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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

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New
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Third N-ECCO Consensus Statements on the Nursing Roles in Caring for Patients with Inflammatory Bowel Disease

Susanna Jäghult

Summary

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Guideline

Introduction

The Nurses Committee of the European Crohn’s and Colitis Organisation (N-ECCO) is an active Committee of the ECCO that aims to improve access to nurse education in inflammatory bowel disease (IBD) throughout Europe and to provide a link with national nursing networking organisations. The first N-ECCO Consensus Statements were published in 2013 and sought to identify the positioning of nurses in the care of patients with IBD and to provide a consensus on the ideal standard of minimum care that patients with IBD might expect. The first update was made in 2018. The N-ECCO Consensus Statements have been widely distributed internationally, guiding IBD centers and IBD nurses to establish the most optimal quality of care in IBD. High-quality IBD care requires working within a multidisciplinary team (MDT). Core team members should include at least one IBD nurse, a gastroenterologist, a colorectal surgeon, a radiologist, and a dietitian. In this MDT, the IBD nurse has a clear role as coordinator between the patient and the different disciplines, with the objective of providing a holistic approach to care.1,2 In addition to administering and monitoring treatments, IBD nurses provide education, support, counselling, and advocacy for patients. Even if the role of the IBD nurse has become more established in recent years, several differences between countries remain, including variations in education and role. In the two previous N-ECCO Consensus Statements, the statements were divided into fundamental and advanced IBD nursing. Due to the different conditions across countries, this division was removed in this update.

The overall aim of ECCO is to improve the care of patients with IBD through development of guidelines, education, and research. The N-ECCO Consensus Statements seek to realise this aim from an IBD nursing perspective, by providing statements and evidence to guide and ensure the ideal standard of care.3,4 This third update aims to provide a framework for IBD nurses to continue delivering high-quality and evidence-based care, to consider the needs of diverse patient populations, and to include new technical tools.

Publisher

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

Guideline

Consensus

Topics

IBD

Published

2026

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Advancing IBD precision medicine: The next frontier

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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

Summary

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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 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

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The diagnosis

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The diagnosis

Bruce E. Sands 1

Affiliations

1 Icahn School of Medicine at Mount Sinai, New York, United States of America

Summary

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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 Berlin 2025

Topics

IBD Primary Care

Session

When IBD and IBS experts collaborate for optimal diagnosis and treatment of IBD with IBS-like symptoms

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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AN IBD ASSOCIATED TNRC18 VARIANT IS LINKED TO INCREASED DISEASE BURDEN AND THE NEED FOR MORE INTENSIVE THERAPIES

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Severine Vermeire Severine Vermeire, Wojciech Niezychowski, Sarah Sidhu, Irene Modesto, Ernest Law, Sujatha S. Menon, Wenjin Wang, Chuanbo Zang, Nervin Lawendy, Jin Yu, Guibao Gu, Krisztina Lazin, Filip Baert, Geert R. D'Haens, Brian G. Feagan, David T. Rubin, Marla C. Dubinsky, Andres Yarur, Laurent Peyrin-Biroulet, Martina Goestch, Silvio Danese

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AN IBD ASSOCIATED TNRC18 VARIANT IS LINKED TO INCREASED DISEASE BURDEN AND THE NEED FOR MORE INTENSIVE THERAPIES

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AN IBD ASSOCIATED TNRC18 VARIANT IS LINKED TO INCREASED DISEASE BURDEN AND THE NEED FOR MORE INTENSIVE THERAPIES

Anna Aarni 1, Arto Lehisto 1, Elisa Lahtela 1, Paavo Häppölä 1, Pauliina Molander 2, Jukka Koskela 1

Affiliations

1 University of Helsinki, Helsinki, Finland

2 Helsinki University Hospital, Peijas Hospital, Helsinki, Finland

Summary

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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

