Teplizumab-mzwv

(Tzield®)

Tzield®

Drug updated on 11/5/2024

Dosage FormInjection (intravenous; 2mg/2mL [1 mg/mL])
Drug ClassCD3-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
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  • 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 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 TitleYearSource
Tzield (teplizumab-mzwv) Prescribing Information.2023Provention Bio, Inc., Bridgewater, NJ

Systematic Reviews / Meta-Analyses