Type 1 diabetes doesn’t always get as much attention as type 2 diabetes, especially from the pharmaceutical industry. As a result of this inattention, decades passed without the introduction of a new treatment option for this condition. However, this all changed when the FDA recently approved Tzield as a treatment option for people with pre-symptomatic type 1 diabetes. Tzield, as we will discuss below, has shown to dramatically delay the onset of symptoms for many type 1 patients that have taken the drug.

What Is Tzield?

Tzield, or teplizumab or teplizumab-mzwv, is the only drug that has received FDA approval (through both priority review and as a breakthrough therapy) to delay the onset of type 1 diabetes. In fact, Tzield is the first drug since insulin, approved almost a century ago, to reach the market for people with autoimmune diabetes. Before Tzield’s approval as a monoclonal antibody, many of these affected individuals had no other treatment option than insulin.

Unlike insulin therapy, which aims to mitigate disease symptoms, Tzield is focused on going to the heart of the disease. It works by changing the disease mechanism and how it attacks pancreatic beta cells. The medication effectively slows down or even stops the onslaught on these insulin-producing cells. It is the first medication shown to delay the development of symptomatic, or Stage 3, Type 1 diabetes.

Who Is Tzield For?

Currently, Tzield is approved for patients 8 years of age or older. However, even though Tzield could be a game changer for many people impacted by type 1 diabetes, several factors currently prevent its widespread use.

To start, Tzield needs to be delivered to individuals when they’re pre-symptomatic, meaning that they currently don’t have any signs and symptoms traditionally associated with type 1 diabetes. The hiccup is that there is no comprehensive testing for the antibodies associated with type 1 diabetes before symptom onset in the pediatric or adult population. This means it is challenging to identify patients who would be considered to have Stage 1 or Stage 2 type 1 diabetes.

People generally aren’t tested until they start noticing symptoms. However, even then, some of those symptoms (e.g., excessive thirst, frequent urination, and fatigue) are easy for individuals to overlook and can be mistaken for something more minor. This means that the vast majority of patients are not identified at this critical pre-symptomatic phase.

More doctors, though, are pushing for this early pre-screening, especially for patients who have a family history of type 1 diabetes and have a dramatically increased risk of developing the disease themselves based on genetic factors. However, roughly 85% of individuals who develop type 1 diabetes have no known family history of the disease, and it will be difficult to pick up these patients unless full blanket screening is used. Doctors need to be educated about the benefits of this treatment, and insurance companies need to show a willingness to pay for this antibody testing.

If patients can be identified at this early stage of the disease and receive Tzield, their symptoms may be delayed for up to three years. It’s even possible that some may not ever develop type 1 diabetes.

How Does Tzield Work?

Type 1 diabetes occurs when the body produces antibodies that target specific cells within the body’s pancreas. When this happens, it affects the body’s ability to safely and effectively regulate blood sugar levels. Tzield inhibits the ability of these antibodies to attack beta cells within the pancreas, acting as a state-of-the-art immunosuppressive drug that resets the body. Without Tzield, the lifetime risk for a patient progressing from Stage 2 type 1 diabetes to fully-fledged, symptomatic, and insulin-dependent diabetes is almost 100 percent.

How Is Tzield Administered?

Tzield is completed via IV infusion and is done once daily over the course of 14 days. The individual treatment sessions may take an hour or less. While getting the medication, patients may develop unpleasant side effects, but medical professionals have ways to assist. Individuals may receive OTC pain meds, antihistamines, and anti-nausea medicine before the infusion for the first five days of the infusion.

The actual dosage that a patient receives will depend on their calculated body surface area, which hinges on their height and weight. This is reported in square meters. On day 1, the patient receives 65 mcg/sq meter. On day 2, the dose increases to 125 mcg/sq meter, and on day 3, it is 250 mcg/sq meter. By day 4, the patient receives 500 mcg/sq meter, and on days 5 through 14, the dosage increases to 1,030 mcg/sq meter.

The Clinical Trial

Prior to FDA approval, Tzield underwent clinical testing on participants 8 years or older. Seventy-six patients participated in the trial. Each of the participants had Stage 2 type 1 diabetes. In other words, they were still asymptomatic, but antibodies had already started to attack the islet cells in the pancreas responsible for producing insulin to regulate blood sugar.

