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IBD Update Faculty

Waqqas Afif

Associate Professor of Medicine

Department of Gastroenterology

McGill and MUHC GI Division Director

Reena Khanna

Professor (Department of Medicine),

Program Director (Clinician Investigator Program),

University of Western Ontario

Cynthia Seow

Professor of Medicine�Division of Gastroenterology & Hepatology�Departments of Medicine & Community Health Sciences, University of Calgary

Jeff McCurdy

Gastroenterologist, The Ottawa Hospital; Assistant Professor of Medicine, University of Ottawa

Sally Lawrence

Pediatric Gastroenterologist & Clinical Director, Pediatric IBD Program, BC Children’s Hospital; Clinical faculty (Department of Pediatrics), �University of British Columbia

Neeraj Narula

Associate Professor of Medicine, McMaster University; Staff Gastroenterologist, Hamilton Health Sciences; Director

Remo Panaccione

Professor of Medicine; Director, IBD Unit; Dean, MD Admissions; Director, IBD Fellowship Program;

University of Calgary

Expert Guest Commentator

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Abstract Selection Process

All IBD-related Oral �Abstract Presentations

Top 12 Selected �& Summarized

Top 4 Presented �at Webinar

Will be made available after webinar

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Top 12 Oral Abstracts

#	Abstract title
1	Long-term outcomes after appendectomy for maintenance of remission in ulcerative colitis: Five-year NL-results from the ACCURE randomized controlled trial
2	PROFILE 4-year follow-up shows that early effective “top-down” therapy is associated with reduced long-term Crohn’s disease complications
3	Ileocaecal resection versus infliximab for ileal Crohn’s disease: 10-year follow-up of the LIR!C trial
4	The Tasty&Healthy whole food diet improves calprotectin in high risk first-degree relatives of patients with Crohn’s disease (FDRs): The PIONIR randomized controlled prevention cross-over trial
5	Efficacy and safety of vedolizumab combined with upadacitinib as an 8-week induction strategy in moderate-to-severe ulcerative colitis: a multicenter, randomized controlled trial
6	Results from the STENOVA trial: A Phase 2a, randomized, placebo-controlled, double-blind study to assess the safety, pharmacokinetics (PK), and pharmacodynamics of ontunisertib (AGMB-129) in patients with Fibrostenotic Crohn’s Disease (FSCD)
7	Who benefits from endotherapy in Crohn’s disease strictures? Predictors of recurrence, need for reintervention, and surgery from the Balloon Dilation versus Endoscopic Stricturotomy for Crohn’s Disease (BEST-CD) randomised controlled trial
8	Randomised controlled trial of withdrawal of thiopurines in patients with IBD switching from intravenous to subcutaneous infliximab: Results of the MINIMISE study
9	Faecal microbiota transplantation for active Crohn’s disease: The MIRO (Microbial Restoration) randomised placebo-controlled trial.
10	Combination treatment with adalimumab and partial enteral nutrition compared with adalimumab monotherapy in adults with active Crohn’s disease: The BIOPIC study
11	Ustekinumab for Fistulizing Perianal Crohn’s Disease: week-48 results from the USTAP Randomized Placebo-Controlled Trial
12	NORDTREAT: a randomised, multicentre, biomarker-strategy design, open-label, controlled trial of top-down versus clinical management in newly diagnosed IBD
Sponsor poster selection: Real-world effectiveness and safety of etrasimod in Ulcerative Colitis: interim analysis of the EFFECT-UC study
Sponsor poster selection: Evaluation of transmural healing in patients with moderately to severely active Crohn’s disease shows early efficacy of vedolizumab: VECTORS week 14 interim analysis

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Top 4 Selected Abstracts for Webinar

