Could Tzield Help Children Newly Diagnosed with Diabetes? – diaTribe Foundation

Tzield (teplizumab) was approved in2022, becoming the first treatment to delay the onset of type 1 diabetes. Currently, Tzield is for people aged 8 and up who have stage 2type 1 diabetes meaning they have two or more autoantibodies and abnormal blood sugar, but not high enough to be stage 3 which means the person already has type 1 diabetes.

What if Tzield could be used later on, once someone has been diagnosed with diabetes, to prevent progression of the disease?

Since Tzields approval, researchers like Dr. Kevan Herold, professor of immunobiology and of medicine and an endocrinologist at Yale University, have begun testing the medication for different stages of type 1 diabetes. Indeed, previousresearch by Herold and colleagues has suggested that Tzield might preserve beta cells.

If Tzield is able to prevent progression in those with newly diagnosed diabetes, it could potentially be a big improvement. For instance, this could lead to lower insulin or no insulin , meaning fewer or no injections and a lower risk ofhypoglycemia (low blood sugar). Its possible this could even translate to longer-term benefits, such as a lower risk ofdiabetes complications.

Tzield works by attaching to and modifying T-cells, a type of immune cells that destroy the insulin-producing beta cells in type 1 diabetes. In doing so, Tzield helps interrupt the immune systems attack on beta cells and delayed the onset of type 1 diabetes in a clinical trial by two to three years.

ThePROTECT study investigated whether treatment with Tzield could prevent disease progression in people newly diagnosed with type 1 diabetes. The study included 328 children and teens, ages 8 to 17 years old, who had been diagnosed with diabetes for up to 6 weeks. Participants were randomly assigned to receive two courses of Tzield treatment or a placebo.

In the original PROTECT trial, researchers found that Tzield led to significantly greater preservation of beta cells compared to placebo.

The problem, Herold said, was that the PROTECT study was done during theCovid-19 pandemic, which threw a wrench into the conduct of the trial. As a result of the pandemic, some participants were unable to receive a full course of Tzield.

Thecurrent analysis specifically looked at participants who strictly followed the treatment protocol, meaning that they received 80% or more of the prescribed dose of Tzield. Participants who received less than 80% of the recommended dose, took prohibited medications (such as steroids or vaccines), or became pregnant were not included in this analysis.

To measure how well Tzield preserved beta cells, the researchers looked at a metric called C-peptide. C-peptide is made by beta cells during insulin production and is found in blood or urine tests. C-peptide is commonly used in studies of type 1 diabetes, such as in research investigating the cell therapy Lantidra and Vertexs VX-880 stem cell treatment. A higher C-peptide level indicates that more beta cells are working and producing insulin.

This analysis included 275 participants: 180 were randomly assigned to receive Tzield, and 95 were randomly assigned to the placebo. At the start of the study, participants had an average age of 12, BMI of 19, and an A1C of 9%.

At week 78:

Despite these findings, A1C levels were comparable between the Tzield and placebo groups.

An additional analysis found that timing of the second course of Tzield whether participants received it at 6 months as recommended, or at 12 months did not affect preservation of beta cells, Herold noted. This is an encouraging finding, as it suggests participants whose dosing was interrupted by the pandemic were still able to reap the benefits of Tzield.

This analysis of the PROTECT study showed that participants who received Tzield as directed had significantly greater beta cell preservation and time in range. Participants treated with Tzield also had lower insulin needs, which may have contributed to the lower risk of severe hypoglycemia.

These findings suggest that Tzield may be useful in preventing progression of type 1 diabetes in those newly diagnosed with the condition. Note that this study only investigated children and teens, so more research is needed, including whether Tzield is beneficial for the growing population of adults newly diagnosed with type 1 diabetes.

Overall, this analysis suggests that Tzield may be beneficial across a wider time frame not just in stage 2 type 1 diabetes. Hopefully, future research will determine the best time for participants to receive Tzield.

I think the general impression at this point is that theres probably a window of treatment opportunity that is sometime around the rapid decline in beta cell function that occurs in the peri-diagnosis period, Herold said.

Learn more about new treatments for type 1 diabetes:

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Could Tzield Help Children Newly Diagnosed with Diabetes? - diaTribe Foundation