Sunday, 16 June, 2019

Immunotherapy delays type 1 diabetes in people at high risk

IMAGE Brothers volunteer for Type 1 Diabetes TrialNet.  view more  Credit Benaroya Research Institute IMAGE Brothers volunteer for Type 1 Diabetes TrialNet. view more Credit Benaroya Research Institute
Samantha Long | 13 June, 2019, 13:26

Many patients who are at risk of developing type 1 diabetes could have their disease onset delayed or even prevented by a new treatment, in what could be a remarkable breakthrough.

The drug teplizumab works by changing the immune system's white blood cells responsible for killing insulin-producing beta cells. Unlike the more common type 2 diabetes, which affects an estimated 28 million-plus people in this country, type 1 diabetes usually manifests itself in childhood and is tied to genetics.

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All study participants were relatives of people with type 1 diabetes who had two or more autoantibodies and abnormal blood sugar levels as identified by TrialNet's Pathway to Prevention study. "I think most people would tell you a day without diabetes is terrific because the disease is a 24/7 disease".

An experimental drug is found to effectively delay the onset of type 1 diabetes among high-risk individuals to two or more years.

The US biotech firm was established just three years ago, and acquired rights to teplizumab from MacroGenics, which suspended its development of the drug in 2010 after a clinical trial run with Lilly showed it failed to show sufficient efficacy in T1D patients.

An investigative therapy has shown capability to delay type 1 diabetes (T1D) progression in patients at high risk of the chronic autoimmune disease. The effects of the drug were greatest in the first year after it was given, said the study published online in The New England Journal of Medicine. Median time to T1D diagnosis in patients treated with teplizumab was 48.4 months; among placebo patients, time to diagnosis was 24.4 months.

Half the participants received two weeks of daily intravenous infusions with teplizumab; the rest received placebo infusions. "This discovery is the first evidence we've seen that clinical type 1 diabetes can be delayed with early preventive treatment", according to Lisa Spain, PhD, Project Scientist from the National Institute of Health (NIH)'s National Institute of Diabetes and Digestive and Kidney Diseases, and sponsor of TrialNet.

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Teplizumab targets specific types of immune system cells, interfering with the destruction of beta cells.

Dr. Clifford Rosen of the Maine Medical Center Research Institute and Journal deputy editor Dr. Julie Ingelfinger wrote in an editorial, "We can finally say that there has been substantial progress in modulating the early course of type 1 diabetes".

All participants regularly took the glucose tolerance test throughout the study period. A total of 75% of participants who received teplizumab experienced a form of AE relating to blood or bone marrow, such as transient lymphopenia.

The researchers divided the participants.

Researchers speculate that a further round of the drug could delay the condition further but are also wary of its long-term use due to fears it might impact the immune system too much.

Herold disclosed support from the NIH, Juvenile Diabetes Research Foundation; relevant relationships with Provention Bio, Tiziana Life Sciences, Bristol Meyers Squibb, Eli Lilly, Merck, Forkhead, Semma, Toleron; and holding a patent for β-cell death assay. "We will not waver in our mission to eradicate type 1 diabetes". MacroGenics/Provention Bio donated the study drugs and provided funds for additional site monitoring.

The researchers conducted their trial on 76 patients, mostly aged between eight and 18.

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