TY - JOUR
T1 - A value proposition for trough level-based anti-TNFα drug dosing
AU - Scharnhorst, V.
AU - Schmitz, E.M.H.
AU - van de Kerkhof, D.
AU - Derijks, L.J.J.
AU - Broeren, M.A.C.
PY - 2019/2/1
Y1 - 2019/2/1
N2 - Treatment of inflammatory bowel diseases and rheumatic disorders with anti-tumor necrosis factor alpha (TNFα) drugs is expensive, while a significant proportion of patients does not show adequate clinical response. Therapeutic drug monitoring (TDM) enables patient-specific anti-TNFα therapy. The role of laboratory tests in clinical care has recently been described in a value proposition framework. It describes care processes, stakeholders, costs, risks, benefits and patient outcomes based on the use of a laboratory test in a clinical care pathway. We have applied this concept to the use of TDM for anti-TNFα drugs, describing evidence that supports the intervention and its cost effectiveness, steps that need to be adjusted in the care pathway, possible treatment algorithms and measures to assess adoption of this framework into clinical practice. For effective TDM, an assay for measurement of drug levels together with appropriate target ranges and an anti-drug-antibody assay have to be implemented. Also, instead of only reporting the drug concentration, laboratorians, pharmacists and clinicians should deliver added value by introducing a TDM-based treatment algorithm into clinical practice. Thus, to maximize effectiveness of TDM of anti-TNFα therapy in routine care, adjustment of current care pathways and cooperation of many stakeholders are needed.
AB - Treatment of inflammatory bowel diseases and rheumatic disorders with anti-tumor necrosis factor alpha (TNFα) drugs is expensive, while a significant proportion of patients does not show adequate clinical response. Therapeutic drug monitoring (TDM) enables patient-specific anti-TNFα therapy. The role of laboratory tests in clinical care has recently been described in a value proposition framework. It describes care processes, stakeholders, costs, risks, benefits and patient outcomes based on the use of a laboratory test in a clinical care pathway. We have applied this concept to the use of TDM for anti-TNFα drugs, describing evidence that supports the intervention and its cost effectiveness, steps that need to be adjusted in the care pathway, possible treatment algorithms and measures to assess adoption of this framework into clinical practice. For effective TDM, an assay for measurement of drug levels together with appropriate target ranges and an anti-drug-antibody assay have to be implemented. Also, instead of only reporting the drug concentration, laboratorians, pharmacists and clinicians should deliver added value by introducing a TDM-based treatment algorithm into clinical practice. Thus, to maximize effectiveness of TDM of anti-TNFα therapy in routine care, adjustment of current care pathways and cooperation of many stakeholders are needed.
KW - Antibodies, Monoclonal/immunology
KW - Dose-Response Relationship, Immunologic
KW - Drug Monitoring/methods
KW - Female
KW - Humans
KW - Male
KW - Tumor Necrosis Factor-alpha/immunology
UR - http://www.scopus.com/inward/record.url?scp=85057875170&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2018.11.038
DO - 10.1016/j.cca.2018.11.038
M3 - Article
C2 - 30521801
AN - SCOPUS:85057875170
VL - 489
SP - 89
EP - 95
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
SN - 0009-8981
ER -