PMID- 32806874 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211113 IS - 1598-9100 (Print) IS - 2288-1956 (Electronic) IS - 1598-9100 (Linking) VI - 19 IP - 4 DP - 2021 Oct TI - Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease? PG - 461-467 LID - 10.5217/ir.2020.00042 [doi] AB - 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 mug/ 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 mug/mL (1.36- 10.25), higher than the median IFX-TL of patients without AEs (3.40 mug/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 mug/ mL and patients with IFX-TLs < 15 mug/mL. CONCLUSIONS: IFX-TLs are not significantly associated with the development of AEs in IBD patients receiving maintenance treatment with IFX. FAU - Theodoraki, Eirini AU - Theodoraki E AD - Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece. FAU - Orfanoudaki, Eleni AU - Orfanoudaki E AD - Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece. FAU - Foteinogiannopoulou, Kalliopi AU - Foteinogiannopoulou K AD - Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece. FAU - Legaki, Evangelia AU - Legaki E AD - Department of Basic Medical Sciences, Laboratory of Biology, National and Kapodistrian University of Athens Medical School, Athens, Greece. FAU - Gazouli, Maria AU - Gazouli M AD - Department of Basic Medical Sciences, Laboratory of Biology, National and Kapodistrian University of Athens Medical School, Athens, Greece. FAU - Koutroubakis, Ioannis E AU - Koutroubakis IE AD - Department of Gastroenterology, University Hospital of Heraklion, Medical School University of Crete, Heraklion, Greece. LA - eng PT - Journal Article DEP - 20200818 PL - Korea (South) TA - Intest Res JT - Intestinal research JID - 101572802 PMC - PMC8566825 OTO - NOTNLM OT - Adverse drug events OT - Colitis, ulcerative OT - Crohn disease OT - Infections OT - Infliximab COIS- Conflict of Interest No potential conflict of interest relevant to this article was reported. EDAT- 2020/08/19 06:00 MHDA- 2020/08/19 06:01 PMCR- 2021/10/01 CRDT- 2020/08/19 06:00 PHST- 2020/05/02 00:00 [received] PHST- 2020/05/25 00:00 [accepted] PHST- 2020/08/19 06:00 [pubmed] PHST- 2020/08/19 06:01 [medline] PHST- 2020/08/19 06:00 [entrez] PHST- 2021/10/01 00:00 [pmc-release] AID - ir.2020.00042 [pii] AID - ir-2020-00042 [pii] AID - 10.5217/ir.2020.00042 [doi] PST - ppublish SO - Intest Res. 2021 Oct;19(4):461-467. doi: 10.5217/ir.2020.00042. Epub 2020 Aug 18.