P251 High anti-TNF drugs trough levels are not associated with the occurrence of adverse events in patients with inflammatory bowel diseases. (16th January 2018)

• Record Type: Journal Article
• Authors: Bodini, G; Demarzo, M G; Saracco, M; Coppo, C; Baldissarro, I; Anjali, J; Savarino, E; Savarino, V; Giannini, E
• Is Part Of: Journal of Crohn's and colitis. Volume 12:Number 1(2018:Jan.)Supplement 1
• Page Start: S226
• Page End: S227
• Publication Date: 2018-01-16
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx180.378
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: In inflammatory bowel disease (IBD) patients treated with anti-tumour necrosis factor (TNF) drugs there is approximately 40 % per year likelihood of experiencing secondary loss of response (LOR). In these patients, an increase of the dose of the drug is often carried out in order to restore disease response, and as a fact, higher drug trough levels (TL) are associated with a better disease outcome and a lower likelihood of LOR. However, there are no data concerning drug TL and adverse events (AEs). The aim of this study was to evaluate the possible association between drug TL and AEs in IBD patients treated with adalimumab (ADA) and infliximab (IFX). Methods: We included in this analysis 113 patients (65 males, 86 Crohn's disease, 27 ulcerative colitis) treated with IFX (50, 44%) or ADA (63 56%). Twenty-seven patients (24%) were in combo therapy with an immunomodulatory drug. We considered the TL only if it was concomitant (plus/minus 1 week) to the occurrence of the AE. TL were measured using a homogeneous mobility shift assay (Prometheus Laboratories, San Diego, USA). Results: During a median follow-up of 16 months (range, 1–144) we observed 103 AEs, mainly infections ( n = 81, 79%), followed by dermatologic reactions ( n = 13, 13%). TL were available during 88 AEs (85%): 61 samples from patients in monotherapy and 27 from those in combo-. There was no statistical difference in median TL at the time of AEs occurrence in patients in combo- vs. monotherapy (6.9 μg/ml [range 0.0–20.3 μg/ml] vs. 6.2 μg/ml [range 0.0–36.2 μg/ml, p = 0.42). Moreover, considering a cut off of 7 μg/ml for IFX TL ( p = 0.57) and 5 μg/ml for ADA TL ( p = 0.75), we observed no statistical difference in terms of AE occurrence. Moreover, even considering a higher cut off of 15 μg/ml for IFX TL and 10 μg/ml for ADA TL, we still did not observe any statistically significant difference in terms of occurrence of AEs experience. Conclusions: IBD patients with higher anti-TNF TL do not seem have a greater risk of occurrence of AEs as compared with patients with lower TL, independently of mono or combo therapy. Physicians' decision to increase anti-TNF dosage should be based on clinical evaluation and should not be influenced by concerns regarding the potential for AEs occurrence.