Therapeutic Drug Monitoring for Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease
- PMID: 38399538
- PMCID: PMC10890472
- DOI: 10.3390/medicina60020250
Therapeutic Drug Monitoring for Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease
Abstract
Background: Inflammatory bowel disease (IBD), encompassing ulcerative colitis and Crohn's disease, necessitates long-term medical therapy to manage symptoms and prevent complications. Therapeutic drug monitoring (TDM) has emerged as a strategy to optimize treatment efficacy, particularly with anti-tumour necrosis factor (anti-TNF) alpha drugs. This review explores the role of TDM for non-anti-TNF advanced therapies in IBD, focusing on vedolizumab, ustekinumab, tofacitinib, upadacitinib, risankizumab and ozanimod. Methods: The literature search, conducted through OVID (Medline) and PubMed, delves into proactive versus reactive TDM, timing of monitoring and methods for measuring drug levels and anti-drug antibodies. Results: While ustekinumab and vedolizumab exhibit exposure-response relationships, consensus on target levels and the role of TDM adjustments remains elusive. Limited data on risankizumab suggest a dose-dependent response, while for small molecule therapies (janus kinase inhibitors and ozanimod), the absence of real-world data and commercially available TDM tools pose challenges. Conclusion: At present, with the available data, there is a limited role for TDM in non-anti-TNF biologic and small-molecule therapies. This review underscores the need for further research to delineate the utility of TDM in guiding treatment decisions for these agents.
Keywords: JAK inhibitors; filgotinib; inflammatory bowel disease; ozanimod; pharmacokinetics; risankizumab; therapeutic drug monitoring (TDM); tofacitinib; upadacitinib; ustekinumab; vedolizumab.
Conflict of interest statement
A. Vasudevan is on the advisory board for Abbvie. K. Dutt has no conflicts of interest to declare.
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References
-
- Turner D., Ricciuto A., Lewis A., D’Amico F., Dhaliwal J., Griffiths A.M., Bettenworth D., Sandborn W.J., Sands B.E., Reinisch W., et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160:1570–1583. doi: 10.1053/j.gastro.2020.12.031. - DOI - PubMed
-
- Vande Casteele N., Ferrante M., Van Assche G., Ballet V., Compernolle G., Van Steen K., Simoens S., Rutgeerts P., Gils A., Vermeire S. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148:1320–1329.e3. doi: 10.1053/j.gastro.2015.02.031. - DOI - PubMed
-
- Negoescu D.M., Enns E.A., Swanhorst B., Baumgartner B., Campbell J.P., Osterman M.T., Papamichael K., Cheifetz A.S., Vaughn B.P. Proactive vs. Reactive Therapeutic Drug Monitoring of Infliximab in Crohn’s Disease: A Cost-Effectiveness Analysis in a Simulated Cohort. Inflamm. Bowel Dis. 2020;26:103–111. doi: 10.1093/ibd/izz113. - DOI - PMC - PubMed
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