Presenter	Abstract title
Dr. Cynthia Seow	Long-term outcomes after appendectomy for maintenance of remission in ulcerative colitis: Five-year NL-results from the ACCURE randomized controlled trial
Dr. Waqqas Afif	PROFILE 4-year follow-up shows that early effective “top-down” therapy is associated with reduced long-term Crohn’s disease complications
Dr. Cynthia Seow	Ileocaecal resection versus infliximab for ileal Crohn’s disease: 10-year follow-up of the LIR!C trial
Dr. Waqqas Afif	The Tasty&Healthy whole food diet improves calprotectin in high risk first-degree relatives of patients with Crohn’s disease (FDRs): The PIONIR randomized controlled prevention cross-over trial

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Long-term outcomes after appendectomy for maintenance of remission in ulcerative colitis: Five-year NL-results from the ACCURE randomized controlled trial

I. Van Dijk, E. Visser, G. D’Haens, W. Bemelman, C.J. Buskens, AUMC

Slides compiled by Dr. Cynthia Seow

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Introduction

Background & Objectives

The ACCURE trial demonstrated that appendectomy significantly reduced clinical relapse within one year in patients with ulcerative colitis (UC) in remission compared with standard medical therapy alone
Objective: Evaluate the long-term clinical effectiveness of laparoscopic appendectomy for maintenance of remission in UC.

UC, ulcerative colitis; HR, hazard ratio; CI, confidence interval.

Van Dijk I et al. ECCO 26; (Abstract citation ID: jjaf231.034, OP34).

Methods

Design: Long-term (5 year) analysis of participants from the ACCURE trial (n=163)
Clinical and endoscopic remission at inclusion �(Mayo score ≤2, endoscopic subscore ≤1 or Fcal <150)
Follow-up: Prospective follow-up for 5 years after randomization, with assessments every 6 months.

Primary outcome: Initiation of advanced medical therapy
Secondary outcomes:

Colectomy
Colorectal neoplasia
Endoscopic and biochemical remission at 36 months �(MES ≤1 or FCP<150)

Statistics:

Time-to-event and repeated binary outcome analyses

Assessments

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Results:

N=80 (appendectomy group); N=83 (control group)
Baseline characteristics comparable�Mean age 43.9 (SD 12.3) years, median disease duration 5.2 (IQR 1.5-11.3) years, 5-ASA use ~80%
Median follow-up period was 5 years
Primary outcome: �Individuals undergoing appendectomy were less likely to escalate to advanced medical therapy than those managed with medical therapy alone.
8.8% appendectomy group (7/80) vs. �25.3% control group (21/83)�Difference: 16.5% (p=0.012)

mITT, modified intention-to-treat; SD, standard deviation; IQR, interquartile range; HR, hazard ratio; CI, confidence interval; UC, ulcerative colitis

Note: Adjusted for age, sex, smoking, disease extent, time since most recent exacerbation

Van Dijk I et al. ECCO 26; (Abstract citation ID: jjaf231.034, OP34).

�Adjusted HR 0.30; 95% CI, 0.13-0.73; p = 0.003

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Results:

Secondary outcomes:

Colectomy in 3 individuals (in the control group), �incidental finding of dysplasia in one patient.
No evidence of an increased neoplasia risk associated with appendectomy over 5 years

Fcal, fecal calprotectin.

Van Dijk I et al. ECCO 26; (Abstract citation ID: jjaf231.034, OP34).

Outcome	Appendectomy group	Control group	P-value
Colectomy	0/80	3/83 (3.6%)	0.09
Dysplasia	0/80	1/83 (1.2%)	0.325

Remission at 36 months	Appendectomy group	Control group	P-value
Endoscopic subscore (MES ≤1) or Fcal <150	51/61 (83.6%)	38/53 (71.7%)	0.125
Endoscopic subscore (MES ≤1)	28/33 (83.8%)	19/32 (59.4%)	0.022
Fcal <150	23/28 (82.1%)	19/21 (90.5%)	0.409

Note that not all patients underwent endoscopy nor completed fecal calprotectin

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Conclusions

Individuals with UC in remission who underwent appendectomy were significantly less likely to require escalation to advanced medical therapy.
There was no increased risk of colectomy or neoplasia at 5 years in the appendectomy group.

