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An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes
Open accessAbstract
BACKGROUND: Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed. METHODS: We conducted a phase 2, randomized, placebo-controlled, double-blind trial of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals. RESULTS: A total of 76 participants (55 [72%] of whom were ≤18 years of age) underwent randomization - 44 to the teplizumab group and 32 to the placebo group. The median time to the diagnosis of type 1 diabetes was 48.4 months in the teplizumab group and 24.4 months in the placebo group; the disease was diagnosed in 19 (43%) of the participants who received teplizumab and in 23 (72%) of those who received placebo. The hazard ratio for the diagnosis of type 1 diabetes (teplizumab vs. placebo) was 0.41 (95% confidence interval, 0.22 to 0.78; P = 0.006 by adjusted Cox proportional-hazards model). The annualized rates of diagnosis of diabetes were 14.9% per year in the teplizumab group and 35.9% per year in the placebo group. There were expected adverse events of rash and transient lymphopenia. KLRG1+TIGIT+CD8+ T cells were more common in the teplizumab group than in the placebo group. Among the participants who were HLA-DR3-negative, HLA-DR4-positive, or anti-zinc transporter 8 antibody-negative, fewer participants in the teplizumab group than in the placebo group had diabetes diagnosed. CONCLUSIONS: Teplizumab delayed progression to clinical type 1 diabetes in high-risk participants. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01030861.).
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“Family history of autoimmune diabetes and personal or family history of allergic diseases or other autoimmune diseases increases the risk of autoimmune diabetes compared with the general population (78,79).”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [79]
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“Moreover, anti-CD3 treatment (teplizumab) has been shown to induce long-term protection (currently up to six years) from T1D in at-risk individuals, but the mechanisms responsible for this long-term protection remain incompletely understood29,30”
From An autoimmune stem-like CD8 T cell population drives type 1 diabetes (2022) · cites this paper as [29]
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“The CD3 monoclonal antibody teplizumab has been shown to delay progression to type 1 diabetes in high-risk individuals (429).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [429]
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“there is now evidence that the anti-CD3 monoclonal antibody teplizumab delays progression to type 1 diabetes in high-risk individuals (429).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [429]
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“In one 2019 study with a 2year delay, annualised rates of clinical diabetes were 15% in the teplizumab group and 36% in the placebo group (table 1). 18”
From The future of type 1 diabetes therapy (2025) · cites this paper as [18]
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“Teplizumab delays the onset of clinical type 1 diabetes by a median of 24 months.18”
From The future of type 1 diabetes therapy (2025) · cites this paper as [18]
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“Three participants in the teplizumab group and 4 participants in the placebo group did not complete the trial regimen; the reasons were laboratory abnormalities (4 participants), an inability to have intravenous access established (2), or rash (1).”
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Metadata
- Authors
- Herold, K. C., Bundy, B. N., Long, S. A., Bluestone, J. A., DiMeglio, L. A., Dufort, M. J., Gitelman, S. E., Gottlieb, P. A., Krischer, J. P., Linsley, P. S., Marks, J. B., Moore, W., Moran, A., Rodriguez, H., Russell, W. E., Schatz, D., Skyler, J. S., Tsalikian, E., Wherrett, D. K., Ziegler, A.-G., & Greenbaum, C. J.
- Affiliations
- University of Miami (US)
- Children's Mercy Hospital (US)
- University of Minnesota (US)
- University of Iowa (US)
- ORCID
- Herold, Kevan C.
- Bundy, Brian N.
- Long, S. Alice
- Bluestone, Jeffrey A.
- DiMeglio, Linda A.
- Dufort, Matthew J.
- Gitelman, Stephen E.
- Gottlieb, Peter A.
- Krischer, Jeffrey P.
- Linsley, Peter S.
- Marks, Jennifer B.
- Moran, Antoinette
- Rodriguez, Henry
- Russell, William E.
- Schatz, Desmond
- Skyler, Jay S.
- Tsalikian, Eva
- Wherrett, Diane K.
- Ziegler, Anette-Gabriele
- Greenbaum, Carla J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-08-15
- Volume
- 381
- Issue
- 7
- Pages
- 603-613
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6776880
- OpenAlex
- W2948104235
- Semantic Scholar
- a5198a4024a6f0aecc74d1501dd9fd2892f98796
- Cited by
- 1,189
- References
- 48
- Citations by year
- 2026: 186 · 2025: 209 · 2024: 211 · 2023: 181 · 2022: 123 · 2021: 148 · 2020: 98 · 2019: 32
- FWCI
- 60.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (U01 DK061010, U01 DK061034, U01 DK061042, U01 DK061058, U01 DK085461, U01 DK085465, U01 DK085466, U01 DK085476, U01 DK085499, U01 DK085509, U01 DK103266, U01 DK103282, U01 DK106984, U01 DK107013, U01 DK107014, UC4 DK085466, UC4 DK097835, UC4 DK106993)
- JDRF
- American Diabetes Association
- The Immune Tolerance Network (UM1 AI09565)
- National Center for Research Resources, through Clinical Translational Science Awards (UL1TR000064, UL1TR000114, UL1TR000142, UL1TR000445, UL1TR001082, UL1TR001857, UL1TR001872, UL1TR002366, UL1TR002529, UL1TR002537)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- teplizumab, anti-CD3 monoclonal antibody, type 1 diabetes prevention, high-risk relatives, TIGIT, HLA-DR3, HLA-DR4, zinc transporter 8 antibodies, islet autoimmunity, lymphopenia
- MeSH terms
- Adolescent, Adult, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Exanthema, Female, Glucose Tolerance Test, Humans, Lymphopenia, Male, Middle Aged, T-Lymphocytes, HLA-DR3 Antigen, HLA-DR4 Antigen, Proportional Hazards Models, CD3 Complex, Disease Progression, Lymphocyte Count, Young Adult, Antibodies, Monoclonal, Humanized
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