Immune therapy delays diagnosis in people at high risk

SAN FRANCISCO & NEW YORK, JUNE 9, 2019 — Researchers are one step closer to preventing type 1 diabetes, thanks to TrialNet research funded by the National Institutes of Health (NIH), primarily through the Special Diabetes Program, with additional support from JDRF, the leading global organization funding type 1 diabetes (T1D) research.

Presented today at the 2019 American Diabetes Association’s 79th Scientific Sessions and published in the New England Journal of Medicine, findings from the Teplizumab (Anti-CD3) Prevention Study show the immune therapy drug teplizumab delayed type 1 diabetes diagnosis a median of 2 years in children and adults at high risk.

“This is the first study to show any drug can delay type 1 diabetes diagnosis a median of 2 years in people at high risk,” explains TrialNet Teplizumab Prevention Study Chair Kevan Herold, M.D. “As anyone with type 1 diabetes will tell you, and particularly for children who are most commonly affected, every day you can delay this disease is important.” Dr. Herold is Professor of Immunobiology and Internal Medicine at Yale University.

All study participants were relatives of people with T1D who had two or more autoantibodies and abnormal blood sugar levels as identified by TrialNet’s Pathway to Prevention study. These individuals are thought to have a lifetime risk of clinical diagnosis nearing 100%. Of the 76 high risk individuals who participated in the study, 55 were under age 18.

“These results and the potential impact to people living with type 1 diabetes and their families is exactly why JDRF funds prevention research,” said Aaron J. Kowalski, Ph.D., JDRF President and CEO. “Delaying the progression of the disease is an essential and impactful step toward the prevention, and ultimately a cure for type one, as a delay in diagnosis is likely to have long-term benefits on glycemic control and the development of acute and long-term complications of type 1 diabetes.”

Type 1 diabetes occurs when the body’s immune system attacks and destroys insulin-producing beta cells in the pancreas, causing abnormal blood glucose (sugar) levels. Teplizumab interferes with the body’s immune destruction of its own beta cells. While previous studies showed teplizumab prolonged insulin production in people recently diagnosed, this is the first study to test it in people at high risk for the disease.

Importantly, this study highlights that type 1 diabetes is an autoimmune disease that can be delayed with immune therapy.  TrialNet has several other immune therapy trials aiming to delay type 1 diabetes.

TrialNet Chair Carla Greenbaum, M.D., Director of the Diabetes Research Program at Benaroya Research Institute in Seattle, says, “In addition to being able to accurately predict who will develop T1D, we have now found a way to delay it. This is an incredible advancement that gets us one step closer to our ultimate goal: a future without T1D. Relatives are urged to get screened for risk at TrialNet.org.”

The Teplizumab Prevention Study was primarily funded by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and JDRF. MacroGenics/Provention Bio donated the study drug and provided funds for additional site monitoring.

About TrialNet

TrialNet (NCT00097292) is funded by the National Institutes of Health (NIH), primarily through the Special Statutory Funding Program for Type 1 Diabetes. Additional support comes from JDRF, American Diabetes Association.

The largest clinical trial network ever assembled to change the course of type 1 diabetes, TrialNet offers free risk screening for relatives of people with type 1 diabetes and innovative clinical studies testing ways to maintain insulin production before and after diagnosis. There’s also the option to get a test kit in the mail to complete screening at home or take to a local lab. Visit www.trialnet.org.

About JDRF

JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.