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Anti‐CD3 monoclonal antibody treatment in newly diagnosed Type 1 diabetes patients: a hypothetical modelling analysis
Author(s) -
SmithPalmer J.,
Curtis B. H.,
Boye K. S.,
Goodall G.,
Pillemer S. R.
Publication year - 2010
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2009.02902.x
Subject(s) - medicine , life expectancy , diabetes mellitus , monoclonal antibody , type 2 diabetes , quality of life (healthcare) , type 1 diabetes , cohort , immunology , antibody , endocrinology , population , environmental health , nursing
Diabet. Med. 27, 189–196 (2010) Abstract Aims 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 β‐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.