This Is MS Multiple Sclerosis Knowledge & Support Community

Last night, at John Hopkins Univ., there was a webcast for medical professionals. All the info is not available as yet but here is a synopsis of what was said.

The presenters were paid by Biogen. They did a good job of not showing bias, one way or the other, towards Tysabri.

The questions were solicited by the Consortium in advance and consolidated for the webcast. No additional questions were allowed during the presentation.

Tysabri is best when used as the only med early in course of disease. It is NOT for PPMS and not likely to help in more aggressive forms of progressive relapsing MS such as SPMS or PRMS.

It is not recommended for use with Copaxone at this time.

There is a likelihood of NAb's if used with Betaseron or Rebif High which would render the drug ineffective.

9% of Tysabri participants developed antibodies against the drug that would not dissipate and the drug was ineffective in this population. Most developed these by 3 months but if still present at 6 months, the drug was discontinued and other therapies need to be started.

Tysabri should not be considered , except in extreme instances with patients who are on Steroids or Novantrone.

Category C pregnancy drug, although there were patients in both the treatment group and placebo group who became pregnant and had successful deliveries after stopping therapy.

It is not recommended for patients who have failed other therapies UNLESS all other therapies are stopped first!!!!! A couple or three months off therapy of all kinds are preferable before beginning Tysabri therapy. ***(they did say they had no hard data to substantiate this recommendation but felt that patients who were not heavily immunosuppressed or immunomodulated would do better on this drug than those on high dose interferons ...specifically stated)

Although there is only one year data out, the faculty stated this drug had been tested for a total of 7 years with no "significant" adverse reactions. It is similar in action to Campath...mentioned but not discussed.

Now my comment...which hasn't changed since we started to hear about Tysabri....not the great drug that Biogen would have us believe but still too early to really determine due to lack of data. Biogen has done a great job marketing Tysabri but I fear there may be a lot of disappointed MS patients. Maybe I'll be totally wrong on this...who knows!

It addition to the above, I unexpectedly had the opportunity of speaking to a MS neuro today at the large MS Clinic here. I was helping a friend of ours who has MS severely and she had asked me to accompany her at her appointment.

Tysabri has been on trial at this clinic for 3 years. I asked the doc if he would candidly give me his take on Tysabri since he has been one of the trial neuros.

First off, he said that the drug reduced exacerbations and nothing else. I specifically asked him if there was any positive changes in the EDSS scores with their patients and he told me "absolutely none". The reduced exacerbation levels were at least as good as the CRAB drugs and mostly better. The main benefit over the CRABs was the large reduction in risk which he went on to explain as far fewer side effects and only once a month infusion.

Tysabri was not of any benefit to any kind of progressive MS but for mild RRMS.

It would likely be another year before the drug would be approved in Canada because of the minimum one year data that was available. He sort of welcomed that because the clinic wanted to do another year of trials to obtain more data.

Biogen's reliability in giving accurate information to the medical field was not very well trusted. I have heard this comment on the net before and from some of my MS contacts but this is the first time I heard it face to face with a MS neuro!

In general, Tysabri , at this point in time, was not going to provide the huge benefits that some people thought. Many docs were going to treat it with caution until a lot more data from the trials was available.


Harry

Harry Z

I have a couple of questions about the Tysabri webcast.. Did someone
really say <that Tysabri therapy is not recommended for patients who have failed other therapies UNLESS all other therapies are stopped first!!!!! > I thought Biogen was promoting a combination of drugs as one alternative (from the results of their SENTINEL trial). I hear talk of neurologists adding it to an Interferon in cases where the patient wasn't doing that great on an interferon, as long as there weren't persistent
interferon antibodies. Also I recall reading that although 9% of Tysabri patients developed antibodies, only 6 % of participants had persistent antibodies that required them to discontinue the drug.

You say in your remarks that you talked to a MS neuro who said the drug reduced exacerbations and nothing else. From the MRI data, aren't there less enhancing lesions, less T2 lesions and less T1 black holes? I know that doesn't correlate exactly with disability, but all things considered, I would rather have less than more.

And lastly, you say you asked the MS neuro if there were any "positive" changes in the EDSS scores and he said "absolutely none". I am not sure that I would expect "positive" changes--just stability instead of "negative" changes and I will be happy. Did your question include that result? Anyway thanks much for the info. I saw on another site that a transcript of the webcast will soon be available and that would be great too!

