New guideline on proactive therapeutic drug monitoring (TDM) in inflammatory diseases
A REMEDY-led international panel has developed new guidelines based on the best available research, with studies from REMEDY (NOR-DRUM) as a key part of the evidence base. The underlying question: Can proactive TDM improve treatment outcomes for adults with inflammatory bowel disease, inflammatory arthritis or psoriasis using biologics, compared with standard of care?
Proactive TDM involves regularly measuring drug levels in the blood and adjusting dosage to reach optimal levels, regardless of symptoms.
There are three main recommendations:
- Recommendation 1: The panel suggests proactive TDM for patients on maintenance treatment with infliximab.
- Recommendation 2: The panel does not recommend proactive TDM for maintenance treatment with adalimumab or other biologics.
- Recommendation 3: The panel does not recommend proactive TDM when initiating treatment with infliximab, adalimumab, or other biologics
Decisions about the use of proactive TDM should be based on patient values and preferences, as well as the availability of laboratory tests. More studies are needed to clarify the effects of proactive TDM of biologics, especially for drugs other than infliximab.
Contents in BMJ
Contents in MAGICapp
About the development of the recommendations:
The work on the recommendations is led by REMEDY, and is part of the “BMJ Rapid Recommendations” series, which is carried out as a collaboration between MAGIC and The BMJ. This series focuses on providing clinicians with credible recommendations based on up-to-date and potentially practice-changing research. An international panel of patient representatives, clinicians (including rheumatologists, gastroenterologists, dermatologists and clinical pharmacologists) and method experts developed the recommendations, and was led by Eirik Klami Kristianslund at Diakonhjemmet Hospital and Leticia Kawano-Dourado at MAGIC.
The recommendation is based on a systematic review and meta-analysis of 10 randomized controlled trials with a total of 2383 participants. The panel followed the recognized GRADE method (Grading of Recommendations, Assessment, Development, and Evaluation). It provides a structured assessment of the benefits, harms, and burdens of treatment from an individual patient perspective. This also includes analyses of uncertainty in the research, practical challenges, and variation in practice between different countries. Patient representatives contributed valuable input on values and preferences, which ensured that the recommendations resonated with patients' needs and perspectives. The work has been done in such a way that it can be easily adapted to national or local guidelines. Parts of the new Norwegian recommendations on the use of TDM in rheumatology are already based on this recommendation ( https://metodebok.no/index.php?action=topic&item=3RYp5hX9 ).
Key individuals who participated in the work include:
- Clinical experts : First author Eirik Klami Kristianslund (rheumatologist), Tine Jess (gastroenterologist), Catherine Smith (dermatologist), Andrew Owen (pharmacologist) and several other specialists from various fields.
- Methodologists : First author Leticia Kawano-Dourado, Per Olav Vandvik, Gordon Guyatt, Thomas Agoritsas, and Dena Zeraatkar, who led the work on the systematic review and use of the GRADE methodology.
- Patient representatives : Arne Schatten and Camilla Stabell contributed insight into patient preferences and experiences.
The professionals had no financial conflicts of interest, and The BMJ and MAGIC ensured that professional and academic conflicts of interest were managed to ensure objectivity.
