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DIGESTIVE ULTRASOUND: A KEY TOOL IN CROHN'S DISEASE MONITORING

Sarra EL FASSI 1, Soufian AMAZGUIOU 1, Rabii Ajana 1, Walid boukamza 1, Karima Sammoud 1, Faiza Charif 1, Adil Najdi 1, Aicha Akjay 1, Hassan Ouaya 1, Houda Meyiz 1, mellouki ihssane 1

Affiliations

1 CHU Mohammed VI, Tangier, Morocco

Summary

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A prospective study of 49 Crohn's disease patients compared intestinal ultrasound with CT enterography and colonoscopy, finding ultrasound to be a sensitive and accessible monitoring tool despite limitations in examining the proximal intestine and rectum.

Ultrasound detected digestive thickening in 81.6% of cases, mainly in the terminal ileum, with a sensitivity of 84.4% and specificity of 50%
CT enterography detected thickening in the proximal small bowel and rectum in 2.2% of cases that ultrasound missed, and no significant difference was found between ultrasound and CT for overall thickening detection
Ultrasound showed 86.5% sensitivity for mesenteric infiltration and 75% sensitivity for adenopathy detection, both with high specificity
Ultrasound demonstrated 60% sensitivity for detecting complications, which was significantly lower than CT enterography (p = 0.002)
No correlation was found between wall thickening detected on ultrasound and ulcers identified on endoscopy

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Abstract

Introduction

Intestinal ultrasound is a noninvasive and inexpensive tool to assess disease activity in patients with inflammatory bowel disease, such as Crohn's and ulcerative colitis by monitoring the disease activity in real time.

Aims & Methods

Intestinal ultrasound is a non-invasive, cost-effective imaging tool for routine clinical evaluations. This study examines its role in monitoring Crohn’s disease, comparing it with CT Enterography.
This is a prospective, descriptive, comparative study including patients with crohn's disease aged over 16, between March 2023 and March 2024. Every patient had a colonoscopy, enteroscan, and digestive ultrasonography; the delay between each test was limited to one month by the same operator. Patients with ileal or recto-colic resections or pregnant women were not included. We develope a form to collect clinical, therapeutic, and epidemiological informations as well as the outcomes of CT, colonoscopy, and ultrasounds. Between ultrasound, CT scan and colonoscopy, we asked our patients to choose the most widely accepted para-clinical test. Ultrasonography's sensitivity (Se) and specificity (Sp) were determined, and data from enteroscanner and ultrasound were analyzed, with a focus on the wall's thickness, vascularization, damage extent, and peridigestive environment. The statistical study was carried out using SPSS 21.0 software. Quantitative variables were expressed as medians and qualitative variables as numbers and percentages. The McNemar test and the Wilcoxon test for associated samples were applied. The significance level was set at 0.05.

Results

Forty-nine patients were included, with a male-to-female ratio of 0.53 and a median age of 32 years. US detected digestive thickening in 81.6% of cases, mainly in the terminal ileum. CT Enterography detected thickening in the proximal small bowel and rectum in 2.2% of cases, which US missed. US sensitivity was 84.4%, with specificity of 50%. No significant difference was found between US and CT for thickening detection. Mesenteric infiltration detected by US was similar to CT (Se = 86.5%, Sp = 100%). For adenopathy, Se was 75% (Sp = 97%). US showed a 60% sensitivity for detecting complications, with a significant difference compared to CT (p = 0.002). There was no correlation between thickening on US and ulcers on endoscopy.

Conclusion

Despite limitations in examining the proximal intestine and rectum, intestinal ultrasonography is a sensitive, accessible method for monitoring Crohn’s disease and detecting complications.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Advancing IBD precision medicine: The next frontier

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

Lucine Vuitton

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

Moritz Schmelzle

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Gionata Fiorino

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Lucine Vuitton

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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

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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:

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

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

Moritz Schmelzle

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Gionata Fiorino

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Lucine Vuitton

UEG Presentation

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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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Bram Verstockt

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

Lucine Vuitton

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

Moritz Schmelzle

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Gionata Fiorino

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Lucine Vuitton

UEG Presentation

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

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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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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:

