ROCHESTER, MN -- May 3, 2007 -- A study led by Mayo Clinic found that adalimumab (HUMIRA®) is an effective treatment for adults with Crohn's disease who do not respond to infliximab (REMICADE®) therapy. These findings were published online this week by Annals of Internal Medicine.
Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. One common therapy is a series of intravenous infusions of infliximab, which blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease.
"Approximately 50% of Crohn's disease patients who receive repeated administration of infliximab will eventually develop an allergic reaction, need higher doses, or completely stop responding to the therapy," says William J. Sandborn, MD, the lead author and a gastroenterologist at Mayo Clinic. "Our goal with this study was to determine if adalimumab was a safe and effective alternative for these patients."
Like infliximab, adalimumab is a human monoclonal antibody that blocks tumor necrosis factor. However, it is administered via a series of subcutaneous injections, rather than intravenously.
The study included 325 patients at 52 sites with moderate to severe Crohn's disease who continued to have symptoms despite infliximab therapy or who could not take infliximab due to an allergic reaction. Researchers found that 21% of patients who received adalimumab achieved remission after four weeks, while just 7% of patients who received a placebo achieved remission in the same period. Fifty-two percent of patients who received adalimumab achieved an improvement in their clinical symptoms as compared with 34% of patients who received a placebo.
"This study demonstrates that in the short term, adalimumab can be safely administered to Crohn's disease patients who are intolerant of infliximab," says Sandborn. "For those patients, this new therapy is a second chance at remission and a significant improvement in quality of life."
Patients in this study were recruited from tertiary care centers, academic medical institutions and independent research organizations in the United States, Canada and Europe.
This research was funded by Abbott Laboratories. Mayo Clinic receives consulting fees from Abbott Laboratories and Centocor, Inc. for work performed by Sandborn. Humira (adalimumab) is a product of Abbott Laboratories. Remicade (infliximab) is a product of Centocor, Inc.
SOURCE: Mayo Clinic
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