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Mistakes in therapeutic drug monitoring of biologics in IBD and how to avoid them

Adam Cheifetz, Konstantinos Papamichail

Summary

AI Generated

Therapeutic drug monitoring of biologics in inflammatory bowel disease can address primary non-response and secondary loss of response, which affect up to one-third and half of patients respectively.

  • Up to one-third of IBD patients are primary non-responders to biological therapy, and up to half lose response over time due to pharmacodynamic failure, pharmacokinetic issues, or immunogenicity with anti-drug antibodies.
  • Reactive therapeutic drug monitoring measures drug concentrations and anti-drug antibody levels when primary non-response or secondary loss of response occurs to help explain and manage these outcomes.
  • Proactive therapeutic drug monitoring involves routinely measuring drug concentrations and antibodies to achieve and maintain targeted therapeutic levels.
  • The material addresses common mistakes and errors to avoid when using therapeutic drug monitoring of biologics in IBD patients, based on available evidence and clinical experience.
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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

References

Mistakes
References
Mistake 1 Mistake 2 Mistake 3 Mistake 4 Mistake 5 Mistake 6 Mistake 7 Mistake 8 Mistake 9 Mistake 10
1.
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2.
Roblin X, Rinaudo M, Tedesco E, et al. Development of an algorithm incorporating pharmacokinetics of adalimumab in inflammatory bowel diseases. Am J Gastroenterol 2014; 109: 1250-1256.
3.
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4.
Kelly OB, Donnell SO, Stempak JM, et al. Therapeutic drug monitoring to guide infliximab dose adjustment is associated with better endoscopic outcomes than clinical decision making alone in active inflammatory bowel disease. Inflamm Bowel Dis 2017; 23:1202–1209.
5.
Marquez-Megias S, Nalda-Molina R, Sanz-Valero J, et al. Cost-effectiveness of therapeutic drug monitoring of anti-tnf therapy in inflammatory bowel disease: a systematic review. Pharmaceutics 2022; 14: 1009.
6.
Cheifetz AS, Abreu MT, Afif W, et al. A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease. Am J Gastroenterol 2021; 116: 2014-2025.
7.
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8.
Kang B, J S Moon, Y J Lee, et al. Proactive dosing is superior to clinically based dosing in terms of endoscopic healing in paediatric patients with Crohn’s disease receiving maintenance infliximab: A randomized controlled trial. J Crohn's Colitis 2023; 17(Supplement_1): i159.
9.
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16.
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19.
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20.
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21.
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22.
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25.
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Abstract

Biological therapy has revolutionised the treatment of moderate to severe inflammatory bowel disease (IBD), namely Crohn’s disease (CD) and ulcerative colitis (UC). However, up to one-third of patients with IBD are primary non-responders, and up to half can lose response over time.These unwanted outcomes can be explained by either pharmacodynamic (mechanistic failure) or pharmacokinetic (PK) issues with or without the development of anti-drug antibodies (ADA), so-called immunogenicity.1 Reactive therapeutic drug monitoring (TDM), defined as the measurement of drug concentrations and anti-drug antibody (ADA) levels in the setting of primary non-response (PNR) or secondary loss of response (SLR), can help to explain better and manage these unwanted outcomes. However, it would make sense to try to prevent PNR and SLR by routinely measuring drug concentrations and ADA to achieve and maintain a targeted therapeutic drug concentration, the so-called proactive TDM. Here we discuss some common mistakes and significant errors to avoid when utilising TDM of biologics in patients with IBD. The discussion is based on evidence, whenever possible, and our clinical experience and perception of the field.

Topics

IBD

Citation

Konstantinos Papamichail and Adam S. Cheifetz. Mistakes in therapeutic drug monitoring of biologics in IBD and how to avoid them. UEG Education 2023; 23: 13-18.

Published

2023

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Mistakes in abdominal distension and how to avoid them

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References

Mistakes
References
Mistake 1 Mistake 2 Mistake 3 Mistake 4 Mistake 5 Mistake 6 Mistake 7 Mistake 8 Mistake 9 Mistake 10
1.
Fine S, Papamichael K, Cheifetz AS, et al. Etiology and management of lack or loss of response to anti-tumor necrosis factor therapy in patients with inflammatory bowel disease. Gastroenterol Hepatol (N Y) 2019; 15: 656-665.
2.
Roblin X, Rinaudo M, Tedesco E, et al. Development of an algorithm incorporating pharmacokinetics of adalimumab in inflammatory bowel diseases. Am J Gastroenterol 2014; 109: 1250-1256.
3.
Yanai H, Lichtenstein L, Assa A, et al. Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab. Clin Gastroenterol Hepatol 2015; 13: 522-530.
4.
Kelly OB, Donnell SO, Stempak JM, et al. Therapeutic drug monitoring to guide infliximab dose adjustment is associated with better endoscopic outcomes than clinical decision making alone in active inflammatory bowel disease. Inflamm Bowel Dis 2017; 23:1202–1209.
5.
Marquez-Megias S, Nalda-Molina R, Sanz-Valero J, et al. Cost-effectiveness of therapeutic drug monitoring of anti-tnf therapy in inflammatory bowel disease: a systematic review. Pharmaceutics 2022; 14: 1009.
6.
Cheifetz AS, Abreu MT, Afif W, et al. A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease. Am J Gastroenterol 2021; 116: 2014-2025.
7.
Sethi S, Dias S, Kumar A, et al. Meta-analysis: the efficacy of therapeutic drug monitoring of anti-TNF-therapy in inflammatory bowel disease. Aliment Pharmacol Ther 2022. Online ahead of print. [Link]
8.
Kang B, J S Moon, Y J Lee, et al. Proactive dosing is superior to clinically based dosing in terms of endoscopic healing in paediatric patients with Crohn’s disease receiving maintenance infliximab: A randomized controlled trial. J Crohn's Colitis 2023; 17(Supplement_1): i159.
9.
Bergqvist V, Holmgren J, Klintman D, Marsal J. Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2022;55:1389–1401.
10.
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Abstract