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

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

Moritz Schmelzle

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Gionata Fiorino

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Lucine Vuitton

UEG Presentation

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

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

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RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Monique Devillers 1, Sebastiaan ten Bokkel Huinink 1, Toby Hackmann 2, Ewout Steyerberg 3, Bas Oldenburg 4, Remi Mahmoud 4, Pauliina Molander 5, Klaudia Farkas 6, Gionata Fiorino 7, María Chaparro 8, Javier Gisbert 8, María José Casanova 8, Sung-Noh Hong 9, Nikolas Dussias 10, Annemarie de Vries 1

Affiliations

1 Erasmus MC University Medical Center, Rotterdam, Netherlands

2 Leiden University Medical Center, Leiden, Netherlands

3 Utrecht University Medical Center, Utrecht, Netherlands

4 University Medical Center Utrecht, Utrecht, Netherlands

5 Helsinki University Hospital, Helsinki, Finland

6 University of Szeged 1st Dept. of Medicine, Szeged, Hungary

7 San Camillo-Forlanini Hospital, Rome, Italy

8 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain

9 Samsung Medical Center, Seoul, Korea, Republic of

10 IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

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Abstract

Introduction

Side effects, patient preference, and high costs may prompt cessation of anti-TNF therapy in ulcerative colitis (UC) patients in sustained remission. Given the risk of relapse, careful patient selection is essential. This study aimed to assess relapse rates and identify predictors of relapse following anti-TNF cessation in UC patients in remission.

Aims & Methods

A systematic search on cohort studies reporting relapse rates after cessation of anti-TNF therapy in ≥30 UC patients in clinical remission was performed 6 September 2024. Individual patient data was requested. We excluded patients with steroid use, ≤6 months anti-TNF therapy, ≤16 years, previous colectomy (n=4), golimumab as anti-TNF therapy (n=3) or without follow-up. Continuation of treatment with immunomodulators or mesalamine at cessation of anti-TNF was allowed. Relapse was defined as the need to (re)start treatment with steroids, anti-TNF or other advanced therapies, or the need for surgical treatment, as applied by the original author. Pooled relapse rates were computed using a random-effects model. A prediction model was built with a Cox proportional hazards model, performance assessed by iteratively leaving one study out (internal-external cross-validation, IECV). Missing covariate data were multiply imputed 100 times using the MICE algorithm. Variable selection was guided by three criteria: ≤20% missing data, a univariate p-value ≤ 0.2, and input from clinical experts.

Results

In total, 654 patients from 8 studies were included in the individual participant data meta-analysis. At anti-TNF cessation, median age was 40 years (IQR 31-51) with a median anti-TNF treatment of 18 months (IQR 18-36). The majority of patients were treated with infliximab (n = 610, 93%). Only 42 patients (9%) received a second-line anti-TNF therapy. The pooled relapse rate were 24% [95% CI 19-29%, I² = 44%] and 34% [95% CI 29-40%, I²= 39] at 1 and 2 years after cessation, respectively. Upon cessation, 211 patients (33%) continued mesalamine, 239 (39%) thiopurines, and 136 (22%) a combination of both. In our model, thiopurine therapy and older age at cessation were associated with a reduced risk of relapse, whereas immunomodulator refractoriness as an indication for starting anti-TNF therapy was associated with an increased risk. Other factors included in the prediction model were disease extent, type of anti-TNF therapy, history of anti-TNF therapy, fecal calprotectin level and endoscopic activity, leading to a c statistic of 0.55 [95% CI 0.51-0.59] (Table 1).

Table 1: Predictors of relapse in a pooled Cox regression analysis

Variable	Hazard Rate	95% Confidence interval
Age at discontinuation, per 10 years	0.80	0.72 – 0.88
Ulcerative colitis disease extent, Proctitis vs. extensive Left-sided vs. extensive	1.4 1.1	0.92 – 2.1 0.87 – 1.5
Type of anti-TNF therapy, adalimumab vs. infliximab	0.91	0.55 – 1.5
≥1 previous anti-TNF, yes vs. no	1.5	0.95 – 2.3
Indication anti-TNF therapy Immunomodulator refractoriness, yes vs no/unknown	1.5	1.1 – 2.2
Concomitant treatment after anti-TNF therapy, None vs thiopurine Mesalamine vs. thiopurine Combination of mesalamine and thiopurines vs thiopurine	1.8 1.2 1.2	1.1 – 3.0 0.86 – 1.6 0.81 – 1.7
Fecal Calprotectin (µg/g), per 100	1.1	0.95 – 1.3
Endoscopic activity, yes (mild, moderate or severe) vs. no	1.3	0.91 – 2.0

Conclusion

Approximately 1 in 4 patients experience a relapse of UC within 1 year after anti-TNF cessation, increasing to 1 in 3 within 2 years. Continuation of thiopurines is associated with a reduced risk. A prediction model for relapse was developed in this large IPD meta-analysis cohort and may aid in shared decision-making on anti-TNF cessation. However, its limited discriminative ability underscores the need for further refinement, incorporating data on microscopic remission and molecular and immunological markers to better capture deeper disease control.