Significance to clinical practice

Appendectomy may be an effective adjunct to standard medical therapy for maintaining disease remission in individuals with UC.
A detailed discussion of the benefits and risks of undertaking elective surgery (appendectomy) in an asymptomatic individual needs to be undertaken.
Await further data to determine which patients benefit most from appendectomy.

Van Dijk I et al. ECCO 26; (Abstract citation ID: jjaf231.034, OP34).

Added the following:

This study suggests that appendicectomy (a surgical option) may be an effective adjunct to standard medical therapy for maintaining disease remission in individuals with UC.

Further, appendicectomy appeared superior to medical therapy alone with significantly fewer patients requiring escalation to advanced medical therapy.

In this 5-year follow-up study of the ACCURE-trial, appendicectomy was superior to medical therapy alone, with significantly fewer

patients requiring escalation to advanced medical therapy. These findings underscore the long-term benefit of appendicectomy for maintenance of

remission in UC, without evidence of an increased risk of neoplasia.

Which disease characteristics suggest an individual with UC may benefit from appendicectomy?

How would you approach a discussion of the benefits and risks of elective appedicectomy in an individual who is asymptomatic and already in established disease remission?

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PROFILE 4-year follow-up shows that early effective “top-down” therapy is associated with reduced long-term Crohn’s disease complications

N. Noor, H. Zheng, M.T. Sharip, J. Lee, D. Robertson, M. Parkes, PROFILE Study Group

Slides compiled by Dr. Reena Khanna

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Introduction

Background & Objectives

In the original PROFILE RCT (48 weeks): “top-down” (TD; infliximab + immunomodulator) therapy from diagnosis led to better outcomes vs accelerated “step-up” (SU; conventional) treatment.

Abdominal surgeries: 10 in SU vs. 1 in TD

Objective: Determine whether early effective treatment (TD vs SU) modifies the longer-term course of CD with follow-up of PROFILE participants.

CD, Crohn’s Disease; ITT, intention-to-treat; OR, odds ratio; CI, confidence interval.

Noor N et al. ECCO 2026; (Abstract citation ID: jjaf231.005, OP05).

Methods

Design: Medical record review for objective outcomes for up to 5 years after the week-48 end-of-trial visit.
Population: PROFILE RCT participants (Adults with newly diagnosed active Crohn’s disease at trial start); post-trial management per local standard of care
Outcomes: CD-related abdominal surgery; hospital admission and progression to stricturing [B2]/ penetrating [B3] disease
Analysis: Based on PROFILE randomization and modified ITT; ORs (95% CI) for outcomes; time-to-event via Kaplan–Meier and Cox proportional hazards models.

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Patient Characteristics

TD, top-down treatment group; SU, step-up treatment group

Noor N et al. ECCO 2026; (Abstract citation ID: jjaf231.005, OP05).

Follow-up Population

PROFILE RCT (48 weeks): N=386
PROFILE follow-up: N=357 (92%)

180 TD
177 SU

Median follow-up was 1352 days (∼4.5 years from diagnosis).

Treatment Exposure

PROFILE patients receiving anti-TNF:

100% TD
41% SU

Post-PROFILE patients receiving advanced therapy:

100% TD
78% SU.

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Results: Abdominal Surgeries

Post-PROFILE period:

SU: 17 surgeries
TD: 5 surgeries

From diagnosis (aggregate):

SU: 27 surgeries (25 patients)

25/27 for CD complications (12 stricturing [B2], 13 penetrating [B3])

TD: 6 surgeries (6 patients)

5/6 for CD complications (3 B2, 2 B3).

TD, top-down treatment group; SU, step-up treatment group

Noor N et al. ECCO 2026; (Abstract citation ID: jjaf231.005, OP05).

Total number of abdominal surgeries

Time to first abdominal surgery

OR = 5.00; 95% CI 2.02-12.43; p<0.001

Earlier time to first surgery in SU

Incidence of Crohn’s disease abdominal surgery

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Results

TD, top-down treatment group; SU, step-up treatment group; OR, odds ratio; CI, confidence interval; CD, Crohn’s Disease

Noor N et al. ECCO 2026; (Abstract citation ID: jjaf231.005, OP05).

