Further Product Information

AUTHORS:

Gert Van Assche, Séverine Vermeire and Paul Rutgeerts, Division of Gastroenterology, University of Leuven, Leuven, Belgium

ABSTRACT

Although the advent of infliximab has changed the treatment paradigm and goals in inflammatory bowel diseases (IBD), it does not provide a cure for IBD and recent evidence has demonstrated that the immunogenicity of this chimeric anti-TNF antibody is associated with secondary loss of response and intolerance. In ulcerative colitis (UC) the efficacy of infliximab was demonstrated in two large clinical trials, but long-term maintenance efficacy data are lacking. Novel biological agents have entered clinical development and pioneering trials have been reported in the last two years. For Crohn’s disease (CD) two anti-TNF agents, the fully human IgG1 anti TNF monoclonal adalimumab and the humanized pegylated Fab-fragment certolizumab- pegol and the humanized anti a4 integrin IgG4 antibody both have demonstrated efficacy as maintenance agents. Adalimumab has been approved to treat active rheumatoid arthritis, psoriatric arthritis, and ankylosing spondylitis, and recently moderate-to-severe luminal CD has been added as an indication for this agent both by the FDA and EMEA. Further evidence is needed to establish the therapeutic potential of adalimumab in fistulizing CD and in UC. The benefit to risk ratio of anti-TNF agents in refractory IBD is clearly positive and since most of the toxicity is class specific, adalimumab is expected to have a safety profile similar to that of infliximab except for adverse events related to infusions.

ABOUT THE JOURNAL Biologics: targets & therapy. ISSN 1177-5491 An international, peer-reviewed journal focusing on the patho-physiological rationale for and clinical application of Biologic agents in the management of autoimmune diseases, cancers or other pathologies where a molecular target can be identified. This journal will explore the evidence behind new and existing therapies and, importantly, will seek to define their usage in terms of ultimate uptake and acceptance by the patient and health care professional.