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Initial management of Crohn's disease: Time for a new paradigm?

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Initial management of Crohn's disease: Time for a new paradigm?

Nurulamin Noor 1

Affiliations

1 Cambridge University Hospitals, Cambridge, United Kingdom

Summary

AI Generated

The Profile trial demonstrated that initiating infliximab combination therapy within days of Crohn's disease diagnosis (median 12 days) achieved superior efficacy and safety compared to accelerated step-up therapy in patients with moderate to severe disease.

In the Profile trial of 386 patients, top-down therapy (infliximab plus immunomodulator from diagnosis) resulted in 79% sustained steroid-free and surgery-free remission at one year versus 15% with accelerated step-up, and 67% ulcer-free endoscopic remission versus lower rates in the step-up arm.
The speaker reported that top-down early effective therapy had fewer adverse events and serious adverse events than step-up therapy, with lower serious infections and a ten-fold reduction in urgent abdominal surgery.
Real-world data show the average newly diagnosed Crohn's disease patient receives almost five courses of steroids before biologic initiation, a pattern the speaker stated is consistent across the USA, UK, and all countries reporting such data.
The speaker stated that patients with very mild Crohn's disease were not eligible for Profile and cautioned against extrapolating these results to that population.
Current UK adalimumab biosimilar cost is approximately £600 per patient per year, equivalent to one course of steroid foam enema, which the speaker suggested negates cost arguments against early effective therapy.
The speaker emphasized that diagnostic delay means inflammation has been accumulating for months or years before diagnosis, making early treatment after diagnosis critical.

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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.

Abstract

Event

UEG Week Vienna 2024

Topics

IBD Immunology Surgery

Session

IBD: Maximising therapy success

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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ANTI-TNF TREATMENT WITHDRAWAL IN ULCERATIVE COLITIS, A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL

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ANTI-TNF TREATMENT WITHDRAWAL IN ULCERATIVE COLITIS, A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL

Ingrid Prytz Berset 1, Frode Lerang 2, Dag Arne Lihaug Hoff 3, Knut E.A. Lundin 4

Affiliations

1 Gastroenterology Aalesund, Alesund, Norway

2 Central Hosspital of Ostfold, Grålum, Norway

3 Aalesund Hospital, Møre & Romsdal Hospital trust, Aalesund, Norway

4 K. G. Jebsen Coeliac Disease Research Centre, University of Oslo and Oslo University Hospital, Oslo, Norway

Summary

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Abstract

Introduction

The BIOSTOP Trial is a prospective, multicenter, randomized, controlled, open-label study conducted in Norway to evaluate the two-year outcomes of tumor necrosis factor-alpha (anti-TNF) antibody withdrawal in patients with ulcerative colitis (UC) in sustained clinical and endoscopic remission. Prior non-randomized studies have suggested that approximately half of such patients maintain remission after anti-TNF discontinuation and that reintroduction of anti-TNF therapy is generally effective and safe in the event of relapse.

Aims & Methods

A total of 174 UC patients in confirmed clinical and endoscopic remission were enrolled across 19 gastroenterology centers between June 2017 and December 2020 and randomized 1:1 to either continue or discontinue anti-TNF therapy. Eligibility criteria included at least 12 months of first-line anti-TNF maintenance treatment, clinical remission, fecal calprotectin <200 µg/g, and endoscopic remission (Mayo endoscopic score 0 or 1). Two-year follow-up data were available for 172 patients (86 in each group). In 156 of the patients endoscopies were available for central reading (77 in the withdrawal group and 79 in the maintenance group). The primary endpoint was sustained endoscopic remission at two years.

Results

At two years, central reading of follow-up colonoscopies confirmed endoscopic remission in 64 of 77 patients (83%, 95% CI 71.8 – 93.1) in the anti-TNF withdrawal group, compared to 77 of 79 patients (96 %, 95 % CI 92.1 – 100.8) in the anti-TNF maintenance group. The non-inferiority primary endpoint of the study was thus not met. During the study period, 48% of patients in the withdrawal group and 88% in the maintenance group remained in sustained clinical and endoscopic remission without relapse. Among the 45 patients in the withdrawal group who experienced endoscopic confirmed relapse, 28 (62%) resumed anti-TNF therapy, with 26 achieving both clinical and endoscopic remission. Additionally, 10 of 13 patients with mild relapses achieved endoscopic remission with optimized non-biologic therapy. There were no difference in serious adverse events between the groups.

Conclusion

After two years, 83% of patients in the anti-TNF withdrawal group and 96% in the maintenance group were in clinical and endoscopic remission, including those who experienced flares and achieved new remission after reintroduction of anti-TNF or optimized non-biologic therapy. Nearly half of the patients maintained remission without anti-TNF, and the majority of relapses were effectively managed. These findings suggest that anti-TNF withdrawal is a safe option for selected UC patients in confirmed remission, provided they are monitored closely.
Trial Registration: ClinicalTrials.gov Identifier: NCT03011268; EudraCT Number: 2016-001409-18. Trial completion date: 31 January 2025.

Disclosure

No disclosures

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD

Submission format

Abstract

Session

Tackling IBD in clinics

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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UEG Podcast Episode

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Best of UEG Week - IBD

Pradeep Mundre 1, Julia Mayerle 2, Tim Raine 3

Affiliations

1 Bradford Teaching Hospitals NHS trust, Leeds, United Kingdom

2 Klinikum der LMU München-Grosshadern, München, Germany

3 Cambridge University Hopsital NHS Foundation Trust, Cambridge, United Kingdom

Summary

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Abstract

Topics

IBD

Published

2023

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Biological therapy and malignancy: Why is IBD-associated cancer more agressive than incidental CRC?

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Biological therapy and malignancy: Why is IBD-associated cancer more agressive than incidental CRC?

Severine Vermeire 1

Affiliations

1 University Hospital Leuven, Leuven, Belgium

Summary

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Abstract

Event

UEG Week Vienna 2024

Topics

Colorectal Digestive Oncology Endoscopy Histopathology IBD Surgery

Session

IBD-associated colorectal cancer: Under- or overestimated?

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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IBD

Matthew Ciorba 1

Affiliations

1 Waschington University in Saint Louis, Waschington DC, United States of America

Summary

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Abstract

Event

UEG Week Vienna 2024

Topics

Endoscopy Gut Microbiota IBD Oesophagus Stomach & H. Pylori

Session

Best of DDW

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Summary: Decision time in IBD - Difficult cases

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Summary: Decision time in IBD - Difficult cases

Britta Siegmund 1

Affiliations

1 Charité - Universitätsmedizin Berlin, Berlin, Germany

Summary

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Abstract

Event

UEG Postgraduate Teaching Programme Vienna 2024

Topics

Education & Training IBD Immunology Mechanisms & Personalised Medicine Surgery

Session

Decision time in IBD: Difficult cases

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Managing IBD in a patient with new or recent cancer

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

Not sure what you can access? Learn more about account types.

Managing IBD in a patient with new or recent cancer

Hannah Gordon 1

Affiliations

1 Royal London Hospital, London, United Kingdom

Summary

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Summary is not available for this content yet.

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Abstract

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology IBD

Session

Cancer and IBD: Mitigating risk among uncertainty

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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ANTI-TNF TREATMENT WITHDRAWAL IN ULCERATIVE COLITIS, A MULTICENTER, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL

Knut E.A. Lundin

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Tim Raine

Biological therapy and malignancy: Why is IBD-associated cancer more agressive than incidental CRC?

Severine Vermeire

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Matthew Ciorba

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Hannah Gordon

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