First-ever Drug To Delay Type 1 Diabetes: Things You Must Know About Teplizumab

Teplizumab

Type 1 diabetes, or juvenile diabetes, is a chronic autoimmune-mediated disease distinct from type 2 diabetes and progresses in three different stages (stages 1, 2 and 3). It occurs most frequently in children and young individuals. It is caused when the autoantibodies (antibodies that mistakenly attack one’s own body tissues or organs) produced by the immune system attack the insulin-producing beta cells in the pancreas, leading to their destruction. As a result, there is very little or no insulin production, which affects blood sugar control.

The average age for the diagnosis of type 1 diabetes is 13 or 14, which is a difficult age for children and families, particularly for managing diabetes complications. Hormonal changes and growth spurts require frequent blood sugar monitoring and insulin dosage adjustments. Sometimes families need to work with coaches and teachers to help support the kid at school. Delaying the onset of stage 3 type 1 diabetes (with clinical symptoms) can give teens more time to mature and learn about the condition.

Thanks to the recent advancement in medical science, the onset of stage 3 type 1 diabetes can now be delayed by up to two years with the help of a medicine called Teplizumab. Such advancements can help families handle the burden of a chronic disease like diabetes and live with a more positive mindset with better control over their health.
Here we answer some of the most commonly asked questions about type 1 diabetes and the newly launched medicine, Teplizumab:

Q. What are the various stages of type 1 diabetes?
The various stages of type 1 diabetes are:

Stage 1: In this stage, individuals develop two or more diabetes-related autoantibodies, which attack the beta cells in the pancreas. At this point, blood sugar levels remain within the normal range, and no symptoms are present.
Stage 2: In this stage, individuals develop two or more type 1 diabetes-related autoantibodies, which continue to destroy the beta cells leading to the development of abnormal sugar levels without any symptoms. Once two or more autoantibodies develop and the patient begins to experience abnormal sugar levels, progression to stage 3 type 1 diabetes is inevitable.
Stage 3: In this stage, there is a significant loss of beta cells, and individuals start showing clinical symptoms and signs of diabetes like excess urination and thirst, weight loss, fatigue, diabetic ketoacidosis and others.

Q. What is Teplizumab, and how does it work?
Teplizumab is a prescription medicine used in certain patients having stage 2 type 1 diabetes to delay the progression to stage 3. It slows down the immune system’s attack on beta cells. This helps protect some beta cells from the attack, and the body can maintain insulin production for a longer duration.

Q. Who is eligible to take Teplizumab?
Teplizumab is approved for select adults and children eight years and older having stage 2 type 1 diabetes. This means they have tested positive for two or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels and do not have type 2 diabetes.

Q. Who should not receive Teplizumab?
The following criteria of people should not receive Teplizumab:
-People with insulin-dependent stage 3 type 1 diabetes
-People diagnosed with type 2 diabetes
-Children below 8 years of age

Q. What should the patient tell the doctor before taking Teplizumab?
Before taking Teplizumab, the patient should inform their doctor if they have the following conditions:
-A serious infection or an infection that does not go away or keeps coming back
-Are pregnant or planning a pregnancy
-Are breastfeeding or plan to breastfeed. In the case of breastfeeding, the patient may consider pumping and throwing away the breast milk during treatment with Teplizumab and for up to 20 days after receiving the medicine
-Have recently received or are scheduled to receive a vaccine

Q. Does Teplizumab have any side effects?
Like all therapies, this medicine has a few side effects, which include rash, fever, leukopenia (decrease in white blood cell counts), headache, tiredness and muscle pain. The positive news is that these side effects mostly last for only some time.

Q. How effective is Teplizumab?
In a clinical trial, in stage 2 type 1 diabetes patients, Teplizumab delayed the progression of type 1 diabetes from stage 2 to stage 3 by 25 months, or approximately two years. Further follow-up suggests that type 1 diabetes development may be delayed for even longer.

Q. What are the advantages of delaying the onset of type 1 diabetes? How can this finding improve the lives of those at risk for type 1 diabetes?
“Consider a child who is just eight years old and has started to show symptoms of diabetes requiring insulin injections. Two weeks of therapy delaying the onset of such a condition can provide two to three years of burden-free life. This makes a huge difference for a small child who is not mature enough to manage sugar levels”, said Dr. Shrey Bhatia, Manager, Corporate Health, TATA 1MG.
“We’ve been able to identify people at risk for type 1 diabetes for decades, but until now, we haven’t had anything to mitigate that risk, which leaves families just waiting for the disease to develop. To be able to discuss this as an option for delay (almost by 2 years) in the progression of disease severity is incredible. Patients will benefit from Teplizumab as treated patients will have better glucose control and lower insulin requirements and prevent diabetes-associated complications”, said Dr. Mekhala Chandra, Consultant, TATA 1MG.