Patients who received Tzield instead of the controlled placebo had a significantly delayed time till the onset of symptoms and entering Stage 3 of Type 1 diabetes. The average time of symptom onset was 50 months for Tzield users, compared with only 25 months for individuals who received the placebo. This represented a statistically significant difference. These figures are impressive, but some patients have had even more dramatic results. In fact, one young participant is now more than six years post-Tzield and has seen no disease progression.

This was not the only benefit found for participants in the clinical trial. The study also found that those who used Tzield were significantly less likely to develop Stage 3 type 1 diabetes during the three-year period following drug administration. 45% of participants who received the medication developed symptomatic diabetes over the 36-month period. This compares favorably with 72 percent of patients who had received the placebo during the trial.

Given that this clinical trial was relatively small, additional research continues to be conducted into Tzield and the potential impact that it will have on a wide range of patients. Also, research continues to explore how to more effectively identify people with Stage 2 type 1 diabetes in a cost-effective manner.

Tzield Side Effects

Some of the more common side effects of Tzield include rashes, headaches, nausea, diarrhea, and inflammation of the throat and nose. However, one of the most severe concerns associated with the drug is experiencing a decreased white blood cell count. When this occurs, it’s much more challenging for the body to fight off pathogens. As a result, individuals are much more likely to get sick, and if they get sick, the body will have a more challenging time fighting it off.

Another major concern is developing cytokine release syndrome. When this happens, the body responds aggressively to a perceived infection. This condition is accompanied by symptoms such as fever, fatigue, and muscle and joint pain. It may also cause problems with an individual’s liver enzymes.

Given the risk of these serious consequences, people using Tzield must be carefully monitored by their provider for any signs of illness. In addition, they should receive vaccinations before starting their course of Tzield. A patient who is taking Tzield shouldn’t receive live vaccines or any mRNA vaccines. It is essential for doctors to

How Much Does Tzield Cost?

A potential hurdle with Tzield is the cost of the drug. Estimates suggest that a full fourteen-day course of the drug will cost just under $200,000. It’s unclear how insurance companies will react regarding requests to cover this treatment therapy. There’s also uncertainty about how much of this cost will be passed on from the manufacturer to the consumer. In many cases, generic drugs are an option when the brand name is particularly costly, but Tzield is still very new. Therefore, right now, there is no cheaper generic option available.

Tzield vs Wegovy, Ozempic, and Mounjaro

One of the principal differences between Tzield and Wegovy, Ozempic, and Mounjaro is the population the drug is intended for. Wegovy, Ozempic, and Mounjaro are used by adults with type 2 diabetes that has been refractory to more traditional treatment options. Tzield, on the other hand, is designed to prevent individuals aged 8 years and older from developing stage 3, type 1 diabetes.

The other significant difference is that Wegovy, Ozempic, and Mounjaro must be used consistently. If the drug therapy is stopped, people will often see a return of their diabetic symptoms and experience rapid weight gain.

A New Way To Delay Stage 3, Type 1 Diabetes

Once type 1 diabetes becomes symptomatic, it can significantly impact one’s quality of life. Individuals often must take insulin shots daily, be mindful of their food choices, and be diligent about checking their blood sugar levels. However, thanks to Tzied, many individuals may be able to delay symptom development altogether. While additional work needs to be done on effectively identifying patients who would benefit from this treatment protocol, it appears things are moving in the right direction.

References:

https://www.pharmaceutical-technology.com/features/proventions-tzield-can-delay-type-1-diabetes-but-will-it-reach-all-patients/
https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-diabetes.html
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5918237/
https://www.cnn.com/2022/11/17/health/tzield-teplizumab-diabetic-treatment/index.html
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes
https://tzieldhcp.com/pdf/tzield-dosing-and-admin-guide.pdf
https://www.everydayhealth.com/type-1-diabetes/fda-approves-first-drug-to-delay-onset-of-type-1-diabetes/
https://www.goodrx.com/tzield/what-is
https://medlineplus.gov/ency/patientinstructions/000675.htm#
https://my.clevelandclinic.org/health/diseases/22700-cytokine-release-syndrome#