Pediatric Endocrine Society Statement on Considerations for Use of Teplizumab (Tzield™) in Clinical Practice
Open accessAbstract
Teplizumab (TzieldTM, Provention Bio), a monoclonal antibody directed at T-cell marker CD3, is the first medication approved by the FDA to delay progression from stage 2 to stage 3 type 1 diabetes. To date, the overwhelming majority of pediatric endocrinologists do not have experience using immunotherapeutics and seek guidance on the use of teplizumab in clinical practice. To address this need, the Pediatric Endocrine Society (PES) Diabetes Special Interest Group (Diabetes SIG) and Drug and Therapeutics Committee assembled a task force to review clinical trial data and solicit expert recommendations on the approach to teplizumab infusions. We present considerations on all aspects of teplizumab administration, utilizing evidence where possible and providing a spectrum of expert opinions on unknown aspects. We discuss patient selection and prescreening, highlighting the safety and considerations for monitoring and treatment of side effects. We propose a schedule of events, a protocol for administration, and discuss practice management aspects. We advocate for the need for further long-term systematic surveillance studies to continue evaluating the efficacy and safety of teplizumab.
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Teplizumab has been approved by the US FDA for delaying the onset of clinical type 1 diabetes in individuals aged 8 years and older with stage 2 type 1 diabetes.
“Teplizumab, a humanised antiCD3 monoclonal antibody administered as a single 14day course of daily intravenous infusions, 15 is approved in Israel, Saudi Arabia, the UK, and the USA for delaying the onset of clinical type 1 diabetes in individuals aged 8 years and older with stage 2 type 1 diabetes.”
From The future of type 1 diabetes therapy (2025) · cites this paper as [15]
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- Authors
- Mehta, S., Ryabets-Lienhard, A., Patel, N., Breidbart, E., Libman, I., Haller, M. J., Simmons, K. M., Sims, E. K., DiMeglio, L. A., Gitelman, S. E., Griffin, K. J., & Tonyushkina, K. N.
- Affiliations
- New York Medical College (US)
- Children's Hospital of Philadelphia (US)
- NYU Langone Health (US)
- Children's Hospital of Pittsburgh (US)
- University of Florida Health (US)
- University of Colorado Anschutz (US)
- Riley Hospital for Children (US)
- University of California, San Francisco (US)
- Sanford Health (US)
- Rainbow Babies & Children's Hospital (US)
- Corresponding author
- Tonyushkina, Ksenia N.
- ORCID
- Venue
- Hormone Research in Paediatrics
- Publisher
- S. Karger AG
- Published
- 2024-04-30
- Volume
- 98
- Issue
- 5
- Pages
- 597-608
- ISSN
- 1663-2818 (ISSN-L)
- 1663-2826
- PMC
- PMC12416869
- OpenAlex
- W4395479965
- Cited by
- 17
- References
- 19
- Citations by year
- 2026: 6 · 2025: 8 · 2024: 3
- FWCI
- 4.51
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Hormone Research in Paediatrics (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by-nc)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- teplizumab, type 1 diabetes, type 1 diabetes in children, anti-CD3 monoclonal antibody, immunotherapy, disease progression prevention, patient selection, infusion safety, adverse effects monitoring, treatment protocols, long-term surveillance
- MeSH terms
- Child, Diabetes Mellitus, Type 1, Endocrinology, Humans, Pediatrics, Societies, Medical, Antibodies, Monoclonal, Humanized
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