Alfons A den Broeder1,2, Noortje van Herwaarden1, Bart J F van den Bemt3,4. 1. Department of Rheumatology, Sint Maartenskliniek. 2. Department of Rheumatology, Radboudumc. 3. Department of Pharmacy, Sint Maartenskliniek. 4. Department of Pharmacy, Radboudumc, Nijmegen, the Netherlands.
Abstract
PURPOSE OF REVIEW: To give an overview of recently published articles covering therapeutic drug monitoring (TDM) of biological DMARDs (bDMARDs) in rheumatoid arthritis. RECENT FINDINGS: In the last 18 months, two clinical studies and nine reviews were found after a systematic literature search. Most (narrative) reviews conclude that TDM should be used to improve biological treatment in rheumatoid arthritis patients, whereas most of the clinical studies (including 13 studies identified earlier) whenever scrutinized do not support this conclusion. This disconnect between sobering data from prediction studies and test-treatment diagnostic studies and optimistic TDM beliefs in reviews is caused by failure to recognize incorrect study designs, false positives because of lack of validation after explorative multiple testing, cherry picking of studies, and incorrect interpretation of test characteristics. SUMMARY: Serum (anti)-drug level monitoring has been extensively studied in rheumatoid arthritis, but correctly designed and executed interventional prediction studies or test-treatment intervention studies are sparse and mostly negative. In contrast, many reviews advocate use of biological TDM in rheumatoid arthritis. On the basis of current evidence, therapeutic drug monitoring of biologicals cannot be recommended in the treatment of rheumatoid arthritis patients, although two clinical scenarios deserve further study.
PURPOSE OF REVIEW: To give an overview of recently published articles covering therapeutic drug monitoring (TDM) of biological DMARDs (bDMARDs) in rheumatoid arthritis. RECENT FINDINGS: In the last 18 months, two clinical studies and nine reviews were found after a systematic literature search. Most (narrative) reviews conclude that TDM should be used to improve biological treatment in rheumatoid arthritispatients, whereas most of the clinical studies (including 13 studies identified earlier) whenever scrutinized do not support this conclusion. This disconnect between sobering data from prediction studies and test-treatment diagnostic studies and optimistic TDM beliefs in reviews is caused by failure to recognize incorrect study designs, false positives because of lack of validation after explorative multiple testing, cherry picking of studies, and incorrect interpretation of test characteristics. SUMMARY: Serum (anti)-drug level monitoring has been extensively studied in rheumatoid arthritis, but correctly designed and executed interventional prediction studies or test-treatment intervention studies are sparse and mostly negative. In contrast, many reviews advocate use of biological TDM in rheumatoid arthritis. On the basis of current evidence, therapeutic drug monitoring of biologicals cannot be recommended in the treatment of rheumatoid arthritispatients, although two clinical scenarios deserve further study.
Authors: Charlotte Krieckaert; Borja Hernández-Breijo; Johanna Elin Gehin; Guillaume le Mélédo; Alejandro Balsa; Meghna Jani; Denis Mulleman; Victoria Navarro-Compan; Gertjan Wolbink; John Isaac; Astrid van Tubergen Journal: RMD Open Date: 2022-06
Authors: Nils Bolstad; Hilde Berner Hammer; Johanna Elin Gehin; Silje Watterdal Syversen; David John Warren; Guro Løvik Goll; Joseph Sexton Journal: RMD Open Date: 2021-12