Progression to stricturing [B2] / penetrating [B3] disease:

More frequent in SU vs TD (33 vs 13)

OR = 2.61; 95% CI 1.33-5.12

Incidence of CD-related hospital admissions (excluding surgeries):

Higher in SU vs TD (44 vs 15)

OR = 3.75; 95% CI 2.00-7.02

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Conclusions

Although most patients in the step-up group eventually received biologic therapy, the need for surgery, hospitalization and development of stricturing disease was higher in this population compared to the top-down group.

Significance to clinical practice

Early effective therapy may have long term benefits to patient outcomes.
This is thought provoking to consider disease modification as possible with therapy choices.

Noor N et al. ECCO 2026; (Abstract citation ID: jjaf231.005, OP05).

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Ileocaecal resection versus infliximab for ileal Crohn’s disease: 10-year follow-up of the LIR!C trial

A. Haanappel, L. Oldenburg, M. Ali, C. Bosman, C.J. Buskens, C. Ponsioen, G. D’Haens, W. Bemelman, LIR!C study group

Slides compiled by Dr. Cynthia Seow

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Introduction

Background & Objectives

The LIR!C trial demonstrated laparoscopic ileocaecal resection (ICR) as a viable alternative to infliximab (IFX) for uncomplicated ileal Crohn’s disease after failure of conventional therapy, with similar quality-of-life outcomes at 1 and 5 years.
Objective: Determine therapy-free remission and clinical remission rates following ICR vs IFX at 10 years.

CD, Crohn’s disease; ICR, ileocaecal resection; IFX, infliximab.

Haanappel A et al. ECCO 26; (Abstract citation ID: jjaf231.043, DOP006).

Methods

Design: Cohort study derived from the LIR!C multicentre randomized controlled trial comparing ICR vs IFX in ileal CD.
Data collection: Retrospective assessment of long-term outcomes (Feb 3–Jul 17, 2025), including CD treatment initiation or switch, and need for repeat resection.

Outcomes of Interest:

Therapy-free remission:

ICR group: clinical remission without initiation of CD-related therapy
IFX group: clinical remission with IFX discontinuation

Clinical remission rates: No change in CD-related therapy or need for additional resection in either group

Exploratory analysis: Flexible parametric survival models to assess for age-dependent effect modification of ICR vs IFX on 10-year clinical remission rates.

Assessments

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Results:

CD, Crohn’s disease; ICR, ileocaecal resection; IFX, infliximab; CI, confidence interval; IQR, interquartile range.

Haanappel A et al. ECCO 26; (Abstract citation ID: jjaf231.043, DOP006).

ICR Group: 35.8% �(95% CI 25.6–50.1)

IFX group: 13.2% �(95% CI 6.1–23.1)

Individuals undergoing ileocaecal resection (ICR) were 3 times more likely to achieve therapy-free remission compared with those treated with infliximab (IFX) at 10 years.

Difference: 22.6% (95% CI 7.8–36.8); p=0.004

Baseline characteristics	ICR (n=69)	IFX (n=65)
Female	44 (64%)	46 (71%)
Age at randomization (yrs)	28 (23-41)	27 (22-38)
Disease duration (months)	12 (5-34)	14 (6-34)
Active smoking	22 (32%)	36 (48%)
Immunomodulator use	26 (38%)	36 (55%)

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Results:

10-year clinical remission rates were similar between ICR and IFX groups
Interaction analyses suggested greater benefit with ICR in younger patients (p_interactionsss=0.020)
Model-estimated 10-year clinical remission rates for younger patients:

Age 20: 54% (ICR) vs 24% (IFX) → �difference 30% (7 to 53)
Age 30: 38% (ICR) vs 28% (IFX) → �difference 10% (−6 to 26)

CD, Crohn’s disease; ICR, ileocaecal resection; IFX, infliximab; HR, hazard ratio; CI, confidence interval; IQR, interquartile range.

