Can the introduction of rapid testing at the point of care improve the management of common inflammatory disorders, inform changes to medication dosing and provide clinicians with effective tools to improve health outcomes?
Overview of Inflammatory Bowel Disease
Over the past two decades great improvements in therapy of chronic inflammatory diseases have been made. Inflammatory bowel disease (IBD) is a term for two conditions (Crohn’s disease and ulcerative colitis) characterised by chronic inflammation in parts of the gastrointestinal (GI) tract1.
Crohn’s disease can affect any part of the GI tract, whereas ulcerative colitis affects the large intestine and rectum. Both conditions lead to areas of damaged tissue within the GI tract (Crohn’s leads to patches of damaged tissue whereas damage associated with ulcerative colitis is continuous from rectum to colon).
Symptoms and diagnosis
The cause of IBD remains unknown but is linked to deficiencies in the immune system. Inappropriate responses to environmental triggers leads to a range of symptoms including diarrhoea, abdominal pain, bleeding in the rectum with bloody stools, weight loss and fatigue.
Secondary to symptoms of IBD, the diagnosis is confirmed using a range of tools such as endoscopy or colonoscopy, imaging (CT, MRI and contrast radiography) and faecal samples sent to the lab to detect infection.
Once a diagnosis is made a treatment plan is devised to manage the inflammatory processes associated with these conditions. Treatments have traditionally involved the use of aminosalicylates, corticosteroids and immunomodulators. A new class of biologics are now helping patients control inflammatory processes and require therapeutic monitoring to optimise their effectiveness.
True point-of-care for Adalimumab and Infliximab monitoring
The introduction of therapeutic monoclonal antibodies such as adalimumab and infliximab has been a great step forward in managing disease course and can keep inflammations at remission levels for prolonged periods of time, targeting pro-inflammatory cytokine tumour necrosis factor alpha (TNF-α). Therapeutic Drug Monitoring (TDM) of biotherapies is a well-recognized tool allowing clinicians to make evidence-based treatment decisions.
However, all the benefits of TDM for infliximab and adalimumab have not been realised, with current limitations in testing meaning dose adjustments can come weeks after trough level testing. This leads to sub-optimal dosing and doubt around optimising the therapeutic effects.
A new diagnostic rapid testing platform, the ProciseDx™ allows immediate decisions on drug dose adjustments at the time of infusion in only 5 minutes with a finger prick of blood.
Therapeutic drug monitoring of TNFs such as adalimumab has increased over time as doctors improve their treatment of IBD. There is a need to check trough levels before medication to ensure therapeutic levels are maintained. With rapid point of care testing performed during a standard visit with an IBD patient, a clinician can check their levels and adjust medication accordingly, avoiding lengthy waits. Patient samples sent to reference laboratories can take weeks or months for results to be reported which delays changes to dosing.
What do clinicians say?
‘With ProciseDx, we will be able to measure levels of infliximab and adalimumab in five minutes from fingerstick blood. This information during the patient visit will be incorporated into our immediate treatment decisions.’ – Geert D’Haens, Professor of Gastroenterology at AMC & Director of European Operations at Robarts Clinical Trials
Adopting rapid testing in gastroenterology could lead to improved management of these inflammatory disorders and improve patient and clinician experience.
Performance characteristics of the adalimumab and infliximab assays using time-resolved fluorescence resonance energy transfer (trFRET)
Using time-resolved fluorescence resonance energy transfer (trFRET) the donor excites the acceptor fluorophore bound to an antigen or antibody causing light to emit at a specific wavelength. Through specific band pass filters and a silicon photomultiplier within the device, the intensity of the fluorescent signal emitted is converted to Relative Fluorescence Units that are then reported as concentration (µg/mL) using an algorithm.
Refer to the following documents for comparative data on the performance of trFRET versus standard laboratory ELISA assays.
https://poctinnovators.com/wp-content/uploads/2021/11/Poster-ADL-ECCO-21-Padova.pdf
https://poctinnovators.com/wp-content/uploads/2021/11/2021CCF-IFX-ProciseDx-Final.pdf
Visit the ProciseDx vendor pages on POCTInnovators.com for more information on the device and assays available including faecal calprotectin and C-Reactive Protein (CRP). https://poctinnovators.com/vendor/procisedx/
References
1 Centers for Disease Control and Prevention – https://www.cdc.gov/ibd/what-is-IBD.htm
Tony Cambridge is the Managing Director of Thornhill Healthcare Events and Consultancy, and former Lead Biomedical Scientist in the Pathology Management team of a busy acute care hospital in England. He frequently speaks at national and international healthcare events, and is a key opinion leader for point of care testing. He is also a member…
The company was set up in 2018 by Tony Cambridge MSc. BSc. Lead Biomedical Scientist, who is the managing director. With over 20 years experience in Blood Sciences and more recently Pathology management, Tony set out to provide affordable training opportunities to healthcare organisations through a number of different ways, from small group seminars to…