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Engineered Antibody Delays Type 1 Diabetes Onset

TrialNet participants

Two brothers taking part in the TrialNet type 1 diabetes project (Benaroya Research Institute)

10 June 2019. Results from a clinical trial show a synthetic antibody delayed for about 2 years the start of type 1 diabetes symptoms among people at high risk of the disease. Findings from the trial appear in yesterday’s issue of the New England Journal of Medicine and were presented yesterday at a scientific meeting of American Diabetes Association in San Francisco.

People with type 1 diabetes have an inherited autoimmune disorder where beta or islet cells in the pancreas do not produce insulin. Type 1 diabetes is diagnosed primarily in children or young adults, where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing islet cells. From 5 to 10 percent of people diabetes have the type 1 form, estimated at 1.25 million in the U.S.

Few treatments for type 1 diabetes are available beyond managing the condition day to day. And as noted by the authors from several universities and institutes in the U.S., Canada, and Europe, treatments are available for slowing the progression of type 1 diabetes after it’s detected, but nothing is yet available for slowing its onset among people at high risk of the disease.

The treatment tested in this case is teplizumab, an engineered antibody protein designed to change the functioning of T-cells, white blood cells in the immune system that erroneously attack islet cells making insulin. Teplizumab, made by biotechnology company MacroGenics in Rockville, Maryland, binds to a section of the CD3 protein found on the surface of mature T-cells. And as a result, says MacroGenics, teplizumab can slow the immune reaction of T-cells in people with autoimmune disorders like type 1 diabetes and promote more immune-system tolerance. MacroGenics provided the teplizumab used in the study.

The clinical trial, funded by National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK, part of National Institutes of Health, recruited participants from TrialNet, a network of more than 200 study sites in North America, Europe, Australia, and New Zealand testing new methods for preventing type 1 diabetes or slowing its progression. The entire TrialNet project is recruiting some 75,000 participants over 20 years.

To test teplizumab, the researchers enrolled 76 participants age 8 to 49 having relatives diagnosed with type 1 diabetes, but themselves not showing signs of the disease, other than the presence of errant antibodies that could damage islet cells or abnormal tolerance of glucose. Of the 76 participants, 55 or 72 percent were age 18 or younger.

Researchers randomized the group to receive a 14-day course of teplizumab or a placebo. Participants were then screened for glucose tolerance at 3 and 6 months following the treatments, then every 6 months after that until they were diagnosed for type 1 diabetes.

The results show fewer people receiving teplizumab develop type type 1 diabetes, with the onset of the disease taking longer than people receiving the placebo. Among teplizumab recipients, 43 percent were eventually diagnosed with type 1 diabetes compared to 72 percent of placebo recipients. And half or more of placebo recipients showed clinical signs of diabetes within about 24 months, compared to 48 months for teplizumab recipients.

Adverse effects occurred more frequently among teplizumab than placebo recipients, mainly rash and lymphopenia, a condition where certain types of white blood cells are missing. The researchers say the adverse effects were expected and temporary.

“This discovery is the first evidence we’ve seen that clinical type 1 diabetes can be delayed with early preventive treatment,” says Lisa Spain, project scientist for NIDDK in an NIH statement. “The results have important implications for people, particularly youth, who have relatives with the disease, as these individuals may be at high risk and benefit from early screening and treatment.”

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