A new phase 3 trial finds the drug teplizumab can help preserve the ability of children and adolescents with new-onset type 1 diabetes to make their own insulin.
The FDA approved teplizumab in 2022, after the drug was shown to delay onset of stage 3 type 1 diabetes. In the PROTECT study, researchers set out to see whether teplizumab could safely and effectively preserve beta cell function in adolescents who had been recently diagnosed with type 1 diabetes.
Participants received two 12-day courses of treatment with teplizumab or placebo. 18 months later, the subjects treated with teplizumab showed stronger beta cell function and lower risk of severe hypoglycemia, and were able to reduce their insulin use. The team's results were published October 18 in the New England Journal of Medicine.
“We know that kids with new-onset diabetes lose the ability to make insulin over a period of years," says Kevan Herold, MD, C.N.H. Long Professor of Immunobiology at Yale School of Medicine and senior author of the study. "Teplizumab seems to slow that down.”
Researchers found participants treated with teplizumab spent more time in their target glucose range and were more likely to achieve the clinical definition of disease remission.
Teplizumab only requires two 12-day runs of treatment, unlike other available immune therapies which require continuous suppression of the immune system. “This fulfills what we say in immunology as ‘operational tolerance,’” Dr. Herold says. “In other words, you’ve given something for a brief period of time, and you fundamentally change the autoimmune response without continuously suppressing the immune system.”
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