Haanappel A et al. ECCO 26; (Abstract citation ID: jjaf231.043, DOP006).

ICR: 36.5% vs IFX: 28.4%

p=0.27

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Conclusions

A significantly greater proportion of patients who had undergone ileocaecal resection (ICR) for uncomplicated ileal Crohn’s disease were in therapy-free remission at 10 years versus those who had received infliximab.
Younger patients derived greater benefit of sustained clinical remission following ICR (absence of change in CD-related therapy or need for repeat resection) than older patients.

Significance to clinical practice

Limited ileocecal resection could be considered in individuals with ileocecal disease failing conventional therapy as an alternative to advanced medical therapy.
The decision for surgical therapy should integrate risk factors for post operative recurrence, including patient age.

Haanappel A et al. ECCO 26; (Abstract citation ID: jjaf231.043, DOP006).

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The Tasty&Healthy whole food diet improves calprotectin in high risk first-degree relatives of patients with Crohn’s disease (FDRs): The PIONIR randomized controlled prevention cross-over trial

D. Turner, S. Kenigsberg, L. Plotkin, Y. Aharoni-Frutkoff, M. Sokolik, G. Focht, W. Turpin, A.M. Waslyk, O. Ledder, A. Griffiths, I. Martincevic, H. Huynh, L. Godny, I. Avni Biron, J. Tinoco da Silva Torres, S.H. Lee, K. Croitoru

Slides compiled by Dr. Sally Lawrence

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Introduction

Background & Objectives

The rising prevalence of IBD necessitates the development of prevention strategies for at-risk individuals
First-degree relatives (FDRs) of Crohn’s disease (CD) patients represent a higher-risk group with the potential to develop CD
The Tasty&Healthy (T&H) whole-food diet, which avoids processed food, gluten, meat and dairy, has been shown to induce clinical and biologic remission in mild to moderate CD in children and young adults. Given the absence of formula dependence and mandatory food requirements, T&H may represent a potentially attractive prevention strategy.
Aim: Explore whether the T&H diet improves biomarkers in high-risk CD FDRs.

T&H, Tasty&Healthy whole food diet; CD, Crohn’s Disease; FDR, first-degree relative; FC, fecal calprotectin

Turner D et al. ECCO 2026; (Abstract citation ID: jjaf231.017, OP17).

Method

Design: Randomized 16-week crossover study of 2 diets (T&H and habitual diet) from the GEM Project
Inclusion: healthy FDRs <39yrs, FC >70 µg/g x3, non-specific or no mucosal inflammation on panenteric capsule endoscopy or ileocolonoscopy.
Primary outcome: ITT analysis based on Generalized Estimating Equation model of FC accounting for repeated measures, period, sequence and baseline inflammation

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Methods

Turner D et al. ECCO 2026; (Abstract citation ID: jjaf231.017, OP17).

n = 15

n = 15 crossed over to Tasty & Healthy

n = 14

n = 12 crossed over to Habitual Diet

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Baseline Characteristics and Adherence

Turner D et al. ECCO 2026; (Abstract citation ID: jjaf231.017, OP17).

86% of patients were adherent to the diet

Assessed by weekly dietitian interviews with a standardized score and 3 day food diaries at w0, 4, 8.

Characteristic	Overall n=29	Habitual diet n=15	Tasty&Healthy n=14	p-value
Sex (Female)	17 (59%)	8 (53%)	9 (64%)	0.71
Age (years)	25.5±7.3	24.7±6.5	26.4±8.1	0.54
<18	4 (14%)	2 (13%)	2 (14%)
18-25	10 (34%)	6 (40%)	4 (29%)	0.88
>25	15 (52%)	7 (47%)	8 (57%)
Family Type
Multiplex	8 (28%)	3 (20%)	5 (36%)	0.43
Simplex	21 (72%)	12 (80%)	9 (64%)
Proband
>1 siblings	3 (10%)	0 (0.0%)	3 (21%)
Parent & Sibling	5 (17%)	3 (20%)	2 (14%)	0.29
Parent	3 (10%)	1 (6.7%)	2 (14%)
Sibling	18 (62%)	11 (73%)	7 (50%)
VCE results
Macroscopic changes	21 (72%)	9 (60%)	12 (86%)	0.22
Normal study	8 (28%)	6 (40%)	2 (14%)
Week 0 calprotectin (µg/g, median)	205 (97-264)	174 (91-352)	218 (106-264)	0.78

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Results

Turner D et al. ECCO 2026; (Abstract citation ID: jjaf231.017, OP17).

