P676 Faecal monitoring is useful in monitoring treatment response in anti-TNF-treated patients

Abstract Background Faecal drug concentration is not routinely measured as per therapeutic drug monitoring strategies in inflammatory bowel disease (IBD) patients receiving anti-TNF therapy. However, our previous research work suggested the importance of faecal drug monitoring of anti-TNF agents since active disease may be present in spite of normal serum anti-TNF levels. The aim of the present study was to examine the correlation between faecal calprotectin and faecal infliximab (IFX) concentration and to evaluate the cut-off value of faecal drug concentration in the respect of faecal calprotectin in patients treated with maintenance IFX therapy. Methods Consecutive patients with IBD receiving maintenance IFX therapy at 1st Department of Medicine, University of Szeged were enrolled in the present study. Faecal samples were obtained before the subsequent IFX infusion. Faecal calprotectin and IFX concentrations were determined with ELISA. The correlation between faecal calprotectin and faecal IFX concentration was statistically assessed. Results Sixty-seven IBD patients were enrolled. Female/male ratio was 49%–51%. Sixty-five point six% of the patients were diagnosed with Crohn’s disease and 34.3% with ulcerative colitis. Mean disease duration was 14.9 years (SD 9.7) at the time of analysis. Mean duration of IFX therapy was 42.3 month (SD 31.6). Twenty-eight point three% of the patients received escalated IFX therapy. Mean faecal calprotectin concentration was 545.7 µg/g (SD 379.4 µg/g). Mean faecal IFX concentration was 1 ng/ml (SD 1.3). Faecal calprotectin and faecal IFX concentration showed significant correlation (r=0.37, p = 0.002). A cut-off value of faecal IFX level of 0.6 ng/ml was determined at faecal calprotectin concentration of 500 µg/g. Conclusion According to our results IFX is detectable in the faeces at a calprotectin concentration of 500 µg/g. The cut-off value for faecal IFX concentration proved to be 0.6 ng/ml. Simultaneous determination of faecal anti-TNF and faecal calprotectin concentration is supposed to have a higher benefit in the evaluation of response to IFX therapy.

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A Practical Guide to Therapeutic Drug Monitoring of Biologic Medications for Inflammatory Bowel Disease

Journal of Clinical Medicine ◽

10.3390/jcm10214990 ◽

2021 ◽

Vol 10 (21) ◽

pp. 4990

Author(s):

Byron P. Vaughn

Keyword(s):

Inflammatory Bowel Disease ◽

Therapeutic Drug Monitoring ◽

Drug Concentration ◽

Bowel Disease ◽

Drug Monitoring ◽

Therapeutic Drug ◽

Serum Drug Concentration ◽

Inflammatory Status ◽

Therapeutic Decisions ◽

Inflammatory Bowel

Therapeutic drug monitoring (TDM) is a useful strategy to optimize biologic medications for inflammatory bowel disease not responsive to standard dosing regimens. TDM is cost effective for anti-tumor necrosis factor agents in the setting of loss of response (reactive TDM). Optimizing drug dosing when patients are in remission (proactive TDM) may be beneficial in certain circumstances. However, frequently the serum drug concentration in isolation becomes the focus TDM. Additionally, the lines of reactive and proactive TDM can quickly blur in many common clinical settings. Physicians employing a TDM based strategy need to place the drug concentration in context with the inflammatory status of the patient, the underlying pharmacokinetics and pharmacodynamics of the drug, the risk of immunogenicity, and the therapeutic goals for the patient. Physicians should understand the limits of TDM and feel comfortable making therapeutic decisions with imperfect information. The goal of this narrative review is to provide a framework of questions that physicians can use to employ TDM effectively in practice.

