What are the stages of T1D?

Autoimmune T1D has 3 distinct
and detectable stages

In 2015, the ADA, JDRF, and Endocrine Society reclassified T1D as occurring in 3 progressive stages^1,2

Stages are identified by the presence of multiple autoantibodies and abnormal or increasing glycemic levels.

A chart showing the three stages of Type 1 Diabetes

*Autoantibodies may become absent at this stage.

Patients are typically diagnosed in Stage 3, when symptoms arise due to hyperglycemia.¹

In Stage 3, T1D can burden patients and caregivers physically, mentally, and emotionally^3-8†

For example, per year, the average Stage 3 patient may experience^3-5:

1860+ finger pricks^‡

1460+ insulin needle injections^§

120 insulin pump site changes^‖

In addition to the physical burden, patients and caregivers may experience^6-8†:

A sad face with a rain cloud over its head

3x higher depression rates than the general public

Impacted sleep duration and quality

^†There is no evidence to suggest that TZIELD will have any effect on burden of disease or outcomes.

A male wearing a hat and holding an apple

Up to 60% of Stage 3 T1D patients are diagnosed after life-threatening events^9,10

Diabetic ketoacidosis (DKA) can have negative and long-lasting effects.

A patient’s long-term glycemic management can be affected by the intensity of DKA at diagnosis:

0.87%^¶ average increase in HbA1c is associated with mild/moderate DKA at diagnosis

1.35%^¶ average increase in HbA1c is associated with severe DKA at diagnosis¹¹

DKA events can also have lasting
effects on^11-13:

Cognitive and intellectual function

Verbal IQ

A silhouette of a head and torso with a thought bubble in its head

Memory IQ

There is no evidence to suggest that TZIELD will have any effect on the likelihood of or outcomes for those who experience DKA.

^‡If using a CGM vs not using a CGM.

^§If using injectable insulin instead of a pump.

^‖If using insulin pump.

^¶P<0.0001 compared with no DKA at diagnosis; independent of demographic/socioeconomic factors.

CGM=continuous glucose monitor; JDRF=Juvenile Diabetes Research Foundation.

Learn more about early intervention in T1D

Identify and monitor at-risk patients before the onset of Stage 3 T1D

Important Safety Information

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.

Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm.
Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.

References: 1. Insel RA, Dunne JL, Atkinson MA, et al. 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. 2. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2024. Diabetes Care. 2024;47(Suppl 1):S20—S42. 3. Janež A, Guja C, Mitrakou A, et al. Insulin therapy in adults with type 1 diabetes mellitus: A narrative review. Diabetes Ther. 2020;11(2):387-409. 4. van den Boom L, Karges B, Auzanneau M, et al. Temporal trends and contemporary use of insulin pump therapy and glucose monitoring among children, adolescents, and adults with type 1 diabetes between 1995 and 2017. Diabetes Care. 2019;42(11):2050-2056. 5. Schmid V, Hohberg C, Borchert M, et al. Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy—trouble starts on day 3. J Diabetes Sci Technol. 2010;4(4):976-982. 6. Reutrakul S, Thakkinstian A, Anothaisintawee T, et al. Sleep characteristics in type 1 diabetes and associations with glycemic control: Systematic review and meta-analysis. Sleep Med. 2016;23:26-45. 7. Estrada C, Danielson K, Drum M, et al. Insufficient sleep in young patients with diabetes and their families. Biol Res Nurs. 2012;14(1):48-54. 8. Koyama AK, Hora IA, Bullard KM, et al. State-specific prevalence of depression among adults with and without diabetes—United States, 2011-2019. Prev Chronic Dis. 2023;20:E70. 9. Beliard K, Ebekozien O, Demeterco-Berggren C, et al. Increased DKA at presentation among newly diagnosed type 1 diabetes patients with or without COVID-19: Data from a multi-site surveillance registry. J Diabetes. 2021;13(3):270-272. 10. Nakhla M, Cuthbertson D, Becker D, et al. Diabetic ketoacidosis at the time of diagnosis of type 1 diabetes in children: insights from TRIGR. JAMA. 2021;175(5): 518-520. 11. Duca LM, Wang B, Rewers M, Rewers A. Diabetic ketoacidosis at diagnosis of type 1 diabetes predicts poor long-term glycemic control. Diabetes Care. 2017;40(9):1249-1255. 12. Ghetti S, Kupperman N, Rewers A, et al. Cognitive function following diabetic ketoacidosis in young children with type 1 diabetes. Endocrinol Diab Metab. 2023;6:e412. 13. Cato A, Hershey T. Cognition and type 1 diabetes in children and adolescents. J Diabetes. 2016;29(4):197-202.