Abstract
BackgroundCurrently, treatment decisions for people with Crohn disease are based on clinical judgment and trial and error. Consequently, people may continue to receive high drug dosages and experience unnecessary toxicity when it is possible to reduce or discontinue without a detrimental effect on clinical outcomes. Therapeutic drug monitoring (TDM) involves regularly testing blood samples for drug and antibody levels that could help clinicians identify the optimal treatment strategy and pre-empt treatment failure. However, heterogeneity in the assays can lead to a discrepancy in results and difficulties in decision-making. Standardization of the kits, and therefore results, would allow clinicians to optimize the use of biologics. Currently, there is also a lack of evidence for the cost-effectiveness of TDM using commercial test kits.ObjectiveThis study aims to analyze the clinical and cost-effectiveness of 4 commercial enzyme-linked immunosorbent assay (ELISA) kits (LISA TRACKER, IDKmonitor, Promonitor, and RIDASCREEN) to generate evidence which could support a recommendation for wider adoption in the National Health Service.MethodsWe propose to carry out a prospective-retrospective predictive biomarker validation study using the blood samples and clinical/utilization data collected during the ongoing SPARE trial (NCT02177071). A total of 200 stored samples from people with Crohn's disease who respond to treatment with infliximab will be used along with clinical and cost data from the trial. We will investigate the relationship between the drug and antidrug antibody levels with the main clinical outcomes (relapse rate at 2 years and time spent in remission), as well as resource utilization and quality of life.ResultsFunding is being sought to conduct this research.ConclusionsThis is the first study to compare the 4 ELISA kits for monitoring infliximab in patients with Crohn disease. It aims to address the uncertainties in the potential benefits of using the technologies for TDM.International Registered Report Identifier (IRRID)PRR1-10.2196/11218
Highlights
BackgroundCrohn disease and ulcerative colitis are the main conditions described as inflammatory bowel disease
The prevalence of inflammatory bowel disease in the United Kingdom (UK) is estimated to be 240,000 with Crohn disease affecting about 115,000 people [1]
The LISA TRACKER (Theradiag, Croissy-Beaubourg, France), (Immundiagnostik/BioHit Healthcare, Bensheim, Germany), Promonitor (Grifols Diagnostic Solutions, Emeryville, United States) and RIDASCREEN (R-Biopharm, Darmstadt, Germany) are particular examples of these essays classed as solid-phase enzyme-linked immunosorbent assay (ELISA)
Summary
BackgroundCrohn disease and ulcerative colitis are the main conditions described as inflammatory bowel disease. In 2006, the cost of inflammatory bowel disease to the National Health Service (NHS) was estimated at £720 million, based on the prevalence and an average cost of £3,000 per patient per year [2]. At Guy’s and St Thomas’ NHS Foundation Trust, the Inflammatory Bowel Disease Service has approximately 600 patients receiving biological therapies incurring costs of £6 million per year. Objective: This study aims to analyze the clinical and cost-effectiveness of 4 commercial enzyme-linked immunosorbent assay (ELISA) kits (LISA TRACKER, IDKmonitor, Promonitor, and RIDASCREEN) to generate evidence which could support a recommendation for wider adoption in the National Health Service. Conclusions: This is the first study to compare the 4 ELISA kits for monitoring infliximab in patients with Crohn disease It aims to address the uncertainties in the potential benefits of using the technologies for TDM.
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