Optimist

Here is the webcast link - you can launch the multimedia presentation at the bottom of this link. I understand a transcript of the Q&A will be on-line next Monday.

http://www.msleaders.org/ms-leaders/liv ... ations.asp

I have not yet listened to the presentation.

Tysabri was not of any benefit to any kind of progressive MS but for mild RRMS.

Harry, Harry, Harry... unbelievable statement. You know as well as anyone, because you spend a lot of time reading about MS and treatments, that Tysabri is the far and away best treatment for MS patients at any stage. The drug stops new T cells from getting into CNS where they cause demylination. Come on now Harry.

In the face of overwhelming positive response from neurologists and patients, you continue to rake for something dark. Hopefully the 2 year results and EDSS scores will put these efforts to rest.

MS

Optimist,

I have a couple of questions about the Tysabri webcast.. Did someone really say <that Tysabri therapy is not recommended for patients who have failed other therapies UNLESS all other therapies are stopped first!!!!! > I thought Biogen was promoting a combination of drugs as one alternative (from the results of their SENTINEL trial). I hear talk of neurologists adding it to an Interferon in cases where the patient wasn't doing that great on an interferon, as long as there weren't persistent interferon antibodies. Also I recall reading that although 9% of Tysabri patients developed antibodies, only 6 % of participants had persistent antibodies that required them to discontinue the drug.

Yes, supposedly one of the docs that was presenting made this comment. On the Brain Talk MS forum a similar question was asked and the person who was actually on the call replied with this comment as well as others. I believe that the consensus was that since very little work has been done with the combination of CRABs and Tysabri, it would be far better to stop the CRAB treatment first. MS docs, generally, like to see hard data on this kind of combination treatment and that data simply isn't available.

The 6% NAB problem was the figure that we all saw earlier but it has jumped to 9% per this call. The data that was presented by these people came from Biogen. What is a bit of a concern is that the NABs were not returning to normal after 6 months and the patients were going to have to take a specific treatment to correct this situation.

You say in your remarks that you talked to a MS neuro who said the drug reduced exacerbations and nothing else. From the MRI data, aren't there less enhancing lesions, less T2 lesions and less T1 black holes? I know that doesn't correlate exactly with disability, but all things considered, I would rather have less than more.

I would have loved to ask many more questions from this neuro, one being the reduced lesion load. But he had only so much time and I wanted to find out about the EDSS scores. Don't forget that reduced lesion loads, while nice to see in MRIs, have little correlation with MS symptoms and disease progression and this measurement doesn't carry the weight of the exacerbation level or the main one, EDSS levels.

And lastly, you say you asked the MS neuro if there were any "positive" changes in the EDSS scores and he said "absolutely none". I am not sure that I would expect "positive" changes--just stability instead of "negative" changes and I will be happy. Did your question include that result?

My question to him was" Was there any improvement in the EDSS scores?" He replied, "Absolutely none". I then said " You mean the patients didn't show any improvement in EDSS during the trials"? His reply, " No, nothing at all." I said, "You mean all that work and the patients' didn't show improvement in their symptoms." His comment, "Yes, no effect."

Now putting this into perspective, this was one trial being done, which hasn't yet been completed and I can only presume they were measuring EDSS scores as they went. I would have really liked to ask more questions about this and get far more clarification but I didn't want to press him in view of the fact that he was offering this information because he knew me.
I will be the first to air caution here because the EDSS information from all the Phase III trials is nowhere near being tabulated and I suppose it could change when all the trial data is collected. But I can only presume the EDSS scores at this particular trial influenced this doc's comments.

Anyway thanks much for the info. I saw on another site that a transcript of the webcast will soon be available and that would be great too!

Yes, I'm waiting for the entire transcript as well because we all know that some statements could be taken out of context and information on either side of the statement could make things much clearer.

Harry

Meadow,

Harry, Harry, Harry... unbelievable statement. You know as well as anyone, because you spend a lot of time reading about MS and treatments, that Tysabri is the far and away best treatment for MS patients at any stage. The drug stops new T cells from getting into CNS where they cause demylination. Come on now Harry.

