New Crohn's Drug Shows Early Promise

[JLH]

http://www.drugs.com/news/new-crohn-s-s ... 56075.html

[tex]

Hi Joan,

Here's the problem with the trials that are underway with that product: It appears that the researchers cherry-picked their subjects to make sure that they had (on the average) a relatively low inflammation rate going into the study, rather than allowing a truly representative sample of subjects. That's apparently how they got such artificially high remission rates.

And looking at the weak C-reactive protein response rate, that suggests that the inflammation was not actually resolved, despite the remission of clinical symptoms. Why weren't actual inflammation response data provided in the original article?

Roughly four out of 10 patients in the study had normal levels of C-reactive protein, a biomarker for the severity of the disease. Vermeire thought that figure was unusually high, indicating that the investigators were able to clear the bar on efficacy with a patient group that may have been skewed to milder cases more likely to go into remission. She also questioned the inclusion criteria used for the 160 patents in the study while puzzling out why an endpoint like mucosal healing was excluded. In addition, she noted that there was a high remission rate with a relatively low reduction in C-reactive protein levels, a contrast in results on a key biomarker that needs to be explored.

Crohn's expert flags blockbuster potential--and frets--of Celgene's mongersen

Here's a link to the original article in the New England Journal of Medicine:

Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease

Gee, I'm really surprised that a pharmaceutical company might try to cheat, just to get a higher rating for their product.

Thanks for the link.

Tex