From Our 2008 Archives

Aggressive Therapy for Crohn's Disease Produces Better Outcomes

By Amanda Gardner
HealthDay Reporter

FRIDAY, Feb. 22 (HealthDay News) -- Treating Crohn's disease more aggressively resulted in better outcomes for patients, an international team of researchers reports.

Using more than one immunosuppressive drug shortly after a person was diagnosed with the disease was more effective in inducing remission than starting patients on corticosteroids, according to the study in the Feb. 23 issue of The Lancet.

"One swallow doesn't make a spring," said study co-author Dr. Brian Feagan, referring to the fact that clinical practice is rarely modified based on just one study. "[But] this is provocative in the sense that it's saying, if you treat patients earlier with more aggressive therapy that may be better than the conventional approach. There will need to be other studies."

"It is an exciting development," added one expert, Dr. Roshini Rajapaksa, an assistant professor of medicine at NYU School of Medicine in New York City. "We're always looking for ways to avoid steroids."

Crohn's disease involves an inflammation of the gastrointestinal tract that most often affects the lower part of the small intestine. Swelling leads to pain and diarrhea.

"We don't really know the cause, but the current wisdom is [that] you've lost tolerance to normal bacteria in the gut. Normally, you have to get along with bacterial cells, because there are so many of them," explained Feagan, director of Robarts Clinical Trials at Robarts Research Institute at The University of Western Ontario in London, Ontario, Canada. "The immune system is in a controlled inflammatory state. In Crohn's disease, it's thought that the immune system is becoming unhappy with normal flora. White blood cells migrate into the tissue and release nasty things and cause damage."

Currently, standard treatment for Crohn's patients starts with corticosteroids. Then, if side effects or steroid resistance develop, it moves on to broad-spectrum immunosuppressive drugs such as Rheumatrex (methotrexate). If all else fails, doctors try tumor necrosis factor (TNF)-blockers, a targeted therapy.

"There is no evidence that that approach is superior to any other approach," Feagan said. "We just eased into that over time, because that's the way the drugs were developed."

For this study, Feagan and his colleagues randomly assigned 133 patients at 18 centers in Belgium, Holland and Germany to receive either combined immunosuppression or the conventional approach.

Financial support for the trial was provided by Centocor BV and Schering-Plough, which make the two immunosuppressive drugs used.

Sixty-seven patients assigned to combined immunosuppression received three infusions of Remicade (infliximab) with Imuran (azathioprine) at the start, two weeks later and four weeks after that.

The remaining 66 patients received steroids followed by Imuran and Remicade.

At six months, 60 percent of 65 patients in the combined immunosuppression group were in remission without steroids or surgery, compared with 35.9 percent of 64 people in the other group.

At one year, 61.5 percent of those in the combined group were in remission versus 42.2 percent in the control group.

"There was clinically meaningful and statistically significant improvement at six months in favor of the combined immunosuppression," Feagan said.

According to an accompanying commentary, the results of another, similar trial are due in late 2008. If those researchers reach the same conclusion, conventional treatment for Crohn's could well change, the commentary noted.

Rajapaksa had one reservation, however.

"Remicade has its own issues. For instance, it's given intravenously so the individual has to go to the doctor's office," she said.

"And because it works for severe cases and difficult-to-treat cases, you might want to reserve it" for such cases, she added.

SOURCES: Brian Feagan, M.D., professor, medicine, and director, Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Canada; Roshini Rajapaksa, M.D., assistant professor of medicine, NYU School of Medicine, New York City; Feb. 23, 2008, The Lancet

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