Introduction

Genome-wide association studies (GWAS) have identified more than 250 risk variants linked to inflammatory bowel disease (IBD). Most genetic variants increase the risk of disease onset, and their impact on clinical presentation is limited.1,2,3 Variants in NOD2 and IL23R not only modulate the risk of disease onset, but also influence disease behaviour and localisation. Their role in predicting treatment response remains unclear.3,4
A variant in an intron of TNRC18 (rs7486781, allele frequency 3.6%) was recently identified as having a strong risk-increasing effect (OR 3.2, p=2.4x10-61) for IBD in the FinnGen biobank study. The same allele was also associated with a risk for ankylosing spondylitis (AS), uveitis and psoriasis.5 The functional effect of rs7486781 is not yet fully established.6

Aims & Methods

The FinnGen biobank study includes the genotype data of 520 000 individuals and their longitudinal register data from national health registers, including 11 298 individuals with verified diagnosis for IBD. The data also include drug purchases, procedure codes and laboratory measurements of the individuals.
Our aim was to study the impact of the TNRC18-variant on IBD phenotype, particularly disease behavior. We assessed established aspects of disease severity7: use of immunosuppressants and advanced therapies, necessity to switch medications, frequent use of corticosteroids and risk of procedures. We also evaluated the presence of extraintestinal manifestations (EIM) and other disease complications.

Results

Regarding disease severity, the use of therapies beyond 5-ASA was more common among variant carriers; the use of thiopurines and other immunosuppressants (OR 1.21-1.27, p-values 1.35x10-5 - 0.00849), ustekinumab and other IL-inhibitors (OR 1.46-1.48, p-values 0.00324 - 0.00286) and TNF-α-inhibitors (OR 1.26, p=0.00753) was more frequent.
In addition, perianal and anal canal operations were more prevalent with TNRC18 variant carriers (OR 2.44, p=1.41x10-4), indicating perianal disease.
Assessing EIM, we observed that diagnoses for AS and uveitis (OR 1.62-1.67, p=1.3x10-5 - 1.55x10-4) were more frequent within IBD in patients with rs7486781.
Interestingly, a reduced risk of primary sclerosing cholangitis (PSC) was implicated by lower number of cholangitis (K83.0) diagnoses (OR 0.617, p=0.00221) and fewer purchases of ursodeoxycholic acid (OR 0.55, p=2.83x10-5), in addition to lower levels of ALP (mean 75 vs 82, p=0.00296), IgG4 (mean 0.45 g/l vs 0.81 g/l, p=4.81x10-5) and IgM (0.12 vs 0.15, p=0.00115) among variant carriers. All events survived the false discovery rate–adjusted p threshold of 0.05.
Our results also suggest that the cumulative risk for IBD related procedures8 (patients with procedures n=2209) from diagnosis and birth were elevated in TNRC18 variant carriers (HR=1.12 and HR=1.14, p=0.050 and p=0.023, assuming additive effect) using a Cox regression model.
Finally, our results in ulcerative colitis indicate that TNRC18 variant carriers are at higher risk of transitioning from 5-ASA/immunomodulators to biologics/JAK-inhibitors (HR=1.38, p=0.016). Variant carriers receiving immunomodulators or advanced therapies were not, however, in increased risk of colectomy (HR~0.97-1.34, p~0.86-0.37).

Conclusion

TNRC18 variant was associated with greater risk of operative treatment, the need of more advanced medication and perianal disease. AS and uveitis were more common EIMs, but PSC appeared less infrequent. Our preliminary results indicate that TNRC18 variant carriers might benefit from early intervention with immunomodulators or advanced therapies.

References

1. Chang, J. T. Pathophysiology of Inflammatory Bowel Diseases. N Engl J Med 383, 2652–2664 (2020).

2. Cleynen, I. et al. Inherited determinants of Crohn’s disease and ulcerative colitis phenotypes: a genetic association study. Lancet 387, 156–167 (2016).

3. Atreya, R. & Neurath, M. F. Biomarkers for Personalizing IBD Therapy: The Quest Continues. Clin Gastroenterol Hepatol 22, 1353–1364 (2024).

4. Kayali, S. et al. NOD2 and Crohn’s Disease Clinical Practice: From Epidemiology to Diagnosis and Therapy, Rewired. Inflamm Bowel Dis 31, 552–562 (2025).