Abdominal distension and bloating are among the most frequently misunderstood complaints in gastroenterology. They are often used as interchangeable terms, a conceptual mistake that continues to drive diagnostic errors and ineffective treatment. According to Rome IV, bloating and distension may represent either a primary disorder of gut–brain interaction (DGBI) or occur as symptoms with other DGBIs, such as irritable bowel syndrome (IBS), functional dyspepsia (FD) or functional constipation (FC).

Topics

Neurogastroenterology & Motility

Citation

Barba E and Ezquerra-Durán A. Mistakes in abdominal distension and bloating and how to avoid them. UEG Education 2026; 26: 5-9.

Published

2026

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References

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25.
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Abstract

Peritoneal malignancies represent a complex and often misjudged clinical challenge. Historically synonymous with a terminal diagnosis, the advent of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) radically altered the prognosis for selected patients. However, progress has been jeopardised by a series of recurring and preventable errors in diagnosis, staging, and treatment selection. This article delineates the ten most critical pitfalls in managing peritoneal surface malignancies. For each pitfall, we provide evidence-based explanations, concrete clinical examples, and strategic recommendations for avoidance. We emphasise the pivotal role of early multidisciplinary discussion, precise imaging, and timely referral to high-volume expert centres to optimise patient outcomes and offer curative intent where previously there was none.

Topics

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Abstract

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Asma Fikree

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References

Mistakes
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Abstract

The term ‘gastroparesis’ was first coined by Kassander in 1958 to describe the fact that barium did not leave the stomach of patients with diabetes for over 24 hours — so-called ‘gastroparesis diabeticorum’. Nowadays it refers to a delay in gastric emptying that is associated with symptoms primarily of nausea and vomiting as well as the absence of mechanical obstruction. In 1958, 21 cases were described, but in 2019, 5 million US individuals were diagnosed as having gastroparesis. This rapid increase in prevalence is likely to have occurred because it has become much easier to measure gastric emptying and to attribute symptoms to this without necessarily thinking through differentials. The incidence of hospital admissions for patients labelled as having gastroparesis is rapidly rising, increasing at a much faster rate than admissions for patients with nausea and vomiting, gastro-oesophageal reflux disease, gastritis or gastric ulcers, which are all remaining relatively static. Gastroparesis therefore represents a major healthcare burden. Gastroparesis can be idiopathic or is most frequently caused by diabetes (type 1 more than type 2) or surgical procedures that can disrupt the vagus nerve (e.g. Billroth gastrectomy, oesophagectomy, gastric bypass surgery and fundoplication). In this article, I describe the mistakes most frequently made in patients who have a suspected diagnosis of gastroparesis. I base my discussion on the available evidence as well as clinical experience in the field. 


Topics

Neurogastroenterology & Motility Stomach & H. Pylori

Citation

Fikree A. Mistakes in gastroparesis and how to avoid them. UEG Education 2021; 21: 18–22.

Published

2021

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Mistakes in gastrostomy insertion in children and adolescents and how to avoid them

Christos Tzivinikos, Ilse Broekaert, Jorge Amil Dias, Matjaz Homan

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Abstract

Adequate nutrition is essential for the homeostasis of fluids and nutrients, growth and thriving, especially in children. While the underlying principle of percutaneous endoscopic gastrostomy (PEG) placement is the same for both adults and children—providing a means of enteral feeding through the stomach—the indications, considerations and techniques differ owing to anatomical differences, age-dependent physiological concerns, and the age- and disease-specific needs of the child.

If feeding via nasogastric tube (NGT) or naso-jejunal tube (NJT) is necessary for a prolonged time, placement of a PEG or percutaneous endoscopic gastro-jejunal (PEG-J) tube should be considered. A PEG tube also allows the delivery of medications and venting of the stomach when needed. Nutrition via PEG facilitates the transition to out-of-hospital care and improves the quality of life (QoL) for children and families while improving the outcome of children with chronic diseases.

There are recent clinical guidelines providing guidance for PEG tube placement in children, but little advice on, e.g., choosing the right device for the right patient, details on postoperative management, removal of the PEG tube and other specific cases. The following article provides a combination of evidence-based data and the authors’ clinical experience.

Topics

Paediatrics Small Intestine & Nutrition Stomach & H. Pylori

Citation

Broekaert I.J, Dias J.A, Homan M and Tzivinikos C. Mistakes in gastrostomy insertion in children and adolescents and how to avoid them. UEG Education 2024; 24: 34-38.

Published

2024

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Ian Gralnek on UEG Week 2024

Ian Mark Gralnek, Egle Dieninyte - Misiune

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Abstract

Topics

Endoscopy

Published

2025

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