American Diabetes Association
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Teplizumab, A Disease-Modifying Therapy for Type 1 Diabetes That Preserves Beta Cell Function

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posted on 2023-08-22, 21:28 authored by Kevan C. Herold, Stephen E. Gitelman, Peter A. Gottlieb, Laura A. Knecht, Ralph Raymond, Eleanor L. Ramos

Objective: In November 2022, teplizumab-mzwv became the first drug approved to delay the onset of Stage 3 type 1 diabetes in adults and children with diabetes aged 8 years and older with Stage 2 type 1 diabetes based on data from the pivotal study, TN-10.

Research Design and Methods: To provide confirmatory evidence of the effects of teplizumab on preserving endogenous insulin production, an integrated analysis of C-peptide data from 609 patients (375 teplizumab and 234 controls) from five clinical trials in Stage 3 was conducted.

Results: The primary outcome of the integrated analysis, change from baseline in stimulated C-peptide, was significantly improved at years 1 (average increase: 0.08 nmol/l, P<0.0001) and 2 (average increase: 0.12 nmol/l, P<0.0001) after one or two courses of teplizumab. An analysis was also conducted on exogenous insulin use, which showed overall reductions of 0.08 U/kg/d (P=0.0001) and 0.10 U/kg/d (P<0.0001) at years 1 and 2, respectively. An integrated safety analysis of five clinical trials that enrolled 1,018 Stage 2 or Stage 3 patients (approximately 1,500 patient-years of follow-up for teplizumab-treated patients) was conducted.

Conclusions: These data confirm consistency in preservation of beta cell function, as measured by C-peptide, across multiple clinical trials. This analysis showed that the most common adverse events included lymphopenia, rash, and headache, the majority of which occurred during and after the first few weeks following teplizumab administration and generally resolved without intervention consistent with a safety profile characterized by self-limited adverse events after one or two courses of teplizumab treatment.


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