These results were obtained from subset analysis of the Phase 3 evaluation of Natalizumab as Continuous Therapy (ENACT-2) and efficacy of Natalizumab in Crohn’s Disease Response and Remission (ENCORE) trials.
In the 12-week ENCORE induction trial, patients receiving Tysabri (who had failed previous 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.
Brian Feagan, M.D. of the Robarts Research Institute detailing the effects of Tysabri on the full sample of patients in ENACT-2, said that these data showed a similar impact.
“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 QOL as measured by the IBDQ and the SF-36 as compared with placebo,” he added.