Introduction & Objective: In November 2022, teplizumab-mzwv was approved for delaying onset of stage 3 type 1 diabetes (T1D). We designed an early T1D clinic to identify individuals eligible for treatment and provide proper anticipatory guidance around treatment options.
Methods: In December 2022, we opened a weekly clinic staffed with a nurse, physician and psychologist. Individuals with islet autoimmunity and concern for dysglycemia are offered metabolic staging, which includes a fasting glucose level, HbA1C, 2-hour OGTT, and 10-day CGM wear. Patients are offered a health and behavior assessment with a psychologist to assess psychological factors affecting their medical condition (e.g., anxiety, coping). Metabolic staging results are obtained during clinic, and treatment options are discussed. If a patient desires teplizumab-mzwv therapy, we prescribe and initiate the prior authorization process.
Results: We have completed staging and education visits in 32 patients. Using ADA T1D staging criteria, 21/32 (66%) patients were stage 2, 9/32 (28%) stage 1, and two patients were diagnosed stage 3. Since April 2023, we have successfully infused a full 14-day course of teplizumab-mzwv in 10 patients with stage 2 T1D. Most patients treated were adolescents and young adults (age 10-32 years, median age 17.5±17.6 years), male (n=7/10) and non-Hispanic white (n=8/10). Approximately half of treated patients have a first degree relative with T1D (n=6/10). Five patients in stage 2 progressed to symptomatic T1D and were therefore no longer eligible for treatment. Four patients declined treatment, and two are under review for treatment by their insurance carriers at this time.
Conclusions: Individuals attending Early T1D clinic tolerated complete metabolic staging per ADA guidelines. Of those meeting criteria for teplizumab-mzwv treatment, most patients wanted to pursue therapy. We successfully treated approximately half of eligible patients to date.
K.M. Simmons: Advisory Panel; Provention Bio, Inc. Consultant; Provention Bio, Inc. Research Support; Provention Bio, Inc., Novartis AG. Consultant; Medtronic. L. Chesshir: None. H.K. O'Donnell: None. S.C. Walker: Other Relationship; Dexcom, Inc., Insulet Corporation. A.D. Martinez: None. G.T. Alonso: Advisory Panel; MannKind Corporation. T.M. Triolo: None. P. Gottlieb: Other Relationship; IM Therapeutics. Research Support; Imcyse. Advisory Panel; Imcyse. Consultant; Juvenile Diabetes Research Foundation (JDRF). Research Support; Hemsley Charitable Trust, Novartis AG, Provention Bio, Inc., Precigen, Inc. Advisory Panel; ViaCyte, Inc. Research Support; Nova Pharmaceuticals. B.I. Frohnert: None. A. Steck: None.
