Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes – Published online 06/11/2025

Stephen E. Gitelman, Kimber Simmons, Jennifer L. Sherr, Steven B. Leichter, Teresa Quattrin, William E. Russell, Bhuvana Sunil, Steven M. Willi, Laura A. Knecht, Elisabeth Niemoeller, Idlir Licaj, Wolfgang Schmider, Diana Miller, Linda A. DiMeglio

Type 1 diabetes progresses to stage 3 most rapidly in young children and is difficult to manage in this population. Teplizumab is approved in several countries to delay the onset of stage 3 type 1 diabetes in individuals aged ≥8 years with stage 2 type 1 diabetes, but has not previously been investigated in younger children. In this issue, Gitelman et al (https://doi.org/10.1007/s00125-025-06586-1) describe the findings of an interim analysis of the PETITE-T1D trial, a multicentre study of the use of teplizumab in 23 children aged <8 years, conducted when 15 children had been followed for approximately 52 weeks. The safety profile and pharmacokinetics of teplizumab were consistent with what has been observed in older individuals, with no new safety risks identified. The authors report that the estimated probability of remaining free of stage 3 type 1 diabetes was 89.6% at the time of the interim analysis, similar to previous findings at 1 year in older individuals treated with teplizumab. The authors conclude that these results support further investigation into the benefits of teplizumab in young children aged <8 years with stage 2 type 1 diabetes.

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