The international trial included 508 people with Crohn's disease who had never been treated with immunosuppressive drugs. One-third were given infliximab alone, one-third received only azathioprine and one-third were treated with both. The trial was funded by Centocor Ortho Biotech, which markets infliximab, and Schering-Plough.
After 26 weeks, 56.8 percent of those getting combination therapy had complete remission of symptoms, compared to 44.4 percent of those getting only infliximab and 30 percent of those getting only azathioprine.
The most worrisome problem with drugs that repress immune system activity is a severe infection. That problem occurred in 3.9 percent of the people who used combination therapy, 4.9 percent of those in the infliximab group and 5.6 percent of those in the azathioprine group, a difference that is not statistically significant, Sandborn said.
And because the combination therapy is more effective, it helps prevent infections that result from ulceration of the intestinal wall caused by Crohn's disease, he added.
Fear of side effects such as serious infections has held back use of the combination therapy, Katz said.
And while the study "answers our questions in a select group of patients," it does not fully resolve the safety issue, said Dr. Simon Lichtiger, an associate professor of gastroenterology at Mount Sinai Medical Center in New York City.
"The safety data aren't fully known and won't be known for a year," Lichtiger said. "It's not clear yet whether the advantages of the therapy exceed the possibility of long-term toxicity."
Crohn's disease is one of the two major forms of inflammatory bowel disease, whose underlying cause remains unclear. The other form is ulcerative colitis. An estimated 1 million Americans suffer from inflam
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