A study led by Mayo Clinic has found that infliximab (Remicade®) administered alone (monotherapy) or in combination with azathioprine is a more effective treatment for patients with moderate to severe Crohn's disease than azathioprine alone. These findings were presented today at the 2008 American College of Gastroenterology (ACG) Annual Meeting.
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 used to manage the disease is a series of intravenous infusions of infliximab, which blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease. Azathioprine is an orally-administered, small molecule immunosuppressive which has a broad immunosuppressive effect.
"Historically, patients with Crohn's disease have been treated sequentially with steroids, then azathioprine, then monoclonal antibodies such as infliximab. The study definitively demonstrates that infliximab-based strategies are more effective than azathioprine," says William Sandborn, M.D., the lead author and a gastroenterologist at Mayo Clinic. "Clinicians should consider a shift in practice to incorporate this new data."
The study, conducted at more than 200 sites, included 508 patients who have moderate to severe Crohn's disease. Researchers found that 57 percent of patients who received combination therapy with infliximab and azathioprine achieved steroid-free remission after 26 weeks. This is compared to 44 percent of patients who achieved remission with infliximab monotherapy and 30 percent with azathioprine alone. Both the infliximab combination therapy and infliximab monotherapy groups were statistically superior to the azathioprine group. In addition, 61 percent of patients who received the combination therapy of infliximab and azathioprine also experienced healing of the bowel demonstrated by colonoscopy (mucosal healing). This is important because previous studies have suggested that patients who have mucosal healing are less likely to require hospitalization and surgery.
"Our goal with this study was to determine if infliximab-based treatment strategies were safe and more effective than treatment with azathioprine in these patients," says Dr. Sandborn. "For patients, this new therapy is an opportunity for remission and a significant improvement in quality of life."
Patients in this study were recruited from community and tertiary care centers, academic medical institutions and independent research organizations in the United States, Israel and Europe.
This research was funded by Centocor, Inc. Mayo Clinic receives consulting fees for work provided by Dr. Sandborn from Centocor Inc., Abbott Laboratories, and UCB Pharma. Remicade (infliximab) is a product of Centocor, Inc.
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