DOP59 Proactive infliximab drug monitoring is superior to conventional management in inflammatory bowel disease

• Published in: Journal of Crohn's and colitis 2019-01, Vol.13 (Supplement_1), p.S064-S065
• Main Authors: Raimundo Fernandes, S, Bernardo, S, Simões, C, Correia, L, Moura Santos, P, Rita Gonçalves, A, Valente, A, Baldaia, C, Tato Marinho, R
• Format: Article
• Language: English
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjy222.093

Abstract Background There is increasing evidence supporting the use of therapeutic drug monitoring (TDM) of anti-TNF therapies following loss of response in inflammatory bowel disease (IBD). On the other hand, it is still unknown whether proactive TDM can improve clinical outcomes in these patients. The aim of this study was to evaluate clinical and endoscopic outcomes of a proactive TDM strategy following infliximab (IFX) induction therapy. Methods Patients completing IFX induction therapy were prospectively assigned to a proactive TDM protocol (pTDM). Before the fourth infusion and every 2 infusions, IFX drug levels and anti-drug antibodies were measured using a drug-sensitive assay (Theradiag®, Lisa Tracker). Treatment was proactively escalated aiming at an IFX trough level of 3–7 μg/ml—Crohn’s disease (CD) or 5–10 μg/ml—ulcerative colitis. A retrospective cohort of patients treated with IFX but without TDM was used as a control group (noTDM). Endpoints included the need for surgery (perianal or bowel resection), hospitalisation, treatment discontinuation (due to loss of response or serious adverse event), and rates of mucosal healing up until 2 years of follow-up. Primary IFX non-responders were excluded from either group. Results In total, 240 patients were included in the study [pTDM, n = 57 and noTDM, n = 183]; [75.4% with CD]. Disease characteristics, prior anti-TNF exposure and baseline C-reactive protein levels were non-significant between groups. IFX escalation was more common in pTDM patients (73.7% vs. 25.7%, p < 0.001). PTDM patients required less surgery (8.8% vs. 21.3%, p = 0.032) and presented higher rates of mucosal healing (71.9% vs. 44.3%, p