New guideline on proactive therapeutic drug monitoring (TDM) in inflammatory diseases

A REMEDY-led international panel has developed the guidelines based on the best available research. The underlying question: Can proactive TDM improve treatment outcomes for adults with inflammatory bowel disease, inflammatory arthritis, or psoriasis using biologics compared to standard care?

There are three main recommendations:

• Recommendation 1: Maintenance treatment with intravenous infliximab
  • Standard treatment : Reactive or no monitoring.
  • Proactive monitoring : Weak recommendation for proactive TDM.
  • Description: The panel suggests proactive TDM for patients on maintenance treatment with infliximab.
• Recommendation 2: Maintenance treatment with adalimumab or other biological drugs
  • Standard treatment : Reactive or no monitoring.
  • Proactive monitoring : Weak recommendation against proactive TDM.
  • Description: The panel does not recommend proactive TDM for maintenance treatment with adalimumab or other biological drugs.
    
    
• Recommendation 3: Start of treatment (induction) with infliximab, adalimumab or other biological drugs
  • Standard treatment : Reactive or no monitoring.
  • Proactive monitoring : Weak recommendation against proactive TDM.
  • Description: The panel does not recommend proactive TDM when starting treatment with these biological drugs.

Content in BMJ

Content in MAGICapp

About the recommendations:

The work on the recommendations is led by REMEDY. The first authors are Eirik Klami Kristianslund at Diakonhjemmet hospital and Leticia Kawano-Dourado at MAGIC. The recommendations are largely based on the NOR-DRUM studies.

The international panel has been put together by the MAGIC Evidence Ecosystem Foundation and The BMJ in connection with the BMJ Rapid Recommendations series. This series focuses on providing clinicians with credible recommendations based on up-to-date and potentially practice-changing research.

Proactive TDM involves regular measurement of drug levels in the blood and adjustment of dosage to reach optimal levels, regardless of symptoms.

Decisions about the use of proactive TDM should be based on the patient's values ​​and preferences, as well as the availability of laboratory tests. More studies are needed to clarify the effect of proactive TDM.

The panel consisted of patient representatives, clinicians (including rheumatologists, gastroenterologists, dermatologists and clinical pharmacologists) and methodologists.

To develop the guideline, the panel followed recognized standards for reliable guidelines, where they applied the GRADE method (Grading of Recommendations, Assessment, Development, and Evaluation). The GRADE approach provides a structured assessment of the advantages, disadvantages and burdens of treatment from an individual patient perspective. This also included analyzes of uncertainty in research, practical challenges and variation in practice between different countries. Patient representatives contributed valuable input regarding values ​​and preferences, which ensured that the recommendations resonated with patients' needs and perspectives.

The recommendations are based on a linked systematic review and meta-analysis of 10 randomized controlled trials with a total of 2383 participants. This research, which was analyzed in MAGICapp, provides detailed information on the evidence base, methodology and an algorithm for implementing proactive TDM, which can be adapted to national or local guidelines.

The panel consisted of professionals with no financial conflicts of interest, and The BMJ and MAGIC ensured that professional and academic conflicts of interest were managed to ensure objectivity.

Key people 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 systematic review and use of the GRADE methodology.
• Patient representatives : Arne Schatten and Camilla Stabell contributed with insight into patient preferences and experiences.