Abbott’s HUMIRA® (Adalimumab) Meets Primary Endpoints In Phase III Ulcerative Colitis Study

medicine,stupid — commander flatus @ 8:53 pm May 21, 2011

Abbott’s HUMIRA® (Adalimumab) Meets Primary Endpoints In Phase III Ulcerative Colitis Study

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.

0 Comments »

No comments yet.

RSS feed for comments on this post. TrackBack URI

Leave a comment

This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported License.
(c) 2019 polydipsia | powered by WordPress with Barecity