Abstract Background Empirical dose intensification and therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels (ITL) and antibody (ATI) assays are recognised approaches for managing the loss of response (LoR) in inflammatory bowel disease (IBD) patients. Aim To compare these two interventions in a clinical setting, in terms of effectiveness and cost savings. Methods Consecutive IBD patients, experiencing LoR, were clinically managed according to a TDM algorithm. A historical group of empirically treated patients, for whom sera for ITL and ATI assays were collected, served as the control group. Clinical outcomes 12 weeks after the therapeutic interventions were compared between the two groups. A cost-minimization analysis was performed to compare the economic impact of these two approaches. Results Ninety-six patients were enrolled prospectively and compared with 52 controls. The two cohorts were similar in characteristics and the distribution of TDM results. In the prospective cohort, however, we observed less IFX dose escalations compared with controls (45% versus 71%, p=0.003). Also, more patients were switched to a different anti-TNF in the prospective cohort than in the control one (25% versus 4%, p=0.001). The percentages of patients achieving a clinical response at 12 weeks were 52% and 54% for the prospective and control groups, respectively. By cost analysis, we estimated a savings of 15% if the TDM algorithm was applied. Conclusions In our population, applying a TDM algorithm for LoR to IFX resulted in less dose escalations, without loss of efficacy, compared with empirical adjustment. In addition, the TDM approach was cost-effective. Biologics, Health economics, Crohn’s disease, Ulcerative colitis Copyright © 2018 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: firstname.lastname@example.org This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)
Journal of Crohn's and Colitis – Oxford University Press
Published: May 31, 2018
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