5. Kurki, M. I. et al. FinnGen provides genetic insights from a well-phenotyped isolated population. Nature 613, 508–518 (2023).

6. Rahimov, F. et al. A genome-wide CRISPR screen supported by human genetics identifies the TNRC18 gene locus as a novel regulator of inflammatory signaling. bioRxiv 2023.10.04.560902 (2023) doi:10.1101/2023.10.04.560902.

7. Swaminathan, A. et al. The Disease Severity Index for Inflammatory Bowel Disease Is a Valid Instrument that Predicts Complicated Disease. Inflamm Bowel Dis 30, 2064–2075 (2024).

8. Forss, A. et al. Validating surgical procedure codes for inflammatory bowel disease in the Swedish National Patient Register. BMC Med Inform Decis Mak 19, 217 (2019).

Disclosure

Anna Aarni: Speaker fee from Abbvie, Clinic visit: travelling expenses from Tillots Pharma

Pauliina Molander: Speaker, consultancy and advisory board member fees from Abbvie, Johnson & Johnson, Lilly, Pfizer and Takeda. Clinic visit: traveling expenses from Tillots Pharma

Jukka Koskela: Pfizer-FinnGen genetic advisory board, traveling, clinic and congress visits: FinnGen partners, Tillots Pharma, Takeda, consulting: Pfizer

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

New insights into IBD pathology

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Third N-ECCO Consensus Statements on the Nursing Roles in Caring for Patients with Inflammatory Bowel Disease

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Advancing IBD precision medicine: The next frontier

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The diagnosis

The diagnosis

Bruce E. Sands Bruce E. Sands

AN IBD ASSOCIATED TNRC18 VARIANT IS LINKED TO INCREASED DISEASE BURDEN AND THE NEED FOR MORE INTENSIVE THERAPIES

AN IBD ASSOCIATED TNRC18 VARIANT IS LINKED TO INCREASED DISEASE BURDEN AND THE NEED FOR MORE INTENSIVE THERAPIES

Jukka Koskela Jukka Koskela, Pauliina Molander, Paavo Häppölä, Elisa Lahtela, Arto Lehisto, Anna Aarni

THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL

THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL

Severine Vermeire Severine Vermeire, Wojciech Niezychowski, Sarah Sidhu, Irene Modesto, Ernest Law, Sujatha S. Menon, Wenjin Wang, Chuanbo Zang, Nervin Lawendy, Jin Yu, Guibao Gu, Krisztina Lazin, Filip Baert, Geert R. D'Haens, Brian G. Feagan, David T. Rubin, Marla C. Dubinsky, Andres Yarur, Laurent Peyrin-Biroulet, Martina Goestch, Silvio Danese

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

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

Moritz Schmelzle Moritz Schmelzle

UEG Presentation
Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky
THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL

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THE EFFICACY AND SAFETY OF ETRASIMOD IN MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE GLADIATOR TRIAL

Silvio Danese 1, Martina Goestch 2, Laurent Peyrin-Biroulet 3, Andres Yarur 4, Marla C. Dubinsky 5, David T. Rubin 6, Brian G. Feagan 7, Geert R. D'Haens 8, Filip Baert 9, Krisztina Lazin 2, Guibao Gu 10, Jin Yu 10, Nervin Lawendy 11, Chuanbo Zang 11, Wenjin Wang 11, Sujatha S. Menon 12, Ernest Law 13, Irene Modesto 13, Sarah Sidhu 13, Wojciech Niezychowski 11, Severine Vermeire 14

Affiliations

1 Division of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita Salute San Raffaele University, Milan, Italy

2 Pfizer AG, Zürich, Switzerland

3 Department of Gastroenterology, CHRU Nancy, INSERM NGERE, Université de Lorraine, Vandœuvre-lès-Nancy, France

4 Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, CA, United States

5 Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY, United States

6 University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, United States

7 Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada|||Alimentiv Inc, London, ON, Canada

8 Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, Netherlands

9 Department of Gastroenterology, AZ Delta, Roeselare, Belgium

10 Pfizer Inc, La Jolla, CA, United States

11 Pfizer Inc, Collegeville, PA, United States

12 Pfizer Inc, Groton, CT, United States

13 Pfizer Inc, New York, NY, United States

14 Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium

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Abstract

Introduction

Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC), with demonstrated efficacy in patients (pts) with baseline modified Mayo Score (MMS) 4–9.1 No prior clinical trials of advanced therapies in UC have studied efficacy only in pts with baseline MMS ≤6.

