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Ther Drug Monit. 2016 Apr;38 Suppl 1:S1-20. doi: 10.1097/FTD.0000000000000287.

Barcelona Consensus on Biomarker-Based Immunosuppressive Drugs Management in Solid Organ Transplantation.

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*Pharmacology and Toxicology Laboratory, Biomedical Diagnostic Center (CDB), Hospital Clinic of Barcelona, University of Barcelona, Spain; †Klinikum Stuttgart, ZentralInstitut für Klinische Chemie und Laboratoriumsmedizin, Stuttgart, Germany; ‡Departments of Internal Medicine and Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, the Netherlands; §Department of Nephrology, University of Heidelberg, University Hospital Heidelberg and Mannheim, Heidelberg; ¶Medizinische Klinik mit Schwerpunkt Nephrologie, Charité Universitätsmedizin Berlin, Germany; ‖Louvain Centre for Toxicology and Applied Pharmacology, Institut de Recherche Expérimentale et Clinique and Clinical Chemistry Department, Université catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium; **C42 Clinical Research & Development, Department of Anesthesiology, University of Colorado, Aurora; ††Immunology Laboratory, Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain; ‡‡Department of Cardiovascular Surgery, University Heart Center Hamburg, Germany; §§Department of Pharmacology, Oslo University Hospital, Norway; ¶¶U850 INSERM, Université de Limoges, CHU Limoges, France; ‖‖Division of Nephrology and Renal Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands; ***Liver Diseases Department, National Center for Liver Transplantation, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay; †††Department of Drug Chemistry, Faculty of Pharmacy, Medical University of Warsaw, Poland; and ‡‡‡Department of Clinical Pharmacology, University Medical Center Göttingen, Georg-August University, Göttingen, Germany.


With current treatment regimens, a relatively high proportion of transplant recipients experience underimmunosuppression or overimmunosuppression. Recently, several promising biomarkers have been identified for determining patient alloreactivity, which help in assessing the risk of rejection and personal response to the drug; others correlate with graft dysfunction and clinical outcome, offering a realistic opportunity for personalized immunosuppression. This consensus document aims to help tailor immunosuppression to the needs of the individual patient. It examines current knowledge on biomarkers associated with patient risk stratification and immunosuppression requirements that have been generally accepted as promising. It is based on a comprehensive review of the literature and the expert opinion of the Biomarker Working Group of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. The quality of evidence was systematically weighted, and the strength of recommendations was rated according to the GRADE system. Three types of biomarkers are discussed: (1) those associated with the risk of rejection (alloreactivity/tolerance), (2) those reflecting individual response to immunosuppressants, and (3) those associated with graft dysfunction. Analytical aspects of biomarker measurement and novel pharmacokinetic-pharmacodynamic models accessible to the transplant community are also addressed. Conventional pharmacokinetic biomarkers may be used in combination with those discussed in this article to achieve better outcomes and improve long-term graft survival. Our group of experts has made recommendations for the most appropriate analysis of a proposed panel of preliminary biomarkers, most of which are currently under clinical evaluation in ongoing multicentre clinical trials. A section of Next Steps was also included, in which the Expert Committee is committed to sharing this knowledge with the Transplant Community in the form of triennial updates.

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