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XOMA Corporation Message Board

  • gypsumtangles gypsumtangles Jan 7, 2013 4:04 PM Flag

    Please explain:

    The sentence is:

    "The 0.6mg/kg dose group demonstrated both a clinically and statistically significant improvement in IGA at Day 84, showing a 31 percent responder rate versus a 5 percent responder rate in the placebo group (p=.031)."

    Does that mean:

    ASSUME: [92 patients with data in 3 arms is 30.67 patients in each arm]

    1) That 31% of patients (.31* 30.67=9.5 patients) in the 0.6mg/kg arm showed improvement in IGA?

    or does it mean

    2) each patient in the 0.6mg/kg dose group improved their IGA score by 31%?

    Thanks for any help on clarifying this.

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    • It is #1. Two slides from acne study are on XOMA Web site. Slide #2 shows that proportion of subjects with response is 31%.

      • 1 Reply to dcaf7
      • This morning xoma has 3 slides. I would say the results look worse than mediocre. In fact, they raise serious doubts. If I recall correctly, there is a similarity to the diabetes trials. What is most disturbing is that after day 56 when the 3rd dose is given, the results get worse and in fact parallels placebo. In other words, not only do the benefits not continue, but the patients get worse! How can one explain the parallels with the placebo curve?!

        My guess is that the eyeball is unique in the body in that maybe it is almost isolated from the typical pace of the body chemistry. The eyeball then is more sensitive to the monoclonal antibody (mab) affects while at the same time shows less resistance to the mab over time which has been shown in the diabetes and now acne trial. Now I know this is a complete uneducated guess and the words and ideas are not correct, but there exists in the xoma charts a not very encouraging trend to parallel PLACEBO after 56 days. Further, there is a general trend in the charts to parallel placebo in the overall. Maybe the ideas of patient care and attention were the biggest winners in these trials.

 
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