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Patients received daily injections of GM-CSF for eight weeks. They were evaluated during the study both for the severity of their disease -- using a tool called the Crohn's disease activity index (CDAI) -- and their quality of life -- using the Inflammatory Bowel Disease Questionnaire (IBDQ).

Of the 15 patients who received GM-CSF, 12 (80 percent) improved significantly during the study, and eight (53 percent) were considered to be in clinical remission following treatment. The average CDAI score fell by 190 points, indicating a significant decrease in Crohn's disease symptoms. The average IBDQ score increased from 108 to 179, indicating significant improvements in quality of life.

The researchers have continued to follow many of the 15 study patients, and they have found that when treatment with GM-CSF stops, symptoms tend to return. But when treatment resumes, symptoms again improve.

"The results of this open-label trial make us optimistic that this approach may someday help large numbers of patients who don't respond to traditional Crohn's disease therapy," says Korzenik. "However, we need to test our findings in a larger, randomized, placebo-controlled trial."

Based on these preliminary results, Berlex Laboratories Inc. -- the pharmaceutical firm that owns Leukine -- has initiated a large-scale, multi-center study to see if these findings can be replicated.

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Contact: Jim Dryden
drydenj@msnotes.wustl.edu
314-286-0110
Washington University School of Medicine
7-Nov-2002