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

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

Publicated to:ANNALS OF THE RHEUMATIC DISEASES. 82 (1): 65-73 - 2022-05-12 82(1), DOI: 10.1136/annrheumdis-2022-222155

Authors: Krieckaert CLM; Van Tubergen A; Gehin JE; Hernández-Breijo B; Le Mélédo G; Balsa A; Böhm P; Cucnik S; Elkayam O; Goll GL; Hooijberg F; Jani M; Kiely PDW; McCarthy N; Mulleman D; Navarro-Compán V; Payne K; Perry ME; Plasencia-Rodriguez C; Stones SR; Syversen SW; De Vries A; Ward KM; Wolbink G; Isaacs JD

Affiliations

Amsterdam Rheumatology and Immunology Center - Author

Centre for Epidemiology Versus Arthritis , Salford Royal NHS Foundation Trust - Author

Centre Hospitalier Regional et Universitaire de Tours - Author

Collaboro Consulting - Author

Collaboro Consulting, EULAR Patient Res Partner, Manchester, Lancs, England - Author

Deutsch Rheuma Liga Bundesverband, Bonn, Germany - Author

Diakonhjemmet Hosp, Dept Rheumatol, Oslo, Norway - Author

Diakonhjemmet Hosp, Rheumatol & Res, Oslo, Norway - Author

Diakonhjemmet Sykehus - Author

Diakonhjemmet Univ Coll & Hosp, Rheumatol, Oslo, Norway - Author

Diakonhjemmet University College - Author

Forschungspartner - Author

Hospital Universitario La Paz - Author

La Paz Univ Hosp, Immunorheumatol Res Grp, Madrid, Spain - Author

La Paz Univ Hosp, Rheumatol, Madrid, Spain - Author

Ljubljanski Univ, Klin Ctr, Rheumatol, Ljubljana, Slovenia - Author

Maastricht Univ, Care & Publ Hlth Res Inst, CAPHRI, Maastricht, Netherlands - Author

Maastricht Univ, Med Ctr, Div Rheumatol, Med, Maastricht, Netherlands - Author

Manchester Acad Hlth Sci Ctr, Div Populat Hlth, Hlth Serv Res & Primary Care, Manchester, Lancs, England - Author

Manchester Univ NHS Fdn Trust, Arthrit Res UK Ctr Epidemiol, Manchester, Lancs, England - Author

Manchester Univ NHS Fdn Trust, NIHR Manchester Biomed Res Ctr, Manchester, Lancs, England - Author

Manchester University NHS Foundation Trust , Health Innovation Manchester - Author

Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England - Author

Newcastle University , The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Author

Newcastle Upon Tyne Hosp NHS Fdn Trust, Manchester, Lancs, England - Author

Newcastle Upon Tyne Hosp NHS Fdn Trust, Musculoskeletal Unit, Newcastle Upon Tyne, Tyne & Wear, England - Author

Oslo Univ Hosp, Dept Med Biochem, Oslo, Norway - Author

Oslo Universitetssykehus , Medisinske Fakultet - Author

Reade Hoofdlocatie Dr Jan van Breemenstr, Rheumatol, Amsterdam, Netherlands - Author

Reade Hoofdlocatie Dr Jan van Breemenstraat - Author

Reade, Amsterdam Rheumatol & Immunol Ctr, Reumatol, Amsterdam, Netherlands - Author

Reg Univ Hosp Ctr Tours, Rheumatol, Tours, France - Author

Royal Alexandra Hosp, Ctr Rheumat Dis, Paisley, Renfrew, Scotland - Author

Royal Alexandra Hospital - Author

Salford Royal NHS Fdn Trust, Rheumatol, Salford, Lancs, England - Author

Sanquin Res, Amsterdam, Netherlands - Author

Sanquin Res, Immunopathol, Amsterdam, Netherlands - Author

Sanquin Research - Author

Sanquin Research , Amsterdam Rheumatology and Immunology Center - Author

St George's University Hospitals NHS Foundation Trust - Author

St Georges Univ Hosp NHS Fdn Trust, Dept Rheumatol, London, England - Author

St Georges Univ Hosp NHS Fdn Trust, Inst Med & Biochem Educ, London, England - Author

Tel Aviv Sourasky Med Ctr, Rheumatol, Tel Aviv, Israel - Author

Tel Aviv Sourasky Medical Center - Author

The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Author

Univ Ljubljana, Fac Pharm, Ljubljana, Slovenia - Author

Univ Oslo, Fac Med, Oslo, Norway - Author

Univ Tours, Dept Rheumatol, Tours, France - Author

Université de Tours - Author

Universiteit Maastricht - Author

Univerza v Ljubljani , Univerzitetni Klinični Center Ljubljana - Author

Abstract

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.

Keywords

arthritis, psoriaticarthritis, rheumatoidbiological therapypharmacokineticsArthritis, psoriaticArthritis, rheumatoidBiological therapyPharmacokineticsSpondylitis, ankylosing

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal ANNALS OF THE RHEUMATIC DISEASES due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position 2/34, thus managing to position itself as a Q1 (Primer Cuartil), in the category Rheumatology. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 4.47. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

Weighted Average of Normalized Impact by the Scopus agency: 7.27 (source consulted: FECYT Feb 2024)
Field Citation Ratio (FCR) from Dimensions: 29.16 (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-23, the following number of citations:

WoS: 16
Scopus: 48
OpenCitations: 37

Impact and social visibility

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: France; Germany; Israel; Netherlands; Norway; Slovenia; United Kingdom.

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