Aims & Methods

GLADIATOR (NCT04607837) was a proof-of-concept, global, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of etrasimod in adults with mildly to moderately active UC (MMS 4–6; endoscopic subscore ≥2; rectal bleeding subscore ≥1) and inadequate response, loss of response or intolerance to ≥1 UC therapy. Pts were randomised 2:1 to etrasimod 2 mg or placebo once daily, stratified by previous biologic/Janus kinase inhibitor exposure and baseline corticosteroid use. GLADIATOR used a treat-through design (12-week [wk] induction period followed by a 40‑wk maintenance period). From Wk 12, pts whose disease had worsened or not improved vs baseline may have been eligible to enrol in an open-label extension trial (NCT03950232). The primary efficacy endpoint was the proportion of pts achieving clinical remission at Wk 52; additional endpoints are shown in the Table. Safety was monitored throughout the study.

Results

In the primary analysis set for efficacy, 127 and 60 pts received etrasimod and placebo, respectively. At Wk 52, 26.0% and 18.3% of pts receiving etrasimod and placebo, respectively, were in clinical remission (p=0.2524; Table). At Wk 12, a greater proportion of pts receiving etrasimod achieved clinical remission, endoscopic improvement (EI) and endoscopic improvement-histologic remission (EIHR) vs placebo (p<0.05; Table). Pts receiving etrasimod were more likely to achieve sustained clinical remission vs placebo (p=0.0104; Table). Etrasimod was generally well tolerated and findings were consistent with the known safety profile.

Table. Proportions of pts (n [%]) achieving endpoints at Wk 12 and Wk 52 in GLADIATOR (nonresponder imputation)a​​​​EndpointPlacebo
(N=60)
Etrasimod 2 mg
(N=127)
% difference from placebob (95% CI)Difference from placebo p valuec​
Wk 12

Wk 12 completers:
Placebo: 56 (93.3)d
Etrasimod: 122 (96.1)e​​​​
Clinical remissionf​​​​7 (11.7)36 (28.3)15.6 (4.3, 26.9)0.0068
EIg​​​​12 (20.0)56 (44.1)23.3 (9.8, 36.9)0.0007
EIHRh​​​​8 (13.3)37 (29.1)15.0 (3.2, 26.8)0.0128
Wk 52

