Intest Res.  2021 Oct;19(4):461-467. 10.5217/ir.2020.00042.

Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?

Affiliations
  • 1Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece
  • 2Department of Basic Medical Sciences, Laboratory of Biology, National and Kapodistrian University of Athens Medical School, Athens, Greece

Abstract

Background/Aims
The measurement of infliximab trough levels (IFX-TLs) in patients with inflammatory bowel disease (IBD) is performed to optimize treatment. However, the association between the development of adverse events (AEs) and IFX-TLs has not been sufficiently studied thus far. To investigate the possible association of IFX-TLs with AEs in Greek patients with IBD receiving maintenance treatment with IFX.
Methods
A retrospective analysis of the registry data of the Gastroenterology Department of the University Hospital of Heraklion, from IBD patients with at least one available IFX-TL measurement during the years 2016 to 2017 was conducted. AEs reported 4 months before and 4 months after the measured IFX-TLs were recorded. The IFX-TLs of patients with or without AEs were compared.
Results
Of a total of 83 IBD patients (61 Crohn’s disease [73%]; 52 men [63%]; mean age ± standard deviation, 43.3 ± 16.0 years), 147 measurements of IFX-TLs were available (median 4.69 μg/ mL [1.32–9.16]), and 99 AEs (67.3%, 14 severe) were registered. The median IFX-TL of patients with AEs was 5.79 μg/mL (1.36– 10.25), higher than the median IFX-TL of patients without AEs (3.40 μg/mL [1.30–5.92]), but the difference was not significant (P= 0.97). The presence of infections or dermatologic reactions was not correlated with IFX-TLs. There was no difference in the prevalence of the total AEs (66.7% vs. 73.3%, P= 0.77) or in the analysis of AEs by group between patients with IFX-TLs ≥ 15 μg/ mL and patients with IFX-TLs < 15 μg/mL.
Conclusions
IFX-TLs are not significantly associated with the development of AEs in IBD patients receiving maintenance treatment with IFX.

Keyword

Adverse drug events; Crohn disease; Infliximab; Infections; Colitis, ulcerative

Figure

  • Fig. 1. Median infliximab trough levels (IFX-TLs) of all measurements and comparison of IFX-TLs between patients with and without adverse events (AEs).


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