Teplizumab (Tzield) — Real-World Data: 3+ Year T1D Onset Delay

Type: immunotherapy

Status: Real-World Evidence Accumulating

Developer: Provention Bio / Sanofi

Breakthrough Summary

Teplizumab, the first FDA-approved disease-modifying therapy for Stage 2 T1D, has now accumulated substantial real-world evidence through 2025-2026. Registry data confirms median delay of clinical T1D onset by 3+ years in at-risk individuals. Post-marketing studies show best response in patients with higher C-peptide at baseline and specific HLA genotypes.

Mechanism of Action

Anti-CD3 monoclonal antibody that partially depletes and functionally inactivates autoreactive T cells attacking beta cells. A 14-day IV infusion course resets the immune balance, preserving remaining beta cell mass in Stage 2 T1D.

Year: 2025-2026