Please, please, please....don't shoot the messenger! I took this info, almost word for word, from the Brain Talk MS forum. I DID NOT make this statement, one of the presenters supposedly did.

So far, the comments that Tysabri is only good for initial, mild MS patients is being repeated by MS docs in the field. It all goes back to only one year data of one Phase III trial and I have heard time and time over that the docs out there are extremely cautious because of this. Perhaps when all the Phase III trial data is presented, their caution will disappear but until that happens, these docs aren't going to change their mind.

In the face of overwhelming positive response from neurologists and patients, you continue to rake for something dark. Hopefully the 2 year results and EDSS scores will put these efforts to rest.

For every positive response on Tysabri, there are cautionary responses. The cautionary responses should not be viewed as "something dark".

When I questioned my wife's neuro about Tysabri yesterday, I was expecting to hear far more positive info about it than what I did. After all, this is a very established, heavy duty MS trial clinic and the docs here have been working with MS for decades. In your view, perhaps I should have told him that his comments were "dark" and "negative" and that there were many neuros who were very excited about Tysabri. I can certainly tell you that he was one of the docs that wasn't!

And when he mentioned, totally unsolicited by me, that Biogen data is quite suspect in the field, I almost fell over!! And that is not the first time I have heard that comment about Biogen.

Harry

The following quote was taken from the Brain Talk MS Forum and made by a MS professional who works with MS patients and has many contacts in MS medicine. She was replying to some questions by readers about the web-cast at John Hopkins University. And please, don't say that I'm being negative again about Tysabri....It's not me making these comments.... they are coming from people who know a lot more about MS than I do.

________________

"It's not whether this is a good or effective drug (I think it is in some circumstances). It's the fact that erroneous and premature information was leaked to the public and it has given false hope to a great number of people. I have been privy to additional information which will be publically released in March or April on year two data. Because of that, I'm skeptical...even more so than a year ago. I wish I could share more but, for now, suffice it to say, the target population (for very good reason) is the newly diagnosed person with minimal disability."

___________________

Harry

Harryz - more hearsay. An 'MS Professional' who is privy to something. That's simply wrong (on the Professional's part) to say things like that and NOT give details. "I've got a secret" How childish of this person on the Braintalk forum, and this person further claims that erroneious information (presumably from Biogen Idec) has falsely raised people's hopes, and then she goes and tries to throw cold water on those hopes WITHOUT PRESENTING ANY FACTS OR DATA. Good grief!

More rumourmongering. Very disappointing indeed. And I might add that on the Braintalk Forum the 'MS Professional' has been criticized and her interpretation of the Webcast has been disputed. I do not intend to get into that, but its important that readers are aware of it - supposedly people 'who know a lot about MS' are making comments that perhaps reflect their personal bias more than the facts. Again, disappointing, but to be honest we ALL have our biases (yours truly included!).

I urge readers to listen to the webcast, and there apparently is a transcript to be made available on the msleaders.org website (though I cannot yet find it). However, for those interested it has already been posted in multiple parts on the Elan Yahoo Message Board. Here is the link to the first part of the transcript on the YMB:

http://finance.messages.yahoo.com/bbs?. ... mid=502628

There are several parts, so after reading this first post, select Msg List and you'll see the next several parts in sequence.

Tysabri SEEMS to be indicated for any form of MS which has relapses, which means that SPMS and others might be viable candidates. Obviously ALL patients should check with their neurologists on this, but there has been a lot of, I believe, possibly wrong information posted that it is only for RRMS. Please see this post from a neurologist

"Tysabri is indicated for 'relapsing forms' of MS. This includes relapsing remitting MS and also secondary progressive MS WITH relapses. About 60% of MS patients are RRMS and 30% are SPMS, 5% are progressive relapsing MS and 5% are PPMS. About 1/2 of SPMS patients continue to have relapses thus are included in 'relapsing forms' of MS. Therefore, there are about 75-80% of MS patients that have relapses. Secondary progressive MS without relapses did not benefit from interferon at all. It would not be expected that there would be any significant benefit from Tysabri in these patients. The main reason is that Tysabri, like the interferons, is basically an advanced anti-inflammatory drug and SPMS without relapses has little inflammatory component. To date, nothing has been that promising for PPMS. Copaxone showed a possible trend for improvement but it was not significant. Rituxan is being used in a study and will hopefully be beneficial."

