TEPLI-REAL: First Real-World Study Confirming Teplizumab Treatment Patterns in T1D

TEPLI-REAL, the first real-world retrospective study examining patients with type 1 diabetes (T1D) treated with Sanofi’s teplizumab and monitoring their metabolic outcomes, has demonstrated the drug’s prescription patterns in a clinical setting.¹

These data were presented at the American Diabetes Association (ADA) Scientific Sessions 2026, in New Orleans, Louisiana, by Stephen Eric Gitelman, MD, a pediatric endocrinologist and the director of the pediatric diabetes program at the University of California, San Francisco. TEPLI-REAL was a real-world observational study aiming to characterize patients with T1D who received teplizumab treatment, so that clinicians could better understand how these patients were managed following treatment.^1,2

Teplizumab, an anti-CD3 monoclonal antibody, was approved in November 2022 under the brand name Tzield to delay the onset of stage 3 T1D; this indication was expanded in April 2026 to include pediatric patients aged ≥1 year who were diagnosed with stage 2 T1D. The expansion was based in large part on results from the 1-year PETITE-T1D phase 4 study, which determined the safety and pharmacokinetics of teplizumab in young children.^1,3

Gitelman and colleagues examined all individuals with ≥1 day of teplizumab treatment across a total of 27 participating sites, following them until data abstraction. Of these locations, 24 were in various states in the US, while 3 were in Israel. Patients were excluded from the study if they were participating in an interventional clinical study on the index date.^1,2

The study’s primary outcomes included the presence of T1D susceptibility, based on genetic risk scores and human leukocyte antigen haplotype, and blood glucose test results via continuous glucose monitoring. Secondary endpoints included the development of stages of T1D, HbA1c and fasting plasma glucose via blood glucose tests, and C-peptide and autoantibody test results, among others.²

A total of 110 patients were enrolled in the study, of whom 101 were from the US and 9 were from Israel. Median age was 13 years (range 8-62; 74% <18 years) at teplizumab initiation, 54% of patients were female, and 57% had a family history of T1D. Additionally, 10% of patients had Hashimoto’s and 4% had celiac disease. The median number of positive islet autoantibodies (IA) per individual was 3, and 99% of patients had ≥2 IA.¹

Patients were identified with dysglycemia first (41%), IA first (36%), or both at the same time (23%). Median HbA1c for these subgroups was 6.1% (n = 41), 5.6% (n = 32), and 6% (n = 23), respectively, at or near screening. 94% of patients completed 14 days of teplizumab treatment, and >70% remained in stage 2 T1D, according to a mean follow-up period of 14.3 months.¹

These data reflect high teplizumab infusion completion in patients ≥8 years, which provides clinicians with insight into the active use of teplizumab in treatment from several different diagnostic pathways.¹

References

1. Gitelman S, Simmons K, Graham T, et al. TEPLI-REAL: A Real-World Retrospective Study Characterizing Individuals with Type 1 Diabetes Treated with Teplizumab and Their Metabolic Outcomes. Abstract presented at the American Diabetes Association (ADA) Scientific Sessions 2026, New Orleans, LA. June 5-8, 2026.

2. Sanofi. Description of Patients With Type 1 Diabetes Treated With Teplizumab (TEPLI-REAL). ClinicalTrials.gov Identifier: NCT06892002. Updated August 15, 2025. Accessed June 6, 2026. https://clinicaltrials.gov/study/NCT06892002

3. Sanofi. Sanofi’s Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children. April 22, 2026. Accessed June 6, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-05-00-3278650