Rup B, Pallardy M, Sikkema D, Albert T, Allez M, Broet P, Carini C, Creeke P, Davidson J, De Vries N, Finco D, Fogdell-Hahn A, Havrdova E, Hincelin-Mery A, C Holland M, H Jensen P E, Jury E C, Kirby H, Kramer D, Lacroix-Desmazes S, Legrand J, Maggi E, Maillère B, Mariette X, Mauri C, Mikol V, Mulleman D, Oldenburg J, Paintaud G, R Pedersen C, Ruperto N, Seitz R, Spindeldreher S, Deisenhammer F
Pfizer, Immunogenicity Sciences Disciple, Pharmacokinetics, Dynamics and Metabolism.
INSERM, UMR996, Faculté Pharmacie, Université Paris Sud, France.
Clin Exp Immunol. 2015 Sep;181(3):385-400. doi: 10.1111/cei.12652. Epub 2015 Jul 2.
Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti-Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp).
生物制药（BPs）是一类快速增长的已获批和正在研究的药物疗法，对推进多种疾病领域的治疗做出了重大贡献，这些疾病领域包括炎症性和自身免疫性疾病、遗传性缺陷和癌症。不幸的是，对生物制药产生的不良免疫原性反应，尤其是那些影响临床安全性或疗效的反应，仍然是与这类重要药物相关的最常见负面影响之一。为了管理和降低不良免疫原性的风险，临床医生、制药行业和学术科学家等不同群体参与到以下方面：对生物制药免疫原性的临床和生物学结果进行解读和管理；改进描述、预测和减轻免疫原性风险的方法；阐明潜在原因。由于在与免疫原性相关的概念、实践以及标准化术语和定义方面缺乏共识，这些群体之间的协作和努力协调变得困难。创新药物倡议组织（IMI；www.imi - europe.org）、ABIRISK联盟[抗生物制药（BP）免疫预测与临床相关性以降低风险；www.abirisk.eu]由顶尖临床医生、学术科学家和欧洲制药工业协会联合会（EFPIA）成员组成，旨在阐明潜在原因，改进免疫原性预测和减轻方法，并围绕与免疫原性相关的术语和概念建立通用定义。这些努力有望促进更广泛的合作，并产生管理免疫原性的新指南。为了支持协调一致，本文提供了ABIRISK迄今采用的一组关键术语和定义背后概念的概述，以及访问和下载ABIRISK术语和定义并发表评论的链接（http://www.abirisk.eu/index_t_and_d.asp）。
