Immunogenicity of Biological Agents: Basic Knowledge and Clinical Implications

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-, diseaseand 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 IgEor 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 likelihood of ADA onset and related