The objective of this study was to test the hypothesis that maintenance-phase infliximab concentrations higher than what is recommended in clinical guidelines are associated with histologic remission in IBD [27]. The mean infliximab concentration with standard deviation was calculated for each participant using all drug concentrations recorded during the study period. The primary endpoint was histologic remission, defined as an absence of active chronic inflammation and/or deemed "normal" by an expert GI pathologist. Secondary outcomes included sustained histologic remission (histologic remission documented at both the baseline and follow-up colonoscopies), histologic disease relapse (defined as the presence of chronic, active inflammation on the follow-up colonoscopy), new histologic remission (defined as the presence of chronic, active inflammation at the baseline colonoscopy and histologic remission on the follow-up colonoscopy) and failure to recapture response (secondary non-responders with histologic disease activity at both colonoscopies). Other endpoints included determination of an infliximab concentration threshold associated with histologic remission and sustained histologic remission. Intra-patient variation (IPV) (calculated by dividing the standard deviation by the mean infliximab trough concentration) in infliximab trough concentrations based on histologic remission was also assessed.

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