Abstract

Teplizumab, also referred as humanized monoclonal antibody, first developed in Columbia University, and later improved at MacroGenics, to have Fc receptor non-binding properties to reduce the incidence of CRS, was introduced to slow down stage 3 of type 1 diabetes mellitus. The US FDA in November 2022 approved this drug for the first time for type 1 diabetes mellitus. This article reviews summary of pathogenesis of type 1 diabetes mellitus, mechanism of action, pharmacodynamics, pharmacokinetics, efficacy, and safety of Teplizumab. In type 1 diabetes mellitus, autoantibodies were produced by immune cells against pancreatic beta cells leading to the depletion of pancreatic beta cells, the only insulin producing cells. After which, the patient has to be purely dependent on exogenous insulin injections to maintain normal blood sugar levels, which is essential for survival. Anti CD3 therapy has been used traditionally in organ transplantation, but more recently been tried in type 1 diabetes mellitus patients. Since Teplizumab is a newer version of CD3 monoclonal antibody, the clinical data on its pharmacodynamics and pharmacokinetic properties were limited. C peptide is a substance formed when the hormone insulin is produced and released into the body, so, measuring C peptide is an accurate way to find out how much insulin is produced. Both Phase 2 and 3 studies were revealed on C peptide to make sure the insulin production is adequate. In type 1 diabetes mellitus patients, 12 to 14 day Teplizumab infusion showed an improved glycemic control. Initial studies showed that Teplizumab was well tolerated. The only adverse effect is self-limited rash.