Q. What is the significant health risk associated with stage 3 type 1 diabetes?
Stage 3 type 1 diabetes is associated with serious health risks, including diabetic ketoacidosis, which can be life-threatening. It occurs when the insulin levels in the body are so low that glucose (blood sugar) cannot enter the cells to be used as a fuel source. As a result, the cells cannot use the sugar in the blood to produce energy, so they use fat as fuel instead. This process produces acids called ketones. When excess ketones are produced, they can accumulate at dangerous levels in the body, leading to diabetic ketoacidosis.

Q. How is Teplizumab administered to patients?
Teplizumab injection is to be given once daily for 14 days. It is administered by a doctor or nurse using a needle placed in a vein (intravenous infusion) in the arm for over 30 minutes. Treatment will be continued on the next scheduled day if the patient misses a scheduled infusion. Two infusions will never be given on the same day to avoid an overdose.

Q. How is Teplizumab available?
Teplizumab injection is available as a preservative-free, sterile, clear, and colorless solution in a 1 mg/mL single-dose vial. Teplizimab has been launched in the USA by the biopharmaceutical company Provention Bio, Inc. There is no information regarding its availability in India yet.

Q. What’s next?
Health experts said they would continue to explore and develop Teplizumab’s potential in younger and newly diagnosed patients and investigate whether it could be re-dosed or combined with other treatments for more benefits.

(The article is written by Monalisa Deka, Senior Health Content Editor and reviewed by Dr. Rajeev Sharma, Vice President (Medical Affairs))

Recommended Reads:

Prediabetes: Your Body’s Call To Act Early

Juvenile Diabetes: Practical Tips To Help You Manage It Better!

References
1.Teplizumab [FDA Label]. USA: Provention Bio, Inc. 2022. [Accessed 23 Nov. 2022] (online) Available from: https://static1.squarespace.com/static/5f4574ed93f3456c76f3a95d/t/6376c9452abcde44dd5d8ae5/1668729158250/tzield-prescribing-information-and-medication-guide.pdf

2. Type 1 Diabetes: FDA Approves New Drug Teplizumab That Delays Onset. [Healthline]. 2022. [Accessed 23 Nov. 2022] (online) Available from: https://www.healthline.com/health-news/type-1-diabetes-why-cases-are-expected-to-double-worldwide-by-2040

3. American Diabetes Association Professional Practice Committee. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes. Diabetes Care. 2022;45(Suppl 1):S17-S38. [Accessed 23 Nov. 2022] (online) Available from: https://diabetesjournals.org/care/article/45/Supplement_1/S17/138925/2-Classification-and-Diagnosis-of-Diabetes

4. American Diabetes Association Professional Practice Committee. Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 2015;38(10):1964–1974. [Accessed 23 Nov. 2022] (online) Available from: https://diabetesjournals.org/care/article/38/10/1964/37704/Staging-Presymptomatic-Type-1-Diabetes-A?searchresult=1#3933065

5. Provention Bio. 2022. [Accessed 23 Nov. 2022] (online) Available from: https://investors.proventionbio.com/2022-11-17-TZIELD-TM-teplizumab-mzwv-approved-by-FDA-as-the-first-and-only-treatment-indicated-to-delay-the-onset-of-Stage-3-type-1-diabetes-T1D-in-adult-and-pediatric-patients-aged-8-years-and-older-with-Stage-2-T1D

6.Teplizumab. [Medscape]. [Accessed 23 Nov. 2022] (online) Available from: https://reference.medscape.com/drug/tzield-teplizumab-4000164#10

7. Diabetic ketoacidosis. [MedlinePlus]. USA: National Institutes of Health. 2022. [Accessed 23 Nov. 2022] (online) Available from: https://medlineplus.gov/ency/article/000320.htm

8. Masharani UB, Becker J. Teplizumab therapy for type 1 diabetes. Expert Opin Biol Ther. 2010;10(3):459-65. [Accessed 23 Nov. 2022] (online) Available from: https://pubmed.ncbi.nlm.nih.gov/20095914/

Related Articles