During the 2026 American Diabetes Association (ECO) Scientific Sessions in New Orleans, a real-world cohort of type 1 diabetic (T1D) patients was analyzed for outcomes after treatment with teplizumab, including insulin usage and overall disease progression. However, usage of teplizumab has been limited to trial data and lacks real-world patient data.
Teplizumab is the first immunotherapy drug indicated for treatment of early-stage T1D. Currently, Sanofi holds the patent for the drug, with generic versions not expected to be available for several years. Teplizumab slows the progression of T1D by preventing the destruction of insulin-producing cells in the pancreas. Although teplizumab is unable to completely halt the progression of the disease, it can delay the onset of stage 3 T1D and the usage of insulin to maintain healthy glucose control in patients newly diagnosed with T1D. Patients with late-stage T1D are highly unlikely to see any benefit from teplizumab therapy.
This cohort study analysed patients with stage 2 T1D. To determine the success of teplizumab, participants were given an oral glucose tolerance test (OGTT). The primary outcome measured for the study was T1D progression after 12 months and 2 years. In patients where the disease progressed, researchers measured daily insulin dose, HbA1c, and blood glucose time in range.
Out of the 35 patients followed during the study, 36% (9 patients) progressed to stage 3 T1D. 84% of patients had no progression at 1 year, and 57% of patients remained disease-free at 2 years. In patients who progressed to stage 3 T1D, total daily insulin dose remained low, with time in range and HbA1c being well within clinical guidelines.
This real-world cohort demonstrates the value of teplizumab to delay the onset of stage 3 T1D. Strategically, this presents an opportunity for Sanofi to market the drug to healthcare providers as a treatment to reduce the initial disease burden of T1D. Although teplizumab cannot delay the progression of T1D indefinitely, delaying the onset of insulin dependence for patients may provide patients with more time to adjust to living with the disease.
This study also indicates another potential use for teplizumab in newly diagnosed patients. Even after T1D had progressed to stage 3 and insulin dependence, patients who had undergone teplizumab infusions required a lower total daily insulin dose to maintain glucose control. Although this is an early finding, it may be a worthwhile association to pursue in additional studies. If teplizumab can reduce the total daily dose required by T1D, there may be an opportunity for label expansion in the future.
