Immunogenicity-unwanted immune responses to biological drugs - can we predict them?

Andrea Matucci, Francesca Nencini, Emanuele Vivarelli, Susanna Bormioli, Enrico Maggi, Alessandra Vultaggio

Research output: Contribution to journalReview articlepeer-review


INTRODUCTION: Biological agents (BAs) target molecules involved in disease mechanisms and have modified the natural history of several immune-mediated disorders. All BAs are immunogenic, resulting in the formation of antidrug antibodies (ADAs), which can neutralize drug activity leading to loss of response and potential relapse, or serious adverse events such as infusion hypersensitivity reactions. The production of ADAs is the result of a specific adaptive immune response in which T and B cells are involved.

AREAS COVERED: Factors conditioning the immunogenicity of BAs, including drug-, treatment- and patient-related factors are currently the subject of many studies. Among them, a lot of attention is dedicated to define the impact of BAs structure, the effect of targeting (soluble or membrane) molecules, the impact of interruption of therapy as well as the role of genetic (HLA and non-HLA) predisposing factors and disease activity.

EXPERT OPINION: Knowledge of factors capable of influencing the immunogenicity of BAs may help to understand, in a predictive manner and at the single patient level, the presence of risk factors influencing the production of ADAs and their impact on clinical outcomes.

Original languageEnglish
Pages (from-to)47-53
Number of pages7
JournalExpert Review of Clinical Pharmacology
Issue number1
Publication statusPublished - Jan 2021


  • Animals
  • Antibody Formation/immunology
  • B-Lymphocytes/immunology
  • Biological Factors/administration & dosage
  • Humans
  • Immunity/immunology
  • Risk Factors
  • T-Lymphocytes/immunology


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