Again, I am unable to judge whether the above is accurate.

Disclaimer: Applicability of Tysabri should be decided by patients and their doctors.

I suggest that those confidently posting that Tysabri is not beneficial for SPMS should include that disclaimer with their post. And readers should beware of theories, rumours and half-truths disguised as facts, particularly on message boards. That's IMHO, by the way.


Wonder how Harryz's post at 1226 am on 19 Dec came before my post at 1129 am on 19 Dec 04. Harryz, I guess you're just ahead of me!

Observer,

Harryz - more hearsay. An 'MS Professional' who is privy to something. That's simply wrong (on the Professional's part) to say things like that and NOT give details. "I've got a secret" How childish of this person on the Braintalk forum, and this person further claims that erroneious information (presumably from Biogen Idec) has falsely raised people's hopes, and then she goes and tries to throw cold water on those hopes WITHOUT PRESENTING ANY FACTS OR DATA. Good grief!

It's not heresay despite how much you want it to be. This person moderates a FAQ section over on Multiple Sclerosis Sucks and gives a lot of sources and factual information on MS and related topics. She is a specialized MS nurse, is a member of the Consortium and "tells it like it is"! Despite how much you trust Biogen and want to believe everything they tell us, I'm afraid it simply isn't' so. And you will discover this in due time.

More rumourmongering. Very disappointing indeed. And I might add that on the Braintalk Forum the 'MS Professional' has been criticized and her interpretation of the Webcast has been disputed. I do not intend to get into that, but its important that readers are aware of it - supposedly people 'who know a lot about MS' are making comments that perhaps reflect their personal bias more than the facts. Again, disappointing, but to be honest we ALL have our biases (yours truly included!).

She has been criticized by readers who simply refuse to believe what she is stating is not in agreement with Biogen's marketing plan. Clinical 1, the poster, has also told the readers that the transcript will be available next week so she isn't attempting to hide anything.

It's also interesting to note that much of what she briefly stated was echoed by my wife's neurologist when I spoke to him on Thursday. And he has been working with this drug for 3 years. While Tysabri will have some benefit to a certain sector of MS patients, he stated it won't be anything close to what Biogen would lead us to believe it will be.

Harry

A poster on Braintalk forum has indicated that the webcast transcript is available now.

Here is the webcast link - you can launch the multimedia presentation at the bottom of this link. I understand a transcript of the Q&A will be on-line next Monday.

http://www.msleaders.org/ms-leaders...mplications.asp

Scoll to the bottom of the page and after clicking on the media presentation at the bottom of the link, click on "transcript" toward the top of left hand column on the next page and finally click on "printer friendly version". Read the conference transcript and judge for yourself if it has been accurately summarized.

Harryz

It's not heresay despite how much you want it to be. This person moderates a FAQ section over on Multiple Sclerosis Sucks and gives a lot of sources and factual information on MS and related topics. She is a specialized MS nurse, is a member of the Consortium and "tells it like it is"! Despite how much you trust Biogen and want to believe everything they tell us, I'm afraid it simply isn't' so. And you will discover this in due time.

My dictionary defines hearsay as 'things heard in rumour.' What that poster stated and you reposted is hearsay - pure and simple. Unless the poster can support it with facts, she is talking rumours. If she gives a lot of sources and factual information, why doesn't she tell us like it is, and give us the facts about the 2yr data she is privy to? Seems rather strange, or maybe she is a bit concerned that the FULL STORY (not half of it) will be somewhat different than her speculation?

We'll see in time. And I'll be happy to eat any crow I'm due. Will you?

She has been criticized by readers who simply refuse to believe what she is stating is not in agreement with Biogen's marketing plan. Clinical 1, the poster, has also told the readers that the transcript will be available next week so she isn't attempting to hide anything.

It's also interesting to note that much of what she briefly stated was echoed by my wife's neurologist when I spoke to him on Thursday. And he has been working with this drug for 3 years. While Tysabri will have some benefit to a certain sector of MS patients, he stated it won't be anything close to what Biogen would lead us to believe it will be.

The transcript is available as above. Let the readers review and decide for themselves. And Biogen does not have a marketing plan for Tysabri, Biogen Idec and Elan do.

