1656-P: TEPLI-REAL: A Real-World Retrospective Study Characterizing Screening and Treatment Patterns for Type 1 Diabetes (T1D) in Individuals Treated with Teplizumab in the U.S.

Introduction and Objective: Teplizumab (TPZ), an anti-CD3 monoclonal antibody, is approved in the US to delay stage 3 T1D onset in individuals aged ≥8 years (y) with stage 2 T1D. We present screening and real-world treatment (Tx) patterns from individuals in the US who received TPZ according to their age group. Methods: TEPLI-REAL (NCT06892002) was a chart review study including 24 sites in the US. Eligible individuals had ≥1 day of TPZ Tx and were followed until data abstraction. Results: Median follow-up was 14.6 months (mo). The median age of individuals (n=101) at TPZ initiation was 13.0 y (range 8-62); 75 (74%) were 18 y. For youth, islet autoantibody (IA) testing was most requested by a pediatric endocrinologist (endoc; n=36; 48%) and performed by Autoimmunity Screening for Kids/TrialNet (n=27; 36%) research programs; 74 (99%) had ≥2 IAs (GADA: 73 97%, IAA: 38 61%, IA-2A: 49 78%, and ZnT8A: 56 85%). At screening, 67 (90%) had HbA1c tests (median 5.8%; range 4.8-11.5), 36 (49%) had oral glucose tolerance tests (OGTTs), and 7 (9%) had continuous glucose monitoring (CGM) data. The median (range) time between stage 2 confirmation and TPZ initiation was 3.5 (0.6-119.6) mo. TPZ Tx occurred most commonly in hospitals (n=33; 44%), and 71 (95%) completed 14 days of Tx. For adults, IA testing was most requested by an adult endoc (n=9; 35%) and performed at a commercial laboratory (n=10; 38%); 26 (100%) had ≥2 IAs (GADA: 25 100%, IAA: 7 33%, IA-2A: 18 69%, and ZnT8A: 17 71%). At screening, 20 (77%) had HbA1c tests (median 6.1%; range 4.7-13.8), 13 (50%) had OGTTs, and none had CGM data. The median (range) time between stage 2 confirmation and TPZ initiation was 6.4 (1.5-184.6) mo in adults. Most TPZ Tx occurred in infusion centers (n=19; 73%), and 23 (88%) completed 14 days of Tx. Conclusion: This TEPLI-REAL US cohort provides important insights into the care pathway of youth and adults who were treated with TPZ in clinical practice. Disclosure M. Tuffaha: None. J. Felton: Advisory Panel; Ended; Sanofi. Other - Gave educational lectures.; Ended; Sanofi, Med Learning Group, LLC. 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. K. Simmons: None. 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. 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.