If teplizumab is approved for use, it could be the first drug to delay the onset or completely prevent type 1 diabetes in risk groups.
According to a new study, five years after patients at high risk of developing type 1 diabetes (T1D) received two weeks of treatment with teplizumab, an experimental immunotherapy drug, half of the treated group stayed disease-free compared with just 22 Percent of the placebo recipients.
The new paper describes the results of an extended follow-up (923-day median) from an earlier study that found that only 42 of the 76 enrolled 76 people between the ages of eight and 43 were at a relatively high risk of developing T1D After a was diagnosed, median follow-up was 742 days. At the end of the extension period, 25 of 32 (78 percent) of the placebo-treated and 22 of 44 (50 percent) of the teplizumab-treated participants were diagnosed with T1D.
Teplizumab was also found to increase median time to diagnosis (59.6 months) [almost five years] versus 27.1 months). In addition, 10 of 13 subjects who were followed beyond 60 months were not diagnosed with T1D, eight in the teplizumab group and two in the placebo group.
“If approved for use, this will be the first drug to delay or prevent type 1 diabetes,” said Kevan Herold, CNH long-term professor of immunobiology and medicine (endocrinology) at Yale University and co-senior author of the Paper.
Teplizumab, developed by biotechnology company Provention, is an Fc receptor non-binding anti-CD3ε monoclonal antibody that has received breakthrough status from the US Food and Drug Administration (FDA) and will be approved for general use by this summer could, added Herold.
Type 1 diabetes is an autoimmune disease in which T cells in a person’s immune system attack insulin-producing beta cells on islets of Langerhans in the pancreas. As a result, patients cannot produce insulin, the hormone that allows them to store glucose. They require lifelong insulin replacement treatment and are at higher risk of death and diseases that affect the heart, kidneys, and eyesight. The disease is often diagnosed in childhood or adolescence.
Importantly, the authors found that subjects treated with teplizumab had less T-cell damage, improved the function of insulin-producing beta cells, and therefore increased glucose tolerance. In addition, they reported that treatment reversed a decrease in insulin secretion before ingestion. According to the study, the decreased levels of damage caused by T cells, as measured by C-peptide area under the curve (AUC) with teplizumab, were associated with increases in partially depleted memory CD8 + T cells, which decreased Secretion of the pro showed -inflammatory cytokines IFN? and TNF?.
Herold emphasized that although it is not known whether some of the patients who received teplizumab will never develop T1D, delaying the onset of the disease could have a major impact on the development of those at risk: “Any time without diabetes is important, but especially for those children who might have the chance to grow up without them. “
The study was published in Science Translational Medicine.