ABIRISK Consortium Recommendations for Terms and Definitions for Describing and Interpreting Unwanted Immunogenicity of Biopharmaceuticals

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 responses that affect clinical safety or efficacy, remain among the most common negative effects associated with this important class of drug therapies. Therefore, there is a growing need to elucidate the underlying causes and to evaluate methods for predicting and mitigating immunogenicity. Supported by the Innovative Medicines Initiative (IMI; www.imi-europe.org), the ABIRISK consortium (Anti-Biopharmaceutical [BP] Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu), was formed in 2012 with participants representing a network of leaders from various communities who have an interest in furthering the understanding and reducing the risk of BP immunogenicity: clinicians involved in the care of patients treated with various type of BPs, academic scientists researching mechanisms of immunogenicity, and EFPIA (European Federation of Pharmaceutical Industries and Associations) scientists involved in development of BPs. ABIRISK’s goal of improving the understanding of BP immunization should also lead to the generation of guidelines for drug development and the clinical care of patients. A prerequisite to understanding the impact of immunogenicity is to provide clear definitions around terms and concepts related to immunogenicity, its prediction, and associated clinical events. An overview of the concepts behind key terms and definitions adopted to date by ABIRISK is provided in this document along with a link to the documented ABIRISK terms and definitions that will be maintained on the ABIRISK website throughout the duration of the consortium. It is anticipated that refinement of definitions as well as introduction of new terms will be needed over the 5 year duration of the consortium’s work. In addition, ABIRISK will invite comment on these terms, definitions and concepts from other immunogenicity experts within the broader community of medical, academic, and pharmaceutical scientists outside of the ABIRISK consortium. Therefore, it is the consortium’s intention to maintain the most current version on the ABIRISK site for public use, review and comment.