OBJECTIVES: Our objective is to examine the extent of available evidence on attitudes and barriers towards real-world adoption of Therapeutic Drug Monitoring (TDM), for biological treatments for immune-mediated inflammatory diseases, by any of the relevant stakeholders, such as patients, healthcare professionals, payers, or healthcare decision-makers.

METHODS: A scoping review considered both experimental and quasi-experimental study designs, limited to primary research. A literature search was conducted for journal articles published in the last ten years in the databases PubMed, Medline, EBSCO, and Web of Science. No language limitation was considered for inclusion or exclusion. Abstracts were screened by ten independent reviewers, and a narrative synthesis approach was used to report the evidence.

RESULTS: Of the 7,062 search hits after the removal of duplicates, 218 articles fit the inclusion criteria and were deemed relevant for data extraction. Most of the retrieved literature revolved around biomarkers in inflammatory conditions and assay methods towards qualitative and quantitative identification. The main limitation of our study was the lack of relevant literature concerning all relevant stakeholders.

CONCLUSIONS: We have identified a literature gap in the field of real-world adoption of TDM for biologics in immune-mediated inflammatory diseases. Further research is warranted to develop a more concise strategy that will streamline the use of TDM for biological treatments for immune-mediated inflammatory diseases in current clinical practice and reimbursement systems.