Event

UEG Week Berlin 2025

Topics

Gut Microbiota IBD Immunology Mechanisms & Personalised Medicine

Submission format

Late-Breaking Abstract

Session

Late-breaking trials in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

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

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

Moritz Schmelzle

RISK OF RELAPSE AFTER CESSATION OF ANTI-TNF THERAPY IN ULCERATIVE COLITIS IN CORTICOSTEROID-FREE CLINICAL REMISSION: AN INDIVIDUAL PARTICIPANT DATA META-ANALYSIS (IPD-MA) ON 654 PATIENTS FROM 8 STUDIES

Gionata Fiorino

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Lucine Vuitton

UEG Presentation

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

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

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DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN’S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY

Vipul Jairath 1, Bruce E. Sands 2, Silvio Danese 3, Ken Abrams 4, Hadas Barkay 5, Phillip Levine 6, Bogdan Ratiu-Duma 7, Walter Reinisch 8

Affiliations

1 Western University, London, Canada

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

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

4 Teva Branded Pharmaceutical Products R&D LLC, Parsippany, United States

5 Teva Pharmaceutical Industries Ltd, Netanya, Israel

6 Sanofi, Cambridge, United States

7 Teva Pharmaceuticals, Bucharest, Romania

8 Medical University of Vienna, Wien, Austria

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Abstract

Introduction

Duvakitug, a human IgG1 monoclonal antibody, inhibits TL1A binding to death receptor 3 (DR3), which drives inflammation in Crohn’s disease (CD). The RELIEVE-UCCD trial (NCT05499130), a 14-week induction study, evaluated duvakitug in ulcerative colitis and CD. This was the first placebo-controlled study of an anti-TL1A in moderately to severely active CD. This subgroup analysis was performed to understand the impact of duvakitug in patients with moderate and severe endoscopic inflammation by assessing Week 14 outcomes in subgroups based on endoscopic disease severity at baseline.

Aims & Methods

Patients with CD (N=138) were randomized (1:1:1) to receive a subcutaneous (SC) loading dose (LD) of duvakitug 2250 mg followed by SC duvakitug 900 mg or duvakitug 450 mg every 2 weeks (q2w), or matching placebo LD followed by placebo q2w. Patients were required to have a simple endoscopic score for Crohn’s disease (SES-CD) ≥6 (≥4 for isolated ileal disease) for study eligibility. In this analysis, endoscopic and patient-reported clinical outcomes were assessed by baseline SES-CD scores of ≤15 (moderate) and >15 (severe).¹ Endpoints included response and remission based on endoscopic assessment (SES-CD) and clinical assessment [2-item Patient Reported Outcome assessment tool (PRO2)] at Week 14. Outcomes were analyzed using descriptive summary statistics.

Results

Among patients with severe endoscopic activity (SES-CD >15) at baseline, endoscopic response was achieved by 36% in the duvakitug 900 mg arm, and 18% in the duvakitug 450 mg arm compared to 8% in the placebo arm. In patients with moderate endoscopic activity (SES-CD ≤15) at baseline, endoscopic response was achieved by 51% in the duvakitug 900 mg arm, and 29% in the duvakitug 450 mg arm compared to 15% in the placebo arm (Table). Greater proportion of patients achieved endoscopic remission, clinical response and remission with both doses of duvakitug compared to placebo in the moderate and severe endoscopic subgroups (Table). The overall adverse event profile was similar across treatment arms by disease severity subgroups.

