GASTROENTEROLOGY
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
units to patients’ homes – eliminating the need for frequent hospital visits. POC devices are opening the door to real-time adjustments in drug dosing, allowing healthcare providers to fine-tune treatment plans immediately based on up-to-date drug and antibody levels. This advancement is particularly valuable for patients receiving infusions, as clinicians can adjust doses on-site to optimise therapeutic outcomes.
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 periods. This finding suggests that TDM during the early stages of treatment could be key to determining long-term patient outcomes, allowing clinicians to adjust doses early and improve the chances of remission.
Studies like the OPTIMIZE IBD trial26
are also shedding light on how TDM can be used effectively during the loading phase of anti-TNF treatment. This study, which recently finished recruiting participants, is investigating whether proactive monitoring during this phase can improve patient outcomes. If the trial shows clear benefits, it could lead to national and international guidelines formally endorsing proactive TDM. Such an endorsement would likely boost its use and give clinicians greater confidence in incorporating proactive TDM as a key part of a broader IBD management strategy. The overall success of TDM depends on enhanced standardisation of testing, improved endorsement by professional bodies, and increased awareness of the potential benefits of proactive patient monitoring. In addition, innovative solutions like near-patient testing could improve acceptance of the TDM service, by allowing patients to perform drug and antibody level tests at home.
Bringing TDM closer to the patient
The advent of point-of-care (POC) testing is one of the most promising developments in TDM, offering unprecedented accessibility and convenience for patients. POC testing allows TDM to be conducted in a variety of settings – from clinics and infusion
36
– a remote TDM trial conducted during this time – highlighted the significant advantages of decentralised testing. Results showed that capillary blood samples taken via fingerpricks were analytically equivalent to traditional venous samples for measuring ADM and IFX drug levels, as well as ADAs. Additionally, the study found that collected blood samples remained stable in whole, uncentrifuged blood for up to seven days, addressing potential concerns about sample transport and ensuring accuracy even with any potential of delayed processing. A purpose- designed accessibility questionnaire also revealed high patient satisfaction, with many patients finding home collection acceptable, and even preferable, to repeated hospital visits for venepuncture.
Embracing a data-driven future in healthcare Beyond clinical advantages, remote sampling and digital health platforms are empowering patients to play a more active role in their own care. For example, home blood collection kits allow patients to conveniently collect a capillary blood sample from home and send it to a lab for analysis using validated IDKmonitor® TDM assays. Results are then delivered digitally, minimising the need for in-person appointments and reducing travel, while freeing up healthcare resources. This remote access to TDM also supports a more flexible and patient-centred approach, aligning treatment with each patient’s specific physiological response. Looking forward, advances in TDM technology hold exciting potential for revolutionising IBD management. Self- testing kits are currently being explored, an innovation that would empower patients to monitor drug levels from home, granting them unprecedented control over their treatment. Improvements in biomarker analysis are set to enhance immunogenicity
The use of POC devices for remote testing became especially relevant during the COVID-19 pandemic, when in-person appointments were limited. The Patient-led Remote IntraCapillary pharmacoKinetic Sampling (fingerPRICKS) study27
assessments, allowing clinicians to identify patients at risk of LOR with greater accuracy. Genetic testing focusing on biomarkers like the HLA-DQA1*05 allele may also enable more personalised treatment plans, by predicting individual responses to TNF-α inhibitors prior to commencing treatment.
The integration of TDM data with digital health monitoring systems presents another transformative step forward. By combining TDM results with other health metrics – such as symptoms, inflammatory markers, dietary habits and lifestyle factors – clinicians will gain a comprehensive view of each patient’s overall health. This holistic approach enables more precise and tailored adjustments to treatment, ensuring that each patient receives care optimised to their unique physiological profile.
A new era in personalised IBD care
As TDM technologies evolve, the future of IBD care promises to be more personalised, data-driven, and patient- centred than ever before. Clinicians are now equipped with tools to make informed, proactive decisions, while patients gain greater autonomy over their health through at-home monitoring. With its potential to anticipate LOR, streamline therapeutic strategies and support early intervention, TDM is set to redefine the future of IBD care, driving better patient outcomes and enhancing quality of life for people around the world.
References n References for this article are available upon
request.
Acknowledgement n This article first appeared in
The Clinical Services Journal (CSJ. 2025 Mar; 24[3]: 51-4) and is reproduced here by kind permission.
Graham Johnson is Managing Director (UK) and Head of Global Sales at BIOHIT HealthCare, the UK subsidiary of BIOHIT Oyj. With over 20 years at the BIOHIT Group, Graham combines a background in biomedical science with extensive industry experience to drive innovation in diagnostics and gastrointestinal health solutions.
To dive deeper into these
advancements and understand the latest trends in TDM, we encourage you to watch the recent webinar sponsored by BIOHIT HealthCare. View the webinar at: the webinar at:
https://bit.ly/PIP-IBDweb MAY 2025
WWW.PATHOLOGYINPRACTICE.COM
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