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

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...

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Main Authors: Eirini Theodoraki, Eleni Orfanoudaki, Kalliopi Foteinogiannopoulou, Evangelia Legaki, Maria Gazouli, Ioannis E. Koutroubakis
Format: Article
Language:English
Published: Korean Association for the Study of Intestinal Diseases 2021-10-01
Series:Intestinal Research
Subjects:
Online Access:http://www.irjournal.org/upload/pdf/ir-2020-00042.pdf
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author Eirini Theodoraki
Eleni Orfanoudaki
Kalliopi Foteinogiannopoulou
Evangelia Legaki
Maria Gazouli
Ioannis E. Koutroubakis
author_facet Eirini Theodoraki
Eleni Orfanoudaki
Kalliopi Foteinogiannopoulou
Evangelia Legaki
Maria Gazouli
Ioannis E. Koutroubakis
author_sort Eirini Theodoraki
collection DOAJ
description 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.
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spelling doaj.art-cb0022506df546938ac7fd59871103ce2022-12-21T20:37:09ZengKorean Association for the Study of Intestinal DiseasesIntestinal Research1598-91002288-19562021-10-0119446146710.5217/ir.2020.00042865Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?Eirini Theodoraki0Eleni Orfanoudaki1Kalliopi Foteinogiannopoulou2Evangelia Legaki3Maria Gazouli4Ioannis E. Koutroubakis5 Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece Department of Basic Medical Sciences, Laboratory of Biology, National and Kapodistrian University of Athens Medical School, Athens, Greece Department of Basic Medical Sciences, Laboratory of Biology, National and Kapodistrian University of Athens Medical School, Athens, Greece Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, GreeceBackground/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.http://www.irjournal.org/upload/pdf/ir-2020-00042.pdfadverse drug eventscrohn diseaseinfliximabinfectionscolitis, ulcerative
spellingShingle Eirini Theodoraki
Eleni Orfanoudaki
Kalliopi Foteinogiannopoulou
Evangelia Legaki
Maria Gazouli
Ioannis E. Koutroubakis
Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
Intestinal Research
adverse drug events
crohn disease
infliximab
infections
colitis, ulcerative
title Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
title_full Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
title_fullStr Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
title_full_unstemmed Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
title_short Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?
title_sort is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease
topic adverse drug events
crohn disease
infliximab
infections
colitis, ulcerative
url http://www.irjournal.org/upload/pdf/ir-2020-00042.pdf
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