Teplizumab: A Drug for Diabetes Prevention, What to Know

Posted March 10, 2021 by Clint Kelly - See Editorial Guidelines

About 1.25 million Americans currently have type 1 diabetes. That number is expected to jump to 5 million by the year 2050. But what if there is a treatment that could potentially delay or prevent type 1 diabetes from developing?

An experimental drug called teplizumab is currently under research and could be the answer.

In this article, we will discuss what exactly teplizumab is and how it may delay the onset of type 1 diabetes. First, here is a quick answer to get us started, then we will dive into the details.

What is Teplizumab?  Teplizumab is an antibody that has been engineered in a lab and targets immune cells. Researchers have found that this drug could potentially delay the onset of type 1 diabetes in those who are high-risk for up to two years. More research will need to be done to determine if it can completely prevent the condition from occurring.

Now that you have the basics in mind, we can get into some of the specifics. However, it is important that we give an overview of type 1 diabetes, so we can better understand how this drug can work.

Overview of type 1

Teplizumab

Type 1 diabetes is different than type 2, as it is an autoimmune condition. This means that the body mistakenly attacks itself by destroying insulin-producing cells (beta cells) in the pancreas.

With this chronic condition, the pancreas is not making any insulin or not enough insulin.

Insulin is a crucial hormone that acts as a lock and key mechanism with cells. It allows cells to uptake glucose from the bloodstream to be stored and used for energy.

Without insulin, a person’s blood sugar can skyrocket and cause severe symptoms and complications.

Therefore, an outside source of insulin is needed for those with type 1 diabetes. Insulin is often administered through an insulin pen, syringe and vial, a pump, or even inhaled in some cases.

Type 1 diabetes can develop at any age, but it is most often diagnosed in children and teens.

The risk factors for type 1 diabetes are not always so clear. However, family history certainly appears to be one major risk factor.

Now that we have a basic understanding of type 1 diabetes, we can get into details of teplizumab.

What is teplizumab?

Teplizumab is an anti-CD3 monoclonal antibody. More simply, it is an immunotherapy drug that is engineered in a lab.

It was created by a biotechnology company called Provention Bio.

Provention Bio discovered that roughly 300,000 people in the United States are living with preclinical type 1 diabetes. Therefore, there is an opportunity to delay the onset of type 1 if possible.

 After clinical research, an application was submitted to the FDA for approval. At the time of writing this, the application is still under review by the FDA.

What do clinical trials reveal?

A clinical trial was done using 76 individuals that were considered high-risk for developing type 1 diabetes. Participants were between the age of 8 and 45 years old. Most individuals had a sibling, parent, or another relative that had type 1 diabetes.

The study would follow the subjects for 2-3 years after the start of the trial.

44 participants were given teplizumab as an intravenous infusion for 14 consecutive days. The other 32 participants were given a placebo for those same 14 days.

The results of this trial determined that half of those treated with teplizumab remain diabetes-free, compared to 22% of those that received the placebo. The delay in diabetes onset was close to 3 years.

A phase 3 trial is currently being conducted and is not expected to be done until May of 2022. This phase is seeking to determine if different administration methods have better results.

Who is teplizumab for?

With teplizumab showing some positive results during the clinical trials, you may be asking who should receive this treatment.

With teplizumab still needing FDA approval to move forward, there is no official guidance yet on who should receive this drug.

However, those who are at an increased risk of having type 1 diabetes are certainly at the forefront.

Therefore, teplizumab will most likely be available and prescribed to those with a family history of type 1 diabetes and those with antibodies of beta-cell autoimmunity.

There are four autoantibodies that are prevalent in those that develop type 1 diabetes. These include:

  • Islet cell antibodies
  • Antibodies to glutamic acid decarboxylase
  • Insulin autoantibodies
  • IA-2A, to protein tyrosine phosphatase

Teplizumab mechanism of action

The mechanism of action for teplizumab is not fully understood. However, it is clear that the drug preserves C-peptide levels and slows the rate at which beta-cell function is lost over a few years.

As phase 3 progresses and wraps up and more research is done, the exact way teplizumab works will become clearer.

Cost of teplizumab

As we have mentioned throughout, teplizumab has not received approval from the FDA yet and is not available to the public.

Therefore, there is not an official price yet. However, experts are expecting the cost of teplizumab to be potentially high.

Despite the expected high price for this drug, it could still be worth it. The average out-of-pocket cost a person with type 1 pays every year is around $2,500. Some patients will pay more than $5,000 every year.

These costs can add up over the years, as type 1 diabetes is a life-long illness. So, if teplizumab has the potential to delay and maybe even prevent diabetes, then the high price may be worth it.

Final thoughts

We hope this has given you more insight into teplizumab and how it can work. As mentioned, more research concerning this experimental drug will be coming out over the next months and years, so be on the lookout.

For questions regarding your specific health and treatment, always consult your doctor.



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