Withdrawn drug may help in Crohn’s disease
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A drug pulled from the market by the manufacturer following reports of serious side effects in patients with multiple sclerosis may help some sufferers of Crohn’s disease, a new study showed.
But in many instances, the drug natalizumab will be no better than a placebo, said the study published in the November 3rd edition of The New England Journal of Medicine.
Crohn’s disease is an inflammation of the digestive tract that affects a half million Americans, many age 15 to 35.
In a 10-week test of more than 900 volunteers with Crohn’s disease, the response rate among placebo recipients was 49 percent and the rate for natalizumab users was lackluster—just 7 percentage points higher.
But when people who seemed to respond to the initial treatment with the drug were kept on the medicine for another 46 weeks, 61 percent responded versus 28 percent who got the placebo, the study said.
The drug is sold under the brand name Tysabri by Irish drug maker Elan Corp. and Biogen Idec Inc. of Cambridge, Massachusetts.
In an editorial, Daniel Podolsky of Massachusetts General Hospital said that “our understanding of the benefits of natalizumab in patients with Crohn’s disease is too incomplete” to say whether its potential benefits are worth the risk.
The drug was withdrawn in February after a multiple sclerosis patient died from a brain disorder known as progressive multifocal leukoencephalopathy. The companies said last month a new safety study had failed to uncover new cases in patients’ treatment for Crohn’s or rheumatoid arthritis.
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