Immunogenicity of biological agents leads to the development of anti-drug antibodies (ADA) and it may be associated to all biologicals irrespective of the presence of xenoantigens. Several drug-, patients-, disease- and treatment-related factors contribute to immunogenicity. Low ADA levels can influence the efficacy of the drugs, whereas high levels can induce hypersentivity reactions. Immediate infusion reactions occur during or within one hour after infusion, and their clinical manifestations range from mild to severe. The application of novel methods for detecting ADA has allowed to distinguish between the involvement of IgE- or non-IgE isotypes. It is important for clinicians to recognize symptoms of reactions, but also their pathophysiological mechanisms to evaluate risk assessment and prophylactic regimens. The studies on immunogenicity may help to determine optimal treatment regimen required to minimize the likelih ood of ADA onset and related side effects. This review summarizes i) the epidemiological data on immunogenicity of biologicals leading to the loss of response to the treatment or to hypersensitivity reactions, ii) the current knowledge of factors influencing immunogenicity to biologicals as well as the pathogenic mechanisms of drug-induced hypersensitivity reactions, iii) the assays to monitor immunogenicity and iv) the risk factors to prevent hypersensitivity reactions.

Immunogenicity of Biological Agents: Basic Knowledge and Clinical Implications / Andrea Matucci; Giulia Petroni; Sara Pratesi; Francesca Nencini; Enrico Maggi; Alessandra Vultaggio. - In: DRUG DEVELOPMENT RESEARCH. - ISSN 1098-2299. - ELETTRONICO. - Vol. 2 No 1:(2014), pp. 11-21.

Immunogenicity of Biological Agents: Basic Knowledge and Clinical Implications

PETRONI, GIULIA;PRATESI, SARA;NENCINI, FRANCESCA;MAGGI, ENRICO;
2014

Abstract

Immunogenicity of biological agents leads to the development of anti-drug antibodies (ADA) and it may be associated to all biologicals irrespective of the presence of xenoantigens. Several drug-, patients-, disease- and treatment-related factors contribute to immunogenicity. Low ADA levels can influence the efficacy of the drugs, whereas high levels can induce hypersentivity reactions. Immediate infusion reactions occur during or within one hour after infusion, and their clinical manifestations range from mild to severe. The application of novel methods for detecting ADA has allowed to distinguish between the involvement of IgE- or non-IgE isotypes. It is important for clinicians to recognize symptoms of reactions, but also their pathophysiological mechanisms to evaluate risk assessment and prophylactic regimens. The studies on immunogenicity may help to determine optimal treatment regimen required to minimize the likelih ood of ADA onset and related side effects. This review summarizes i) the epidemiological data on immunogenicity of biologicals leading to the loss of response to the treatment or to hypersensitivity reactions, ii) the current knowledge of factors influencing immunogenicity to biologicals as well as the pathogenic mechanisms of drug-induced hypersensitivity reactions, iii) the assays to monitor immunogenicity and iv) the risk factors to prevent hypersensitivity reactions.
2014
Vol. 2 No 1
11
21
Andrea Matucci; Giulia Petroni; Sara Pratesi; Francesca Nencini; Enrico Maggi; Alessandra Vultaggio
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/963038
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