The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.
Teplizumab (Anti-CD3 mAb) Treatment Preserves C-Peptide Responses in Patients With New-Onset Type 1 Diabetes in a Randomized Controlled Trial
Open accessAbstract
Trials of immune therapies in new-onset type 1 diabetes (T1D) have shown success, but not all subjects respond, and the duration of response is limited. Our aim was to determine whether two courses of teplizumab, an Fc receptor–nonbinding anti-CD3 monoclonal antibody, reduces the decline in C-peptide levels in patients with T1D 2 years after disease onset. We also set out to identify characteristics of responders. We treated 52 subjects with new-onset T1D with teplizumab for 2 weeks at diagnosis and after 1 year in an open-label, randomized, controlled trial. In the intent to treat analysis of the primary end point, patients treated with teplizumab had a reduced decline in C-peptide at 2 years (mean −0.28 nmol/L [95% CI −0.36 to −0.20]) versus control (mean −0.46 nmol/L [95% CI −0.57 to −0.35]; P = 0.002), a 75% improvement. The most common adverse events were rash, transient upper respiratory infections, headache, and nausea. In a post hoc analysis we characterized clinical responders and found that metabolic (HbA1c and insulin use) and immunologic features distinguished this group from those who did not respond to teplizumab. We conclude that teplizumab treatment preserves insulin production and reduces the use of exogenous insulin in some patients with new-onset T1D. Metabolic and immunologic features at baseline can identify a subgroup with robust responses to immune therapy.
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Cites
Interleukin-1-receptor antagonist in type 2 diabetes mellitus
Larsen, C. M., Faulenbach, M., Vaag, A., Vølund, A., Ehses, J. A., Seifert, B., Mandrup-Poulsen, T., & Donath, M. Y. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa065213 · Cited by 1,798
Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus
Herold, K. C., Hagopian, W., Auger, J. A., Poumian-Ruiz, E., Taylor, L., Donaldson, D., Gitelman, S. E., Harlan, D. M., Xu, D., Zivin, R. A., et al. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa012864 · Cited by 1,222
Self-citationMolecular Antagonism and Plasticity of Regulatory and Inflammatory T Cell Programs
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Glucose-induced β cell production of IL-1β contributes to glucotoxicity in human pancreatic islets
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Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes
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Rituximab, B-lymphocyte depletion, and preservation of beta-cell function
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Self-citationGlucose-induced β cell production of IL-1β contributes to glucotoxicity in human pancreatic islets
Maedler, K., Sergeev, P., Ris, F., Oberholzer, J., Joller-Jemelka, H. I., Spinas, G. A., Kaiser, N., Halban, P. A., & Donath, M. Y. (2002) · Journal of Clinical Investigation · doi:10.1172/jci200215318 · Cited by 1,005
Glucose Toxicity in β-Cells: Type 2 Diabetes, Good Radicals Gone Bad, and the Glutathione Connection
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Cited by
An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes
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., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1902226 · Cited by 1,189
Self-citationType 1 diabetes immunotherapy using polyclonal regulatory T cells
Bluestone, J. A., Buckner, J. H., Fitch, M., Gitelman, S. E., Gupta, S., Hellerstein, M. K., Herold, K. C., Lares, A., Lee, M. R., Li, K., et al. (2015) · Science Translational Medicine · doi:10.1126/scitranslmed.aad4134 · Cited by 1,033
Self-citationMarek-Trzonkowska, N., Myśliwiec, M., Dobyszuk, A., Grabowska, M., Derkowska, I., Juścińska, J., Owczuk, R., Szadkowska, A., Witkowski, P., Młynarski, W., et al. (2014) · Clinical Immunology · doi:10.1016/j.clim.2014.03.016 · Cited by 384
Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals
Sims, E. K., Bundy, B. N., Stier, K., Serti, E., Lim, N., Long, S. A., Geyer, S. M., Moran, A., Greenbaum, C. J., Evans-Molina, C., et al. (2021) · Science Translational Medicine · doi:10.1126/scitranslmed.abc8980 · Cited by 377
Self-citationde Groot, P., Nikolic, T., Pellegrini, S., Sordi, V., Imangaliyev, S., Rampanelli, E., Hanssen, N., Attaye, I., Bakker, G., Duinkerken, G., et al. (2021) · Gut · doi:10.1136/gutjnl-2020-322630 · Cited by 316
Metadata
- Authors
- Herold, K. C., Gitelman, S. E., Ehlers, M. R., Gottlieb, P. A., Greenbaum, C. J., Hagopian, W., Boyle, K. D., Keyes-Elstein, L., Aggarwal, S., Phippard, D., Sayre, P. H., McNamara, J., Bluestone, J. A., & and the AbATE Study Team
- Venue
- Diabetes
- Publisher
- American Diabetes Association
- Published
- 2013-10-18
- Volume
- 62
- Issue
- 11
- Pages
- 3766-3774
- ISSN
- 0012-1797 (ISSN-L)
- 1939-327X
- OpenAlex
- W2098954537
- Cited by
- 411
- References
- 31
- FWCI
- 20.84
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: Teplizumab (Anti-CD3 mAb) Treatment Preserves C-Peptide Responses in Patients With New-Onset Type 1 Diabetes in a Randomized Controlled Trial. https://app.cochat.ai/papers/10.2337/db13-0345
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- Herold, K. C., Gitelman, S. E., Ehlers, M. R., Gottlieb, P. A., Greenbaum, C. J., Hagopian, W., Boyle, K. D., Keyes-Elstein, L., Aggarwal, S., Phippard, D., Sayre, P. H., McNamara, J., Bluestone, J. A., & and the AbATE Study Team. (2013). Teplizumab (Anti-CD3 mAb) Treatment Preserves C-Peptide Responses in Patients With New-Onset Type 1 Diabetes in a Randomized Controlled Trial. Diabetes. https://doi.org/10.2337/db13-0345
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