Objectives: Subtherapeutic drug concentrations contribute to both primary and secondary nonresponse to infliximab in children with Crohn's disease (CD). The aim of this study was to evaluate treatment outcomes and infliximab concentrations at infusions 2 and 3 with an objective to establish infliximab targets during induction for primary responders. Methods: Single-center, prospective cohort of anti-TNF naïve CD patients 50% improvement in fecal calprotectin) and maintenance concentrations ≥5 μg/ml were secondary outcomes. Results: We enrolled 72 CD patients with 70/72 receiving infliximab monotherapy. Clinical response, biological response, and start of maintenance concentrations ≥5 μg/ml were achieved in 64%, 54% and 22% respectively. The median (interquartile range) infliximab concentrations at infusion 2 and 3 in clinical responders were 27.8 μg/ml (19.5–40) and 14 μg/ml (8.3–24) compared to 18.8 μg/ml (9.1–23, p 5 μg/ml (AUC 0.85). Independent predictors for infusion 3 levels
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