P265 Pharmacokinetic and pharmacodynamic evaluation of radiological healing in Crohn’s disease patients treated with Infliximab: a TAILORIX MRE substudy
P. Bossuyt*1,2, E. Dreesen3, J. Rimola4, S. Devuysere5, Y. De Bruecker5, R. Vanslembrouck6, V. Laurent7, M. Zappa8, C. Savoye-Collet9, A. Gils3, S. Vermeire1, L. Peyrin-Biroulet10
1University Hospitals Leuven, Catholic University of Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium, 2Imelda General Hospital, Department of Gastroenterology, Bonheiden, Belgium, 3Catholic University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, 4Hospital Clínic of Barcelona, IBD Unit, Radiology Department, Barcelona, Spain, 5Imelda General Hospital, Department of Radiology, Bonheiden, Belgium, 6University Hospitals Leuven, Catholic University of Leuven, Department of radiology, Leuven, Belgium, 7Nancy University Hospital, INSERM U947 and Department of Radiology, Vandoeuvre-lès-Nancy, France, 8Beaujon Hospital, Department of Radiology, Clichy, France, 9Rouen University Hospital, Normandy University, Department of Radiology, Rouen, France, 10Nancy University Hospital, INSERM U954 and Department of Hepato-Gastroenterology, Vandoeuvre-lès-Nancy, France
Higher infliximab (IFX) trough levels (TL) are associated with clinical and endoscopic remission in Crohn’s disease (CD). The relationship between pharmacokinetic (PK) and pharmacodynamic (PD) monitoring and radiological healing evaluated by magnetic resonance enterography (MRE) are unknown. We here assessed the correlation between IFX TL and radiologic remission in a post hoc analysis of the prospective randomised TAILORIX trial.1
This study included all patients from TAILORIX that had baseline and Week 54 MRE available. The MARIA score was calculated by two independent blinded central readers (CR). In case of discrepancy a third CR provided adjudication. Radiologic response and remission were defined as MARIA in all segments <11 and <7, respectively. Prospectively collected PK markers (IFX TL), PD markers (CRP and Faecal Calprotectin [FC]) and endoscopic remission (CD endoscopic index of severity, CDEIS <3) were used for the analysis.
Thirty-six patients were included in the analysis (50% female; median age 35.7 years IQR 25.6–48.6; median disease duration 1.44 months IQR 0.6–22.4). Radiologic response and remission at w54 was 32.3% and 25.8%, respectively; endoscopic remission was 67.7%. The correlation between CDEIS and MARIA at w0 was moderate (Pearson 0.46;
In this post hoc analysis of TAILORIX, radiologic response and remission following infliximab induction and maintenance were observed in 32 and 26% of patients. IFX TL >7.8 µg/ml at the end of induction therapy predicted both radiologic remission and response at w54 in patients with CD.1
1. D'Haens G, Vermeire S, Lambrecht G,