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Old 07-06-2008, 01:45 PM #34
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lady_express_44 lady_express_44 is offline
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lady_express_44 lady_express_44 is offline
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Join Date: Aug 2006
Location: Vancouver, Canada
Posts: 3,300
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Quote:
Originally Posted by chrishadms View Post
See...your data is skewed because of the small study. It looks way worse.

You can call JH and they will confirm this:

All 9 of the patients stopped progressing over the 2 years even though some of them did need to be retreated. 7 of the 9 over the 2 years improved in all MS testings. The 2 that didn't improve, but got no worse, were late SPMS /PPMS. ( I hate those terms)

All 9 in that first trial stabilized, some after retreating. 7 of the 9 folks got better to some degree. Most were EDSS of 6 and after 2 years were close to a 3. They learned a valuable lesson about axonal death and neutrophils and the correlation with MS cells because of two of the folk who needed to be retreated in this trial.
It's not my data, it's their's . . . but I agree nine people is not enough to prove statistical significance. Twenty-one people were screened for that trial, but only 9 were accepted. Part of that protocol included that they had to be:

- Aggressive RRMS
- 2 or more gad-enhancing lesions
- 1 exacerbation in the preceeding 12 months
- no exacerbation in the last 3 months

*The median age at time of entry was 29 yrs old.*

Two of the people received either steroids or rituximab during the follow-up period, and the trial did not count exacerbations that did not SHOW active inflammation, by way of a MRI. I don't think this is an accurate assessment, since we already know that a HUGE % of lesions are not even visible on a MRI . . . but whatever. Either way, I think it would be fair to take those two out of the equation, since it was likely the other treatments they used helped to reduced their EDSS.

Of the 7 remaining, two saw no improvement in EDSS, but no advancement either. That is not necessarily uncommon for someone with early RRMS.

Some saw substantial improvement in EDSS, as much as 100% in one case.

Their gad-enhanced lesions seemed to stabilize quite a bit over this period, but this reduction did not seem to correlate with a reduction in EDSS, ie. even if they had/did not have Gad-enhancing lesions, their EDSS still fluctuated.

Sorry, I don't really have time right at the moment to analyze all the information in detail, but here it is:

http://archneur.ama-assn.org/cgi/rep...noc80042v1.pdf

Cherie
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