Recently approved Tzield (teplizumab-mzwv), is delivering breakthrough results that suggest it may delay the onset of Stage 3 Type 1 diabetes by an average of two years.

The first-in-class drug is approved for adults and children ages 8 and older with Stage 2 Type 1 diabetes.

“Delaying the onset of Stage 3 not only postpones the need for daily insulin injections and the need to count all carbohydrates before eating, it can also postpone the potential disease burden of Type 1 diabetes for months or years,” said Lisal J. Folsom, M.D., M.S., an adult and pediatric endocrinologist with Wendy Novak Diabetes Institute, a part of Norton Healthcare and Norton Children’s.

The Food and Drug Administration approved Tzield in November 2022 after granting the drug breakthrough therapy status and a priority review. Adult and pediatric endocrinologists with Wendy Novak Diabetes Institute are the only providers in Kentucky currently administering the medication.

Adult patients can receive Tzield at the Norton Infusion Center downtown location. Pediatric patients receive Tzield treatment at Norton Children’s Endocrinology, affiliated with the UofL School of Medicine, at the Novak Center for Children’s Health and Norton Children’s Hospital.

Type 1 diabetes is an autoimmune disease affecting insulin-producing cells (beta cells) in the pancreas. There are three stages of Type 1 diabetes. In Stage 1, at least two diabetes-related autoantibodies are positive, but the person has normal blood sugar levels. In Stage 2 Type 1 diabetes, two or more diabetes-related autoantibodies are positive. In this stage individuals typically do not have symptoms but do have abnormal blood sugar levels as beta cell function declines. In Stage 3, individuals develop hyperglycemia and require treatment with insulin, frequent glucose monitoring and close attention to nutrition and activity levels. Once someone has been found to have Stage 1 Type 1 diabetes, the disease is certain to progress to Stage 3 over the lifetime.

To be eligible for Tzield, individuals need to have at least two positive pancreatic beta cell autoantibodies and dysglycemia as measured by fasting glucose, hemoglobin A1C, or an oral glucose tolerance test.

Tzield is administered by intravenous infusion once daily for 14 consecutive days. The drug works by binding to certain immune cells, which in some cases may delay progression of Stage 3 Type 1 diabetes.

In a randomized, double-blind, event-driven clinical trial, 44 people with Stage 2 Type 1 diabetes received Tzield, while 32 received placebo. Those who received Tzield treatment did not reach Stage 3 for four years on average, while those receiving the placebo were more likely to be diagnosed with Stage 3 after an average of two years. The mean follow-up time was 51 months.

In people who receive Tzield, the most common side effects are rash (36%), leukopenia (21%) and headache (11%), according to Provention Bio, the company that developed the drug. Tzield was associated with cytokine release syndrome in 2% of those receiving the drug.

Contraindications for Tzield include current pregnancy or breastfeeding, active infection, or recent vaccinations within two to eight weeks, depending on the type of vaccine.

Type 1 diabetes can be diagnosed at any time in a person’s life. Not all people with Type 1 diabetes are diagnosed during childhood. A patient with Type 1 diabetes requires an estimated 1,500 finger sticks and nearly 1,250 insulin injections each year.

If Tzield can delay Stage 3, it can give families additional time to prepare for the multiple daily diabetes management tasks that are required in Type 1 diabetes. It can reduce the risk of diabetic ketoacidosis and has the potential to forestall complications of diabetes including kidney failure, cardiovascular diseases, peripheral neuropathy and blindness.