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Biotech / Medical : Neuroscience -- Ignore unavailable to you. Want to Upgrade?


To: scott_jiminez who wrote (248)1/6/2003 10:48:33 PM
From: Biomaven  Read Replies (1) | Respond to of 278
 
I looked at the actual NEJM article, and it seems that the 3mg group did a little better in all measures at all times through 6 months. In one case (the subgroup with remitting-relapsing ms) the 3mg group actually achieved significance (p=.005) while the 6mg group did not (p=.08).

What is interesting, however, is that during follow-up (9 and 12 months) the 6mg group turned tables and did a very little bit better than the 3mg group, although neither reached significance for new lesions or increased lesion size compared with placebo.

Also worth noting in this context is that in the Crohn's trial the lower dose again did better than the higher dose. (The 3mg achieved significance at all measurement dates, whereas the 6mg did not).

In the PK discussion, they mention that the lower dose produced 80% saturation of the alpha4 integrin receptors on peripheral blood leukocytes during the treatment period, vs. 90% for the higher dose.

But by and large the two doses were very similar in effect, and any apparent differences might easily be a statistical artifact. I imagine they will just go with the 3mg dose from here.

In any event, very promising results overall - made me go out and buy more ELN. (I figure that ELN is the purer play than BGEN here, although of course ELN is pretty muddy for a pure play. <g>)

Peter