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P254 Relationship between severe endoscopic lesions and plasmatic and fecal infliximab levels in acute severe ulcerative colitis: a case control study

Poullenot F.*1, Nivet D.2, Paul S.3, Ricard J.1, Roblin X.4, Laharie D.1

1CHU Bordeaux, Department of Gastroenterology, Bordeaux, France 2CHCB, Gastroenterology, Bayonne, France 3CHU Saint-Etienne, Immunology, Saint-Etienne, France 4CHU Saint-Etienne, Gastroenterology, Saint-Etienne, France

Background

Recent data suggest that early fecal excretion of infliximab (IFX) in acute severe ulcerative colitis (ASUC) is associated with poor treatment response [1]. Severe endoscopic lesions (SEL), such as deep ulcerations eroding the muscle layer, deep ulcerations not eroding the muscle layer but involving more than one third of the mucosal area, and mucosal detachment on the edge of ulcerations, could favor infliximab fecal leakage.

The aim of this study was to search for an association between SEL and IFX levels in blood and stools in ASUC.

Methods

This was a case-control, observational (with collection of biological samples), prospective, two-center study that recruited between February 2015 and July 2016 consecutive patients admitted for an ASUC treated with IFX who had a flexible sigmoidoscopy before starting the drug. Patients who received any anti-TNF within the previous 8 weeks were excluded. Cases were patients with SEL and controls those without. IFX serum levels were measured at D0, D1, D2 and fecal levels at D0, D1, D2 and D14. The objectives of the study were to compare the detection of IFX in the stool at D1 and/or D2 and, IFX serum levels at D1 and D2 between cases and controls.

Results

Sixteen patients were recruited (10 men, median age: 49 years). After exclusion of one patient for insufficient pharmacological data, 6 had SEL at baseline. IFX was detected in the stool at D1 and/or D2 in 2/6 (33%) of cases and 4/9 (44%) of controls (OR =0.6, 95% CI [0.03–7.9], p=1) and no difference was observed between the two groups regarding the plasma levels of IFX on D1 or D2. At D98, 3/6 (50%) cases and 1/9 (11%) controls had been colectomized.

Conclusion

In a group of patients admitted for an ASUC treated with IFX, SEL were not associated with more detection of the drug in the stools or less plasmatic levels. In this pilot study, primary IFX failure in ASUC does not seems related SEL and drug fecal leakage. The place of these early dosages remains to be studied in larger populations.

References:

[1] Brandse JF, van den Brink GR, Wildenberg ME, van der Kleij D, Rispens T, Jansen JM, Mathôt RA, Ponsioen CY, Löwenberg M, D'Haens GR, (2015), Loss of Infliximab Into Feces Is Associated With Lack of Response to Therapy in Patients With Severe Ulcerative Colitis, Gastroenterology, 149(2):350–5