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news.Elan and Biogen Idec has announced that Tysabri (natalizumab) has successfully improved health-related quality of life (QOL) in patients suffering from Crohn’s Disease (CD), who had previously been exposed to or failed anti-TNF therapy versus placebo.
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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.