What is Tzeild?
Tzield (teplizumab-mzwv) is an injectable medicine that is used to delay the onset of stage 3 Type 1 diabetes in people whose immune system has begun attacking their insulin-producing cells. Research has shown that Type 1 diabetes is a sequential disease that progresses through three distinct stages:
- Stage 1: B-cell autoimmunity is present and blood sugar levels are normal and there are no symptoms. Insulin is not necessary for survival
- Stage 2: B-cell autoimmunity is present, blood sugar levels are unstable, but there are no symptoms. Insulin is not necessary for survival
- Stage 3: B-cell autoimmunity is present, blood sugar levels are unstable, and symptoms of type 1 diabetes are present. Insulin is necessary for survival.
Tzield is given to adults and children aged 8 years and older with stage 2 type 1 diabetes. It was approved on November 17th, 2022.
The onset of Stage 3 T1D is life-changing and once insulin-producing cells are no longer able to keep blood glucose levels under control, extensive monitoring, and frequent insulin administration are necessary. Having T1D can take more than a decade off a person's life, reducing life expectancy by an average of 16 years for people diagnosed before the age of 10.
References
- Tzield Injection Prescribing Information. Updated 11/2022. Provention Bio, Inc. https://www.drugs.com/pro/tzield-injection.html
- Insel, R. A., Dunne, J. L., Atkinson, M. A., Chiang, J. L., Dabelea, D., Gottlieb, P. A., Greenbaum, C. J., Herold, K. C., Krischer, J. P., Lernmark, Å., Ratner, R. E., Rewers, M. J., Schatz, D. A., Skyler, J. S., Sosenko, J. M., & Ziegler, A. G. (2015). Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes care, 38(10), 1964–1974. https://doi.org/10.2337/dc15-1419
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How does Tzield work?
Tzield is thought to work by binding to CD3 (a cell surface antigen present on T lymphocytes) to delay the onset of stage 3 type 1 diabetes in adults and children 8 and older with stage 2 type 1 diabetes. Tzield may also deactivate the immune cells that attack insulin-producing cells while increasing the proportion of cells that help moderate the immune response. Tzield is classified as an anti-CD3 monoclonal antibody. Continue reading
How effective is Tzield?
Tzield has been shown to delay the progression of Stage 2 type 1 diabetes to Stage 3 type 1 diabetes by 25 months (approximately 2 years) in a phase 3, randomized, double-blind clinical trial. In an extended follow-up of this trial (duration 923 days), the average time to diagnosis of stage 3 type 1 diabetes was 59.6 months for Tzield-treated patients compared with 27.1 months for patients given a placebo (a difference of 32.5 months). Continue reading
How is Tzield administered?
Tzield is given by intravenous infusion over a minimum of 30 minutes once daily for 14 consecutive days. Dosage is based on body surface area and increases. Continue reading
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