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Therapeutic drug monitoring with vedolizumab in inflammatory bowel disease

Minerva Gastroenterologica e Dietologica ◽

10.23736/s1121-421x.19.02625-4 ◽

2020 ◽

Vol 65 (4) ◽

Author(s):

Daniela Pugliese ◽

Giuseppe Privitera ◽

Fabrizio Pizzolante ◽

Antonio Gasbarrini ◽

Luisa Guidi ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Therapeutic Drug Monitoring ◽

Bowel Disease ◽

Drug Monitoring ◽

Therapeutic Drug ◽

Inflammatory Bowel

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Faculty Opinions recommendation of Therapeutic Drug Monitoring During Induction of Anti-Tumor Necrosis Factor Therapy in Inflammatory Bowel Disease: Defining a Therapeutic Drug Window.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.728770716.793568133 ◽

2019 ◽

Author(s):

Ashish Patel

Keyword(s):

Inflammatory Bowel Disease ◽

Tumor Necrosis Factor ◽

Therapeutic Drug Monitoring ◽

Bowel Disease ◽

Drug Monitoring ◽

Tumor Necrosis ◽

Therapeutic Drug ◽

Factor Therapy ◽

Inflammatory Bowel ◽

Necrosis Factor

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Disease monitoring of biologic treatment in IBD: early impact and future implications of COVID-19 pandemic

Frontline Gastroenterology ◽

10.1136/flgastro-2020-101563 ◽

2020 ◽

pp. flgastro-2020-101563

Author(s):

Stephanie Shields ◽

Allan Dunlop ◽

John Paul Seenan ◽

Jonathan Macdonald

Keyword(s):

Clinical Care ◽

Chronic Illnesses ◽

Therapeutic Drug ◽

Disease Monitoring ◽

Biologic Treatment ◽

Faecal Calprotectin ◽

Routine Clinical Care ◽

Risk Of Disease ◽

Inflammatory Bowel ◽

The Impact

COVID-19 has dominated life in 2020 with, at the time of writing, over 4.9M global cases and >320 000 deaths. The impact has been most intensely felt in acute and critical care environments. However, with most UK elective work postponed, laboratory testing of faecal calprotectin halted due to potential risk of viral transmission and non-emergency endoscopies and surgeries cancelled, the secondary impact on chronic illnesses such as inflammatory bowel disease (IBD) is becoming apparent. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a dramatic drop in TDM testing since the pandemic onset. April 2020 saw a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing when compared with February 2020 data, a reduction coinciding with the widespread cancellation of outpatient and elective activity. It is feared that disruption to normal patterns of care and disease monitoring of biologic patients could increase the risk of disease flare and adverse clinical outcomes. Urgent changes in clinical practice have been instigated to mitigate the effects of the pandemic on routine clinical care. Further transformations are needed to maintain safe, effective, patient-centred IBD care in the future.

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Rapid point-of-care anti-infliximab antibodies detection in clinical practice: comparison with ELISA and potential for improving therapeutic drug monitoring in IBD patients

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284821999902 ◽

2021 ◽

Vol 14 ◽

pp. 175628482199990

Author(s):

Sonia Facchin ◽

Andrea Buda ◽

Romilda Cardin ◽

Nada Agbariah ◽

Fabiana Zingone ◽

...

Keyword(s):

Clinical Practice ◽

Therapeutic Drug Monitoring ◽

Drug Monitoring ◽

Point Of Care ◽

Drug Clearance ◽

Elisa Test ◽

Enzyme Linked Immunosorbent Assay ◽

Therapeutic Drug ◽

Drug Concentrations ◽

Inflammatory Bowel

Anti-drug antibodies can interfere with the activity of anti-tumor necrosis factor (TNF) agents by increasing drug clearance via direct neutralization. The presence of anti-drug antibodies is clinically relevant when trough drug concentrations are undetectable or sub-therapeutic. However, traditional immunoassay is not easily and rapidly accessible, making the translation of the results into treatment adjustment difficult. The availability of a point-of-care (POC) test for therapeutic drug monitoring (TDM) might represent an important step forward for improving the management of inflammatory bowel disease (IBD) patients in clinical practice. In this pilot study, we compared the results obtained with POC tests with those obtained by enzyme-linked immunosorbent assay (ELISA) in a group of IBD patients treated with Infliximab (IFX). We showed that POC test can reliably detect presence of antibody-to-IFX with 100% of specificity and 76% sensitivity, in strong agreement with the ELISA test ( k-coefficient = 0.84).

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