An experimental immunotherapy drug, teplizumab, was found to have a lasting effect delaying the diagnosis of type 1 diabetes in people at high risk for the condition, according to a new study published in the journal Science Translational Medicine.
The study’s participants were 76 children and youth who had a close relative with type 1 diabetes, but who didn’t have a clinical diagnosis of diabetes themselves at the beginning of the study. As noted in a Healio article, all participants were at least eight years old, with a median age of 13. Each participant tested positive for at least two diabetes autoantibodies — proteins made by the immune system that indicate an attack on insulin-producing pancreatic beta cells — and had somewhat abnormal results from an oral glucose tolerance test (but not high enough glucose level for a diabetes diagnosis).
Each participant was randomly assigned to receive either a 14-day course of teplizumab or a placebo (inactive substance), which was administered intravenously (by IV). Participants were then followed for an extended period — a median of 923 days — and had a number of different diabetes-related outcomes tracked during that time. These outcomes included glucose tolerance, C-peptide levels (a blood marker that closely tracks insulin levels, showing insulin secretion over time), actual insulin secretion, and certain measures of immune system function and response.
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After the extended follow-up period, the researchers found that 50% of the teplizumab group had developed type 1 diabetes, while 78% of the placebo group had done so. Among those who developed diabetes, there was also a longer time to diagnosis in the teplizumab group — a median of 59.6 months, compared with 27.1 months in the placebo group. Needless to say, this represents a delay of a couple of years in a child’s diabetes diagnosis.
The researchers also found that teplizumab improved pancreatic beta cell function, as indicated by total C-peptide production during a time-based test — with an average level of 1.96 pmol/L compared with 1.68 pmol/L in the placebo group. The treatment group saw a reversal in their declining insulin secretion soon after receiving teplizumab, but then saw their levels stabilize and then continue to decline again. Members of the treatment group also tended to have a better response to a glucose tolerance test, and had differences in immune system activity that indicated a less robust attack on pancreatic beta cells.
The researchers are still following study participants who did and didn’t develop diabetes, and are offering pretreatment with teplizumab as an option for those who have type 1 diabetes. It’s unknown what effect this treatment will have once children have developed diabetes, but any improvement in glucose control could be beneficial, even if this isn’t enough to reverse a diabetes diagnosis.
Provention Bio, the maker of teplizumab, filed an application for the drug’s approval with the U.S. Food and Drug Administration (FDA) in January 2021 as a treatment to delay or prevent the onset of type 1 diabetes in high-risk individuals. The FDA granted the application priority review and is set to respond by July 2.
Want to learn more about type 1 diabetes? Read “Type 1 Diabetes Questions and Answers,” “Six Type 1 Diabetes Symptoms You Need to Know” and “Living With Type 1 Diabetes: Four Tips to Get You Started.”
Source URL: https://www.diabetesselfmanagement.com/news-research/2021/03/24/immunotherapy-treatment-delays-type-1-diagnosis-in-long-follow-up/
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