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TL1a

Silvio Danese 1

Affiliations

1 Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milan, Italy

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Session

What's new in advanced therapies for IBD in 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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… after ileocecal resection of localised Crohn's disease

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… after ileocecal resection of localised Crohn's disease

Matthieu Allez 1

Affiliations

1 Saint-Louis Hospital, AP-HP, Université Paris Cité, Paris, France

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Abstract

Event

UEG Week Berlin 2025

Topics

Colorectal IBD Surgery

Session

Predicting patient outcomes...

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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

Advancing IBD precision medicine: The next frontier

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

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Advancing IBD precision medicine: The next frontier

Bram Verstockt 1

Affiliations

1 University Hospitals Leuven and KU Leuven, Translational Research in Gastrointestinal Disorders - IB, Leuven, Belgium

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Session

The art of making clinical research precise: Predicting therapy response in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

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CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Bénédicte Caron 1, Elodie Jeanbert 1, Florian Poullenot 2, Yoram Bouhnik 3, Lucine Vuitton 4, Catherine Reenaers 5, Stephane NANCEY 6, pierre Blanc 7, Xavier Roblin 8, Stéphanie Viennot 9, Jean-Louis Dupas 10, Anne Laure Pelletier 11, Arnaud Bourreille 12, Jacques Moreau 13, Jerome Filippi 14, Maria Nachury 15, Guillaume Bouguen 16, Marion Simon 17, Ludovic Caillo 18, Anthony Buisson 19, Laurianne Plastaras 20, Vered Abitbol 21, Alexandre Aubourg 22, Médina Boualit 23, David Laharie 24, Laurent Peyrin-Biroulet 25

Affiliations

1 Nancy University Hospital, Vandoeuvre les Nancy, France

2 Bordeaux University Hospital, Bordeaux, France

3 CHU Beaujon Dept. of IBD and Nutrition, Clichy, France

4 Besançon university hospital gastroenterology, Courbevoie, France

5 Assistants en formation gastro, réseau Ulg - CHU Sart Tilman, Assistants en formation gastro, réseau, Lantremange, Belgium

6 Lyon University Hospital, Pierre Benite, France

7 Hopital Saint Eloi, Montpellier, France

8 University of St. Etienne Dept. de Gastroenterologie, Saint Etienne, France

9 CHRU de Caen HGE 19è étage, Caen Cedex, France

10 CHU Nord Amiens, Amiens, France

11 Hopital Beaujon, Paris, France

12 Hopital Hotel Dieu Et Hme - Hge Aile Sud, Nantes Cedex 1, France

13 Centre Hospitalier Universitaire de Toulouse, Hopital Rangueil, Toulouse, France

14 Hopital de lAchet Dept. de Gastroenterlogie Dept. de Nutrition Oncologie, Nice Cedex 3, France

15 CHRU Lille, Courbevoie Cedex, France

16 CHU Pontchaillou, Rennes, France

17 Institut Mutualiste Montsouris, Paris, France

18 CHU DE NIMES, Nîmes, France

19 CHU Estaing Clermont-Ferrand, Clermont-ferrand, France

20 Chu Colmar, Colmar, France

21 Hopital Cochin Gastroentérologie AP-HP, Paris Cedex 14, France

22 Cabinet Medical, Chambray Les Tours, France

23 Ch Valenciennes, Valenciennes Cedex, France

24 CHU de Bordeaux Hopital Haut-Leveque Dept. de Gastroenterologie, Pessac cedex, France

25 Inserm U1256, Nancy University Hospital, Vandoeuvre-les-Nancy, France

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Abstract

Introduction

Crohn's disease (CD) is a disabling and destructive disease. Early intervention associated with tight monitoring appear to the best way to achieve deep remission and to prevent disease progression. Whether anti-TNF (tumor necrosis factor) therapy can be interrupted in patients with early CD who have undergone a period of prolonged deep remission is unknown.

Aims & Methods

The primary objective was to evaluate the sustained deep remission rate one year after discontinuation of a 12-month course of adalimumab in adult patients with early CD who achieved deep remission at 12 months after treatment induction and who were already in clinical remission and biomarker remission at 6 months.
We carried out a multicentre prospective GETAID cohort study. All patients had early luminal CD less than 24 months since diagnosis, and were naïve to biologics. The primary study endpoint was percentage of patients with sustained deep remission one year after stopping a 12-months course of adalimumab (+/- 3 months) in adult patients with early-stage CD who achieved deep remission without therapeutic intervention (i.e. no surgery, no clinical flare-up, no introduction of CD-related treatment, no need for adalimumab optimization) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. A clinical flare-up was defined as a CDAI > 220 or an increase in CDAI between two subsequent visits > 70.

Results

A total of 171 patients received treatment with adalimumab between March 2015 and March 2019.
In this cohort, 39.2% (67/171) were active smokers. The median disease duration was 4 [2-9] months. CD location was ileal (42.7%, 73/171), colonic (12.3%, 21/171), and ileo colonic (44.4%, 76/171). Twenty-one patients (12.3%) had perianal disease. The majority of patients had an inflammatory phenotype (71.3%, 122/171). At inclusion, median CRP level was 9.0 [3.0-24.0] mg/L, and median fecal calprotectin was 440.5 [159.0-838.0] µg/g.
Overall, 38/171 (22.2%) of patients achieved deep remission after a 12-month course of adalimumab. From those who achieved deep remission, 7 patients did not discontinue adalimumab. In this study, 7/31 (22.6%) patients maintained their deep remission for one year after their treatment discontinuation (24 months from initiation of adalimumab). Among the whole cohort, only 4% (7/171) of patients were in deep remission off adalimumab at 2 years. Median time between adalimumab discontinuation and the first clinical relapse was 14 months. No predictive factor associated with loss of deep remission in the year following treatment discontinuation was identified. No serious adverse event was reported.

