An analysis of multiple clinical trials confirms the consistency of teplizumab-mzwv for preserving β-cell function in patients with type 1 diabetes based on C-peptide levels. Approved in Nov. 2022 based on data from the pivotal study TN-10, the drug was the first to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years or older with stage 2 type 1 diabetes. The drug’s “most common adverse events included lymphopenia, rash, and headache, a majority of which occurred during and after the first few weeks of 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,” the authors conclude.
Based on C-peptide data from 375 patients receiving teplizumab and 234 control patients, the authors found: “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 of exogenous insulin use was also conducted, showing overall reductions of 0.08 (P = 0.0001) and 0.10 units/kg/day (P < 0.0001) at years 1 and 2, respectively. An integrated safety analysis of five clinical trials that enrolled 1,018 patients with stage 2 or 3 type 1 diabetes (∼1,500 patient-years of follow-up for teplizumab-treated patients) was conducted.”