EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases.

To develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs). 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. 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. 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.

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Competing interests: AvT: has received unrestricted research grants from Pfizer, Abbvie, Novartis, UCB and Biogen and consultancy fees from Novartis; AB: has received Grant/research support, fees for consultancies or as a speaker from Abbvie, Amgen, Pfizer, Novartis, BMS, Nordic, Sanofi, Sandoz, Lilly, UCB, Roche; GLG: has acted as a consultant or received speakers fees from AbbVie, Boehringer-Mannheim, Eli Lilly, Novartis, Orion Pharma, Pfizer, Roche and UCB; MJ: has received travel expenses from Abbvie and speakers fees from Grifols in the last 5 years; PDWK: consultancy/speaker fees/sponsorship from Abbvie, Gilead, Lilly, Novartis, Sanofi, Sobi; DM: has acted as a consultant and given lectures on behalf of his institution for Pfizer, Novartis, Grifols; he has been invited to attend an international congress by Janssen-Cilag. His institution received grants for research from the non-governmental organisation Lions Club Tours Val de France; VN-C: has received research grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer, and UCB; MP: speaker or consultancy from Abbvie, Celltrion, Gilead, Lilly, Biogen Janssen- Cilag. Unrestricted educational grants Abbvie, Celgene, Lilly, Roche, Grifols, Biogen; SRS: has received consulting/speaker’s fees from 67 Health, Ampersand Health, Envision Pharma Group, Janssen, and On The Pulse Consultancy, and is an employee of Envision Pharma Group, unrelated to the work presented in this manuscript; JDI: grant income from Pfizer, GSK, Janssen and consultancy/speaker fees/sponsorship from Abbvie, BMS, Gilead, Roche, UCB.