title: Efficacy and safety of biologicals against immune-mediated diseases: do benefits outweigh risks?
abstract: The success of molecular biology in identifying molecular pathways underlying chronic immune-mediated diseases and the rapid development of gene/cell engineering biotechnologies has resulted in the development of a number of targeted biological drugs, which have revolutionized the therapy of these diseases. Numerous data published over the last 10-15 years demonstrate a dramatic improvement in the clinical efficacy of biologics compared with conventional drugs. However, professional and public concern about serious biological drug-associated adverse events has also been growing steadily. We critically analyze recent literature on the efficacy and safety of biologics in the management of rheumatoid arthritis, psoriasis, psoriatic arthritis and immune thrombocytopenia. Our analysis of benefits, resistance to the therapy, risk of infections, tumors and other serious complications related to chronic administration of biologics is based on the molecular/cellular mechanisms of their interaction with the immune system. We also address whether it is feasible to attenuate the risks associated with biologics without limiting their benefits.
authors.affiliation: Lab. Tissue Engineering & Skin Pathophysiology, Instituto Dermopatico dell'Immacolata (IDI IRCCS), Rome, Italy. l.korkina@idi.it
authors.forename: Liudmika
authors.initials: L
authors.lastname: Korkina
authors.forename: P
authors.initials: P
authors.lastname: Trakhtman
authors.forename: C
authors.initials: C
authors.lastname: De Luca
authors.forename: L
authors.initials: L
authors.lastname: Leoni
authors.forename: D
authors.initials: D
authors.lastname: Raskovic
authors.forename: S
authors.initials: S
authors.lastname: Pastore
mesh_terms: D001688:Biological Products / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D016503:Drug Delivery Systems; D015195:Drug Design; D006801:Humans; D007154:Immune System Diseases / Q000188:drug therapy* / Q000276:immunology; D007155:Immunologic Factors / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D001688:Biological Products; D007155:Immunologic Factors