This Is MS Multiple Sclerosis Knowledge & Support Community

ptwo, that extremely low incidence of side effects is very interesting and clearly a differentiator (along with twice the efficacy of alternative treatments and once-per-month dosing) from alternatives. Thanks for pointing out another thing to look forward to.

Meadow,

Biogen-Idec and Elan just told you that disability progression as measured by EDSS scores showed Tysabri patients did far better than placebo group. The companies said they would release full data at AAN in April.

I draw your attention to this quote by Bebe from a few messages above...

"The Tysabri data is reporting reduction in RISK of disability progression, not the real effect on disability as measured by progression on the EDSS scale (which is how disability was reported in the other trials)"

Now Bebe works with MS patients every day and picked up on the difference between EDSS scores and the "RISK" of disability progression as stated by Biogen's press release. Perhaps if you want to question what was said by Biogen and what it means in the world of MS medicine, you should be directing your comments and questions to Bebe. She knows a lot more about this than I certainly do!

more mysterious people with information that continues to be contradicted by released data, by anecdotes told by real patients here and on other MS boards, and by the companies themselves.

Well, I don't think I'd call my wife's neuro or Bebe "mysterious". I have read several messages on other boards (MS Foundation,Brain Talk) where the patients' neuros are not planning to use Tysabri until more data is available or they see what happens after several months of general use. All the recent data has been given by Biogen in the form of press releases. What is needed is peer review by other experts who have the ability to scrutinize this data. Like I have said often...perhaps Tysabri will indeed be the drug that Biogen says that it is....or maybe it won't be.

Harry

MeadowStream wrote:ptwo, that extremely low incidence of side effects is very interesting and clearly a differentiator (along with twice the efficacy of alternative treatments and once-per-month dosing) from alternatives. Thanks for pointing out another thing to look forward to.

It will be interesting to see exactly what that side effect was when they release all the information. 1% or less can be low, depending what happened during the serious systemic reaction.

Harry/Bebe

In a relatively short follow-up (2 years), aveareg EDSS won't move much in either the control group or the placebo group. It takes the entire course of the disease (typically 30 y or so) to go from 0 to 10 (and most won’t get to 10, as they'll die from other causes).
Risk for increased disability is just the proportion of patients in each group that showed any worsening -as measured by EDSS.
Probably the results look more impressive when presented that way.
We are all eagerly waiting the full detailed report, but in the meantime there is good reason to feel relieved at what they published so far.

Guy

Guy,

EDSS scores, if I am not mistaking, were the primary end-point of of the Phase III trials. At least that's what I thought I read some time ago but can't quite remember.

EDSS scores don't change much in one year(at least the patient hopes they don't slide the wrong way during this time) but a difference can be definitely seen during a two year period. Now what happened to these scores in the 2 year Phase III trial isn't known yet. I can only go by what my wife's neuro told me in December about the Phase III trials that were done at the MS clinic here in London, Ontario. He said there was no positive effect on the EDSS scores after I asked him the specific question.

Of course, this is only one of many centers were the trials took place so who knows what happened at the other trials.

When Biogen inserts that the RISK of disability was reduced by 42% over placebo, one has to wonder why that terminology was used as opposed to making reference to the actual EDSS numbers. That's what Bebe pointed out and I'm sure other MS experts in the field will have a close look at that as well. Guess we'll just have to wait for the real numbers to be published.

Harry

DrGuy,

You said that:

'It takes the entire course of the disease (typically 30 y or so) to go from 0 to 10 (and most won’t get to 10, as they'll die from other causes)'.


This is not a good start to my Monday morning. Do sufferers always have to go up the scale to the very top? I was under the understanding that ms affects different people in different ways. But I think they tell you this to keep you going. When I met my MS nurse I enquired whether I should go to my local ms society - she suggested that this would not be a good idea (probably didn't want me to see what my future holds).

Until the drugs companies can get to grips with neuro-protection I don't imagine we will see much improvement in the future of sufferers.

I've been wanting to raise an issue for a while, but this might be the right time. Would any members be interested in a forum about quality of life issues as the disease progresses (quite frankly about when one might call it a day). It's not a nice issue, but then this is not a nice disease. Perhaps Aaron could advise if this would be acceptable - only for those who wished to participate.