Wk 52 completers:
Placebo: 28 (46.7)i
Etrasimod: 76 (59.8)j
Clinical remissionf​​​​11 (18.3)33 (26.0)7.4 (-5.2, 19.9)0.2524
EIg​​​​14 (23.3)41 (32.3)8.2 (-5.2, 21.7)0.2302
EIHRh​​​​9 (15.0)32 (25.2)9.6 (-2.1, 21.3)0.1089
CS-free clinical remissionk10 (16.7)32 (25.2)8.5 (-3.7, 20.7)0.1726
Wk 12 and Wk 52Sustained clinical remissionl​​​​3 (5.0)21 (16.5)11.2 (2.6, 19.8)0.0104
aAll randomised pts who received ≥1 dose of study treatment with baseline MMS 4–6, baseline ES ≥2 and baseline RBS ≥1 were included in the primary analysis set for efficacy analysis. All pts with missing data were treated as nonresponders in the primary analysis.
bEstimated common risk difference using the Mantel–Haenszel weighted method, stratified by naïve to biologic/JAKi therapy at trial entry (yes/no) and baseline CS use (yes/no).
cFrom Mantel–Haenszel test and not adjusted for multiplicity.
dIn the placebo group, prior to Wk 12, the following reasons for discontinuation were reported: AE (n=2 [3.3%]); withdrawal by pt (n=2 [3.3%]).
eIn the etrasimod group, prior to Wk 12, the following reasons for discontinuation were reported: AE (n=3 [2.4%]); withdrawal by pt (n=1 [0.8%]); disease worsening (n=1 [0.8%]).
fClinical remission was defined as SFS=0 or 1 (and no greater than baseline), RBS=0 and ES ≤1 (excluding friability).
gEI was defined as ES ≤1.
hEIHR was defined as ES ≤1 with histologic remission measured by Geboes Index score <2.0.
iIn the placebo group, after Wk 12, the following reasons for discontinuation were reported: disease worsening (n=26 [43.3%]); withdrawal by pt (n=2 [3.3%]).
jIn the etrasimod group, after Wk 12, the following reasons for discontinuation were reported: disease worsening (n=33 [26.0%]); withdrawal by pt (n=5 [3.9%]); AE (n=4 [3.1%]); physician decision (n=2 [1.6%]); lack of efficacy (n=1 [0.8%]); study termination by sponsor (n=1 [0.8%]).
kCS-free clinical remission was defined as clinical remission at Wk 52 and CS free for ≥12 wks immediately prior to Wk 52.
lSustained clinical remission was defined as clinical remission at both Wk 12 and Wk 52.
AE, adverse event; CI, confidence interval; CS, corticosteroid; EI, endoscopic improvement; EIHR, endoscopic improvement-histologic remission; ES, endoscopic subscore; JAKi, Janus kinase inhibitor; MMS, modified Mayo score; N, number of pts in cohort; pt, patient; RBS, rectal bleeding subscore; SFS, stool frequency subscore; wk, week.

Conclusion

In pts with mildly to moderately active UC, etrasimod demonstrated higher rates of clinical remission, EI and EIHR at Wk 12, as well as sustained clinical remission at Wk 52, vs placebo. However, the primary endpoint of clinical remission at Wk 52 was not met. Etrasimod demonstrated efficacy in pts with UC with an MMS 4–9, including those with an MMS 4–6, in the ELEVATE UC clinical programme.1 The proof-of-concept GLADIATOR trial further supports etrasimod’s efficacy in active UC and provides important insights on studying pts with mildly to moderately active UC.

