A drug called Leukine, made by Berlex, is apparently no better than an inert placebo in improving active Crohn’s Disease, but the drug could be helpful to some people with the inflammatory bowel condition, according to a new study .

The findings, which appear in this week’s New England Journal of Medicine, come from a study of 124 patients who were randomly assigned to get injections of Leukine or a placebo for 56 days.
The main objective was to see a 70-point drop or greater in the Crohn’s Disease Activity Index (CDAI) during treatment.

Fifty-four percent of Leukine-treated patients achieved this level of improvement, but this response rate wasn’t significantly different from the 44 percent of placebo patients who also improved, Dr. Joshua R. Korzenik, from Massachusetts General Hospital in Boston, and colleagues report.

Still, on other measures Leukine provided significant benefits over placebo treatment. For example, 40 percent of Leukine-treated patients experienced a remission of their disease, compared with 19 percent of the placebo group.

Also, Leukine was associated with significant improvements in quality of life, the investigators note.

In general, Leukine was well tolerated, but injection site reactions and bone pain were more common in the active treatment group than among controls. Moreover, three Leukine-treated patients experienced serious adverse effects that may have been related to the drug.

Overall, Korzenik’s team concludes, Leukine “may have a role in patients with Crohn’s Disease.”

SOURCE: New England Journal of Medicine, May 26, 2005.

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