• А.В. Филиппова
  • А.С. Колбин
  • Е.В. Вербицкая
  • С. В. Глаголев
  • В.А. Поливанов
  • В.И. Мазуров
  • Р.Р. Самигуллина
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.Results. 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. Conclusion. The described patterns of safety should be taken into account when choosing biologic agent.
Translated title of the contributionSAFETY PROFILE OF BIOLOGICAL AGENTS DEPENDING ON THEIR PHARMACOLOGICAL PROPERTIES AND CHEMICAL STRUCTURE
Original languageRussian
Pages (from-to)93-100
JournalКЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯ И ТЕРАПИЯ
Volume28
Issue number3
StatePublished - 2019

    Research areas

  • BIOLOGIC AGENTS, PHARMACOVIGILANCE, MONOCLONAL ANTIBODIES, TUMOR NECROSIS FACTOR ALPHA INHIBITOR, INTERLEUKIN-6 INHIBITOR

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