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 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 mu g/ 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 mu g/mL (1.36- 10.25), higher than the median IFX-TL of patients without AEs (3.40 mu g/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 mu g/ mL and patients with IFX-TLs < 15 mu g/mL. Conclusions: IFX-TLs are not significantly associated with the development of AEs in IBD patients receiving maintenance treatment with IFX.

Automated summary

The study investigated the association of infliximab trough levels with adverse events in Greek IBD patients receiving maintenance treatment. The results showed that there was no significant correlation between IFX-TLs and the development of adverse events.