There are a couple of things that strike me about this study:
- Their placebo response rate is really, really low compared to other UC (and IBD) studies.
- Their aggregate response rate of 16-17% is really pathetic, even compared to other studies of anti-TNF drugs.
- I ain't writing adalimumab for UC based on this data.
Disclosure: I'm on their speaker's bureau and have given promotional talks for them. It's a good drug for Crohn's disease, but these data (which I suspect will lead to an FDA approved indication for ulcerative colitis) are very underwhelming. If I were the FDA, I would request another Phase III study.