Objective

The rise in the development of monoclonal antibodies has brought  about a revolution in the pharmacotherapy of inflammatory bowel disease  (Crohn’s disease and ulcerative colitis). Systematic plasma concentrations monitoring of these biological drugs in anticipation of potential  clinical failures of treatment is known as proactive therapeutic drug  monitoring. New pharmacogenetic analysis techniques have recently been  developed that can predict response to these treatments even before they are administered. The goal of this systematic review is to analyze the potential benefits of proactive therapeutic drug monitoring and of the  harmacogenetic analysis of biological drugs in inflammatory bowel disease  patients in terms of clinical remission.

Method

A systematic search was performed in the MEDLINE/Pubmed, Embase and Cochrane Library databases using the  escriptors proactive drug monitoring, biological drugs, inflammatory bowel  disease and pharmacogenetics. Only randomized clinical trials published  between January 2015 and May 2021 were included; all articles whose main  topic was not related to the topic were excluded by hand. The quality of the  articles  was assessed using the Jadad scale and risk of bias was assessed  using the Cochrane Collaboration tool.

Results

After applying inclusion and exclusion criteria, seven of the 228  retrieved articles were selected for review. Almost all the studies measured the  same clinical variables (Harvey-Bradshaw index for Crohn’s disease and  Mayo score for ulcerative colitis). Only in two of the included studies was  proactive therapeutic drug monitoring superior to reactive monitoring- or no  level-guided dose adjustments. No pharmacogenetic analyses were found that  met the criteria defined. Conclusions: This review shows that the data  supporting the use of proactive therapeutic drug monitoring in inflammatory  bowel disease is limited and of low quality. Although pharmacogenetic analysis  can be a useful tool for personalizing treatment, further and better designed  randomized clinical trials are needed to determine the role of proactive drug monitoring strategies in clinical practice.