Studies yield key insights in preventing destruction of insulin-produ...( minimizes first-dose side effects was...),Health

minimizes first-dose side effects, was studied by comparing 12 people aged 7 to 30 who were treated with the antibody to an equal number of patients in a control group who did not receive the drug. The researchers report that a 14-day course of the drug delayed the progressive decline in insulin production typically seen in type 1 diabetes.

One year after treatment with anti-CD3 mAb, the treated patients produced more insulin and needed less insulin therapy than the untreated patients. Retention of even some insulin production is an important clinical goal in the treatment of patients with type 1diabetes since, in general, most patients with the disease eventually lose the ability to make insulin entirely and need to rely completely on injected insulin to maintain metabolic control. Those who received the antibody treatment also had better hemoglobin A1c (HbA1c) levels, a reflection of average blood glucose over a 2- to 3-month period. "The goal of this trial was to induce tolerance to the beta cell, which is the target of autoimmune destruction in type 1 diabetes. This was in effect achieved, because the clinical effect we saw persisted long after patients had finished treatment with the anti-CD3 antibody," said the lead author, Columbia University's Dr. Kevan Herold.

The anti-CD3 mAb was designed to act on the immune system's T cells in a more specific manner than previous attempts at immune intervention in early diabetes. "Our animal research suggests that it reorients the immune response, suppressing destructive T cells and stimulating production of protective immune-signaling molecules. In fact, the antibody may selectively inhibit previously activated immune cells that are involved in the development of diabetes," said senior author, University of California at San Francisco's Dr. Jeffrey Bluestone. Dr. Bluestone developed the monoclonal antibody in the 1980s in collaboration with Johnson & Johnson.

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Contact: Joan Chamberlain
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
29-May-2002

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