Conclusion

In this first prospective trial exploring withdrawal of advanced therapy in early CD, 22.6% achieved deep remission at one year with adalimumab; among them, about a quarter maintained deep remission at two years. These results demonstrate that anti-TNF therapy should not be discontinued, even in patients with early CD.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Clinical management of IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

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

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REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Federica Di Vincenzo 1, Stephanie Ioannou 2, Chiara Principessa 3, Ivan Capobianco 1, Antonio Gasbarrini 4, Lucrezia Laterza 4, Maria T. Abreu 5, Franco Scaldaferri 4

Affiliations

1 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy

2 University of Miami - Jackson Health System, Miami, United States

3 Università Cattolica del Sacro Cuore, Roma, Italy

4 Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

5 University of Miami Miller School of Medicine, Department of Medicine, Division of Gastroenterology, Miami, FL 33136; F. Widjaja Inflammatory Bowel Disease Institute, Cedars-Sinai Medical Center, Los Angeles, United States

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Abstract

Introduction

Treatment goals in inflammatory bowel disease (IBD) have evolved beyond symptom control to include mucosal healing, prevention of disease-related complications, improvement of health-related quality of life, and reduction of long-term disability, as outlined by the STRIDE II initiative¹. Despite significant progress in the development of advanced therapies (ADTs), up to 50% of IBD patients fail to respond to currently available treatments, underscoring the urgent need for new therapies, which are investigated in randomized clinical trials (RCTs). However, stringent eligibility criteria in RCTs limit the inclusion of real-world IBD patients, potentially compromising the generalizability of trial findings to daily clinical practice.

Aims & Methods

The aim of this study was to evaluate the proportion of real-life IBD patients who would be eligible for ongoing RCTs and to assess the representativeness of this population. Moreover, we aimed to identify the most frequently unmet eligibility criteria leading to patient exclusion and to characterize the clinical profiles that differentiate eligible from ineligible patients.
This prospective, observational, multicenter study was conducted between October 2023 and October 2024 at 2 tertiary IBD referral centers: the Fondazione Policlinico Universitario “A. Gemelli” in Rome, Italy, and the Crohn’s & Colitis Center at the University of Miami, USA. Consecutive patients with IBD indicated for a new ADT were enrolled. Each patient was systematically screened for inclusion and exclusion criteria across all actively recruiting phase 2b and 3 RCTs available at each center at the time of evaluation (6 RCTs in Rome: 4 UC and 2 CD; 5 RCTs in Miami: 3 UC and 2 CD).

Results

A total of 166 IBD patients (69 UC and 97 CD) were enrolled, with 129 patients from the Italian cohort and 37 from the American cohort. Among UC patients, only 16 (23.2%) met the eligibility criteria for at least 1 RCT, whereas 53 (76.8%) were deemed ineligible (p<0.001). In the CD group, just 10 patients (10.3%) were eligible for at least 1 RCT, compared to 87 (89.7%) who were not (p<0.001). The most common reasons for ineligibility among UC patients included: Modified Mayo score not within the required range of 5–9 (50.7%), absence of bowel urgency (63.8%), Mayo Endoscopic Subscore <2 (39.1%), failure to comply with ADT washout requirements (56.5%), insufficient number of prior ADT failures (39.0%), and recent use of topical 5-ASA or steroids within 4 weeks prior to screening (62.3%).
In CD patients, the most frequently unmet criterion was a CDAI between 220 and 450 (92.8%), followed by insufficiently liquid stool frequency (≥4 very soft or liquid stools/day; 75.3%), SES-CD<6 (39.2%), and the presence of CD-related complications such as strictures or fistulas (13.1%).

Conclusion

The majority of real-life IBD patients, particularly those with CD, are ineligible for participation in current RCTs—primarily due to relatively mild disease activity or ongoing need for concomitant therapies that are not permitted by trial protocols. Importantly, many real-world CD patients initiate new ADTs based on radiologic signs of disease activity, the presence of disease complications, or as prophylaxis for post-surgical recurrence, rather than clinical activity scores alone. Similarly, UC patients may require ADTs even in the context of corticosteroid dependence and low-grade disease activity. These findings underscore the need to revisit and broaden eligibility criteria in future RCTs to ensure greater external validity and alignment with the heterogeneity of real-life IBD population.

References

1. Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. PMID: 33359090.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Clinical management of IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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

Robotic living donor hepatectomy: A novel tool to expand the donor pool

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.

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle 1

Affiliations

1 Hannover Medical School, Hannover, Germany

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Abstract

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Surgery

Session

New developments in liver transplantation

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund

UEG Presentation

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

How to boost your biology? Every day strategies to improve therapies and combinations

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.

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund 1

Affiliations

1 Charité - Universitätsmedizin Berlin, Berlin, Germany

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Surgery

Session

How to optimise success in IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

… after ileocecal resection of localised Crohn's disease

Matthieu Allez

Advancing IBD precision medicine: The next frontier

Bram Verstockt

CHANGING THE COURSE OF CROHN’S DISEASE WITH AN EARLY USE OF ADALIMUMAB: THE CURE STUDY FROM THE GETAID

Lucine Vuitton

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Franco Scaldaferri

Robotic living donor hepatectomy: A novel tool to expand the donor pool

Moritz Schmelzle

How to boost your biology? Every day strategies to improve therapies and combinations

Britta Siegmund