Supporting patient wellbeing through remote monitoring of inflammatory bowel disease

Graham Johnson, Managing Director at BIOHIT HealthCare Ltd

Inflammatory bowel disease (IBD) disrupts the lives of over 250,000 people in the UK, costing the NHS an estimated £720 million per year.¹ The condition is characterised by frequent and unpredictable relapses, with debilitating symptoms – including abdominal pain, diarrhoea and fatigue – significantly affecting quality of life for affected individuals. Ongoing management and close monitoring therefore remain essential to maintain control over disease activity. Historically, this has required attending regular hospital appointments to initiate treatment, for example by infusion in the case of biological therapies, and monitor outcomes through clinical assessments. The disruption caused by multiple routine appointments has been flagged by patients as an important source of difficulty in their lives,² not to mention the burden that this creates for healthcare providers. As a result, there is currently a drive to introduce remote, patient-led IBD self-management,¹ using innovations such as telemedicine, subcutaneous therapy and at-home testing to maintain a good level of care outside of a hospital setting. In this blog, Graham Johnson, Managing Director (UK) and Head of Global Sales for BIOHIT HealthCare, explores some of the latest and up and coming technologies that are empowering IBD patients to take more control over their condition.

Keeping tabs on IBD from the comfort of home

IBD has traditionally been assessed using non-invasive inflammatory serum markers – like C-reactive protein and erythrocyte sedimentation rate – along with disease activity questionnaires and clinical indices, and supported by endoscopy when needed. However, traditional serological markers lack specificity, while colonoscopy – the gold standard for investigating and monitoring inflammation in IBD patients, whether for Crohn’s disease or ulcerative colitis – is invasive, costly, requires expertise and carries some risk.

The identification of faecal calprotectin as a sensitive and specific biomarker for gut inflammation has led to the development of reliable, non-invasive and affordable tests using specific anti-calprotectin antibodies. Regular monitoring of faecal calprotectin levels can help to detect early signs of relapse, enabling timely medical intervention. Assays like our SmarTest^® Calprotectin home test allow Crohn’s and ulcerative colitis patients to monitor their disease activity at home, with results shared with their care team via an app, which also includes clinically validated questionnaires capable of generating accurate patient-reported scores. The SmarTest Calprotectin home test kits are also portable and easy to store, offering patients convenient monitoring wherever they are. This approach empowers patients to initiate follow-ups, potentially improving outcomes by preventing progression to severe symptoms and allowing earlier treatment.

Adopting therapeutic drug monitoring (TDM) to pre-empt loss of drug response

Unfortunately, the varied mechanisms of IBD mean that there is no universal cure. Instead, most treatments focus on controlling inflammation and managing symptoms. The introduction of biologics such as the TNF-α inhibitors like infliximab and adalimumab – along with immunomodulators, and other monoclonal antibodies, such as anti-integrins – has significantly improved IBD management, reducing the need for surgery.³ However, about 30 per cent of IBD patients do not respond to anti-TNF-α therapy initially,⁴ and up to 85 per cent of those who do initially respond, eventually experience loss of response (LOR). In addition, approximately 46 per cent of Crohn’s disease patients stop responding to their treatment within a year of commencing therapy.⁵

LOR often occurs when the immune system develops anti-drug antibodies (ADAs), which reduce the drug’s effectiveness by increasing clearance of the drug, lowering trough levels below the therapeutic range. The PANTS study identified several risk factors for immunogenicity, including obesity, smoking and genetic markers like HLA-DQA1*05.⁶ This diminished drug responsiveness can lead to poor symptom control, with 63 per cent of patients failing to achieve remission after 54 weeks. It also results in wasted resources, costing the NHS up to £2,147 per treatment course.⁷ TDM of TNF-α inhibitor trough levels and ADAs is proving to be effective for guiding the appropriate management of patients who experience secondary LOR when applied reactively in clinical practice.⁸ Assays such as the IDKmonitor^® Infliximab Total Anti-drug Antibody ELISA can detect both drug-bound and free ADAs in a patient’s bloodstream, helping to identify those patients with ADAs even at the early phase. With this knowledge, clinicians can adjust their treatment plans to prevent future non-responsiveness, or optimise dosing to avoid undertreatment, ultimately resulting in improved long-term outcomes for IBD patients.

