Fecal calprotectin concentration predicts outcome in inflammatory bowel disease after induction therapy with TNFα blocking agents

Background: Fecal calprotectin (FC) concentration is a useful surrogate marker for mucosal healing (MH) during tumor necrosis factor alpha (TNFa)-blocking therapy for inflammatory bowel disease (IBD). Our aim was to evaluate whether a normal FC after induction therapy with TNFa antagonist predicts the outcome of IBD patients during maintenance therapy. Methods: Sixty IBD patients (34 Crohn's disease [CD], 26 ulcerative colitis [UC]), treated with TNFa antagonists, either infliximab (n = 42) or adalimumab (n = 18), and having a documented FC level at baseline and after induction therapy were included. Disease activity was evaluated by partial Mayo score without endoscopy or HarveyBradshaw index at baseline, after induction, and at 12 months during maintenance therapy. Results: After induction, FC was normalized (=100 mu g/g) in 31 patients (52%, median 42 mu g/g, range 097), whereas the level remained elevated in 29 patients (48%, median 424 mu g/g, range 1165859). At 12 months, 26/31 (84%, 18 CD, 8 UC) of the patients with normal FC after induction were in clinical remission, whereas only 11/29 (38%, 9 CD, 2 UC) of those with an elevated (=100 mu g/g) postinduction FC were in clinical remission, P < 0.0001. After induction therapy with TNFa antagonists, a cutoff concentration of 139 mu g/g for FC had a sensitivity of 72% and a specificity of 80% to predict a risk of clinically active disease after 1 year. Conclusions: A normal FC after induction therapy with TNFa antagonists predicts sustained clinical remission in the majority of patients on scheduled therapy with active luminal disease. (Inflamm Bowel Dis 2012;)