Quote:
Originally Posted by chrishadms
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.
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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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