Table: Week 14 endoscopic and clinical response and remission in CD patients with moderate and severe endoscopic activity at baseline

	Baseline SES-CD ≤15			Baseline SES-CD >15
	Placebo (N=33)	Duvakitug 450mg (N=35)	Duvakitug 900mg (N=35)	Placebo (N=13)	Duvakitug 450mg (N=11)	Duvakitug 900mg (N=11)
Endoscopic Response (SES-CD)	15%	29%	51%	8%	18%	36%
Endoscopic Remission (SES-CD)	12%	20%	31%	0%	9%	9%
Clinical Response (PRO2)	36%	54%	54%	0%	36%	45%
Clinical Remission (PRO2)	33%	40%	40%	8%	27%	27%
CD, Crohn’s disease; PRO2, two-item patient reported outcome measure; SES-CD, simple endoscopic score for Crohn’s disease
Endoscopic response (SES-CD): ≥50% decrease in SES-CD at Week 14 from baseline. Endoscopic remission (SES-CD): SES-CD score ≤2 at Week 14. Clinical response (PRO2): Decrease from baseline of ≥50% in PRO2 (daily average abdominal pain and daily average stool frequency scores). Clinical remission (PRO2): abdominal pain score ≤1 and stool frequency ≤3.

Conclusion

In CD patients, duvakitug demonstrated efficacy in endoscopic and patient-reported clinical outcomes in both moderate and severe endoscopic activity subgroups in this Phase 2b study. Duvakitug was well tolerated across both subgroups. These findings support further development of duvakitug as a potential treatment option for moderately to severely active CD.

References

1. Moskovitz DN, Daperno M, Van Assche G. Defining and validating cut-offs for the Simple Endoscopic Score for Crohn's Disease. Gastroenterology 2007; 132:S1097.

Disclosure

W.R. has served as a speaker for AbbVie, Celltrion, Ferring, Janssen, Galapagos, Merck Sharp & Dohme, Roche, Pfizer, Sobi and Takeda; as a consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead,
Index Pharma, Janssen, Medahead, Microbiotica, Pfizer, Teva and Takeda; as an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, Pfizer and Teva; and have received research funding from AbbVie, Janssen, Sandoz, Sanofi and Takeda.
V.J. has received consulting/advisory board fees from AbbVie, Alimentiv, AnaptyisBio, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Endpoint Health, Enthera, Ensho, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Innomar, JAMP, Janssen, Merck, Metacrine, Mylan, MRM Health, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus Biosciences, Reistone Biopharma, Roche, Roivant, Sandoz, Second Genome, Sorriso, Spyre, Synedgen, Takeda, Teva, Ventyx and Vividion; and speaker’s fees from, Abbvie, Ferring, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, Janssen, Pfizer, Shire, Takeda and Tillotts.
B.S. has served as a consultant or received speaker’s fees from AbbVie, Abivax, Adiso Therapeutics, Alimentiv, Amgen, Arena Pharmaceuticals, Artizan Biosciences, Artugen Therapeutics, AstraZeneca, Bacainn Therapeutics, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celltrion Healthcare, ClostraBio, Connect Biopharm, Cytoki Pharma, Eli Lilly and Company, Entera, Evommune, Ferring, Fresenius Kabi, Galapagos, Gilead, Genentech, Glaxo SmithKline, Gossamer Bio, HMP Acquisition, Imhotex, Immunic, InDex Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Ironwood Pharmaceuticals, Janssen, Johnson & Johnson, Kaleido, Kalyope, Merck, MiroBio, Morphic Therapeutic, MRM Health, OSE Immunotherapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, RedHill Biopharma, Sun Pharma Global, Surrozen, Synlogic Operating Company, Takeda, Target RWE, Theravance Biopharma R&D, TLL Pharmaceutical, USWM Enterprises, Ventyx Biosciences, Viela Bio, and has stock options from Ventyx Biosciences.
S.D. reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor; and reports lecture fees from Abbvie, Amgen, Dr Falk Pharma, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda.
K.A., N.G., B.R-D. are employees of Teva Pharmaceutical Industries Ltd.
P.L. is an employee of Sanofi.
Duvakitug is being developed in partnership by Teva and Sanofi.

