UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: Recommendations of the innovative medicines initiative ABIRISK consortium

Rup, B; Pallardy, M; Sikkema, D; Albert, T; Allez, M; Broet, P; Carini, C; ... ABIRISK Consortium; + view all (2015) Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: Recommendations of the innovative medicines initiative ABIRISK consortium. [Review]. Clinical & Experimental Immunology , 181 (3) pp. 385-400. 10.1111/cei.12652. Green open access

[thumbnail of Rup_Standardizing terms,cei12652.pdf]
Preview
Text
Rup_Standardizing terms,cei12652.pdf

Download (295kB) | Preview

Abstract

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). This article is protected by copyright. All rights reserved.

Type: Article
Title: Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: Recommendations of the innovative medicines initiative ABIRISK consortium
Open access status: An open access version is available from UCL Discovery
DOI: 10.1111/cei.12652
Publisher version: http://dx.doi.org/10.1111/cei.12652
Language: English
Additional information: This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. © 2015 The Authors Clinical & Experimental Immunology published by John Wiley & Sons Ltd on behalf of British Society for Immunology
Keywords: ABIRISK Consortium, anti-drug antibodies, biopharmaceuticals, immunogenicity
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation
URI: https://discovery.ucl.ac.uk/id/eprint/1468817
Downloads since deposit
146Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item