Rick, I guess you mean that you agree with Birchenough's comments:
<With regards to safety and tolerability, the 100mg
side effect profile was tolerable and included just
4% (2/49) rates each of diarrhea, upper GI side
effects, and hypertension, and there were no
cases elevated liver enzymes (ALT >3x ULN). The
10% (5/49) rate of neutropenia observed in the
100mg dose group was manageable with dose
reductions and most importantly with no infections.>
This was a 12 week efficacy study that appears to be superbly carried out, and M. Weinblatt (former pres of the ACR who brought MTX to the current standard of care)commented on the study in the CC as I recall. Note also that the study was performed on top of MTX.
Even though it was stated that the neutropenia was under control, and abated during dose reduction, I would want to see longer term data. One can monitor neutrophils, but I think infections will appear and I think will be problematic. JMO. Only a 12 week study too, so too brief to see the overall risk. I do not see it a a major treatment for ITP as Promacta in my opinion will be used here, and also the AMGN peptibody (though FDA delayed its decision in the face of positive advisory opinion - still an induced antibody possible issue, but that is beyond the scope of this discussion).
BJ |
