Safety of biologics : current issues and future concerns

Advances in biotechnology have yielded new options for the management of chronic inflammatory diseases. During the past five years numerous monoclonal antibodies, several cytokines and systemic antisense have all been evaluated in patients with active Crohn's disease. One of these products, infliximab, is now approved for clinical use (1,2). The fundamental potential of the biologics, enhanced efficacy as a result of selective targeting of key inflammatory mediators, seems on the verge of fulfillment. However our knowledge of the human immune system remains rudimentary. Therefore it is important that the safety of these agents is carefully evaluated. This review describes the overall process of evaluating the potential