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(Reuters Health) – In people at high risk of type 1 diabetes, 14 days of treatment with the experimental drug, teplizumab, delayed the development of the disease for one year or more, according to the results of 39, a mid-term study presented Sunday.
The 76 study participants, aged 8 to 49, were at high risk for type 1 diabetes, in part because their loved ones had autoimmune disease, which kills beta cells in the body. pancreas responsible for the production and release of insulin. In addition, volunteers have all had tests showing diabetes-related autoantibodies that attack the pancreas, as well as unhealthy blood glucose levels.
Of the 44 volunteers randomly badigned to receive the drug, 19, or 43%, developed diabetes, with the disease appearing within 48.4 months in half of them.
In comparison, of the 32 people who received a placebo, 23, or 72%, developed diabetes, with half of the patients contracting it within 24.4 months.
When the study was stopped, the percentage of participants without diabetes was twice as high in the teplizumab group (57%) as in the placebo group (28%).
The main side effects were temporarily low levels of lymphocytes – a type of white blood cell – and a rash.
Provention Bio Inc develops the drug. The trial was funded by the National Institutes of Health and the Juvenile Diabetes Research Foundation. The findings were reported at a meeting of the American Diabetes Association in San Francisco and the New England Journal of Medicine.
"After repeated failures, this is the first time anyone has succeeded in delaying the onset of type 1 diabetes," said lead author Dr. Kevan Herold of Yale University in New Haven, Connecticut, by phone. . "The rate of diabetes development has been cut in half."
Dr. Clifford Rosen of the Maine Medical Center Research Institute and Dr. Julie Ingelfinger, Editor-in-Chief of the Journal, wrote in an editorial, "We can finally say that there is has made substantial progress in modulating the early course of type 1 diabetes. "
Additional studies will be required before regulators approve the drug.
In the United States, about 1.25 million people have type 1 diabetes, and nearly 18,000 new cases are diagnosed every year in people under 20, the American Diabetes Association announced.
Teplizumab works by altering the white blood cells of the immune system that destroy insulin-producing cells in the pancreas.
The most important impact of the drug appears to have been observed in the first year after treatment, while only 7% developed type 1 diabetes, compared with 44% on placebo.
Another set of therapies could further delay the development of diabetes and "that's what we hope to do," said Herold.
He said that there would be a reluctance to give the drug in the long run lest it slow down the immune system too much.
"It has been felt that to have a really effective treatment, you need a drug that you give for a short time so that people are not immunocompromised chronically," he said.
Many new drugs cost more than $ 100,000 a year. If teplizumab was to delay the development of type 1 diabetes for about a year, Herold said, people might think it's worth it.
"You have to talk to a person with diabetes," he said. "I think most people would tell you that a day without diabetes is a great day because the disease is a disease 24 hours a day, 7 days a week. You can not sleep, you can not eat, you can not walk without worrying about it. And three quarters of the people here are kids. We are talking about a critical moment in their development. "
Type 1 diabetes usually takes more than a decade of a person's life.
SOURCE: https://bit.ly/2K474eE New England Journal of Medicine, online June 9, 2019
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