Therapeutic drug monitoring is more cost-effective than a clinically based approach in the management of loss of response to infliximab in inflammatory bowel disease: An observational multicentre study

Luisa Guidi, Daniela Pugliese, Tommaso Panici Tonucci, Alexandra Berrino, Barbara Tolusso, Michele Basile, Laura Cantoro, Paola Balestrieri, Fortunata Civitelli, Lorenzo Bertani, Manuela Marzo, Carla Felice, Elisa Gremese, Francesco Costa, Franca Viola, Michele Cicala, Anna Kohn, Antonio Gasbarrini, Gian Lodovico Rapaccini, Matteo RuggeriAlessandro Armuzzi

Research output: Contribution to journalArticlepeer-review

Abstract

Background and Aims Empirical dose intensification and therapeutic drug monitoring [TDM] of infliximab [IFX] trough levels [ITLs] and antibody to infliximab [ATI] assays are recognized approaches for managing loss of response [LoR] in patients with inflammatory bowel disease [IBD]. The aim of the study was 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 ITLs and ATI assays had been 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 in the distribution of TDM results. In the prospective cohort, however, we observed less IFX dose escalations compared with in the controls [45% versus 71%, p = 0.003]. Also, more patients were switched to a different anti-TNFα in the prospective cohort than in the control cohort [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.

Original languageEnglish
Pages (from-to)1079-1088
Number of pages10
JournalJournal of Crohn's and Colitis
Volume12
Issue number9
DOIs
Publication statusPublished - Aug 29 2018

Keywords

  • Biologics
  • Crohn's disease
  • health economics
  • ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

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