Abstract
OBJECTIVES: Therapeutic drug monitoring of infliximab improves treatment outcomes, but available assays to monitor infliximab lack speed to implement treatment algorithms immediately. Our aim is to validate a rapid, lateral flow-based assay (LFA) for quantitative determination of infliximab and to assess thresholds associated with mucosal healing in patients with ulcerative colitis. METHODS: Samples (n=190) from 29 anti-tumor necrosis factor naive patients with ulcerative colitis starting infliximab induction therapy between June 2010 and February 2012 were prospectively collected. All patients had a Mayo endoscopic sub-score ≥2 at baseline. Mucosal healing (MH), defined as a Mayo endoscopic sub-score ≤1, was evaluated at week 10-14. Infliximab trough concentrations (TC) were determined with a novel LFA, which was benchmarked with the RIDASCREEN infliximab Monitoring (ELISA). RESULTS: The LFA showed an excellent agreement with enzyme-linked immunosorbent assay (ELISA) for quantification of infliximab, as observed from Pearson and intraclass correlation coefficients of 0.95 and 0.95 during induction and 0.93 and 0.87 during maintenance therapy, respectively. In total, 45% of patients achieved MH. Using the LFA, week 14 TC ≥2.1 μg/ml (AUROC: 0.819, P=0.008) were associated with MH. After 2 years follow-up, 77% of patients with MH were still receiving infliximab therapy vs. 25% of patients without MH. CONCLUSIONS: We validated a LFA for quantification of infliximab and identified TC associated with MH. With a time-to-result of 20 min, individual sample analysis and user-friendliness, the LFA outplays ELISA as a rapid, accurate tool to monitor infliximab concentrations.