Fecal calprotectin over time

Adjusted GEE Analysis results (ITT)

Fecal calprotectin µg/g

Estimated marginal (geometric) means of calprotectin mg/g

T&H group – rapid decline in FC by 4 weeks that was maintined through w8 that was highly significant. In the habitual diet phase the FC increased again. In the habitual diet group the FC numerically decreased but it was not significant (highlighting the placebo effect and regression to the mean phenomenon). In the T&H phase the FC was lower all be it not as strikingly as the T&H first group. The differences between the group were significant at w4 and 8

The primary analysis accounted for both periods together in the GEE model and you can see that the T&H group decreased the FC by 61% - and most normalized FC. The habitual diet decreased the FC by 38% highlighting the placebo effect. The ratio of the model was 0.63 which was highly significant. The FC reduction of the T&H diet compared to habitual diet was 37%

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Conclusions

In this randomized IBD trial, the T&H diet intervention was associated with a 37% reduction in fecal calprotectin compared with habitual diet among healthy high-risk FDR .

Significance to clinical practice

This study represents an early randomized evaluation of a dietary prevention strategy in IBD, providing preliminary evidence that targeted nutritional interventions may influence inflammatory biomarkers in at-risk individuals.
Adequately powered prospective cohorts with longer-term follow up are required to evaluate diet adherence sustainability, mechanistic effects and whether biomarker modulation translates into a reduced risk of incident IBD in high-risk individuals.

Turner D et al. ECCO 2026; (Abstract citation ID: jjaf231.017, OP17).

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Efficacy and safety of vedolizumab combined with upadacitinib as an 8-week induction strategy in moderate-to-severe ulcerative colitis: a multicenter, randomized controlled trial

H. Wu, L. Wu, T. Xie, J. Wu, H. Chen, Q. Yu, X. Cao, M. Zhi, J. Yao

Slides compiled by Dr. Reena Khanna

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Introduction

Background and objectives

Advanced monotherapies in UC may face an “efficacy ceiling” (~30% induction remission).
One potential strategy to address this is a ‘hit-hard-and-early’ strategy combining potent, rapid upadacitinib (UPA) for induction with gut-selective, safe vedolizumab (VDZ).
Objective: Test whether 8-week UPA+VDZ induction is superior to VDZ monotherapy.

UC, ulcerative colitis; UPA, upadacitinib; VDZ, vedolizumab; MES, Mayo endoscopic score; HEMI, histologic-endoscopic mucosal improvement

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

Methods

Design: Prospective, multicenter, randomized, open-label trial
Population: Adults with moderate-to-severe UC (modified Mayo 4-9, MES≥2).
Arms (Randomized 1:2): Combination (VDZ 300mg IV wks 0,2,6 + UPA 45mg PO daily for 8 wks) or VDZ monotherapy (VDZ 300mg IV wks 0,2,6).

Primary endpoint (week 8): endoscopic remission (MES=0)
Secondary endpoint (week 8): clinical remission; histologic-endoscopic mucosal improvement (HEMI)

Assessments:

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Results

MES, Mayo endoscopic score; OR, odds ratio; CI, confidence interval

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

Endoscopic Remission

The primary endpoint of endoscopic remission (MES=0) was met:

Combo: 37.5% (15/40)
Mono: 15.1% (11/73)

Absolute risk difference = 22.4%; 95% CI 5.3-39.5; P=0.007
Adjusted OR = 3.34; 95% CI 1.34-8.58

