Studies undertaken to Combat CROHN’S DISEASE

A study has shown that the best way to combat Crohn’s Disease, a condition wherein the body mistakenly attacks its own tissue, is through a combination therapy of two drugs that will control a disorderly immune system.

crohnsdisease Dr. William J. Sandborn, vice chairman of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minn. has made sure that the new data can renew the present mode of treatment for Crohn’s Disease. The results of the study were published in the New England Journal of Medicine, April 15 issue.

Dr. Sandborn said that at present, doctors use steroids as the starting treatment for Crohn’s Disease. If ever the steroids will not prove effective against symptoms like abdominal pain, nausea, fever, diarrhea, weight loss, among others, then they will start using Azathioprine. It is a medication which greatly minimizes the activity of the Immune System. Once this new method will fail, it is the only time when they will try biologics like Infliximab (Remicade). These drugs contain monoclonal antibodies which target an exact part of the Immune System.

The test revealed that the step which only involves Azathioprine should be skipped. Sandborn added that “This study suggests that the therapy that follows steroids should include a biologic.” He also added that if Steroid treatment becomes ineffective, then the use of both Azathioprine and Infliximab becomes the treatment of choice. "What this trial shows is that the most effective strategy is combination therapy," he said.

On the other hand, Dr. Jeffrey A. Katz, who is the spokesperson for the Crohn’s and Colitis Foundation of America, made it clear that "it really does confirm what other studies suggest and what is clinically apparent, that combination therapy is better than treatment with Azathioprine alone." Also an associate professor of Medicine at Case Western University School of Medicine in Cleveland, he said that "It will push me in the direction of using combination therapy a bit more than I have been.”

To make the trial more reliable, 508 people having Crohn’s Disease who have never been treated with immunosuppressive drugs have been included. A third of them were only given Infliximab, another third received Azathioprine, while the remaining third were subjected to both medicines. Centocor Ortho Biotech funded the trial. It is the same company which markets Infliximab, and Schering-Plough.

26 weeks after the trial, the results showed 56.8 percent of the subjects who received the combination therapy had complete remission of their symptoms, as compared to 44.4 percent who received Infliximab and 30 percent who took Azathioprine.

The greatest concern for patients taking immunosuppressive drugs is the possibility of acquiring severe infection. This occurred in 3.9 percent of people who took the two drugs, 4.9 percent of those who took Infliximab and 5.6 percent of those who used Azathioprine. According to Dr. Sandborn, “These are differences that are not statistically significant, 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.”

Dr. Katz also said that “Fear of side effects such as serious infections has held back use of the combination therapy.” Another doctor, Simon Lichtiger, an associate professor of Gastroenterology at Mount Sinai Medical Center in New York City, stated that the study does not fully resolve the issue on safety, even though that it “answers our questions in a select group of patients.” He further added that "The safety data aren’t fully known and won’t be known for a year. It’s not clear yet whether the advantages of the therapy exceed the possibility of long-term toxicity."

There are two major forms of Inflammatory Bowel Disease (IBD): Crohn’s Disease and Ulcerative Colitis. Until now, the cause of Crohn’s Disease is still unknown. It is estimated that 1 Million Americans suffer from IBD.

According to Dr. Sandborn, a same study involving persons with Ulcerative Colitis is ongoing. The results of which, he said, “Will not be available for as much as a year or two.”