1059-OR: TEPLI-REAL: A Real-World Retrospective Study Characterizing Individuals with Type 1 Diabetes Treated with Teplizumab and Their Metabolic Outcomes

Introduction and Objective: Teplizumab (TPZ), an anti-CD3 monoclonal antibody, is approved in several countries to delay stage 3 type 1 diabetes (T1D) onset in individuals aged ≥8 years with stage 2. This is the first comprehensive study to characterize and follow individuals who received TPZ in the real world (RW). Methods: In the chart review study, TEPLI-REAL (NCT06892002), all individuals with ≥1 day of TPZ treatment at 27 participating sites were followed until data abstraction. Results: Among 110 individuals (US: n=101; Israel: n=9), 54% were female, 83% were White, 57% had a family history of T1D, 10% had Hashimoto’s, 4% had celiac disease. Median age was 13 years (range 8-62; 74% 18 years) at TPZ initiation. Median number of positive islet autoantibodies (IA) per individual was 3; 99% had ≥2 IA. Individuals 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 6.0% (n=23), respectively, at or near screening. The median follow-up was 14.3 months. Most (94%) completed 14 days of TPZ. More than 70% remained in stage 2 T1D. Probability of remaining free of stage 3 per diagnostic pathway is shown in Figure. Conclusion: This RW study shows high TPZ infusion completion in those ≥8 years and provides insights into treatment from different diagnostic pathways. Disclosure S.E. Gitelman: Advisory Panel; Current; Sanofi, SAB Biotherapeutics, Inc., Eli Lilly and Company, Genentech, Inc. Research Support; Current; Sanofi, SAB Biotherapeutics, Inc., GentiBio. Other - Member, DSMB; Current; Diamyd. Advisory Panel; Current; AnaptysBio, Inc. K. Simmons: None. T.E. Graham: Research Support; Current; Eli Lilly and Company, Novo Nordisk, Abbott Diagnostics, Tandem Diabetes Care, Inc., Sanofi, Novartis Pharmaceuticals Corporation. Advisory Panel; Current; Ascendis Pharma A/S. Research Support; Current; Ascendis Pharma A/S. Advisory Panel; Current; Sanofi. Research Support; Current; Sequel Med Tech. J. Felton: Advisory Panel; Ended; Sanofi. Other - Gave educational lectures.; Ended; Sanofi, Med Learning Group, LLC. A. Tirosh: Advisory Panel; Current; Medtronic. Research Support; Current; Medtronic. Speaker's Bureau; Ended; Sanofi. Advisory Panel; Ended; Sanofi. Research Support; Current; Sanofi. Speaker's Bureau; Ended; Novo Nordisk A/S, Eli Lilly and Company. Consultant; Current; DreaMed Diabetes, Ltd., Radella Pharma. M. Bonnemaire: Employee; Current; Sanofi. Stock/Shareholder; Current; Sanofi. C.B. Manzano Salgado: Employee; Current; Sanofi. Employee; Ended; IQVIA Inc. T.A. Dex: Stock/Shareholder; Current; Sanofi, Pfizer Inc., Teva Pharmaceutical Industries Ltd. F. Kleinjung: Employee; Current; Sanofi. J.M. Gwinnutt: Employee; Current; IQVIA Inc. F. Negreiro: Employee; Current; IQVIA Inc. J.H. Zaccai: Employee; Current; Sanofi. M. Tuffaha: None.