ABSTRACT

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.

中文翻译：

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免疫原性——对生物药物的不需要的免疫反应——我们能预测它们吗？

摘要

介绍

生物制剂 (BA) 靶向参与疾病机制的分子，并改变了几种免疫介导疾病的自然史。所有 BA 都具有免疫原性，导致形成抗药物抗体 (ADA)，从而中和药物活性，导致反应丧失和潜在复发，或严重的不良事件，如输液过敏反应。ADA 的产生是 T 细胞和 B 细胞参与的特定适应性免疫反应的结果。

涵盖的领域

调节 BA 免疫原性的因素，包括药物、治疗和患者相关因素，目前是许多研究的主题。其中，很多注意力致力于定义BAs结构的影响、靶向（可溶性或膜）分子的影响、中断治疗的影响以及遗传（HLA和非HLA）易感因素的作用和疾病活动。

专家意见

了解能够影响 BA 免疫原性的因素可能有助于以预测方式和在单个患者水平上了解影响 ADA 产生的风险因素的存在及其对临床结果的影响。