Paving the way towards personalised IBD care

Remote and decentralised testing could make TDM more accessible and convenient for patients, ensuring timely adjustments to treatment plans based on drug and antibody levels. For instance, the self-administration of subcutaneous infliximab and adalimumab in particular is becoming increasingly common. This highlights the growing need for easy-to-use tests to enable patients to perform TDM in the comfort and privacy of their own homes. One study at the Royal Devon and Exeter NHS Foundation Trust compared patient-led remote intracapillary pharmacokinetic sampling – known as fingerPRICKS – to traditional venepuncture for TDM.⁹ Blood samples were collected via both methods, and analysed in the hospital’s laboratory on our IDKmonitor Total Anti-drug Antibody and Drug Level ELISAs. The results showed that capillary blood samples were analytically equivalent to venous samples for the most widely used drugs – including adalimumab and infliximab – and ADAs.¹⁰ Notably, over 87 per cent of patients found intracapillary sampling at home easy to perform, and 69 per cent preferred it over conventional sampling with repeated hospital visits. Clinicians can order blood test kits to be sent directly to patients’ homes, and patients can then mail their samples to the lab, where our IDKmonitor assays provide accurate assessment of circulating drug levels and total ADAs. This approach offers patients reliable and convenient remote testing without significantly impacting their day-to-day lives, while giving clinicians valuable insights into treatment efficacy, enabling them to make necessary results-based therapeutic adjustments.

Revolutionising the future of IBD treatment

Advancements in the management of IBD are revolutionising how patients engage with their condition and treatment, shifting from a traditionally clinic-centred model to one that empowers patient autonomy. Integrating at-home and patient-led therapies with remote sampling technologies for TDM and faecal calprotectin testing empowers patients to actively monitor and manage their conditions and treatment responses from the comfort of their own homes. Tests that come with a smartphone app also help to maintain proactive communication between patients and healthcare providers, ensuring that doctors have oversight of their patients’ conditions. This shift represents a significant step towards more personalised and responsive care, and has the potential to transform IBD management for better disease outcomes and improved quality of life.

References

1. UK Parliament. (2013). Written evidence from Crohn’s and Colitis UK (LTC 36). Accessed 12^th August 2024. https://publications.parliament.uk/pa/cm201415/cmselect/cmhealth/401/401vw34.htm
2. Popov, J., et al. (2021). Patients’ Experiences and Challenges in Living with Inflammatory Bowel Disease: A Qualitative Approach. Clinical and experimental gastroenterology, 14, 123–131. https://doi.org/10.2147/CEG.S303688
3. Rungoe, C., et al. (2014). Changes in medical treatment and surgery rates in inflammatory bowel disease: a nationwide cohort study 1979-2011. Gut, 63(10), 1607-1616.
4. Hazel, K., and O’Connor, A. (2020). Emerging treatments for inflammatory bowel disease. Therapeutic Advances in Chronic Disease. 11:2040622319899297. doi: 10.1177/2040622319899297. PMID: 32076497; PMCID: PMC7003169.
5. Ben-Horin, S., and Chowers, Y. (2011). Review article: loss of response to anti-TNF treatments in Crohn’s disease. Alimentary Pharmacology & Therapeutics. 33(9), 987-95. doi: 10.1111/j.1365-2036.2011.04612. x. Epub 2011 Mar 2. PMID: 21366636.
6. Kennedy, N, A., et al. (2019). Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease: A prospective, Multicentre, cohort study. The Lancet Gastroenterology & Hepatology, 4(5), 341-353. doi:10.1016/s2468-1253(19)30012-3
7. National Institute of Health and Care Excellence. (2022). PredictSURE IBD and IBDX to guide treatment of Crohn’s disease. https://www.nice.org.uk/guidance/dg45/chapter/3-Evidence
8. Selinger C, P., et al. (2017). Infliximab Therapeutic Drug Monitoring Changes Clinical Decisions in a Virtual Biologics Clinic for Inflammatory Bowel Disease. Inflammatory Bowel Disease. 23(12), 2083-2088.
9. Chee, D., et al. (2022). Patient-led remote intracapillary pharmacoKinetic sampling (fingerPRICKS) for therapeutic drug monitoring in patients with inflammatory bowel disease. Journal of Crohn’s and Colitis. 16(2), 190-198.
10. Perry, M., et al. (2015). Infliximab and adalimumab are stable in whole blood clotted samples for seven days at room temperature. Annals of Clinical Biochemistry,52:672-4.