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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
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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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ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment

Javier P. Gisbert

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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.

Guideline

Introduction

Ulcerative colitis [UC] is a chronic inflammatory bowel disease [IBD] characterised by colonic inflammation extending to a variable extent from the rectum. Care of the patient with UC requires appropriate input from across the multiprofessional team. These guidelines summarise the recommended medical treatment for adults with UC.

In 2022, the European Crohn’s and Colitis Organisation [ECCO] published new guidelines on the management of UC in two papers focused on the medical and surgical management of the disease.1,2 For the 2022 UC guidelines, ECCO adopted the Grading of Recommendations Assessment, Development, and Evaluation [GRADE] approach, a systematic process for developing guidelines that addresses how to frame healthcare questions, summarise the evidence, formulate recommendations, and grade their strength and the quality of associated evidence.3 The present paper represents an update to the 2022 guidelines and focuses specifically on the medical management of UC, while a companion paper developed as part of the same process addresses optimal surgical management [ECCO Guidelines on Therapeutics in Ulcerative Colitis: Surgical Treatment].

For this iteration of the guidelines, we have introduced several new, clinically relevant questions selected by members of the guidelines group, alongside a systematic approach to reviewing and updating previous topics to incorporate new evidence and to reappraise all findings within the context of contemporary practice. We have also introduced several “practice points” to summarise evidence and provide expert recommendations in key areas where the evidence remains limited but clinical decisions are still required. In such instances, where application of the GRADE methodology may be impractical, we adopted an approach based on systematic literature review, expert discussion, and voting to reach consensus recommendations outside the formal GRADE process.

Patients living with UC can have a variable disease course.4 In this document, we discuss therapeutic approaches stratified by disease severity [mildly-to-moderately active and moderately-to-severely active disease]. Definitions of disease severity are commonly used to establish clinical trial inclusion criteria and may be based on several distinct assessment frameworks.5 It is also important to remember that these definitions capture severity at a given point in time and may not reflect the cumulative long-term burden of disease experienced by a patient.6

It is also important to consider disease extent when planning treatment in UC, as this may affect the optimal route of drug administration. This is typically defined according to disease involving the rectum only [proctitis], disease distal to the splenic flexure [left-sided or distal UC], or disease extending proximal to the splenic flexure [extensive UC].7 It should be noted that disease distribution can change4 and that proximal disease extension can be a negative prognostic marker.8

Publisher

European Crohn’s and Colitis Organisation logo
European Crohn’s and Colitis Organisation

Guideline

Clinical Practice Guideline

Topics

IBD

Citation

Journal of Crohn's and Colitis, Volume 20, Issue 7, July 2026

Published

2026

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Mistakes in the management of peritoneal malignancies and how to avoid them

Francesco Saverio Papadia, Matteo Santoliquido, Andrea Barberis, Tarkan Jäger, Charlotte Rabl

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References

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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

Digestive Oncology Surgery

Published

2026

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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.
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9.
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10.
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11.
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12.
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13.
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14.
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16.
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17.
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18.
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19.
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20.
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21.
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Abstract

Hepatitis C virus (HCV) infection remains an important global health concern. It is estimated that there are approximately 50 million people infected with HCV globally, with around 1 million new infections each year and about 242,000 deaths annually attributed to HCV-related complications. Most acute HCV infections (55–85%) become chronic due to the virus’s effective evasion strategies, with spontaneous clearance being rare once chronicity is established. This condition often progresses silently, with many individuals unaware of their infection until advanced liver damage has occurred. If left untreated, HCV can lead to severe complications, including liver cirrhosis and hepatocellular carcinoma (HCC). HCV transmission occurs mainly through percutaneous exposure to infected blood. HCV can also spread from mother to infant (vertical transmission) and, less frequently, via sexual contact.1,2 In recent years, the introduction of oral direct-acting antivirals (DAAs), with remarkable safety and effectiveness profiles, has led to a sustained virological response (SVR) in virtually all (>97%) HCV-infected patients, regardless of HCV genotype or disease stage. However, significant barriers remain, such as issues with diagnosis, access to treatment and awareness of the disease.

Here, we discuss some of the misconceptions in HCV management and provide a practical management approach grounded in evidence and clinical experience.

Topics

Hepatobiliary

Citation

Garcia A.C and Alexandrino G. Mistakes in hepatits C and how to avoid them. UEG Education 2025; 25: 14-17.

Published

2025

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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.
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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.
Little RD, Ward MG, Wright E, et al. Therapeutic drug monitoring of subcutaneous infliximab in inflammatory bowel disease-understanding pharmacokinetics and exposure response relationships in a new era of subcutaneous biologics. J Clin Med 2022;11:6173.
11.
Berger AE, Duru G, de Vries A, et al. Comparison of immunoassays for measuring serum levels of golimumab and antibodies against golimumab in ulcerative colitis: a retrospective observational Study. Ther Drug Monit 2019; 41: 459–66.
12.
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13.
Verdon C, Vande Casteele N, Heron V, Germain P, Afif W. Comparison of serum concentrations of ustekinumab obtained by three commercial assays in patients with Crohn’s disease. J Can Assoc Gastroenterol 2020; 4: 73–77.
14.
Cherry M, Dutzer D, Nasser Y, et al. Point-of-care assays could be useful for therapeutic drug monitoring of IBD patients in a proactive strategy with adalimumab. J Clin Med 2020; 9: 2739
15.
Yarur AJ, Kanagala V, Stein DJ, et al. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn’s disease. Aliment Pharmacol Ther 2017; 45: 933-940.
16.
Paul S, Tedesco E, Marotte H, et al. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis 2013; 19: 2568-76.
17.
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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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Mistakes in abdominal distension and how to avoid them

Elizabeth Barba Orozco, Alberto Ezquerra-Durán

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References

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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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