Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology.
Journal
Therapeutic drug monitoring
ISSN: 1536-3694
Titre abrégé: Ther Drug Monit
Pays: United States
ID NLM: 7909660
Informations de publication
Date de publication:
17 Apr 2024
17 Apr 2024
Historique:
received:
29
10
2023
accepted:
21
02
2024
medline:
23
4
2024
pubmed:
23
4
2024
entrez:
22
4
2024
Statut:
aheadofprint
Résumé
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. The endorsing TDM of Biologics and Pharmacometrics Committees of the International Association of TDM and Clinical Toxicology collaborated to create this position statement. 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. Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
Successful implementation of TDM for infliximab necessitates interdisciplinary collaboration among clinicians, hospital pharmacists, and (quantitative) clinical pharmacologists to ensure an efficient research trajectory.
Identifiants
pubmed: 38648666
doi: 10.1097/FTD.0000000000001204
pii: 00007691-990000000-00210
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Z. Wang is supported by a doctoral research grant from the Research Foundation—Flanders (FWO), Belgium (grant number: 1SF2922N). M. Barclay received consultancy fees from Douglas Pharmaceuticals and Janssen unrelated to submitted work. T. Mizuno served as a consultant of NDA Partners and received speaker honoraria from Astellas Pharma Inc. and Chugai Pharmaceutical Co. R. J. Keizer is an employee and stockholder of InsightRX, a company developing precision dosing software. S. G. Wicha received research grants from Boehringer Ingelheim and AqVida, consulting fees from Merck KGaA and Medicines from Malaria Venture, and speaker honoraria from GlaxoSmithKline. J. Lambert received unrestricted grants from AbbVie, Almirall, Celgene, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, and UCB, served as a speaker for AbbVie, Almirall, Bristol-Myers Squibb, Janssen-Cilag, Pfizer, and UCB, and served as a consultant for AbbVie, argenx, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, and UCB, with all fees and grants being paid to Ghent University (Hospital) scientific accounts and not to any personal account of Jo Lambert. S. Vermeire received grants from AbbVie, J&J, Pfizer, Galapagos, and Takeda, received consulting and/or speaker fees from AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MRM Health, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG, and Zealand Pharma. K. Papamichael received lecture/speaker fees from Physicians Education Resource LLC and Grifols, scientific advisory board fees from ProciseDx Inc. and Scipher Medicine Corporation, and serves as a consultant from Prometheus Laboratories Inc. E. Dreesen received consultancy fees from Alimentiv, argenx, and Prometheus, lecture fees from Galapagos, and financial support from Janssen and Sandoz, outside the submitted work, with all honoraria/fees being paid to KU Leuven and not to any personal account of Erwin Dreesen. D. Alsoud, D. J. A. R. Moes, R. Soenen, Z. Layegh, I. K. Minichmayr, G. Wolbink, A. de Vries, and N. Padullés-Zamora declare that they have no conflicts of interest.
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