Insulin antibodies in patients with type 2 diabetic receiving recombinant human insulin injection: A report of 12 cases

Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic patients

“…However, the literature and our own experience indicate that the production of IAs in patients with diabetes mellitus continues, especially in Asian populations. Evidence that IAs induced by exogenous insulin therapy can cause clinical significance is limited to case reports, but IA production does greatly affect glycaemic control according to our research ( 10 ). Type 2 diabetic patients receiving long-term recombinant human insulin treatment who have unexplained high plasma glucose or frequent reoccurrence of hypoglycaemia should be investigated for the presence of EIAS.…”

“…Fineberg surmised that there was no relationship between hypoglycaemic event rate and IA level ( 1 ); however, recent studies suggest that high levels of IAs can be associated with clinical hypoglycaemia syndromes in a small number of patients ( 10 , 12 , 17 , 34 , 66 , 69 ). For example, in a recent study, insulin binding to antibodies >15% appears to be a strong risk factor for inexplicable severe hypoglycaemias in type 1 diabetic children.…”

“…In recent years, the use of purified and recombinant human insulin preparations has markedly reduced, but not completely suppressed, the incidence of IAs. Sporadic case reports have been published regarding individuals whose serum had high titre IAs while being treated with recombinant human insulin or human insulin analogues ( 1 ), especially in Asian populations ( 6 , 7 , 8 , 9 , 10 , 11 , 12 ).…”

“…Different from insulin autoimmune syndrome (IAS, also called Hirata disease), which is a condition characterized by spontaneous hypoglycaemia and is associated with the presence of insulin autoantibodies in patients without previous insulin exposure ( 13 ), IAs induced by exogenous insulin in diabetic patients is associated with clinical events, such as hypersensitivity reactions, pregnancy, glycaemia variability and metabolic control ( 1 ), and mainly with insulin resistance/hyperglycaemia ( 6 , 10 , 14 , 15 , 16 ) or hypoglycaemia ( 6 , 7 , 8 , 10 , 17 , 18 ). Therefore, we named this condition exogenous insulin antibody syndrome (EIAS).…”

“…Therefore, we named this condition exogenous insulin antibody syndrome (EIAS). Recently, we reported 12 cases of patients with EIAS in which the clinical characteristics and IA pharmacokinetic parameters were analysed, and all of the patients subsequently received effective treatment ( 10 ). The present review is based on our research and summarizes the characterization of IAs, the factors affecting IA development, the clinical significance of IAs and the treatments for EIAS.…”