Drug updated on 12/11/2024
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.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Insulin Consumption: Teplizumab significantly reduced insulin consumption in individuals with type 1 diabetes, with an odds ratio (OR) of 4.13 (95% confidence interval (CI): 1.72 to 9.90).
- C-peptide Response: Teplizumab was associated with an improved C-peptide response, yielding an OR of 2.49 (95% CI: 1.62 to 3.81).
- Glycated Hemoglobin A1c (HbA1c) Levels: Teplizumab led to a significant change in HbA1c levels, with an OR of 1.75 (95% CI: 1.03 to 2.98) and a risk ratio (RR) of 0.71 (95% CI: 0.53 to 0.95).
- Patients receiving teplizumab experienced a higher incidence of total adverse effects compared to placebo, though this did not reach statistical significance (OR = 2.25, 95% CI: 0.80-6.29, P = 0.12).
- Statistically significant system-based adverse effects included gastrointestinal (OR = 1.60, 95% CI: 1.01-2.52, P = 0.04), dermatological (OR = 6.33, 95% CI: 4.05-9.88, P < 0.00001), hematological (OR = 19.03, 95% CI: 11.09-32.66, P < 0.00001), and active Epstein-Barr Virus (EBV) infection (OR = 3.16, 95% CI: 1.51-6.64, P = 0.002).
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tzield (teplizumab-mzwv) Prescribing Information. | 2023 | Provention Bio, Inc., Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Safety of teplizumab in patients with high-risk for diabetes mellitus type 1: A systematic review | 2024 | World Journal of Diabetes |
Evaluation of teplizumab's efficacy and safety in treatment of type 1 diabetes mellitus: A systematic review and meta-analysis | 2024 | World Journal of Diabetes |