Last Updated: June 10, 2019.
"Rather, these data provide strong albeit indirect evidence about the pathogenesis of beta-cell destruction and the potential to modify the course of type 1 diabetes with newer biologic agents", they commented, adding that this particular trial "will probably prompt the development of more refined screening criteria for treatment of persons at highest risk, although challenges in using immune modulators for type 1 diabetes remain".
Forty-four randomly assigned participants took teplizumab and 32 took a placebo.
In those who did progress to a diagnosis of type 1 diabetes, development was significantly delayed in those who received teplizumab compared with placebo, with a median time to diagnosis of 48.4 months versus 24.4 months, respectively. The drug is being developed by Provention Bio Inc. and is not yet approved by the FDA. "The 2-year delay in diagnosis is clinically important". That might translate into fewer complications later in life, according to the JDRF.
The study, involving treatment with an anti-CD3 monoclonal antibody (teplizumab), was conducted by Type 1 Diabetes TrialNet, an worldwide collaboration aimed at discovering ways to delay or prevent type 1 diabetes.
About 1.25 million Americans suffer from the disease, a form of diabetes in which the pancreas stops producing essential insulin, which regulates blood sugar.
These people must replace that lost insulin through daily injections or an insulin pump. Faster progression of type 1 diabetes is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.
Teplizumab is an immunotherapy drug created to interfere with the body's immune destruction of its own beta cells.
All individuals were at least age 8 years at the time of the study and had at least two diabetes-related autoantibodies detected in two different samples within the past 6 months. Most were under 18 years old. The research team also cautioned that the study had limitations, including the small number of participants, their lack of ethnic diversity, and that all participants were relatives of people with type 1 diabetes, potentially limiting the ability to translate the study broadly. Researchers can now test people's blood for molecules known as autoantibodies, which direct the immune attack. Through a 14-day treatment regimen, patients administered teplizumab received increasing doses until day 4. The others were given a placebo by IV.
Jeffrey Bluestone, a distinguished diabetes researcher and a director of Provention Bio had worked on the drug for over 30 years, and was instrumental in in-licensing.
She said: "In Milton Keynes there are 13,971 people who have been diagnosed and are living with diabetes, and it is thought that more than half of all cases of Type 2 diabetes could be prevented or delayed with the early identification of people at risk of developing it in the future".
The findings were presented Sunday at the American Diabetes Association meeting, in San Francisco.
When 41% of the participants' developed Type-1 diabetes, preliminary in the placebo group, the effects of the drugs were at a higher rate when it was given in the first year.
Dr. Clifford Rosen, from the Maine Medical Research Institute, and Dr. Julie Ingelfinger, from Massachusetts General Hospital, wrote an editorial in the same issue of the journal.
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