Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology-Reference-Cited by-同舟云学术

Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Published:2024-04-17 Issue: Volume: Page:
ISSN:0163-4356
Container-title:Therapeutic Drug Monitoring
language:en
Short-container-title:

Author:

Alsoud Dahham¹^ORCID,Moes Dirk Jan A. R.²^ORCID,Wang Zhigang³^ORCID,Soenen Rani⁴⁵^ORCID,Layegh Zohra⁶^ORCID,Barclay Murray⁷^ORCID,Mizuno Tomoyuki⁸⁹^ORCID,Minichmayr Iris K.¹⁰^ORCID,Keizer Ron J.¹¹^ORCID,Wicha Sebastian G.¹²^ORCID,Wolbink Gertjan¹³¹⁴^ORCID,Lambert Jo⁴⁵^ORCID,Vermeire Séverine¹¹⁵^ORCID,de Vries Annick¹⁶^ORCID,Papamichael Konstantinos¹⁷^ORCID,Padullés-Zamora Núria¹⁸¹⁹^ORCID,Dreesen Erwin³^ORCID

Affiliation:

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

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

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

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

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

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

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

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

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

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

11. InsightRX, San Francisco, California;

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

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

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

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

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

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

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

19. School 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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