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Posted: Fri Oct 29, 2004 1:18 pm Post subject: Antegren -- Neutralizing antibodies
I'm afraid I can't provide a good link (so your option as to whether to believe me!), but the following gives an idea of what is likely to occur for Antegren in MS in terms of neutralizing antibodies:
January 29, 2004 – Transcript of Webcast of Antegren Phase III Maintenance Trial Data in Crohn's Disease:
Q16. (David Marshall, NCB Stockbrokers) One question on the level neutralizing antibodies: I think it was in the region of 6-7% in ENACT, and also in the Phase II Crohn's trial. Is that consistent in what you're seeing so far in the Phase III and do you think that level is very comfortable?
A. (Lars Ekman) We are comfortable with that level. The final analysis of that data is not done yet and we remain comfortable with that level at this moment.
ElanMike-
I really dont appreciate your comments, although it really doesnt matter what you think. I do have MS, and so does a family member! Yes, I am on Rebif and no- I dont love it (as you put it), but I do believe its the best treatment currently available. I have made friends with the local reps in my area, as well as some of the Neurologists, as I am also in the medical industry. I attend the MS meetings and take it upon myself to know the studies and keep up to date on new data. I hope Antegren is as good as it is being touted...Im just passing along the criticisms that I have heard. Why are you so defensive anyways?
Posted: Sun Oct 31, 2004 12:36 pm Post subject: bebe - antegren v rebif
The neutralizing antibody rate for rebif and avonex and betaseron is much, much higher than the 6% rate you cited.
Rebif is one of the two best treatments currently available - the other is Avonex. As stated higher in the thread, these are the same molecule but delivered using different dosing regimens and different injection sites (SC v IM.)
But, Antegren seems likely to seriously outclass both of the above. An Irish newspaper (Sunday Tribune) today cited imminent results and actual improvements in EDSS (Expanded Disability Status Score) among those taking Antegren. The article cites the improvement, but is based on leaks and not on published trial results. If the article is correct, we should get real data this week or next.
And Rebif, which in the most recent study - called the Evidence Study - comparing the effectiveness of Rebif to Avonex over a short time, at the end of 48 weeks the incidence of neutralizing antibodies to Rebif at the higher dosing was approximately 25 percent, whereas the incidence of neutralizing antibodies to Avonex in that same study was only 2 percent. In the packaging, Avonex has a neutralizing antibody incidence of 5 percent overall.
Previous clinical trial data has shown that Avonex(R) (interferon beta-1a
administered once weekly) consistently produces the lowest amount of
neutralizing antibodies among the available beta interferons. At a separate
symposium at the A/ECTRIMS meeting, Dr. Sorensen confirmed this finding by showing that in his study, 76% of Rebif(R) patients developed neutralizing antibodies, versus 33% of Betaseron(R) patients and only 11% of Avonex(R) patients, after three years of treatment.
The above is interesting: I had remembered Avonex with 10% neutralizing antibodies and Rebif with 20% but it looks like those numbers are higher - especially for Rebif. Patients have been dosed with Antegren for over 5 years now and I remember hearing Lars Eckman from Elan say 6%-7%, but cannot find that reference.
The NAb issue is still very controversial. In the Evidence study, that you reference below, the NAb rate for Rebif was much higher than Avonex. However, the patients on Rebif that were NAb positive still did better than patients on Avonex. I think what that shows is that NAbs may reduce efficacy in some patients but it doesnt seem to reduce efficacy to the same level as being on a low-dose interferon. Another interesting point is that NAbs for Rebif, at the end of 8 years, is only 11%. This info was presented at the American Academy of Neurology meeting this year.
I'm a first time poster to this or any other MS related forum.
I'm writting on behalf of my younger 26 year old sister, diagnosted with having MS.
We are trying to get information on any published Antegren study results.
Here's her story.
Being a seemingly healthy person, with no prior medical conditions, she was diagnosed with MS in 2001. She was approached by her neurologist to participate in a Natalizumab study (Biogen Protocol Number C-1801) at St. Micheal's Hospital, in Toronto, Ontario. She was on the drug for over one year. One night, several months ago, she experienced what she thought was a relapse of MS. She called the doctor & hospital with hours of experience MS-like symptoms. They told her not to worry for at least 24 hours. That night she suffered a debilitating stroke.
After seeing the neuroligist, they opened her study files and confirmed that she was in fact part of the study group being receiving Natalizumab.
She was assured by the neurologist (who is the primary investigator for study) that this was not a result of the drug. However, she was immediately removed from the study. None of the doctors, specialists that were called in to investigate her case could provide an explaination as to why a 26 woman, with no blood, heart problems suffered this stroke. Based on the seemingly evasive requests for information and fact that other medical specialists involved in the study were unaware of the fact this had occured to her, we question whether this was ever reported.
Is there anywhere we can go to see the results of these studies? Would this type of thing be reported anywhere that we could verify?
Joined: Feb 02, 2004 Posts: 864 Location: California, USA
Posted: Mon Nov 01, 2004 9:11 pm Post subject:
good information being shared here, but ElanMike-- please do not insinuate another member does or does not have MS.
As you might imagine, that is an extremely sensitive topic for members of our community and we cannot allow members to question each other's "worthiness" to discuss MS-related affairs. For whatever reason, they are on this site and their interest must be treated with dignity.
While some people may be fans of certain treatments, we are all here for the same reason: to take steps to eliminate MS. Whether that comes in the form of Antegren or Rebif or LDN etc. does not matter-- the key is that we share information so people can make informed decisions about their health.
You are contributing just such information for Antegren, and for that we are grateful, but drop the personal attacks please. If there are any issues, please send me or mscaregiver a private message.
Posted: Tue Nov 02, 2004 3:57 pm Post subject: 26 year old sister with MS
Antegren is an anti-inflammatory agent, so was unlikely to have been cause of your sister's incident.
All Serious Adverse Events are reported to the FDA but I am not sure if those are available to the public. I do believe that study results will be available shortly - probably by end of month for 1 year results and early next year for 2 years results. Usually SAE's are released with that data.
Did someone say ategren is an anti-inflammatory agent? I thought it was simply an "adhesion" molecule that limited the blood-brain-barrier migration. Is it also an anti-inflammatory?
Joined: Jun 20, 2004 Posts: 1040 Location: Tennessee
Posted: Sat Nov 06, 2004 1:51 pm Post subject:
Bill,
I think the two can be thought of as related. If you strengthen the BBB, you can help stop inflammation from starting in the CNS and/or brain. T cells get through the BBB, which in turn causes inflammation in those specific areas (the CNS and the brain).
Will it stop inflammation DIRECTLY? No. It stops the migration of the cells through the BBB to the CNS and brain where the inflammation would (or might) cause damage.
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