Teplizumab slows type 1 diabetes in young people newly diagnosed, clinical trial finds

By Editor
27th October 2023
NHS, NHS England Research Type 1 diabetes

Results from the PROTECT study show that teplizumab can preserve beta cell function in children and adolescents newly diagnosed with type 1 diabetes. 

Approved by the US FDA in November 2022, teplizumab is an immunotherapy drug proven to delay the onset of type 1 by up to three years in people at high-risk of developing type 1.

The PROTECT study results, published in the New England Journal of Medicine, show that the drug also has the potential to slow the progression of type 1 in people newly diagnosed with the condition.

Meanwhile, there is a separate study looking at the benefits of type 1 diabetes screening for children and young people that this drug could potentially be a part of.

The ELSA Study is recruiting 20,000 children in the UK to explore the feasibility and benefits of screening for type 1 diabetes.

All children identified at risk are supported through one to one education, referral for follow up, and linking in with their GP or local diabetes centre as appropriate. Families can take part in a number of ways but the most popular has been through ordering a home blood testing kit.

Professor Parth Narendran said: “Over 10,000 children have asked to take part in the ELSA study so far and the study is open across all four nations.

“Whilst detecting risk early comes with some advantages such as reducing the risk of being diagnosed as an emergency, many families say that the availability of teplizumab in the UK would be a strong reason to be screened.”

Teplizumab is the first ever disease-modifying drug licensed for type 1 diabetes. It’s an immunotherapy drug, which means it directly interferes with the immune attack that causes type 1.

Having proved effective at slowing the onset of type 1, researchers are now investigating whether teplizumab can also help people who already have type 1.

The PROTECT study took place at four sites in England and Wales. 300 young people aged between eight and 17 years, who had all been diagnosed with type 1 in the previous six weeks, took part in the study.

Approximately 217 participants were given one course of daily teplizumab injections for 12 days, then another course of injections after six months.

Meanwhile the remaining people who took part received injections in the same procedure, but theirs contained a placebo.

The researchers took the children’s C-peptide levels, which is a measure of the amount of insulin a person can make, at week 78 of the trial.

The children and adolescents who were treated with teplizumab had significantly higher C-peptide levels than those in the placebo group.

Insulin is made by cells in the pancreas called beta cells, so the results suggest that teplizumab can preserve beta cell function in people newly diagnosed with type 1.

The researchers found that the C-peptide levels of the people who received teplizumab declined more slowly than those who had the placebo.

The more beta cells a person has, the more insulin they can make. Being able to make some insulin yourself can make type 1 easier to manage and keep glucose levels more stable.

This is sometimes known as the honeymoon phase or period. Puberty and hormones can make type 1 even more difficult for young people to manage, so teplizumab could help get them through those challenging times.

Discussions are ongoing between Sanofi, the drug company that makes teplizumab, and the MHRA, the government agency that approves new drugs.

The MHRA has already given teplizumab an ‘innovation passport’, which is a way to speed up the approval process.

Photo by Julia M Cameron from Pexels

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