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Studies suggest investigational agent reduces disease activity in MS

rug had relapses than those taking placebo; 14.5 percent of the rituximab patients experienced at least one relapse during the six-month period, compared to 34.3 percent of the patients receiving a placebo.

"Treatment with rituximab was generally safe and well-tolerated in the study," Hauser said. With the exception of infusion-associated adverse events, the rates of adverse events and serious adverse events were comparable between those taking rituximab and those taking placebo. Although there were more first infusion-associated adverse events with rituximab, the majority of adverse events resolved with appropriate medical treatment. The overall rates of infection were also comparable with rituximab and placebo.

In the second study, an uncontrolled open label trial, 26 people received two infusions of rituximab two weeks apart (one course of treatment) and then another treatment course six months later. Patients were followed for a total of at least one year. Though a placebo group was not included in this safety study, brain lesions were reduced by more than 90 percent and the relapse rate was reduced from an average of at least one per patient per year to only a few for the entire group over the year of treatment. Side effects were limited to mild to moderate reactions to the drug infusion, according to study author Amit Bar-Or, MD, of the Montreal Neurological Institute at McGill University in Montreal, Canada, and a member of the American Academy of Neurology.

Both studies were supported by Genentech, Inc., and Biogen Idec., the companies marketing the drug in the United States. The drug is currently approved for use with certain types of lymphoma and for a moderate to severe form of rheumatoid arthritis; it is not approved for use in multiple sclerosis.

Rituximab has been associated with fatal infusion reactions, tumor lysis syndrome, progressive multifocal leukoencephalopathy, renal toxicity, and other adverse e
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Contact: Angela Babb
ababb@aan.com
651-695-2789
American Academy of Neurology
1-May-2007


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