Phase III Study Reveals Positive Results For Crohn’s Drug

1 June 2009 (Last Updated June 1st, 2009 18:30)

Elan and Biogen Idec have announced that Tysabri (natalizumab) has successfully improved the quality of life in patients suffering from Crohn's disease (CD) who had previously been exposed to or failed anti-TNF therapy versus placebo testing. These results were obtained from subset anal

Elan and Biogen Idec have announced that Tysabri (natalizumab) has successfully improved the quality of life in patients suffering from Crohn's disease (CD) who had previously been exposed to or failed anti-TNF therapy versus placebo testing.

These results were obtained from subset analysis of the phase III evaluation of Tysabri as a continuous therapy and efficacy of the drug in CD Response and Remission (ENCORE) trials.

In the 12-week ENCORE induction trial, patients receiving Tysabri who had previous failed anti-TNF therapy achieved statistically significant improvements compared with those receiving placebo on the total IBDQ scale and the two summary scales of the SF-36, the Physical Component Summary and the Mental Component Summary.

Robarts Research Institute managing director Brian Feagan said the effects of Tysabri on the full sample of patients in ENACT-2 were similar to those found in the subset.

"In the more difficult-to-treat subsets of patients studied here, Tysabri helped patients with moderate to severe CD achieve and maintain a considerably improved quality of life as measured by the IBDQ and the SF-36, as compared with placebo," Feagan said.