TY - JOUR
T1 - EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases
AU - Krieckaert, Charlotte L. M.
AU - van Tubergen, Astrid
AU - Gehin, Johanna Elin
AU - Hernández-Breijo, Borja
AU - le Mélédo, Guillaume
AU - Balsa, Alejandro
AU - Böhm, Peter
AU - Cucnik, Sasa
AU - Elkayam, Ori
AU - Goll, Guro L.
AU - Hooijberg, Femke
AU - Jani, Meghna
AU - Kiely, Patrick D. W.
AU - McCarthy, Neil
AU - Mulleman, Denis
AU - Navarro-Compán, Victoria
AU - Payne, Katherine
AU - Perry, Martin E.
AU - Plasencia-Rodriguez, Chamaida
AU - Stones, Simon R.
AU - Syversen, Silje Watterdal
AU - de Vries, Annick
AU - Ward, Katherine M.
AU - Wolbink, Gertjan
AU - Isaacs, John D.
N1 - Funding Information: This project was funded by EULAR (project number CLI114). Funding Information: Work in JDI’s laboratory is supported by the National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre for Ageing and Long Term Conditions, and the Research Into Inflammatory Arthritis Centre Versus Arthritis. JDI is an NIHR Senior Investigator. MJ is funded by an (NIHR) Advanced Fellowship (NIHR301413). The authors thank the librarians of the Paris Descartes University, the Spanish Society of Rheumatology (SER), the Medical Library, Division of Rheumatology and Research, Diakonhjemmet Hospital and the Amsterdam Rheumatology and immunology Center|Reade for their assistance defining the terms of the search on the technical aspects of TDM. Publisher Copyright: © 2022 Authors. All rights reserved.
PY - 2022/5/12
Y1 - 2022/5/12
N2 - Objective To develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs). Methods The points-to-consider were developed in accordance with EULAR standardised operation procedures by a multidisciplinary task force from eight European countries, based on a systematic literature review and expert consensus. Level of evidence and strength of the points-to-consider were determined, and mean levels of agreement among the task force were calculated using a 10-point rating scale. Results Six overarching principles and 13 points-to-consider were formulated. The level of agreement among the task force for the overarching principles and points-to-consider ranged from 8.4 to 9.9.The overarching principles define TDM and its subtypes, and reinforce the underlying pharmacokinetic/pharmacodynamic principles, which are relevant to all biopharmaceutical classes. The points-to-consider highlight the clinical utility of the measurement and interpretation of biopharmaceutical blood concentrations and antidrug antibodies in specific clinical scenarios, including factors that influence these parameters. In general, proactive use of TDM is not recommended but reactive TDM could be considered in certain clinical situations. An important factor limiting wider adoption of TDM is the lack of both high quality trials addressing effectiveness and safety of TDM and robust economic evaluation in patients with RMDs. Future research should focus on providing this evidence, as well as on further understanding of pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals. Conclusion These points-to-consider are evidence-based and consensus-based statements for the use of TDM of biopharmaceuticals in inflammatory RMDs, addressing the clinical utility of TDM.
AB - Objective To develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs). Methods The points-to-consider were developed in accordance with EULAR standardised operation procedures by a multidisciplinary task force from eight European countries, based on a systematic literature review and expert consensus. Level of evidence and strength of the points-to-consider were determined, and mean levels of agreement among the task force were calculated using a 10-point rating scale. Results Six overarching principles and 13 points-to-consider were formulated. The level of agreement among the task force for the overarching principles and points-to-consider ranged from 8.4 to 9.9.The overarching principles define TDM and its subtypes, and reinforce the underlying pharmacokinetic/pharmacodynamic principles, which are relevant to all biopharmaceutical classes. The points-to-consider highlight the clinical utility of the measurement and interpretation of biopharmaceutical blood concentrations and antidrug antibodies in specific clinical scenarios, including factors that influence these parameters. In general, proactive use of TDM is not recommended but reactive TDM could be considered in certain clinical situations. An important factor limiting wider adoption of TDM is the lack of both high quality trials addressing effectiveness and safety of TDM and robust economic evaluation in patients with RMDs. Future research should focus on providing this evidence, as well as on further understanding of pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals. Conclusion These points-to-consider are evidence-based and consensus-based statements for the use of TDM of biopharmaceuticals in inflammatory RMDs, addressing the clinical utility of TDM.
KW - Arthritis, Psoriatic
KW - Arthritis, Rheumatoid
KW - Biological Therapy
KW - Pharmacokinetics
KW - Spondylitis, Ankylosing
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85145491757&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/35551063
UR - http://www.scopus.com/inward/record.url?scp=85145491757&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/annrheumdis-2022-222155
DO - https://doi.org/10.1136/annrheumdis-2022-222155
M3 - Article
C2 - 35551063
SN - 0003-4967
VL - 82
SP - 65
EP - 73
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 1
ER -