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An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk

One-paragraph summary

TN-10 randomized 76 stage-2 relatives to a 14-day teplizumab course or placebo. Median stage-3 diagnosis was 48.4 versus 24.4 months; HR 0.41 (95% CI 0.22–0.78). Stage 3 occurred in 43% versus 72% in the report, with rash and transient lymphopenia expected (PMID 31180194; NCT01030861).

Key findings

  • First randomized evidence that therapy can delay clinical T1D before symptoms.
  • Annualized diagnosis rates were 14.9% versus 35.9%.
  • KLRG1+TIGIT+CD8+ T cells increased with treatment.

Limitations

  • Small, relative-enriched cohort.
  • Demonstrated delay, not permanent prevention.
  • Subgroup-response hypotheses were exploratory.

Why it matters

The trial made stage 2 actionable and changed the rationale for screening.

Cited by wiki pages

  • disease-modifying immunotherapy
  • screening and early detection
  • clinical trials landscape
  • overview