Table 2

Scientific agenda

1. Pharmacokinetic/pharmacodynamic models
 

  • What is the critical minimal blood concentration of a specific biopharmaceutical in inflammatory RMDs for efficacy of the drug and for optimal target binding?

 

  • At what blood concentration does a specific biopharmaceutical reach its maximum pharmacodynamic effect?

 

  • What pharmacokinetic models exist for biopharmaceuticals in inflammatory RMDs?

 

  • What is the interpatient variability in pharmacokinetics and pharmacodynamics with biopharmaceuticals?

 

  • Can patient characteristics or biomarkers predict ADAb development?

2. Prospective studies/RCTs
 

  • Prospective studies comparing TDM with standard of care with regard to clinical utility and cost-effectiveness of TDM, for a range of biopharmaceuticals in different inflammatory RMDs.

 

  • Prospective studies comparing proactive and reactive TDM, with regard to clinical utility and cost-effectiveness of TDM.

 

  • Prospective tapering studies comparing TDM and standard of care.

 

  • Prospective switching studies comparing TDM and standard of care.

3. Adverse event studies
 

  • Cohort or registry studies to evaluate the role of high biological drug levels in risk of infections.

 

  • Cohort or registry studies to seek association of ADAb with specific adverse events/side effects, for example, injection site reactions, infusion reactions, hypersensitivity reactions (immediate and delayed).

4. Economic evaluations
 

  • Economic analyses specific to the relevant clinical context to quantify the incremental costs and consequences of TDM compared with the current practice of prescribing biopharmaceuticals for people with inflammatory RMDs

5. International collaborative opportunities
 

  • Development of an international biobank/databank to facilitate guidance on recommended pharmacokinietic/pharmacodynamic parameters for distinct biopharmaceuticals in different inflammatory arthritides.

 

  • What is the ‘minimal data set’ required to provide confidence around TDM of distinct biopharmaceuticals prescribed for different inflammatory RMDs?

 

  • Can this ‘minimal data set’ be integrated into intuitive models suitable for remote monitoring (eg, via smartphone applications)?

6. The patient perspective

  • Exploration of patient knowledge and preferences about TDM, including how they view its usefulness as part of shared decision making?

  • ADAb, antidrug antibody; RCT, randomised controlled trial; RMDs, rheumatic and musculoskeletal diseases; TDM, therapeutic drug monitoring.