Background:: Fecal calprotectin (FC) concentration is a useful surrogate marker for mucosal healing (MH) during tumor necrosis factor alpha (TNFα)‐blocking therapy for inflammatory bowel disease (IBD). Our aim was to evaluate whether a normal FC after induction therapy with TNFα 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 TNFα 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 Harvey–Bradshaw index at baseline, after induction, and at 12 months during maintenance therapy.
Results:: After induction, FC was normalized (≤100 μg/g) in 31 patients (52%, median 42 μg/g, range 0–97), whereas the level remained elevated in 29 patients (48%, median 424 μg/g, range 116–5859). 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 μg/g) postinduction FC were in clinical remission, P < 0.0001. After induction therapy with TNFα antagonists, a cutoff concentration of 139 μg/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 TNFα antagonists predicts sustained clinical remission in the majority of patients on scheduled therapy with active luminal disease. (Inflamm Bowel Dis 2012;)