Janssen Research & Development, LLC (Johnson & Johnson), 1400 McKean Road, P.O. Box 776, Spring House, Pennsylvania, 19477, USA,
AAPS J. 2014 Jul;16(4):658-73. doi: 10.1208/s12248-014-9599-2. Epub 2014 Apr 24.
Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. To date, the descriptions of product immunogenicity have varied not only due to different degrees of understanding of product immunogenicity at the time of licensing but also due to an evolving lexicon that has generated some confusion in the field. In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Harmonization of the strategy for the elucidation of product immunogenicity by drug developers, as well as the use of defined common terminology, can benefit medical practitioners, health regulatory agencies, and ultimately the patients. Clearly, understanding the incidence, kinetics and magnitude of anti-drug antibody (ADA), its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and related clinical impact may enhance clinical management of patients treated with biologic drugs. To that end, the authors present terms and definitions for describing and analyzing clinical immunogenicity data and suggest approaches to data presentation, emphasizing associations of ADA development with pharmacokinetics, efficacy, and safety that are necessary to assess the clinical relevance of immunogenicity.
免疫原性是生物药物的一个重要关注点，因为它会影响安全性和疗效。迄今为止，产品免疫原性的描述不仅因在许可时对产品免疫原性的理解程度不同而有所不同，而且还因不断发展的词汇在该领域造成了一些混淆。近年来，人们对于评估产品免疫原性所需的数据已经达成了越来越多的共识。药物开发商阐明产品免疫原性的策略的协调一致，以及使用明确的通用术语，可以使医疗从业者、卫生监管机构，最终使患者受益。显然，了解抗药物抗体（ADA）的发生率、动力学和幅度、其中和能力、与内源性分子或其他已上市的生物药物的交叉反应性以及相关的临床影响，可以增强接受生物药物治疗的患者的临床管理。为此，作者提出了用于描述和分析临床免疫原性数据的术语和定义，并建议了数据呈现方法，强调了 ADA 与药代动力学、疗效和安全性的发展之间的关联，这些关联是评估免疫原性临床相关性所必需的。
