Optimizing therapeutic drug monitoring in inflammatory bowel disease: a focus on therapeutic monoclonal antibodies

ABSTRACT

Introduction

Therapeutic drug monitoring (TDM) is useful for optimizing monoclonal antibodies (mAbs) for the treatment of immune-mediated inflammatory disorders including inflammatory bowel disease (IBD). However, TDM in clinical practice is still restricted by long turnaround times between sampling and results and the fact that dosing of mAbs to a target drug concentration is challenging due to high pharmacokinetic (PK) variability at both a population and patient level. Overcoming these barriers may be addressed by point-of-care (POC) assays, model-informed precision dosing (MIPD), and pharmacogenetics/pharmacogenomics.

Areas covered

This review provides an overview of the optimization of TDM of mAbs in IBD including POC testing, MIPD, and pharmacogenetics.

Expert opinion

Recent advances in sampling, quantification, and support of clinical decisions include POC assays and PK dashboards, which may allow for prompt and precise application of TDM in clinical practice. Future perspectives toward a more personalized implementation of TDM could include the incorporation of pharmacogenetics/pharmacogenomics to identify subgroups of patients who would benefit more from proactive TDM or combination therapy such as those prone to immunogenicity and/or accelerated drug clearance. However, there are still challenges regarding the implementation of these innovative approaches, and more data from prospective studies and randomized controlled trials are needed.

KEYWORDS:

• Inflammatory bowel disease
• therapeutic drug monitoring
• pharmacokinetic dashboards
• point of care assays
• pharmacogenetics
• model-informed precision dosing

Declaration of interest

K Papamichail reports lecture fees from Mitsubishi Tanabe Pharma and Physicians Education Resource LLC; consultancy fee from Prometheus Laboratories Inc; and scientific advisory board fees from ProciseDx Inc and Scipher Medicine Corporation. AS Cheifetz reports consultancy fees from Janssen, Abbvie, Artugen, ProciseDx, Prometheus, Arena, Grifols, Bacainn, and Bristol Myers Squibb. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

K Papamichail and AS Cheifetz contributed to manuscript writing and critical revision. All authors reviewed and approved the final version of the manuscript.

Additional information

Funding

This paper was not funded.