13/01/2026
Teplizumab is a humanized anti-CD3 monoclonal antibody used in type 1 diabetes (T1D) to delay disease progression by modulating the immune response.
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🔬 Mechanism of Action
• Targets CD3 receptor on T lymphocytes
• Induces partial T-cell exhaustion and immune tolerance
• Reduces autoreactive T-cells attacking pancreatic β-cells
• Preserves residual insulin secretion
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🩺 Clinical Use (FDA-Approved)
Indication
• Delay onset of Stage 3 Type 1 Diabetes
• In high-risk individuals (Stage 2 T1D):
• ≥2 positive pancreatic autoantibodies
• Dysglycemia but not yet insulin-dependent
Who Benefits Most
• First-degree relatives of T1D patients
• Children and adolescents (≥8 years)
• Recently diagnosed autoimmune diabetes (early stage)
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💉 Administration
• IV infusion for 14 consecutive days
• Dose escalation over initial days to reduce cytokine release
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📊 Key Evidence
TrialNet Study
• Median delay of ~2 years in progression to clinical T1D
• Some patients delayed >5 years
• Improved C-peptide preservation
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⚠️ Adverse Effects
Common:
• Flu-like symptoms
• Rash
• Headache
• Nausea
Important:
• Transient lymphopenia
• Elevated liver enzymes
• Cytokine release syndrome (usually mild–moderate)
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🧪 Monitoring
• CBC with differential
• Liver function tests
• EBV/CMV status (baseline)
• Blood glucose and HbA1c
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💊 Trade Name
• Tzield®️ (by Provention Bio / Sanofi)
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🌍 Status in India
• Not yet widely available
• No CDSCO approval as of now
• Access mainly via clinical trials or compassionate use
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🔮 Future & Research Directions
• Combination therapy (e.g., with anti-IL-21, low-dose IL-2)
• Use in LADA and newly diagnosed T1D
• Personalized immunotherapy using immune profiling
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🧠 Take-home Message
Teplizumab is the first disease-modifying immunotherapy in T1D that delays clinical diabetes, shifting management from treatment to prevention.