TY - JOUR T1 - EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis DO - 10.1136/annrheumdis-2022-222155 SP - annrheumdis-2022-222155 AU - Charlotte LM Krieckaert AU - Astrid van Tubergen AU - Johanna Elin Gehin AU - Borja Hernández-Breijo AU - Guillaume Le Mélédo AU - Alejandro Balsa AU - Peter Böhm AU - Sasa Cucnik AU - Ori Elkayam AU - Guro L Goll AU - Femke Hooijberg AU - Meghna Jani AU - Patrick DW Kiely AU - Neil McCarthy AU - Denis Mulleman AU - Victoria Navarro-Compán AU - Katherine Payne AU - Martin E Perry AU - Chamaida Plasencia-Rodriguez AU - Simon R Stones AU - Silje Watterdal Syversen AU - Annick de Vries AU - Katherine M Ward AU - Gertjan Wolbink AU - John D Isaacs Y1 - 2022/05/11 UR - http://ard.bmj.com/content/early/2022/05/23/annrheumdis-2022-222155.abstract 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. ER -