Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was linked to three cases of a serious brain infection in large clinical trials halted in early 2005.
The new study found no new cases of progressive multifocal leukoencephalopathy (PML) and confirmed the three previously identified cases of PML associated with use of the drug. One fatal and one nonfatal case of PML occurred in a trial using natalizumab as a multiple sclerosis treatment; a second fatality happened in a trial that used the drug to treat patients with Crohns disease, an inflammatory bowel disorder.
"Our analysis suggests about one in every1,000 people who took natalizumab contracted this disease; however, there werent enough patients exposed to the drug to allow us to precisely estimate the risk, which could be as low as one in 5,000 or as high as one in 300," says senior author David Clifford, M.D., the Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology at Washington University School of Medicine in St. Louis.
Michael C. Purdy | EurekAlert!
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