New Drug Reduces Insulin Needs For Type 1 Diabetes

An antibody directed at CD3 can preserve beta-cell function for 18 months in patients with early stage type 1 diabetes. Six days of injections of the antibody drug, ChAgylCD3, appeared to halt the destruction of insulin-producing beta cells in at least 12 of 40 volunteers diagnosed with diabetes less than three weeks before receiving the usual treatment.

"If this is safe and not toxic, one could hope to use this to prevent the onset of the disease, or to delay the onset of the disease," said Robert Goldstein, chief science officer at the Juvenile Diabetes Research Foundation International.
"Both effects are potentially very significant and need to be tested," he added.

Of the remaining subjects, 24 had already lost most of their beta cells, leading doctors to believe that the sooner the patient receives the therapy, the more effective it will be.

In cases where the drug worked, the benefits lasted for 18 months and doctors are still following patients to determine whether the impact could live on even longer.

If the treatment proves to be safe, it may be reasonable for doctors to start giving it to people who face a genetic risk of juvenile diabetes and who show early signs that their beta cells are under attack.

Up to 40,000 Americans, mostly children but some much older, develop juvenile diabetes each year.

By the time symptoms appear, 80 to 90 percent of the beta cells in the pancreas have already been destroyed. All the patients in the study, conducted in Europe, had been diagnosed with the so-called type 1 diabetes less than three weeks before getting the drug.

Short-term treatment with CD3 antibody preserves residual beta-cell function for at least 18 months in patients with recent-onset type 1 diabetes.

The treatment would, however, be of no help to people who develop adult-onset or type 2 diabetes.

In an accompanying editorial, Ake Lernmark, MD, from the University of Washington in Seattle, discusses the immunology of diabetes in the context of the present study.

"The demonstration that the ChAglyCD3 antibody was effective primarily in patients with substantial residual beta-cell function suggests that it may be necessary to increase the efficacy of immunotherapy for type 1 diabetes," Dr. Lernmark writes. "A recent phase 2 study suggests that the treatment of latent autoimmune diabetes in adults with alum-formulated GAD65 is safe and may also have a beneficial effect on fasting C-peptide levels. If CD3 monoclonal antibodies are shown to be safe, perhaps their use in combination with agents for inducing immune tolerance could lead to improved therapies for type 1 diabetes."

NEJM Volume 352:2598-2608June 23, 2005 Number 25

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