title: Adverse side-effects to biological agents.
abstract: Biological agents-like cytokines, monoclonal antibodies and fusion proteins are widely used in anti-inflammatory and tumour therapy. They are highly efficient in certain diseases, but can cause a great variety of adverse side-effects. Based on the peculiar features of biological agents a new classification of these adverse 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 because of high cytokine levels (type alpha), hypersensitivity because of an immune reaction against the biological agent (beta), immune or cytokine imbalance syndromes (gamma), symptoms because of cross-reactivity (delta) and symptoms not directly affecting the immune system (epsilon). 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.
authors.affiliation: Department for Rheumatology and Clinical Immunology/Allergology, Inselspital, University of Bern, Bern, Switzerland.
authors.forename: W J
authors.initials: WJ
authors.lastname: Pichler
mesh_terms: D001688:Biological Products / Q000009:adverse effects* / Q000145:classification / Q000276:immunology* / Q000627:therapeutic use; D016207:Cytokines / Q000097:blood / Q000276:immunology / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000097:blood / Q000145:classification / Q000209:etiology / Q000276:immunology*; D009369:Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D012307:Risk Factors
chemical_list: D001688:Biological Products; D016207:Cytokines