Safety profile of biological agents depending on their pharmacological properties and chemical structure

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To study the safety profile of biologic agents using the spontaneous individual case study reports (ICSRs).

Material and methods

We studied ICSRs in the database of the Federal Service for Health Supervision from 01.01.2009 to 08.05.2018.


We identified 1 217 ICSRs describing adverse drug reactions (ADRs) during treatment with biologic agents. Soluble receptors and PEGylated Fab-fragment were associated with a lower risk of ADRs compared to classic monoclonal antibodies (MABs). Tumor necrosis factor alpha inhibitors had more beneficial safety profile than inhibitors of interleukin-6. The risk of ADRs decreased with a higher proportion of the human component in the structure of a MAB.

Key words

Biologic agents, pharmacovigilance, monoclonal antibodies, tumor necrosis factor alpha inhibitor, interleukin-6 inhibitor.