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-对生物药物的有害免疫反应-我们可以预测它们吗？

介绍

。生物制剂（BAs）靶向与疾病机制有关的分子，并改变了几种免疫介导的疾病的自然史。所有BA均为免疫原性，导致形成抗药抗体（ADAs），可中和药物活性，导致反应丧失和潜在的复发，或严重的不良事件，例如输液超敏反应。ADA的产生是特定的适应性免疫反应的结果，其中涉及T细胞和B细胞。

覆盖区域

。目前，许多研究都涉及调节BAs免疫原性的因素，包括与药物，治疗和患者相关的因素。其中，很多注意力都集中在定义BAs结构的影响，靶向（可溶或膜）分子的作用，治疗中断的影响以及遗传（HLA和非HLA）诱因的作用上。和疾病活动。

专家意见

。了解能够影响BAs免疫原性的因素可能有助于以预测方式并在单例患者水平上了解影响ADA产生及其对临床结果影响的风险因素的存在。