Results from the largest trial yet of the selective adhesion molecule inhibitor Tysabri (natalizumab) for Crohn's Disease produced mixed results that raised more questions than they answered.
While the induction phase of the trial failed to demonstrate superiority to placebo, the maintenance phase demonstrated significant benefit over placebo -- but only in patients who responded to the drug initially.
Furthermore, one patient treated with the drug died from a complication associated with it, progressive multifocal luekoencephalopathy, William J. Sandborn, Ph.DM.D.., of the Mayo Clinic here, and colleagues reported in the Nov. 3 issue of the New England Journal of Medicine.
Another death from this complication in a trial of the drug for multiple sclerosis led the manufacturer to withdraw the drug from the market in February of this year. Subsequently more deaths have been reported. The current study had finished in March of 2004.CME Teaching Brief - MedPage Today