Therapeutic Advances in Gastroenterology (Sep 2017)

Clinical performance of an infliximab rapid quantification assay

  • Fernando Magro,
  • Joana Afonso,
  • Susana Lopes,
  • Rosa Coelho,
  • Raquel Gonçalves,
  • Paulo Caldeira,
  • Paula Lago,
  • Helena Tavares de Sousa,
  • Jaime Ramos,
  • Ana Rita Gonçalves,
  • Paula Ministro,
  • Isadora Rosa,
  • Tânia Meira,
  • Patrícia Andrade,
  • João-Bruno Soares,
  • Diana Carvalho,
  • Paula Sousa,
  • Ana Isabel Vieira,
  • Joanne Lopes,
  • Cláudia Camila Dias,
  • Karel Geboes,
  • Fátima Carneiro

DOI
https://doi.org/10.1177/1756283X17722916
Journal volume & issue
Vol. 10

Abstract

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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 µg/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 µg/ml was 88% both for a Mayo endoscopic score ⩽ 1 and for an FC concentration <250 µg/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 µg/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.