Bromley

Do sufferers always have to go up the scale to the very top?

We all gotta go sometime. I think what DrGuy was saying is that not many reach the top of the scale through MS, they die from totally unrelated causes before then.

Until the drugs companies can get to grips with neuro-protection I don't imagine we will see much improvement in the future of sufferers.

They are doing so, albeit slowly.. For example take a look at the results from the Campath trials. Treated early enough, patients are actually improving on the disability scales ( Find LabRats testimonial in the Campath forum ). It isn't neuroprotection per se, it's trying to stop the damn thing in its tracks before it gets a firm grip.

There is hope Bromley.

Robin

Raven,

Thanks for your post.

Hopefully Tysabri will slow down the progression of disability. However, I suspect that it will be a number of years before patients receive it in the UK. As usual I suspect budgetary reasons rather than safety - if it isn't safe why are US citizens being given it.

I agree with you on Campath - the results to date appear to show that relapses are almost eradicated (which is a substantial improvement over CRABs and also Tysabri) and Dr Coles has noted on the UK MS Society website that most people receiving a dose have seen improvements in their disability. However, given this, why can't they fast track this treatment - for those willing to take the risk. I know that safety and risks need to be considered, but when this is set alongside a chance that severe disability might be reduced or deferred it must be a risk worth taking.




Bromley

Tysabri should be approved in the EU by late 2005. Then of course comes the hurdle of getting NICE to agree the prescription. Given the cost and the previous hassle with the interferons that could take forever!

However, given this, why can't they fast track this treatment - for those willing to take the risk. I know that safety and risks need to be considered, but when this is set alongside a chance that severe disability might be reduced or deferred it must be a risk worth taking.

Campath is not being fasttracked because it is an already approved treatment for Leukemia. I'm not sure why, given the results so far, the prescription for MS is not much more common.

Having jumped up and down on my neuro, I have a meeting with the trial organisers to discuss my participation in the latest trial (camms224). I personally believe any risk is well worth taking.

Sorry that I've taken this thread off-topic. Bromley, if you wish to discuss Campath further either pm me or lets post in the Campath forum. Gotta keep the site tidy

Robin

Bromley,

I've been wanting to raise an issue for a while, but this might be the right time. Would any members be interested in a forum about quality of life issues as the disease progresses (quite frankly about when one might call it a day). It's not a nice issue, but then this is not a nice disease. Perhaps Aaron could advise if this would be acceptable - only for those who wished to participate.

Marg finds the "quality of life" a HUGE issue while living with MS! Although she has had the disease since 1971, it has been in the last 10 years where the big slide has taken place, primarily between 1994 and now. (breaking her leg in March 2001 certainly didn't help matters)
Living with pain and unable to do most tasks without a struggle can certainly take its toll on anyone. It's probably one aspect of the disease that most healthy people have little understanding about.

Harry

Bromely,
If it is any help, my husband Gary has had a fairly good quality of life until the past 5 years. We know now that his disease started over 25 years ago. He walks on a cane and the dang stuff won't leave his eyes alone. But he does EVERYTHING he possibly can. He finds a new or different way. And this didn't happen overnight. The disease is usually slow enough that you start adapting a little each year or couple of years. In the 25+ years of MS, Gary had a 8 year remission. And had we known then what we know now, he might have still been in it. He hurt his back and that brought up everything. Understand that Gary's MS started out paralyzing his from the neck down about 6 different times in 3 years. He got back almost everything each time. He is NOT typical of MS. Many people only have mild symptoms the whole course of the disease. You might try what we did. The disease can leave you in a very bad way, but you just don't think about it. Kinda Scarlett O'Hara metality, I'll think about that tomorrow. BTW, go to the meetings, we do. No one in our group resembles Gary's disease. We have them in all walks, some in a wheel chair and some you wouldn't know anything wrong with them. We laugh and learn about things ONLY people with MS could know about.

I am not averse to setting up a Quality of Life forum if enough members are interested... shoot me a PM if you are