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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EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

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EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

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EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

Manon Haas 1, Laurent Abramowitz 2, Stephanie Hamonic 3, Amandine Landemaine 3, Guillaume Bouguen 3, Anne Laurain 2, Lucine Vuitton 4, Isabelle Etienney 5, Gauthier Pellet 6, Kristell Coat 3, Ronan Garlantezec 3, Laurent Siproudhis 3, Xavier Treton 1

Affiliations

1 Institut des MICI - Clinique Ambroise Paré Hartmann, Neuilly sur Seine, France

2 CHU Bichat, Paris, France

3 CHU Pontchaillou, Rennes, France

4 Besançon university hospital gastroenterology, Courbevoie, France

5 Diaconesses-Croix St Simon Hospital, Paris, France

6 CHU Bordeaux, Bordeaux, France

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Abstract

Introduction

Management of perianal fistulas in Crohn’s disease (CD) is challenging and requires a multidisciplinary approach, combining surgical drainage and biologic therapies, such as infliximab (IFX). Higher IFX trough concentrations have been associated with improved fistula healing rates. The subcutaneous (SC) formulation of IFX achieves 2–3 times higher and more stable trough levels compared to intravenous (IV) formulation. This study hypothesizes that SC IFX could enhance perianal fistula healing rates in CD patients.

Aims & Methods

REMSILAP study is part of the 3TLAP cohort, a French prospective multicenter observational study evaluating optimal therapeutic strategies for achieving clinical and radiological remission of perianal fistulas in CD at 12 months post-surgical drainage. The REMSILAP substudy focuses specifically on patients receiving SC IFX. Patients who received SC IFX after or within six months prior to surgical drainage were included. Baseline was defined as the day of surgical drainage. The primary outcome was the proportion of patients achieving complete clinical remission defined as Perianal Disease Activity Index (PDAI) fistula drainage subscore = 0 associated with PDAI activity restriction subscore <3 and absence of seton, and radiological remission at 12 months. Here, we present preliminary findings from REMSILAP.

Results

Among the 353 patients enrolled in the 3TLAP cohort, 54 were included in REMSILAP. The cohort consisted of 61.1% male patients, with a median age of 36 years and a median disease duration of 4.5 years. Penetrating disease (B3 phenotype) was present in 40.7%, and 33.3% had a history of surgical resection. At baseline, 40.7% of patients had quiescent disease regarding Harvey-Bradshaw index, while 5.6% had severe disease activity. Biologic exposure prior to inclusion was noted in 42.6%. Surgical drainage, with seton placement, was performed in 74.1% of patients. Forty-eight patients (88%) initiated SC IFX treatment after surgical drainage. Of the patients receiving SC IFX, 50% transitioned to SC IFX after less than three IV infusions. Among those on IV IFX at baseline, 20.4% were receiving a 10 mg/kg dose. Forty-three patients (79.6%) received SC IFX in combination with immunomodulators (azathioprine, methotrexate, or 6-mercaptopurine). The median duration of SC IFX treatment was 13.1 months, with treatment maintained for 67.5% of the follow-up period (mean: 19.3 ± 11.3 months). Forty-three patients (79.6%) were treated with a stable dose of 120 mg/14 days and 6 patients (11.1%) had an intensification of SC IFX dosage to 120mg / 7 days. At 12 months, 42 patients were evaluable for clinical outcomes. Complete clinical healing at 12 months was achieved in 11 patients (27.5%) and association of PDAI restriction subscore <3 and drainage subscore = 0 was found in 18 patients (42.9%). Thirteen patients (34.2%) from the 25 patients who had received at least 6 months of SC IFX treatment showed clinical healing at 6 months. Out of the 26 patients treated with at least 12 months of SC IFX treatment, clinical healing was achieved in 16 patients (61.5%) at 12 months. Among the 11 patients with clinical healing at 12 months, 8 (72.2%) were treated with SC IFX treatment following more than three IFX IV infusions. None of the 11 patients with available MRI date showed radiological healing at 12 months.

Conclusion

Subcutaneous infliximab following surgical drainage of Crohn’s disease perianal fistula demonstrates high treatment persistence and promising rates of fistula healing.

Disclosure

This study was funded by Celltrion Healthcare France

Event

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Treatment of fistulas in Crohn's disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

Advancing IBD precision medicine: The next frontier

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Moritz Schmelzle

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Walter Reinisch

EVALUATION OF SUBCUTANEOUS INFLIXIMAB FOR PERIANAL FISTULA HEALING IN CROHN’S DISEASE: PRELIMINARY RESULTS FROM THE REMSILAP MULTICENTER OBSERVATIONAL COHORT STUDY

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