Summary

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• Tzield (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• Increase in Endogenous Insulin Production (C-Peptide AUC): Anti-CD3 monoclonal antibodies, including teplizumab, significantly increased C-peptide AUC, with observed mean differences ranging from 0.08 to 0.20 across time points of 12 to 24 months (95% CI ranges [0.01, 0.30]; p-values from 0.03 to 0.0003).
• Reduction in Insulin Use: Anti-CD3 monoclonal antibodies significantly reduced insulin use, with mean differences ranging from -0.09 to -0.22 (95% CI ranges [-0.32, -0.04]; p-values from <0.001 to 0.003) across follow-up periods of 6 to 24 months.
• Effect on HbA1c Levels: No significant impact on HbA1c levels was observed across all time points in the reviewed studies.
• Vomiting, nausea, rash, pyrexia, and headache were reported more frequently with anti-CD3 monoclonal antibodies compared to placebo; teplizumab specifically was associated with lymphopenia, skin, and subcutaneous tissue disorders.
• The incidence of total adverse events and serious adverse events was similar when comparing anti-CD3 monoclonal antibodies with placebo.
• There is no population type or subgroup information available in the reviewed studies.