After seven injections given weekly, 12 of 16 people receiving the higher dose of anti-IL-12 antibody responded to the treatment. At the end of the 24-week trial, six of those volunteers' symptoms were in remission.
Other volunteers received seven injections, with four weeks between the first and second injection, followed by six weekly injections. In this group, 9 of 16 people receiving the higher dose had responded to the treatment at week nine. At the end of the 18-week follow-up phase, half of this group (8 people) had remission of their symptoms.
The researchers also measured levels of the other immune system proteins--interferon, tumor necrosis factor, IL-10, IL-6 and IL-18--that are produced by the activated T cells in eight volunteers who received treatment at the National Institutes of Health Clinical Center. The researchers measured the proteins before and after treatment and found that many of the inflammatory proteins had dropped dramatically by the end of treatment. The decline in these proteins suggests that blocking IL-12 worked as the doctors hoped it would, by slowing or halting the Crohn's disease process.
"Data from this early study show us that the treatment was safe and also provide evidence that the antibody treatment may be effective against inflammation in Crohn's disease. The next step is to test the treatment in a larger group of volunteers and seek the most effective dose and treatment schedule," says Dr. Mannon.
Abbott Laboratories produced the anti-IL-12 antibody. Another pharmaceutical company, Wyeth, and the National Cancer Institute, also part of NIH, contributed to study costs.
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Contact: Linda Joy
ljoy@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
10-Nov-2004