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

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

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

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

§Dermatology Research Unit, Ghent University, Ghent, Belgium;

¶Department of Dermatology, Ghent University Hospital, Ghent, Belgium;

║Department of Pathology, Amsterdam University Medical Center, Amsterdam, the Netherlands;

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

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

‡‡Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio;

§§Department of Clinical Pharmacology, Medical University Vienna, Vienna, Austria;

¶¶InsightRX, San Francisco, California;

║║Department of Clinical Pharmacy, Institute of Pharmacy, University of Hamburg, Hamburg, Germany;

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

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

‡‡‡Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium;

§§§Sanquin Diagnostic Services, Pharma & Biotech Services, Amsterdam, the Netherlands;

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

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

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

Correspondence: Erwin Dreesen, PharmD, PhD, ON2 Herestraat 49, Box 521, 3000 Leuven, KU Leuven, Leuven, Belgium (e-mail: [email protected]).

Conceptualization: Ideas; formulation or evolution of overarching research goals and aims: D. Alsoud, D. J. A. R. Moes, Z. Wang, S. G. Wicha, G. Wolbink, A. de Vries, K. Papamichael, and E. Dreesen. Writing—Original Draft: Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation): D. Alsoud, D.J. A. R. Moes, Z. Wang, R. Soenen, Z. Layegh, K. Papamichael, N. Padullés-Zamora, and E. Dreesen. Writing—Review & Editing: Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review, commentary or revision—including pre-or post-publication stages: D. Alsoud, D. J. A. R. Moes, Z. Wang, R. Soenen, Z. Layegh, M. Barclay, T. Mizuno, I. K. Minichmayr, R. J. Keizer, S. G. Wicha, G. Wolbink, J. Lambert, S. Vermeire, A. de Vries, K. Papamichael, N. Padullés-Zamora, and E. Dreesen. Visualization: Preparation, creation and/or presentation of the published work, specifically visualization/ data presentation; E. Dreesen. Supervision: Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team: N. Padullés-Zamora, K. Papamichael and E. Dreesen. Project administration: Management and coordination responsibility for the research activity planning and execution. E. Dreesen. Funding acquisition: Acquisition of the financial support for the project leading to this publication; NA.

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.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.drug-monitoring.com).

D. Alsoud, D. J. A. R. Moes, and Z. Wang share first authorship.

K. Papamichael, N. Padullés, and E. Dreesen share senior authorship.

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