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Dreesen E, Bossuyt P, Mulleman D, et al. Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases. Clin Pharmacol. 2017;9:101-111doi: 10.2147/CPAA.S138414.
Dreesen, E., Bossuyt, P., Mulleman, D., Gils, A., & Pascual-Salcedo, D. (2017). Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases. Clinical pharmacology : advances and applications, 9101-111. https://doi.org/10.2147/CPAA.S138414
Dreesen, Erwin, et al. "Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases." Clinical pharmacology : advances and applications vol. 9 (2017): 101-111. doi: https://doi.org/10.2147/CPAA.S138414
Dreesen E, Bossuyt P, Mulleman D, Gils A, Pascual-Salcedo D. Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases. Clin Pharmacol. 2017 Oct 03;9:101-111. doi: 10.2147/CPAA.S138414. eCollection 2017. PMID: 29042821; PMCID: PMC5633318.
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Clin Pharmacol. 2017 Oct 03;9:101-111. doi: 10.2147/CPAA.S138414. eCollection 2017.

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases.

Clinical pharmacology : advances and applications

Erwin Dreesen, Peter Bossuyt, Denis Mulleman, Ann Gils, Dora Pascual-Salcedo

Affiliations

  1. Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven.
  2. Imelda GI Clinical Research Centre, Imelda Ziekenhuis, Bonheiden.
  3. Translational Research in GastroIntestinal Disorders (TARGID), Department of Clinical and Experimental Medicine, KU Leuven, Leuven, Belgium.
  4. Department of Rheumatology, Université François-Rabelais de Tours, CNRS, UMR 7292, Tours, France.
  5. Institute for Research IdiPAZ, University Hospital La Paz, Madrid, Spain.

PMID: 29042821 PMCID: PMC5633318 DOI: 10.2147/CPAA.S138414

Abstract

Biopharmaceuticals directed against tumor necrosis factor-alpha, integrins, interleukins, interferons and their receptors have become key agents for the management of inflammatory diseases in the fields of gastroenterology, rheumatology, dermatology and neurology. However, response to these treatments is far from optimal. Therapeutic failure has been attributed in part to inadequate serum concentrations of the drug and the formation of antidrug antibodies (ADA). Therapeutic drug monitoring (TDM) based on drug concentrations and ADA represents a pharmacologically sound tool for guiding dosage adjustments to optimize exposure. Although becoming standard practice in tertiary care centers, the widespread accessibility and recognition of TDM is hindered by several hurdles, including a lack of education of health care providers on TDM. In this paper, the Monitoring of monoclonal Antibodies Group in Europe (MAGE) provides an introduction on the fundamental principles of the concept of TDM, aiming to educate clinicians and assist them in the process of implementing TDM of anti-inflammatory biopharmaceuticals.

Keywords: antidrug antibodies; biopharmaceuticals; immunogenicity; inflammatory diseases; therapeutic drug monitoring; trough concentration

Conflict of interest statement

Disclosure PB has served as a speaker for AbbVie and Takeda and as a consultant for Merck Sharp & Dohme (MSD), Janssen Biologicals, Hospira, Mundipharma, Roche, Takeda and AbbVie. DM participated on b

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