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The Importance of Delaying the Onset of Type 1 Diabetes with New Treatment
For those with type 1 diabetes, a new monoclonal antibody treatment delays the clinical diagnosis of stage 3 diabetes for 2 years, pausing disease burdens and improving the quality of life.
With a new FDA-approved immunotherapy treatment designed to delay the onset of type 1 diabetes (T1D), patients — 8 years or older — can enjoy more years without the physical and financial burdens of living with T1D.
“Every year, each patient with type 1 diabetes requires around 1,500 finger sticks to monitor and manage blood glucose levels and nearly 1,250 insulin injections,” said Konda Reddy, MD, a board-certified pediatrician and pediatric endocrinologist, Medical Director of Pediatric Endocrinology, Diabetes, and Metabolism at Advent Health Children. “By delaying the diagnosis of diabetes, patients can delay insulin injections, complex medication regimes, and strict diets — that's the gift of this treatment.”
What Is Type 1 Diabetes?
Type 1 diabetes (once called insulin-dependent or juvenile) is a chronic condition in which the pancreas produces very little or no insulin, a hormone produced by the pancreas to regulate the amount of glucose in the blood. Typically appearing in adolescence, type 1 diabetes is much less common than type 2, making up 5–10% of total diabetes cases in the United States. According to the American Diabetes Association, 1.6 million Americans have type 1 diabetes, including 187,000 children and adolescents.
“With T1D impacting 1 in 300 school-aged children in the US, cognitive deficits have the potential to affect the growth and neuropsychological development of young children if not managed properly,” Reddy explained to PharmaNewsIntelligence.
Symptoms of T1D include increased thirst, frequent urination, hunger, fatigue, and blurred vision, and treatment plans focus on maintaining normal blood sugar levels through routine glucose monitoring, insulin therapy, diet, and exercise.
“Because type 1 diabetes affects every system in the body, patients who don’t control their condition are at risk for blindness, heart problems, stroke, limb amputation, among others,” Reddy added. “This medication can provide patients with months or years without the burden of the disease, including ketoacidosis, low blood glucose levels, and hypoglycemia.”
What Is TZIELD?
On November 17, 2022, the FDA approved Provention Bio’s TZIELD (teplizumab), a prescription anti-CD3 monoclonal antibody that delays the onset of stage 3 type 1 diabetes (T1D) in people 8 years and older diagnosed with stage 2 T1D. This humanized antibody works by binding to CD3, a cell surface antigen present on T lymphocytes, to delay the onset of stage 3 T1D.
According to Reddy, those with stage 2 T1D have two or more diabetes-related autoantibodies and abnormal blood sugar levels, often showing no symptoms. In stage 3 T1D, symptoms become present due to a substantial loss of beta cells, which make insulin.
Pregnant and breastfeeding people should avoid taking TZIELD, as researchers are unsure if it can be passed to infants from breast milk. Additionally, patients with an active infection should not be given this treatment, and people actively receiving any concurrent vaccination must wait for a certain time interval before receiving TZIELD, cautioned Reddy.
Ingredients, Dosing, and Pricing
TZIELD uses the active ingredient teplizumab-mzwv and inactive ingredients, dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 80, sodium chloride, and water for injection, respectively.
According to Reddy, healthcare providers administer TZIELD by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows:
Day 1 = 65 mcg/m²
Day 2 = 125 mcg/m²
Day 3 = 250 mcg/m²
Day 4 = 500 mcg/m²
Days 5–14 = 1030 mcg/m²
Although this new 14-day treatment comes with a hefty price tag of roughly $175,000, Reddy indicated that insurance would cover this treatment for patients with stage 1 or stage 2 T1D only.
Side Effects
As mentioned in a study, teplizumab's most common side effects include rash, headache, and a decrease in white blood cell counts. Cytokine release syndrome (CRS) is a rare but severe side effect, mentioned Reddy. Signs and symptoms of CRS include fever, fatigue, muscle and joint pain, nausea, headache, and increased liver enzymes.
“Because this monoclonal antibody therapy can cause allergic reactions through cytokine release, some patients are pre-medicated with antihistamines, Tylenol, and Motrin. If necessary, steroids and epinephrine are used to treat anaphylaxis,” shared Reddy.
Because those with lower lymphocyte counts are more prone to infections, Reddy suggested that healthcare providers monitor white blood cell counts during infusion treatment.
“CNS is extremely uncommon in this patient population, but the other side effects mentioned — fever, rash, joint pain, and low white blood cell counts — occur in roughly 7–10% of the population,” Reddy explained.
Benefits of Delaying T1D
Because there is no cure for T1D, delaying the onset of T1D provides several benefits, such as improved quality of life, reduced risk of complications, increased research opportunities and chances to develop better behavioral habits, and decreased healthcare costs. Early diagnosis and treatment can also help reduce the risk of complications, especially in children.
“Studies show that this medication has the potential to delay the diagnosis for 2–5 years,” highlighted Reddy.“It cannot be emphasized enough how precious a delay in the onset of diagnosis can be from the patient and their family perspectives — especially in the younger population.”
By delaying the final stages of Type 1 diabetes, patients can erase years of taking insulin, counting foods, and monitoring blood sugar while saving money on associated medical expenses. This gives younger patients time to develop healthy habits and learn what is required to manage a life-long chronic disease effectively.
Improving T1D Screening
“Across the globe, there is no universal screening program for type 1 diabetes,” Reddy told PharmaNewsIntelligence. “Population screening will be the next big development in diabetes care.”
Although no universal screening program has been developed, Reddy insisted that primary care physicians have the capability to routinely screen for T1D and identify eligible candidates for TZIELD with blood glucose, hemoglobin A1C, and antibody testing.
Today, most screening and monitoring programs target genetic family members who may be at risk of developing T1D and follow up with a random blood sugar test, the primary screening tool for T1D. However, implementing a mass screening program could save lives, reduce the likelihood of diabetic ketoacidosis and hospitalization, and identify asymptomatic individuals who could greatly benefit from new treatments.
“The most important component of this medication is that it gives patients time to prepare themselves for the future,” Reddy concluded.
