WEDNESDAY, June 3 (HealthDay News) -- Crohn's disease patients who received a combination of the drugs infliximab (Remicade) and azathioprine (Azasan) were more likely to have the disease go into steroid-free remission than those who received only one of the drugs, researchers say.
The study was presented Tuesday at Digestive Disease Week 2009 in Chicago.
Crohn's disease is an inflammation of the digestive tract, most often the lining and wall of the lower small intestine, or the ileum, according to the National Digestive Diseases Information Clearinghouse. When inflamed, the lining of the intestinal wall can become swollen, causing diarrhea. Severe cases can require surgery.
In an international study, researchers divided 508 patients with moderate to severe Crohn's who had not yet received immunomodulator drugs into three groups. One group received infliximab plus azathioprine, a second group received infliximab plus a placebo and the third group received azathioprine plus a placebo for 30 weeks, with the option to continue in a blinded study extension through week 50.
After 50 weeks, 72.2 percent of patients who'd received the infliximab/azathioprine drug combination were in steroid-free remission, compared to 60.8 percent who'd received infliximab alone and 54.7 percent who had taken azathioprine alone, according to a Digestive Disease Week news release.
The researchers used colonoscopies and a Crohn's Disease Activity Index score to measure clinical symptoms. Assuming the patients who did not enroll in the study extension continued to have Crohn's symptoms at week 50, the proportion of the patients who were in steroid-free remission at week 50 was 46.2 percent with infliximab plus azathioprine, 34.9 percent with infliximab monotherapy and 24.1 percent with azathioprine monotherapy, the study found.
Looking at all treatment groups, the percentage of patients who developed serious infections was similar in all groups, and during the study extension there were no new opportunistic infections, malignancies or deaths.
"Results of this study will provide practitioners and their patients with more clinical data on how to use these drugs most appropriately to most effectively treat Crohn's disease," study author Dr. William J. Sandborn, vice chair of the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, said in the news release. "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."
Monoclonal antibodies, such as infliximab, are increasingly used to treat several types of gastroenterological disorders.
"The use of monoclonal antibodies is rising for a number of gastroenterological disorders, such as inflammatory bowel disease," said Dr. Nicholas J. Shaheen, of the University of North Carolina School of Medicine, in the news release. "New indications for these treatments are continuing to be developed and the safety profile is better understood, making them good treatment options for patients with recurrent or chronic gastrointestinal diseases."
This study is the first to provide longer term data on the benefits of combination infliximab-azathioprine and infliximab therapy. In the study, patients were started on the drugs earlier in the course of the disease than typically occurs, Sanborn noted.
For more on Crohn's disease, visit the National Digestive Diseases Information Clearinghouse.
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