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Combination therapy better for Crohn's disease, researchers say

April 19, 2010 |  5:07 pm

A combination of two drugs normally used individually to treat Crohn's disease is better than either one used alone and should be the first choice for treatment of the disease, researchers say. "These study results are strong enough to change clinical practice," said Dr. William Sandborn, a gastroenterologist at the Mayo Clinic in Rochester, Minn., one of the authors of the paper. "They have certainly changed mine."

Crohn's is an inflammatory disorder of the intestines that affects an estimated 500,000 Americans. Its symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. The symptoms can be disabling for those most seriously affected. It is commonly treated first with steroids, which may provide temporary benefit but can have side effects in the long term. After steroids, physicians typically prescribe azathioprine, an oral drug that reduces inflammation. When patients fail that, they often graduate to infliximab, a monoclonal antibody that targets a biological molecule called tumor necrosis factor-alpha. It must be given via an intravenous infusion.  But both drugs have relatively low success rates, so researchers at Mayo decided to try a combination of the two drugs.

The team enrolled 508 Crohn's patients who had not received any immunosuppressive drugs: 169 of them received infusions of infliximab (brand name Remicade) plus an oral placebo, 170 received azathioprine plus an infused placebo and 169 received both drugs.

After 26 weeks, 57% of the patients receiving the combination therapy were in remission, compared with 44% of those who received only infliximab and 30% of those who received only azathioprine, the team reported in the New England Journal of Medicine last week. The benefits persisted for at least a year, they found. "For the first time, we have longer term outcome data on the advantages of combination therapy that will help guide our treatment of patients with Crohn's disease," Sandborn said in a statement.

The research was funded by Centocor Ortho Biotech, which manufactures Remicade.

— Thomas H. Maugh II

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