Drug updated on 4/18/2024
| 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.
Summary
- Teplizumab-mzwv (Tzield) is a humanized anti-CD3 monoclonal antibody used to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 T1D. It modulates the autoimmune response against pancreatic beta cells, responsible for insulin production.
- Three studies concerning teplizumab’s efficacy and safety in managing Type 1 diabetes mellitus were analyzed.
- Compared to traditional management methods like insulin therapy and lifestyle modifications, teplizumab offers a novel approach by directly interacting with the immune system to slow down beta-cell destruction. This results in increased C-peptide levels, indicating preserved beta-cell function, and reduced daily insulin dosage needs. However, no significant impact on glycated hemoglobin (HbA1c) levels was observed across all studies.
- Side effects associated with teplizumab include vomiting, nausea, rash, pyrexia, headache, as well as lymphopenia and skin/subcutaneous tissue disorders. These adverse effects were generally comparable in frequency to placebo groups without significantly higher serious adverse events reported.
- The primary demographic analyzed includes both adult patients and pediatric ones aged eight years or more, diagnosed at stage two of T1D. This stage is characterized by the presence of multiple diabetes-related autoantibodies and dysglycemia but not yet symptomatic diabetes. Patient ages centered around an average age of fifteen years, suggesting younger populations may benefit from early intervention to delay disease progression.
- While demonstrating a promising safety profile and effectiveness compared to standard treatments, such as insulin therapy or lifestyle changes alone, it introduces a beneficial alternative specifically targeting a subset of patients. This aims at preserving pancreatic beta-cell functionality and reducing daily dependence upon external sources. However, its long-term implications regarding side effects need further investigation.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tzield (teplizumab-mzwv) prescribing information. | 2022 | 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 |