The introduction of biopharmaceuticals (BPs) has been a critical step forward in the treatment of many severe diseases including juvenile idiopathic arthritis (JIA). There are now several BPs for the treatment of JIA, and numerous novel molecules are anticipated in the next few years. A major limitation to the use of BPs is the development of anti-drug antibodies (ADA) in a subset of patients. ADAs may decrease the efficacy of BPs by neutralizing them or modifying their clearance, and they may be associated with BP-specific hypersensitivity (HS) reactions. The prediction, prevention and cure of anti-drug immunogenicity are thus major goals in BP drug development and patient safety.

ABIRISK (Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk), whose enrollment ended on 31^st March 2016, is a large European project funded by the Innovative Medicines Initiative (IMI) and it aims to provide an integrated approach to investigate anti-drug antibody formation in JIA, adult rheumatoid arthritis and other conditions treated with biopharmaceuticals.

PRINTO managed this project as a sub-study of PharmaChild and succeeded to collect the biologic samples (Serum and RNA) of 147 children with juvenile idiopathic arthritis newly treated with adalimumab, etanercept or tocilizumab at start of therapy and at 4 follow-up visits during the first year of treatment, with an extra visit between month 15 and month 18 for a total of 6 study visits.

The samples will be sent to the PRINTO facilities in Genoa (Italy), then transferred to the ABIRISK consortium for antibodies evaluation. The clinical data are the data collected for the PharmaChild registry.

The ABIRISK Consortium, composed of 36 partners from both academia and industry, has the chance to bring together a large network of adult and paediatric clinicians from various specialties with broad experience in the care of patients treated with BP known to develop ADA, access to clinical samples from large cohorts of treated patients, renowned academic scientists, immunologists, biologists, database experts, statisticians and leading companies of European Federation of Pharmaceutical Industries and Associations (EFPIA).

For further information, you can contact the PRINTO office.

Download ABIRISK brochure.