Four-year experience of infliximab and adalimumab pharmacokinetics monitoring in patients with inflammatory bowel disease

Czech version

Authors: Svoboda P. ^1,2; Kupka T. ^1,2; Krnáčová A. ³
Authors‘ workplace: Interní klinika, FN Ostrava ¹; Katedra interních oborů, LF OU, Ostrava ²; Ústav laboratorní diagnostiky, Oddělení klinické biochemie, FN Ostrava ³
Published in: Gastroent Hepatol 2020; 74(2): 139-147
Category:
doi: https://doi.org/10.14735/amgh2020139

Overview

Introduction: This study was designed to measure infliximab (IFX) and adalimumab (ADM) levels in patients with non-specific inflammatory bowel disease, to evaluate the influence of pharmacokinetics monitoring on optimization of treatment, to correlate the concentrations of these biologics with selected parameters, and to compare two laboratory methods of measuring IFX concentrations.

Methods: Patients with Crohn’s disease and ulcerative colitis, who were treated with IFX or ADM at the University Hospital of Ostrava between 1/2016 and 10/2019, were evaluated. Concentrations of biologics were measured in all patients using immunochromatographic methods, including enzyme-linked immunosorbent assay (ELISA) and point of care testing (POCT). Other demographic and clinical characteristics were measured, as were antibodies to IFX and ADM.

Results: Of the patients evaluated, 43.9% had IFX concentrations < 3 mg/l, 17.5% had IFX concentrations > 7 mg/l, and 7% had anti-IFX antibodies. Moreover, 18.5, 52.6, and 28.9% had ADM concentrations < 4 mg/l, 4–8 mg/l, and > 8 mg/l, resp. with 5.2% being positive for anti-ADM antibodies. Patient weight and duration of biological therapy showed statistically significant negative correlations with ADM concentration. Therapy was optimized in 56% of patients by intensification, in 12% by switching, in 8% by swapping, in 8% by adjustment of concomitant therapy, by dose reduction in 4% and by treatment termination in 12%. Clinical remission was achieved in 47.6% of patients and therapeutic responses in an additional 33.3%. Patients who completed treatment remained in remission, whereas de-escalation led to relapse. Concentrations measured by POCT and ELISA methods did not show statistically significant differences, with occasional casuistic clinically significant differences probably due to human error.

Conclusion: Reactive pharmacokinetic monitoring has become a regular part of the clinical practice and is widely applied, representing a rational foundation for biological therapy optimization. The future use of proactive monitoring is still open to discussion, dependent in particular on the health care payers’ attitudes.

Keywords:

infliximab – Ulcerative colitis – pharmacokinetics – adalimumab – Crohn’s disease

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