides, doctor notes, and so forth, they told me that they were not responsible for my lung and heart damage. Even though Mayo, who examined me did attribute it to the recalled avonex.

Its just another case of refusing to grow up and accept responsiblity for wrongdoing, in my opinion.

I'm anxiously awaiting the results of this trial too, mostly because I want to know if this lady actually had MS or not.

For a long time there was much discussion about whether we can "count" her, because it was alledged that she "didn't really have MS". I'm not quite sure why she wouldn't count anyway :confused:, but she had the MS label for quite some time and had been treated with Avonex for yrs.

If not having MS was indeed a factor in her death, ie. she shouldn't have been on immunosuppressants, then I would be very concerned that there are potentially many people who don't know WITHOUT DOUBT that they have MS. Clearly they thought she did . . . And if she did have it, we're back to square one; another MS'er who died from this drug (combined with Avonex).

Cherie

You should have sued them, BBS, the bastids.:mad:

The Lawfirm representing Mr Smith, has gotten all kinds or interesting info and scientific reports. On report shows that by adding Avonex to the tysabri, actually increased the half life of the Ty, causing it to stay in the system longer, so that the Tysabri was accumulating and She was getting twice as much as she should have.:eek:

Google Anita Smith Lawsuit..Lots of info. Did you know that one of the scientists who came up with Tysabri and tested it on animals, said that it was too dangerous to use on humans?:eek:

Thanks Cherie,

I just hope I have the T cells when I get the blood test. :) Seems odd to wish for something like that, but that's what it takes to qualify for the trial. BTW, you're doing a fine job here.

I suppose that was possible but the patient's health, with the exception of the problems associated with Crohn's, was very good when he started on the Tysabri. His viral blood count was normal...until he started to use the Tysabri which indicates the JCV virus was not active.

You are very right in saying that we will just have to wait for more safety data as more patients start to use Tysabri.

Harry

Sally,

Other than seeing more $$$$ at the end of the rainbow, I just don't understand why Biogen combined Tysabri with Avonex in a trial:confused:

Here they were testing a new drug in a Phase III trial, certainly had very little safety data about it at that point ....yet were mixing it with another immunomodulating drug!! I mean, really:eek:

Harry

Yes, and what gets me even more, Harry, is that Biogen didn't miss a beat in advising patients to continue right along with their Avonex.:mad: Elan lost their shirts but Biogen, not so much.

???

If you shorten the half life of Tysabri, it stays in the body for less time, not more.

Azathioprine has an extremely short half-life itself, minutes, and its active derivatives have a half-life in the hours (1-3). I would be very surprised if it exerted any effect on the immune system months after discontinuation.

Thanks Pantos, I misstyped. I corrected my post.

BTW, Here is where I got the info.

http://www.yourlawyer.com/articles/read/10734

Pantos,

Yet Biogen tried to infer to this patient's family that, because of Azathioprine and other drugs the patient had used months earlier, this was the main reason he ended up with PML!!!

Harry

Hi Sally,

Thanks for the link. You gotta remember though that those are only allegations made relating to a lawsuit, none of those things have been proven. Also the guy who claims it's not safe works for competing MS drug co's.

I would really like to see the scientific research about whether Avonex with Tysabri increases the bioavailability of Tysabri or whether use of immunosupressants affect Tysabri's effects on the body. Could people who use Avonex use LESS Tysabri then to get the same effect but without going over to increasing the risks of developing infections?

I am surprised the FDA allowed it back on the market before knowing this. Avonex is not really even considered an "immunosuppressant" so much as immuno-modulating. But given that MSer's often ARE given immunosuppressants which would seemingly have more effect at suppressing the immune system in conjunction with Tysabri, and given that the Crohn's patient had been OFF Azathioprine for a while yet still developed PML, I would think that we really need the answer to the question of what the risks are of developing PML having EVER used an immunosuppressant or immuno-modulator.

Maybe the risks are still not huge given that we can assume that probably a fair # of people in the MS or Crohn's trials had used some kind of immunosuppressants at some point in their illness and only a very few developed PML. But how long does one need to wait to make sure that there is no contraindication occurring? What parameters put one at risk for PML? Is it even related to use of immune suppressants at all.

I really wish we could know exactly WHAT puts someone at risk for PML.

Hi Harry,

You slipped in there while I was writing my post.

Well given that both MS and Crohn's patients are often prescribed immune suppressants, I would not think it was in Biogen's best interests to try to attribute the cases of PML to prior or current use of immunosuppressants. It doesn't make much financial sense given that so many patients HAVE used immunosuppressants (or immune modulators if Biogen wants to assert it was concomitant use of Avonex that caused PML). They'd be better off saying it was just an unknown and extremely rare result than blaming the use of immunosuppressants or modulators.

But then again the strategy worked in pushing it through the FDA again.

When, in fact, you believe that the PML was caused by...what?

You would think that but that's indeed what the family was being told. It was interesting to note that shortly after PML showed up and Tysabri was pulled, Biogen's CEO James Mullen stated that in hundreds of thousands of patient years of Avonex use, there had never been a known case of PML. He was obviously protecting Avonex at the time.

The main problem that Biogen had then and still has now is that there are no real answers as to why these patients ended up getting PML. I'm sure that the company execs are holding their breath and really hoping that they don't hear the word "PML" for a very long time in conjunction with Tysabri use.

Harry

Hey Lauren, For the record, I was not rolling my eyes at you for your exuberance or the published data, but only at your rude assertion that I was grossly misinformed.:rolleyes:

Sorry Sweety, come back and talk to us. I am truely interested in seeing you do well with Tysabri.

Hugs,