A treatment that affects the immune system slowed the progression to clinical type 1 diabetes in high- risk individuals, according to a new study in The New England Journal of Medicine. The study involved treatment with teplizumab, an anti-CD3 monoclonal antibody, and findings show that the disease can be delayed by two or more years among people who are at high risk.
Researchers enrolled 76 participants ages 8-49 who were relatives of people with type 1 diabetes, had at least two types of diabetes-related autoantibodies, and had abnormal glucose tolerance.
Participants were randomly assigned to either the treatment group or placebo group. All subjects received glucose tolerance tests regularly until the study completion or until they developed clinical type 1 diabetes–– whichever one came first.
During the trial, 72% of control patients developed clinical diabetes, compared to 43% of teplizumab patients. The median time for control patients to develop clinical diabetes was just over 24 months, whereas patients in the treatment group had a median time of 48 months before diagnosis.
The researchers say the discovery is the first evidence that clinical type 1 diabetes can be delayed with early preventative treatment. The results also have important implications for young people in particular who have relatives with the disease; they could be at high risk and would thus benefit from early screening and treatment.
The effects of teplizumab were greatest during the first year after it was given, when 41% of participants, mostly from the placebo group, developed clinical diabetes.
A number of factors, including age, could have contributed to the drug’s ability to delay clinical disease; at-risk children and adolescents progress to type 1 diabetes faster than adults. Faster progression of this disease is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.
Source: NIH, June 10, 2019