Combo

Mono

Clinical Remission

Combination therapy also improved clinical remission (P=0.013):

Combo: 66.7%
Mono: 40.0%

Endoscopic Remission

Clinical Remission

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Results

HEMI, histologic-endoscopic mucosal improvement; OR, odds ratio; CI, confidence interval; SAE, serious adverse events

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

HEMI

Histologic-endoscopic mucosal improvement was increased with combination therapy:

Combo: 45.7%
Mono: 17.7%

Adjusted OR = 3.58; 95% CI 1.41-9.41; P=0.008

Combo

Mono

Adverse Events

Adverse events during the 8-week induction were comparable (P=0.9):

Combo: 7.5%
Mono: 7.0%

No SAEs were reported

HEMI

Adverse Event

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Conclusions

In this two-arm study, combination vedolizumab and upadicitinib was superior to vedolizumab monotherapy to attain clinical remission, endoscopic remission, and HEMI at week 8.
No increase in adverse events was observed.

Significance to clinical practice

Although data for dual advanced therapy is important for clinical practice, the lack of a UPA monotherapy arm limits conclusions about the incremental benefit of vedolizumab.
Longer term data to establish durability of this early response is required.
The safety profile is promising.

Wu H et al. ECCO 2026; (Abstract citation ID: jjaf231.002, OP02).

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Results from the STENOVA trial: A Phase 2a, randomized, placebo-controlled, double-blind study to assess the safety, pharmacokinetics (PK), and pharmacodynamics of ontunisertib (AGMB-129) in patients with Fibrostenotic Crohn’s Disease (FSCD)

F. Rieder, B.G. Feagan, C. Lu, A. Poulsen, W. Reinisch, J. Kierkuś, E. Ricart Gomez, P.J. Stiers, K. Thys, R. Brys, M. Brill, C. Fleurinck, R. Van Heeswijk, A. Saez, T. Van Kaem, P. Wiesel

Slides compiled by Dr. Reena Khanna

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Introduction

Methods

Design: Phase 2a, randomized, placebo-controlled, double-blind study.
Population: Adults with symptomatic FSCD with ≥1 MRE-confirmed ileal stricture.
Arms (Randomized 1:1:1): Ontunisertib 200mg BID, 100mg QD, or placebo (PBO) for 12 weeks.

Open label treatment extension ongoing

PK, pharmacokinetics; FSCD, fibrostenotic Crohn’s Disease; TEAE, treatment-emergent adverse event; SAE, serious AE; SES-CD, Simple endoscopic score for CD; MRE, magnetic resonance enterography.

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

Background and objectives

Ontunisertib is an oral GI-restricted ALK5 inhibitor that blocks signaling of the pro-fibrotic TGFβ pathway.
It is designed to avoid ALK5 inhibitor systemic toxicity (including cardiac toxicity) by reducing clinically relevant systemic exposure through high first-pass liver metabolism.
Objective: Assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ontunisertib (AGMB-129) in patients with Fibrostenotic Crohn’s Disease (FSCD).

Primary outcome: Safety and tolerability

TEAEs/SAEs; labs, vitals, physical exam; cardiac parameters incl. ECG + echocardiography

Secondary outcome: Plasma PK
Exploratory Outcomes: PK in ileal and colonic mucosa, change in SES-CD, and change in MRE-based stricture parameters.

Assessments:

