Biological Therapeutics and Pharmacovigilance in Italy

Biological Therapeutics (BTs) present a novel frontier for the treatment of autoimmune diseases, such as rheumatoid arthritis, psoriasis, Crohn's disease and several other conditions. BTs constitute highly selective compounds targeted upon specific structures that may be proteins, receptors, or DNA sequences. In the case of autoimmune diseases, the use of BTs is directed against pro-inflammatory cytokines that exert a central role in the inflammatory machinery. In the present review, attention is focused upon BTs that inhibit proinflammatory cytokines thereby blocking the inflammation, such as monoclonal antibodies (e.g. infliximab and adalimumab) and soluble receptors (e.g. etanercept). The interleukin-1 and interleukin-6 antagonists, anakinra and tocilizumab, rituximab, which decrease the number of circulating B-lymphocytes and abatacept, thereby counteracting T-lymphocyte activation, are described also. Despite the utility of BTs for patients presenting autoimmune diseases, they have been linked to opportunistic viral, bacterial, mycotic infections and to tumor cases. The occurrence of these pathologies is due to their immunosuppresssive functions thereby requiring the meticulous monitoring by pharmacovigilance and drug safety techniques to assess risk analysis. Whether or not Adverse Drug Events (ADEs) occur more frequently in patients administered BTs, compared to traditional drugs, is currently an essential topic of investigation.