Gastroenterology


In addition to its reactive use, TDM can be applied proactively through regular measurement of drug and ADA levels, even before any clinical signs of drug unresponsiveness or LOR appear. This proactive approach offers notable advantages: it reduces adverse effects by preventing unnecessary dose escalations, improves patient outcomes by sustaining the therapeutic efficacy of TNF-α inhibitors, and lowers healthcare costs by extending the effective lifespan of these biologics. Preliminary data suggests that proactive TDM may outperform empirical dose optimisation and reactive TDM,18-20


promoting


higher rates of mucosal healing and lowering the risk of hospitalisations and treatment failures.17,21


Limitations and levers for implementing proactive TDM Proactive TDM has demonstrated clear potential for enabling timely interventions and improving patient outcomes in IBD care, yet its adoption among clinicians remains limited. Currently, only 54 per cent of clinicians take advantage of proactive TDM in their practice.16


This modest


uptake is partly due to its recent emergence in the standard of care for IBD, meaning that many healthcare professionals have had limited exposure to its benefits and practical applications.


Challenges in testing A major hurdle in implementing TDM overall is the variability in laboratory testing methods and results.22


earlier stage. However, interpreting results can be complex for both assay types, and greater knowledge among clinicians is essential to interpret and apply results optimally, ensuring the best outcomes for patient care.


Different laboratories may employ


various analysers and assay formulations, leading to inconsistent results that can vary significantly across testing facilities. These inconsistencies make it challenging for clinicians to interpret results with confidence, particularly when the data from different labs aren’t directly comparable. Although the introduction of World Health Organisation (WHO) standard materials has improved overall test consistency, notable discrepancies remain. Much of this challenge stems from ADA monitoring. ADA tests come in two primary formulations: drug-sensitive assays – which detect free antibodies that are not bound to circulating drug – and drug-tolerant assays, which incorporate an acid dissociation step to release ADAs from bound drug to detect total ADAs in the serum, regardless of circulating drug levels.23 Each assay type offers distinct advantages for specific clinical needs; for instance, drug- sensitive assays are particularly effective for reactive monitoring, as they identify antibodies only after a substantial immune response has begun. In contrast, drug-tolerant assays offer a broader measurement, allowing clinicians to capture all ADAs in the serum, and potentially identify issues related to immunogenicity at an


Lack of endorsement Compounding these challenges is the absence of formal endorsement from influential gastroenterology organisations. Although NHS Scotland has led the way by introducing a centrally funded TDM service supporting both proactive and reactive testing,24


this


model has yet to gain official support from the British Society of Gastroenterology (BSG) or the European Crohn’s and Colitis Organisation (ECCO). Without support and approval from these key bodies, many clinicians remain hesitant to fully embrace proactive TDM. This lack of endorsement acts as a substantial barrier to widespread TDM adoption, even as evidence of its benefits accumulates.


Potential for future change Despite these obstacles, ongoing research suggests that proactive TDM could soon play a larger role in clinical practice. For example, the follow-up study from the PANTS cohort25


involved


monitoring of patients’ serum drug levels during the initial phase of ant-TNF management – also known as the loading phase – and found that therapeutic levels achieved at week 14 could predict LOR up to three years later. A clear dose-response relationship emerged: higher drug levels at week 14 correlated with greater likelihood of sustained remission over extended


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