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Introduction

Ustekinumab (USK) is a biological drug that inhibits interleukins 12 and 23. It has been approved for the treatment of inflammatory bowel disease (IBD) as an induction agent, which is administered intravenously, followed by a maintenance subcutaneous therapy at a dose of 90 mg every 8 or 12 weeks. In patients who do not achieve an adequate response with the usual doses, a common clinical practice is to optimise the USK dose.

Aims & Methods

The objective of this study was to evaluate the existence of risk factors associated with the need for this dose optimisation.
Methods: This was a retrospective observational single-centre study which included all adult patients with IBD treated with USK between 2013 and 2023 in the IBD Unit of the Santiago de Compostela Hospital, Spain. The following variables were evaluated: demographic variables (age, sex, BMI, smoking habit), descriptive variables of the disease (type, extension, behaviour, perianal involvement), biomarkers (calprotectin, CRP) and endoscopic characteristics. Furthermore, intestinal ultrasound was conducted in patients with Crohn's disease (CD). Dose optimization was defined as a reduction in the time interval between USK doses. The chi-square test was employed for qualitative variables, while quantitative variables were analysed using the Shapiro-Wilk test, Student's t-test, and Mann-Whitney U test. A multivariate logistic regression analysis was conducted to identify factors associated with the need for therapy optimization. Drug persistence measurements were represented using the Kaplan-Meier method.

Results

A total of 189 patients (50.3% men) with a mean age of 51.9 years (SD 16.7) were included in the study. Crohn's disease (CD) was present in 84.7% of the patients, while the remaining patients had ulcerative colitis (UC). The dosage of ustekinumab (USK) was optimised to 90 mg/4 weeks in 67.2% of all patients (69% in CD and 63% in UC). The univariate analysis revealed that BMI (p = 0.023), disease pattern (p = 0.016), presence of perianal disease (p = 0.011), high calprotectin levels (p = 0.039) and CRP (p = 0.006) were significantly associated with the need for therapy optimisation. In the logistic regression analysis, BMI was the only significant risk factor for dose intensification of USK (OR 1.093, IC 95% 1.001-1.194). Conversely, an identified protective factor was an inflammatory pattern (OR 0.234, IC 95% 0.069-0.800). The mean time from the commencement of therapy to the necessity for optimisation was 10 months in patients with CD and 5 months in patients with UC.

Conclusion

In more than half of the patients treated with ustekinumab, dose optimization is required. The necessity for dose optimization of ustekinumab in patients with Crohn's disease may be influenced by a higher body mass index value and the non-inflammatory pattern of the disease.

WHAT FACTORS ARE ASSOCIATED WITH THE NEED FOR DOSE OPTIMISATION OF USTEKINUMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD)?

Christian Navarro Gerrard 1, Iria Bastón-Rey 2, Martiño Loureiro-Veira 2, Monica Otero-Iglesias 2, Rocío Ferreiro-Iglesias 2, Jaime Gonzalez-Lopez 1, J. Enrique Domínguez Muñoz 2, Manuel Barreiro de Acosta 2

1 University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

2 University Hospital of Santiago de Compostela, Santiago de Compostela, Spain|||Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

Conference

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Podcast Episode

Journal Podcast

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Episode 6: UEG Journal October Spotlight

Mohsan Subhani, Maria Manuela Estevinho

Topics

Endoscopy Hepatobiliary IBD Pancreas

Published

2025

UEG Podcast Episode

UEG Podcast

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IBD treatment beyond anti-TNF (Part 2: Personalized medicine)

Pradeep Mundre 1, Ignacio Catalan-Serra 2

1 Bradford Teaching Hospitals NHS trust, Leeds, United Kingdom

2 Norwegian University of Science and Technology, Centre for Molecular Inflammation, Trondheim, Norway

Topics

IBD

Published

2024

UEG Mistakes In Articles

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Nonalcoholic fatty liver disease (NAFLD) is a growing cause of chronic liver disease worldwide that can manifest as nonalcoholic fatty liver (NAFL) or nonalcoholic steatohepatitis (NASH). Compared with NAFL, NASH poses a substantially higher risk of progression to advanced liver disease, cirrhosis and hepatocellular carcinoma (HCC). Given the lack of directed pharmacological therapies and the complex, multifactorial disease aetiology and pathology, NAFLD is expected to become the leading cause of end-stage liver disease in the coming decades.

Mistakes in mouse models of nonalcoholic steatophepatitis and how to avoid them

Rui Castro

Topics

Hepatobiliary

Citation

Castro RE and Diehl AM. Mistakes in animal models of nonalcoholic steatohepatitis and how to avoid them. UEG Education 2018; 18: 30–34

Published

2024

UEG Mistakes In Articles

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Familial Mediterranean fever (FMF), also called periodic disease, Armenian disease, etc., is a prototypical autoinflammatory disorder where the underlying mechanism is the dysfunction of innate immunity, resulting in unprovoked episodes of inflammation.¹ Although considered rare worldwide, it is prevalent in people of Mediterranean origin; however, one can expect to encounter patients in all parts of the modern world. FMF is a monogenic disease with autosomal recessive inheritance.² Unlike other monogenic disorders, the diagnosis remains largely clinical, and it is important to understand the limitations of genetic testing. Another distinguishing feature is the well-established effectiveness of lifelong monotherapy with colchicine in preventing attacks and complications.³

Mistakes in Familial Mediterranean Fever and how to avoid them

Manik Gemilyan, Gagik Hakobyan

Topics

Primary Care

Published

2025

UEG Standards and Guidelines

Consensus

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Abstract

Background

The incidence and prevalence of inflammatory bowel disease [IBD] have increased significantly in low- and middle-income countries [LMICs] in recent decades. Managing IBD in these settings presents substantial challenges. This consensus aims to describe the epidemiology of IBD in LMICs and to highlight the key challenges in its diagnosis and treatment.

Method

The consensus-defining strategy followed the previous European Crohn’s and Colitis Organisation [ECCO] consensus guidelines [available at www.ecco-ibd.eu]. The authors reviewed the available evidence and formulated statements accordingly. Provisional ECCO statements and supporting text were drafted based on a comprehensive literature review and further refined through two voting rounds, which included external reviewers and national representatives from ECCO’s 36 member countries. The final ECCO statements, representing a consensus of at least 80% agreement among participants, were approved during an online meeting. Consensus statements should be interpreted in context with their accompanying commentary rather than in isolation and should not be used solely to guide patient management. The supporting text was finalized under the guidance of each working group leader [VP, HY, TK, AH] and subsequently integrated by the consensus leader [AE].

Results

Data on IBD epidemiology in LMICs remain limited. Public and healthcare professional awareness and timely access to early diagnostic modalities, advanced medical and surgical therapies, and specialist multidisciplinary care are key gaps in IBD care in LMICs. The complexity and chronic nature of IBD, along with the necessity for a multidisciplinary approach, pose significant challenges to adopting a holistic management strategy in LMICs.

Conclusion

There is a critical need for further studies to assess the specific needs of LMICs. Such research will help guide resource allocation and improve IBD management in these settings.