Ther Drug Monit. 2024 Jun 1;46(3):291-308. doi: 10.1097/FTD.0000000000001204.Epub 2024 Apr 17.

Dahham Alsoud ¹, Dirk Jan A R Moes ², Zhigang Wang ³, Rani Soenen ^4 5, Zohra Layegh ⁶, Murray Barclay ⁷, Tomoyuki Mizuno ^8 9, Iris K Minichmayr ¹⁰, Ron J Keizer ¹¹, Sebastian G Wicha ¹², Gertjan Wolbink ^13 14, Jo Lambert ^4 5, Séverine Vermeire ^1 15, Annick de Vries ¹⁶, Konstantinos Papamichael ¹⁷, Núria Padullés-Zamora ^18 19, Erwin Dreesen ³

Author information

¹Translational Research in Gastrointestinal Disorders, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.

²Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, the Netherlands.

³Clinical Pharmacology and Pharmacotherapy Unit, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

⁴Dermatology Research Unit, Ghent University, Ghent, Belgium.

⁵Department of Dermatology, Ghent University Hospital, Ghent, Belgium.

⁶Department of Pathology, Amsterdam University Medical Center, Amsterdam, the Netherlands.

⁷Departments of Gastroenterology and Clinical Pharmacology, Christchurch Hospital, Te Whatu Ora Waitaha and University of Otago, Christchurch, New Zealand.

⁸Division of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

⁹Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.

¹⁰Department of Clinical Pharmacology, Medical University Vienna, Vienna, Austria.

¹¹InsightRX, San Francisco, California.

¹²Department of Clinical Pharmacy, Institute of Pharmacy, University of Hamburg, Hamburg, Germany.

¹³Department of Rheumatology, Amsterdam Rheumatology and Immunology Center Location Reade, Amsterdam, Netherlands.

¹⁴Sanquin Research and Landsteiner Laboratory, Department of Immunopathology, Amsterdam UMC, Amsterdam, Netherlands.

¹⁵Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

¹⁶Sanquin Diagnostic Services, Pharma & Biotech Services, Amsterdam, the Netherlands.

¹⁷Center for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

¹⁸Department of Pharmacy, Bellvitge University Hospital, Bellvitge Biomedical Research Institute (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain; and.

¹⁹School of Pharmacy, University of Barcelona, Barcelona, Spain.

Abstract

Background: Infliximab, an anti-tumor necrosis factor monoclonal antibody, has revolutionized the pharmacological management of immune-mediated inflammatory diseases (IMIDs). This position statement critically reviews and examines existing data on therapeutic drug monitoring (TDM) of infliximab in patients with IMIDs. It provides a practical guide on implementing TDM in current clinical practices and outlines priority areas for future research.

Methods: The endorsing TDM of Biologics and Pharmacometrics Committees of the International Association of TDM and Clinical Toxicology collaborated to create this position statement.

Results: Accumulating data support the evidence for TDM of infliximab in the treatment of inflammatory bowel diseases, with limited investigation in other IMIDs. A universal approach to TDM may not fully realize the benefits of improving therapeutic outcomes. Patients at risk for increased infliximab clearance, particularly with a proactive strategy, stand to gain the most from TDM. Personalized exposure targets based on therapeutic goals, patient phenotype, and infliximab administration route are recommended. Rapid assays and home sampling strategies offer flexibility for point-of-care TDM. Ongoing studies on model-informed precision dosing in inflammatory bowel disease will help assess the additional value of precision dosing software tools. Patient education and empowerment, and electronic health record-integrated TDM solutions will facilitate routine TDM implementation. Although optimization of therapeutic effectiveness is a primary focus, the cost-reducing potential of TDM also merits consideration.

Conclusions: Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.