Insulin immunogenicity: clinical manifestations and its significance

A.A. Mosikyan¹, Yu.E. Isaieva²

¹Almazov National Medical Research Centre, Saint-Petersburg, Russia

²Pavlov First Saint Petersburg State Medical University, Russia

Biotechnological drugs (BTD) are substances of a protein nature, which can cause an immune response development (antibodies formation to the drug in response to its administration). The most common pathophysiological mechanism underlying the immune response is the BTD binding with antibodies without neutralizing activity changing its pharmacokinetic properties, in more rare cases — BTD neutralization with neutralizing antibodies. Much less common, the immune response is associated with the activation of Fc receptors and complement, the launch of the cytokine cascade and the cross-reactivity development of antibodies with endogenous proteins structurally similar to BTD. The reaction type is due to the molecule structure and BTD mechanism of action. In particular, insulin medications can not activate Fc receptors and complement and are not able to launch the cytokine cascade. However , during therapy with insulin medications, antibodies to insulin form in a significant number of patients, including neutralizing antibodies, although this rarely leads to clinical outcomes.

This review provides data on the possible clinical outcomes concerning immune response development, as well as its clinically significant incidence and antibodies formation without clinically significant manifestations during therapy with insulin medications, both original and biosimilar.

Keywords: insulin, biosimilars, immunogenicity, immune response, antibodies.

For citation: Mosikyan A.A., Isaieva Yu.E. Insulin immunogenicity: clinical manifestations and its significance. RMJ. 2020;1:19–22.