Folia Biologica
Journal of Cellular and Molecular Biology, Charles University 

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Fol. Biol. 2007, 53, 146-155

https://doi.org/10.14712/fb2007053040146

The Spectrum and Types of Adverse Side Effects to Biological Immune Modulators: A Proposal for New Classification

Marcela Zemková1,2, L. Jebavý3,4, J. Kotlářová1, J. Vlček1, R. H. B. Meyboom2,5

1Department of Social and Clinical Pharmacy, School of Pharmacy Hradec Králové, Charles University in Prague, University Hospital and Medical Faculty Hradec Králové, Hradec Králové, Czech Republic
2Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
3Department of Clinical Haematology, 2nd Internal Clinic, Charles University in Prague, University Hospital and Medical Faculty Hradec Králové, Hradec Králové, Czech Republic
4Department of Field Internal Medicine, Faculty of Military Health Sciences, University of Defence Hradec Králové, Hradec Králové, Czech Republic
5Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands

Received February 2007
Accepted April 2007

In recent years, a growing number of biological agents such as cytokines, monoclonal antibodies and fusion proteins have become available for the treatment of various autoimmune, neoplastic, cardiovascular, infectious, allergic, and other conditions. Their introduction has resulted in marked clinical improvements for many patients. Nevertheless, a variety of adverse side effects have been observed with these agents. Based on the special features of biological agents a new classification of these side effects of biological agents is proposed – related but clearly distinct from the classification of side effects observed with chemicals and drugs. This classification differentiates five distinct types, namely clinical reactions due to high cytokine levels (type α), hypersensitivity due to an immune reaction against the biological agents (type β), immune or cytokine imbalance syndromes (type γ), symptoms due to cross-reactivity (type δ), and symptoms not directly affecting the immune system (type ε). This classification could help to better deal with the clinical features of these side effects, to identify possible individual and general risk factors and to direct research in this novel area of medicine.

This article has been retracted: Fol. Biol. 2007, 53(6), 222-222

Funding

This work was supported in part by grant of the Ministry of Education, Youth and Sports of the Czech Republic 11600004 and the EU Grant Leonardo da Vinci CZ/05/A/PL/134 243.

References

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