title: Anti-CD3 monoclonal antibody treatment in newly diagnosed Type 1 diabetes patients: a hypothetical modelling analysis.
abstract: OBJECTIVE
  Although limited clinical data exist for anti-CD3 monoclonal antibody therapies, it is believed that they may influence glycaemic control, endogenous insulin secretion and hypoglycaemic event rates in individuals newly diagnosed with Type 1 diabetes. In the absence of suitable empirical evidence, the objective of this study was to estimate the potential long-term clinical outcomes associated with treatment via a hypothetical modelling analysis.
  
  
  METHODS
  Analyses were performed using a published and validated computer simulation model of diabetes in a hypothetical US cohort based on published literature and expert opinion. The efficacy of anti-CD3 monoclonal antibody treatment was estimated from clinical data and expert opinion and simulations were performed over a 60-year time horizon. The impact on quality of life associated with treatment was also captured via published utility values.
  
  
  RESULTS
  Assuming that a treatment course of an anti-CD3 monoclonal antibody produced an initial reduction in glycated haemoglobin of -0.8%, and that the effects persisted for up to 5 years, treatment was projected to lead to an increase in undiscounted life expectancy of 0.43 years and an increase in quality-adjusted life expectancy of 0.36 quality-adjusted life years compared with conventional exogenous insulin.
  
  
  CONCLUSIONS
  A course of a hypothetical anti-CD3 monoclonal antibody treatment associated with improved glycaemic control and, potentially, the preservation of pancreatic beta-cell function was estimated to lead to improved life expectancy and quality-adjusted life expectancy compared with conventional treatment in patients with newly diagnosed Type 1 diabetes.
authors.affiliation: IMS Health, Allschwil, Switzerland. jsmith-palmer@ch.imshealth.com
authors.forename: J
authors.initials: J
authors.lastname: Smith-Palmer
authors.forename: B H
authors.initials: BH
authors.lastname: Curtis
authors.forename: K S
authors.initials: KS
authors.lastname: Boye
authors.forename: G
authors.initials: G
authors.lastname: Goodall
authors.forename: S R
authors.initials: SR
authors.lastname: Pillemer
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D017252:CD3 Complex / Q000276:immunology*; D015331:Cohort Studies; D003198:Computer Simulation; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy*; D005260:Female; D006801:Humans; D008017:Life Expectancy; D008297:Male; D008954:Models, Biological; D011788:Quality of Life
chemical_list: D000911:Antibodies, Monoclonal; D017252:CD3 Complex