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

Therapeutic Drug Monitoring:  April 2016 – Volume 38 – Issue 2 – p S1–S20
Brunet, Mercè PhD; Shipkova, Maria MD; van Gelder, Teun MD, PhD; Wieland, Eberhard MD; Sommerer, Claudia MD; Budde, Klemens MD, PhD; Haufroid, Vincent PharmD, PhD; Christians, Uwe MD, PhD; López-Hoyos, Marcos MD, PhD; Barten, Markus J. MD; Bergan, Stein PhD; Picard, Nicolas PharmD, PhD; Millán López, Olga PhD; Marquet, Pierre MD, PhD; Hesselink, Dennis A. MD, PhD; Noceti, Ofelia PharmD, PhD; Pawinski, Tomasz MD; Wallemacq, Pierre PharmD, PhD; Oellerich, Michael MD

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Abstract: 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 IATDMCT. 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.