The Kaplan-Meier curve shows the sustained delay of T1D for approximately 3 years in the teplizumab group. The updated data, with the long-term follow-up by TrialNet of the TN-10 study cohort, were presented as an oral presentation at the American Diabetes Association Scientific Sessions in June 2020.1
In addition, we show the primary endpoint from the TN-10 study published in 2019. The median time to T1D diagnosis was 48.4 months for the group treated with teplizumab, compared to 24.4 months for the placebo group.2
Improvement in C-peptide translated to3:
†ANCOVA model fitted to baseline glucose AUC, age, and teplizumab showed a statistically significant effect of treatment with teplizumab to decrease the on-study mean glucose values vs placebo.
1. Sims EK, Bundy B, Stier K, et al. Teplizumab reverses the loss of C-peptide in relatives at-risk for type 1 diabetes (T1D). 80th Scientific Sessions: A Virtual Experience. American Diabetes Association. June 2020. 2. Herold KC, Bundy BN, Long SA, et al; for Type 1 Diabetes TrialNet Study Group. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613. 3. Data on file. Provention Bio, Inc. 2020.