References

1. Sandborn WJ et al. Lancet 2023; 401: 1159–1171.

Disclosure

SD: Lecture fees: AbbVie, Amgen, Ferring Pharmaceuticals Inc, Gilead, Janssen, Mylan, Pfizer Inc, Takeda; Consultancy fees: AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Gilead Sciences, Hospira, Janssen, Johnson&Johnson, MSD, Mundipharma, Pfizer Inc, Roche, Sandoz, Takeda, TiGenix, UCB, Vifor; Directorship: Gastroenterology and Endoscopy.
MG, KL: Employees of Pfizer AG; shareholders of Pfizer Inc.
LPB: Consultancy fees: AbbVie, Abivax, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GlaxoSmithKline, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer Inc, Prometheus, Protagonist, Roche, Roivant, Samsung, Sandoz, Sanofi, Takeda, Theravance, Thermo Fisher, Tigenix, Tillotts, Viatris, Vifor, Vectivbio, Ventyx, Ysopia; Grants: Takeda, Fresenius Kabi, Celltrion; Lectures: AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Genetech, Gilead, Janssen, Lilly, Medac, MSD, Pfizer Inc, Sandoz, Takeda, Tillotts, Viatris, Vifor.
AJY: Consultancy fees: AbbVie, Arena, BMS, Celltrion, Pfizer Inc, Takeda; Lectures: AbbVie, BMS.
MCD: Consultancy fees: AbbVie, Abivax, Arena Pharmaceuticals, AstraZeneca, BMS, Eli Lilly, Galapagos, Genentech, Gilead Sciences, Janssen Pharmaceuticals, Johnson&Johnson, Merck, Pfizer Inc, Prometheus Laboratories, Prometheus Biosciences, Sanofi, Sphyre, Takeda, UCB; Shareholder: Trellus Health; Directorship: Trellus Health.
DTR: Consultancy fees: AbbVie, Abivax SA, Altrubio, Avalo Therapeutics, Bausch Health, Bristol Myers Squibb, Buhlmann Diagnostics Corp, Celltrion, ClostraBio, Connect BioPharma, Douglas Pharmaceuticals, Eli Lilly & Co., Foresee, Genentech, Image Analysis Group, InDex Pharmaceuticals, Iterative Health, Janssen Pharmaceuticals, Odyssey Therapeutics, Pfizer Inc, Sanofi, Takeda Pharmaceuticals, Throne, Vedanta; Grants: Takeda.
BGF: Senior Scientific Director of Alimentiv Inc, which provides central reading services. He is not a company employee and has no equity stake in the organisation, which is owned by a medical trust; Speaker fees: AbbVie, Janssen, Takeda; Consultancy fees: AbbVie, AbolerIS, AgomAB Therapeutics, Allianthera, Amgen, AnaptysBio, Applied Molecular Transport Inc, Arena Pharma, Avoro Capital Advisors, Atomwise, BioJamp, Biora Therapeutics, Boehringer Ingelheim, Boxer, Celsius Therapeutics,Celgene/BMS, Connect BioPharma, Cytoki, Disc Medicine, Duality, EcoR1, Eli Lilly, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech, Gilead, Gossamer Pharma, GSK, Hinge Bio, Hot Spot Therapeutics, Index Pharma, Imhotex, Immunic Therapeutics, JAKAcademy, Janssen, Japan Tobacco Inc, Kaleido Biosciences, Landos Biopharma, Leadiant, L.E.K. Consulting, Lenczner Slaght, LifeSci Capital, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic Therapeutics, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion Therapeutics, Pendopharm, Pfizer Inc, Prometheus Therapeutics and Diagnostics, Play to Know AG, Progenity, Protagonist, PTM Therapeutics, Q32 Bio, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres Therapeutics, Silverback Therapeutics, Surrozen Inc, Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx Biosciences, VHSquared Ltd, Viatris, Ysios, Ysopia, Zealand Pharma; Shareholder: Gossamer Pharma.
GRDH: Advisory fees: AbbVie, AstraZeneca, Alimentiv, BMS, Boehringer Ingelheim, Celltrion, Cosmo, Eli Lilly, Galapagos, GSK, Johnson&Johnson, Takeda, Pfizer Inc, Polpharma, Prometheus Biosciences, Tillotts, Ventyx; Speaker fees: AbbVie, Boehringer Ingelheim, Celltrion, Eli Lilly, Johnson&Johnson, Takeda, Pfizer Inc, Tillotts.
FB: Research/grants: AbbVie, Amgen, Eurogenerics, Janssen, Takeda; Lectures: AbbVie, Arena Pharmaceuticals, Celltrion, Ferring, Galapagos, Janssen, Merck Sharp & Dohme, Pfizer Inc, Takeda; Consultancy fees: AbbVie, Abivax, Amgen, Arena Pharmaceuticals, Celgene, Celltrion, Ferring, Fresenius Kabi, Janssen, Merck Sharp & Dohme, Pfizer Inc, Sandoz.
GG, JY, NL, CZ, WW, SM, EHL, IM, SS, WN: Employees/shareholders of Pfizer Inc.
SV: Lectures: AbbVie, Dr. Falk Pharma, Ferring, Galapagos, Hospira, Janssen, MSD, Takeda, Tillotts; Consultancy fees: AbbVie, AbolerIS Pharma, Alimentiv, Arena, AstraZeneca, Avaxia, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, CVasThera, Dr Falk Pharma, Eli Lilly, Ferring, Galapagos, Genentech/Roche, Gilead, Hospira, Imidomics, Janssen, Johnson&Johnson, Materia Prima, MiroBio, Morphic, MrMHealth, MSD, Mundipharma, Pfizer Inc, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance Biopharma, Tillotts Pharma AG, Zealand Pharma; Grants: AbbVie, MSD, Pfizer Inc, Galapagos, Janssen, Takeda.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Advanced therapies in ulcerative colitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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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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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 Berlin 2025

Topics

Hepatobiliary Surgery

Session

New developments in liver transplantation

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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