Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 2mg/2mL (1 mg/mL)) |
Drug Class | CD3-directed antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
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Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tzield (teplizumab-mzwv) prescribing information. | 2023 | Provention Bio Inc., Red Bank, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy of anti-CD3 monoclonal antibodies in delaying the progression of recent-onset type 1 diabetes mellitus: a systematic review, meta-analyses and meta-regression. | 2023 | Diabetes. Obesity & Metabolism |
Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis. | 2023 | Endocrine |
Safety and efficacy of teplizumab for treatment of type one diabetes mellitus: a systematic review and meta-analysis. | 2021 | Endocrine, Metabolic & Immune Disorders - Drug Targets |