Clinical performance of an infliximab rapid quantification assay

• Type: Article in International Scientific Journal
• Date: 2017

Authors

Magro F (Author) FMUP; Afonso, J (Author) FMUP; Lopes, S (Author) Other; Coelho, R (Author) Other; Goncalves, R (Author) Other; Caldeira, P (Author) Other; Lago, P (Author) Other; de Sousa, HT (Author) Other; Ramos, J (Author) Other; Goncalves, AR (Author) Other; Ministro, P (Author) Other; Rosa, I (Author) Other; Meira, T (Author) Other; Andrade, P (Author) Other; Soares, JB (Author) Other; Carvalho, D (Author) Other; Sousa, P (Author) Other; Vieira, AI (Author) Other; Lopes, J (Author) Other; Dias C (Author) FMUP; Geboes, K (Author) Other; Carneiro F (Author) FMUP

Journal

Title: Therapeutic Advances in Gastroenterology

Vol. 10

Pages: 651-660

ISSN: 1756-283X

Publisher: SAGE

Indexing

ISI Web of Knowledge - 16 Citations

Scopus - 17 Citations

Other information

Authenticus ID: P-00N-0TS

DOI: 10.1177/1756283x17722916

Abstract (EN): Background: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 mu g/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 mu g/ml was 88% both for a Mayo endoscopic score <= 1 and for an FC concentration <250 mu g/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 mu g/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 10