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The FDA approval of teplizumab — brand name Tzield — was announced today on November 17, 2022 for use in people ages 8 years and older in stage 2 of type 1 diabetes. Designated as a “breakthrough therapy,” Teplizumab is the first-ever FDA-approved drug to delay the full onset of type 1 diabetes for an average of two years in children with no symptoms of the disease.
Developed by Provention Bio, this immunotherapy drug works hand-in-hand with research that has led to the development of early screening for the T1D-related autoantibodies that typically develop years before traditional symptoms.
Decades of research from a variety of organizations have pinpointed the stages of T1D as:
- Genetic risk: Even without any family history of T1D, certain genes increase a person’s risk of developing T1D.
- Autoimmune activation: When the immune system begins attacking insulin-producing cells.
- Stage 1: When two or more T1D-related autoantibodies are present but blood sugars are normal.
- Stage 2: When two or more T1D-related autoantibodies are present but blood sugars are abnormal but there are no other symptoms.
- Stage 3: When two or more T1D-related autoantibodies are present, symptoms develop, blood sugar levels are persistently high, and insulin therapy is immediately necessary.
With financial support from Sanofi, Provention Bio’s next challenge will be educating the healthcare industry and the general public about the importance of early screening for T1D. Early screening will identify eligible candidates to receive infusions of Tzield.
What is Tzield (teplizumab)?
Tzield is an anti-CD3 monoclonal antibody (mAb) immunotherapy drug that works by deactivating the autoimmune attack on beta-cells. Beta cells are produced by the pancreas and responsible for secreting insulin — these are the cells the immune system attacks throughout the development of T1D. At the same time, Tzield also increases the cells that properly manage the immune system.
Tzield is delivered intravenously once a day for 14 days to delay the progression to stage 3 of T1D when daily insulin therapy becomes necessary.
“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
How long can Tzield delay the full onset of T1D?
Using C-peptide measurements to track how much insulin the body is producing, Tzield has proven to delay the progression to stage 3 T1D compared to those taking the placebo.
“The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo,” explained the press release.
Participants who received Tzield progressed to stage 3 of T1D (requiring insulin therapy) an average of 50 months after receiving treatment. Participants who received the placebo progressed to stage 3 of T1D after only 25 months.
While an additional 25 months may not seem significant to those who’ve lived with T1D for decades, it can make a large difference in the life of a child — having to manage T1D at age 9 compared to age 11.
This research was performed with participants who tested positive for at least two of the T1D-related autoantibodies that indicate the earliest stages of the disease — long before symptoms develop.
Provention Bio is also evaluating the potential of Tzield in those newly diagnosed with T1D already dependent on insulin therapy.
What are the side effects of Tzield?
“The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache,” explained the press release.
“The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield.”
Understanding the value of early screening for type 1 diabetes
To appreciate the potential of teplizumab, it’s important to grasp the tremendous progress T1D detection and prevention research has made over the last 30 years.
The ability to detect the earliest stages of T1D is thanks to global research efforts from Trial Net, JDRF, the Diabetes Prediction and Prevention study in Finland, the Immune Tolerance Network, and others.
Essentially, there are several specific autoantibodies (the result of your immune system attacking you) that are present in your bloodstream years before insulin production decreases enough to produce the classic symptoms of T1D: weight-loss, severe thirsty, frequent urination, fatigue, blurry vision, sweet-smelling breath, yeast infections (in women), bed-wetting (children), and dry feces (babies).
Research has pinpointed that even in a person who isn’t diagnosed until their teens, these autoantibodies are present in most people before age 5.
This means screening for T1D in very young children is critical to ensuring a child receives infusions of teplizumab when it has the most potential to delay the full onset of the disease. Screening involves getting a blood sample via the at-home T1Detect test kit (for $55) or with an intravenous blood draw by enrolling in Trial Net’s ongoing research.
Considering that approximately 1 in every 300 people who are diagnosed with T1D have no relatives with the disease, research is encouraging any and every family to participate in screening.
*The author of this article has screened both her children three times each!
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