Certolizumab pegol in the treatment of Crohns disease: evidence from the PRECiSE clinical trial program

Author(s): Ian C Lawrance

Certolizumab is an IgG4-binding pegylated humanized Fab´ fragment that is the third anti-TNF-α agent available for the treatment of Crohn’s disease (CD). It has clearly demonstrated efficacy in the maintenance of CD disease response and remission, with recent data demonstrating that it also has long-term efficacy in CD with no new concerns about its safety. Evidence is mounting for a role of certolizumab pegol in patients who have lost response to infliximab and adalimumab and for a role in the treatment of perianal fistualizing disease. Unfortunately, the pivotal double-blinded, placebo-controlled study investigating its efficacy in the induction of response in CD did not fully meet its primary end points, making registration of this agent for use in CD difficult.