Sanchez-Hernandez JG^1,2,3, Rebollo N^1,2,3, Martin-Suarez A^2,3, Calvo MV^1,2,3, Muñoz F^3,4. Br J Clin Pharmacol. 2020 Feb 5. doi: 10.1111/bcp.14229. [Epub ahead of print]

Author information

1 Pharmacy Service, University Hospital of Salamanca, Spain.

2 Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Salamanca, Salamanca, Spain.

3 Biomedical Research Institute of Salamanca (IBSAL), Spain.

4 Gastroenterology Service, University Hospital of Salamanca, Spain.

Abstract

AIMS: Therapeutic drug monitoring (TDM) of trough serum infliximab concentrations (TSIC) has been mainly used in case of loss of response in patients with inflammatory bowel disease (IBD). The aim of this study was to evaluate the effectiveness and safety of a multidisciplinary early proactive TDM (mep-TDM) program for dose adjustment.

METHODS: A three-year prospective study was conducted based on a sample of 81 patients who started treatment and were subsequently subjected to mep-TDM with the first control at week 14. Data of a historical control group of 72 patients treated with infliximab and managed with empirical dosing were included. Effectiveness variables were treatment failure, IBD-related surgery and IBD-related hospitalization. Safety variables were serious infusion reactions (SIR) and adverse reactions. Cox regression was used for survival analysis.

RESULTS: In the mep-TDM study group, compared to the control group, there was a significant reduction in the risk of treatment failure (hazard ratio [HR]: 0.51; 95% confidence interval [CI]: 0.27-0.92; p=0.037), IBD-related surgery (HR: 0.14; 95% CI: 0.03-0.65; p=0.012) and hospitalization (HR: 0.38; 95% CI: 0.17-0.87; p=0.022). SIRs were lower in the mep-TDM group (2.5% vs 10.4%; p<0.050); the incidence of adverse reactions was similar (3.7% vs 3.9%; p=1.000).

CONCLUSIONS: This study found that compared to empirical dosing, mep-TDM is associated with improved the efficacy and safety of infliximab therapy, reducing IBD-related hospitalization and surgery and the incidence of SIRs, and increasing long-term durability of treatment effects.