As for your wife's neurologist, please see my post above concerning another neurologist's view - he claims its applicable to 75-80% of patients. Whom to believe? Again, I think patients should discuss the applicability of Tysabri with their doctors, as there are obviously varying views.

Observer,

Wonder how Harryz's post at 1226 am on 19 Dec came before my post at 1129 am on 19 Dec 04. Harryz, I guess you're just ahead of me!

I'm not sure how This Is MS logs posts....I've never really paid any attention to the times. Any notification of an update on a particular thread gets emailed to me, I click on the URL in the email which then brings me directly to the posting and I answer it. Perhaps This Is MS posts those messages first which it thinks are more believable

The understanding of the various levels of MS is difficult at the best of times. It wasn't until 1993 that the various MS classifications appeared and that was done by the NMSS in an attempt to help research and drug approvals. Even today, neurologists have different explanations.

In my talk with my wife's neurologist the other day, he told me that Tysabri would only be effective for initial, mild cases of RRMS. He went on to say that it would not be beneficial for any other kind of MS. Of course, other neurologists may have a different opinion. And yes, the patient is going to have to sit down with their doc and discuss whether they want to use Tysabri based on their kind of MS. Hopefully the doc will spend the time with the patient in this instance and give them all the info that is available.

Harry

Harryz

Since we are talking about the credibility of this poster and the snippet about 'privy to 2yr data', lets look at something she's posted on Braintalk. [For the record, I don't post there, but it does make an interesting read - seems much different in some ways from this forum.]

I think we're going to have to wait a while longer for more proof in the pudding as folks of all levels of MS are started on it by thier docs. My opinion: The trial was limited in the type of patient treated and short enough that we really don't have good enough data to speculate on future use.

There's also been a great deal of advance "propaganda" (for lack of a better term) by the Biogen crew that has gotten the hopes of many who are probably inappropriate candidates for the med. Not nice. They get lumps of coal in their stockings this year from me at least.

mmcc,
The stated opinion/observation was that those who'd had the disease longer, had a higher EDSS score and were more disabled, did not significantly improve in the trial. Again, this drug does not impact lesion load as the CRABS do but minimizes the frequency of relapse.

Because those of us who've had the disease longer and are more disabled, tend to relapse less often, the testers did not see improvement or significant impact in that group of patients.

Paj,
Thank you. You are absolutely right and Biogen should have done just that over the past year and not given information that was not approved and gotten hopes up inappropriately.

I certainly agree that we need more data, but I'd like ANYONE to show me what information Biogen Idec has given out that was not approved or did not come from FDA-approved clinical trials. Show me anything. I believe nothing will be found, suggesting that this contention by the poster is simply false.

And she also says that Tysabri does not impact lesion load. One only need to look at the label (available at www.tysabri.com) to see that she's made another false statement. Tysabri has significant effects on lesion load. Hmm.

Now, the purpose of this note is NOT to disparage this poster, as she is obviously a dedicated, caring individual who knows a lot more about MS than I'll ever know. But Harryz has referenced this poster as a very reliable source, and it appears that there are some things the poster is saying that are just incorrect. Readers should be aware of that.

Perhaps it is simply that I'm misinterpreting what she is saying, but the point that I was making in my previous post is this

"Readers should beware of theories, rumours and half-truths disguised as facts, particularly on message boards."

Comments such as being privy to 2 yr data and saying the drug has been falsely promoted are inappropriate. Whether they ultimately are proven to be true, we shall see.

Sorry, time to leave the board.

-finn

Finn

Looks like you and I, and I'm sure Harryz, agree on one thing: the sooner they get the 2yr data out, the better!

The companies say they'll get the data out at ASN in April, but I'd guess they will have it compiled sooner and perhaps release it. Lets hope so, as you state and I agree, there is too much room for interpretation at present.

I sure wish Biogen Idec and Elan would join the effort to put ALL their clinical trials and data on a public forum. I guess their concern is the possible 'slant' that competitors could give it (of course, BIIB and ELAN have a vested interest in their own 'slant' - a point that Harryz, OddDuck and others rightfully make).

One final point is the Tysabri - Copaxone study. I wonder if they're going to publicize that information. Maybe we'll hear something about that in April.