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Page: << Prev | 1 | 2 | 3 | Next >> MRI brain scans showed that patients treated with 240 milligrams of BG00012 three times a day had 69 percent fewer new gadolinium enhancing (GdE) lesions -- a marker of MS-related inflammatory activity -- from week 12 to 24 than those who received the placebo. They also had fewer new or enlarging T2-hyperintense and T1-hypointense lesions at week 24.
The study also found that BG00012 reduced the annual relapse rate by 32 percent, but this finding wasn't statistically significant. Patients who received the drug were more likely than those in the placebo group to suffer adverse events such as abdominal pain and hot flush. Dose-related adverse events in patients taking the drug included headache, fatigue and feeling hot, the researchers said.
"Longer-term (phase III) studies of BG00012 in larger patient populations are underway to define its place in the future of relapsing-remitting multiple sclerosis treatment. If these studies show similar relapse rate reductions with BG00012, interferon beta, and glatiramer acetate, BG00012 could be a suitable initial treatment for relapsing-remitting multiple sclerosis," wrote Professor Ludwig Kappos, of University Hospital Basel, in Switzerland, and colleagues.
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The study was published in the Oct. 24 issue of the The Lancet.
In an accompanying comment in the journal, Professor Per Soelberg Sorensen and Dr. Finn Sellebjerg of the Danish Multiple Sclerosis Research Center, noted that "BG00012 might have a favorable benefit-to-risk ratio profile compared with its oral competitors and the currently available first-line injectable drugs. However, we will have to await the results from the ongoing large phase III trials to establish the place of BG00012 and of other oral drugs in the treatment of relapsing-remitting multiple sclerosis."
The study of the leukemia drug alemtuzumab, which temporarily depletes white blood cells and is part of a class of drugs called monoclonal antibodies, included 334 patients. Patients were randomly assigned to get either alemtuzumab or interferon beta, a standard MS therapy, for three years.
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-- Robert Preidt
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