U. seeks Crohn's patients

Doctors at the University of Utah are recruiting clinical trial patients for a promising Crohn's disease medication that turns scientific thinking on its head by doing exactly the opposite of existing treatments.

Experts say using Leukine — a modified version of a naturally occurring protein given to cancer patients — to treat the inflammatory bowel disease Crohn's is conceptually akin to throwing oil on a grease fire.

"All therapies for Crohn's are geared toward suppressing inflammation," says Dr. Scott Kuwada, associate professor of medicine and one of the U. investigators in the multi-center, national clinical trial.

"This drug is doing the opposite, actually stimulating the immune system. It's a radical new concept, because the whole basis of Crohn's is that individuals have an abnormality in their immune system such that it gets turned on in the bowel and cannot be turned off easily."

Crohn's disease, which affects a half million Americans, is a chronic disorder that causes inflammation in the gastrointestinal tract, most often in the small intestine. Primary symptoms are diarrhea and abdominal pain. It's not curable, although some people experience it in episodes with periods of remission. Treatments range from medications and nutrition supplements to surgery where sections of the affected bowel are removed, or a combination.

Crohn's is considered an inflammatory response to bacteria in the bowel. While most treatments try to suppress the inflammation, the clinical trial of Leukine increases the population of white blood cells, boosting the immune system to fight the bacteria and, in the process, Crohn's.

"From a scientific standpoint, it's turning everything on its head," says Kuwada.

The drug is taken as a daily injection just beneath the skin for a period of eight weeks. And here, again, the clinical trial does things backwards. Instead of participants randomly assigned so some receive a placebo, all enrolled in this study will receive the medication. Patients who respond to the drug but then relapse can be enrolled in a randomized study later where some receive Leukine and some a placebo for eight more weeks.

The reason for doing it that way is to see if the response really is because of Leukine. As many as 30 percent of patients in earlier studies seem to get better at least temporarily even on placebo, Kuwada says.

The U., which is the only Utah site in the multi-center study, hopes to enroll at least a handful of patients in the coming months. But there are very specific criteria to participate:

• Enrollees must be 18 or older

• Have a confirmed diagnosis of moderate to severe Crohn's

• Cannot have been taking steroids or a popular Crohn's treatment, Remicade, within four weeks.

• Cannot be on one of a broad category of compounds that modulates the immune system, also common with severe cases of Crohn's.

For information on the study, call 801-587-9854.

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