Sustained reduction in delaying type 1 diabetes with teplizumab

Previous phase II randomised controlled trials have shown that teplizumab (an Fc receptor–nonbinding anti-CD3 monoclonal antibody) was able to delay progression to type 1 diabetes in high-risk patients.

The study enrolled 76 participants (55 children and 21 adults) who were the relatives of people with type 1 diabetes and did not have diabetes themselves, but were at high risk for developing the condition. At the end of the trial, 53% of the teplizumab-treated group did not have type 1 diabetes, compared to 28% in the placebo group.

New follow up data, presented at the American Diabetes Association's virtual meeting in 2020 have showed sustained reduction in the onset of type 1 diabetes - a delay of as much as three years, compared to placebo.

In addition, people who were treated with teplizumab showed a significant reversal in C-peptide decline in the six months following treatment, after which C-peptide levels seemed to stabilize. These findings provide early evidence for the potential of this therapy to prevent type 1 diabetes in high risk patients, and an FDA decision could be expected by mid-2021.