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).

译文

生物药物(BPs)代表了快速增长的一类经过批准和研究的药物疗法,为促进多种疾病领域的治疗做出了重要贡献,包括炎性和自身免疫性疾病,遗传缺陷和癌症。不幸的是,对BP的有害的免疫原性应答,尤其是那些影响临床安全性或功效的免疫原性应答,仍然是与这一重要药物类别相关的最常见的负面作用。为了管理和减少不良免疫原性的风险,临床医生,制药行业和学术界科学家参与了以下工作:解释和管理BP免疫原性的临床和生物学结果,改进描述,预测和减轻免疫原性风险的方法以及阐明潜在的免疫原性。原因。由于缺乏对与免疫原性有关的概念,实践以及标准化术语和定义的共识,使得跨这些社区的工作难以进行协作和统一。创新药物倡议(IMI; www.imi-europe.org),ABIRISK联盟[抗生物制药(BP)免疫预测和降低临床风险的临床意义; www.abirisk.eu]由领先的临床医生,学术科学家和EFPIA(欧洲制药工业和协会联合会)成员组成,旨在阐明根本原因,改进免疫原性预测和缓解方法,并围绕与免疫原性相关的术语和概念建立通用定义。预计这些努力将促进更广泛的合作,并为管理免疫原性带来新的指导方针。为了支持一致性,此处提供了ABIRISK迄今为止采用的一组关键术语和定义背后的概念概述,以及访问和下载ABIRISK术语和定义并提供注释的链接(http://www.abirisk.eu /index_t_and_d.asp)。

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