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Baseline Demographics

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

Parameter	Ontunisertib 200mg BID (N=34)	Ontunisertib 100mg QD (N=34)	PBO (N=35)	All subjects (N=103)
Age (years), mean (SD)	44.2 (12.6)	41.0 (13.5)	42.8 (15.3)	42.7 (13.8)
Female, n (%)	9 (26.5)	9 (26.5)	12 (34.3)	30 (29.1)
White, n (%)	32 (94.1)	31 (91.2)	30 (85.7)	93 (90.3)
Body mass index (kg/m²), mean (SD)	25.87 (5.49)	26.59 (5.33)	26.67 (5.53)	26.38 (5.41)
Disease duration (years), mean (SD)	16.98 (10.42)	15.64 (10.36)	17.79 (13.87)	16.80 (11.59)
Ileocolonic disease, n (%)	15 (45.5)	19 (55.9)	25 (71.4)	59 (57.8)
History of intestinal resection, n (%)	15 (44.1)	17 (50.0)	16 (45.7)	48 (46.6)
Crohn's Disease Activity Index, mean (SD)	144.1 (94.6)	166.0 (74.4)	152.0 (80.6)	154.1 (83.1)
SES-CD, mean (SD)	6.9 (4.0)	7.5 (5.0)	7.9 (4.1)	7.4 (4.4)
S-PRO severity score, mean (SD)	6.50 (3.78)	7.09 (3.51)	6.50 (2.82)	6.70 (3.37)
C-reactive protein (mg/L), mean (SD)	3.80 (5.28)	4.20 (4.45)	4.23 (7.21)	4.07 (5.73)
Fecal calprotectin (mg/kg), mean (SD)	344.8 (445.5)	460.0 (696.2)	522.9 (588.5)	442.6 (583.9)
Prior biologics, n (%)	30 (88.2)	29 (85.3)	29 (82.9)	88 (85.4)
Concomitant biologics, n (%)	26 (76.5)	25 (73.5)	27 (77.1)	78 (75.7)
Concomitant thiopurine, n (%)	3 (8.8)	3 (8.8)	4 (11.4)	10 (9.7)
Concomitant corticosteroids, n (%)	5 (14.7)	4 (11.8)	6 (17.1)	15 (14.6)

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Results:

Subjects with any, n (%)	Ontunisertib 200 mg BID (N=34)	Ontunisertib 100 mg QD (N=34)	Placebo (N=35)
TEAE	21 (61.8)	22 (64.7)	25 (71.4)
Serious TEAE	4 (11.8)	0	4 (11.4)
Worst-case:
Moderate TEAE	5 (14.7)	9 (26.5)	5 (14.3)
Severe TEAE	4 (11.8)	1 (2.9)	4 (11.4)
Life-threatening TEAE	0	0	1 (2.9)*
Fatal TEAE	1 (2.9)**	0	0
Related TEAE	8 (23.5)	2 (5.9)	4 (11.4)
Temporary treatment interruption due to TEAE	1 (2.9)	3 (8.8)	3 (8.6)
Permanent treatment interruption due to TEAE	5 (14.7)	0	2 (5.7)
Study discontinuation due to TEAE	0	0	1 (2.9)

Serious = requires hospitalization. Worst-case = Severity grading based. *Small intestinal obstruction not related. ** Atrial fibrillation and lacunar infarct not related.

TEAE, treatment-emergent adverse event; SAE, serious adverse event.

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

High study completion rate (89%)
AE incidence and severity balanced across treatment arms, with no dose-related increase
No evidence of cardiac valve toxicity, pro-inflammatory effects, or vasculitis
No safety signals observed in laboratory parameters, vital signs, or physical examinations
No safety concerns identified by the Data Safety Monitoring Board

Primary Endpoint: Safety and Tolerability

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Results:

PK, pharmacokinetics; SES-CD, simple endoscopic score for CD

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

GI-restricted PK profile

Low systemic exposure to ontunisertib; high exposure to inactive metabolite MET-158.
High ileal and colonic ontunisertib exposure confirmed.

Endoscopy (SES-CD)

200 mg BID vs placebo: higher endoscopic response and remission rates, driven by improvement in inflammatory & narrowing components.
Non-passable strictures: higher proportion became passable with 200 mg BID vs placebo.

MRE

Both doses vs placebo: positive trends, mainly stricture length.

No significant difference in obstructive symptoms was noted.

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Results:

Mean values at baseline: structure length = 104 mm; associated dilatation diameter = 28.3 mm; bowel wall thickness = 8.16 mm.�BSL, baseline; W12, Week 12; SE, standard error of the mean.

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

Centrally-read MRE stricture features

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Conclusions

In this phase 2a study, Ontunisertib demonstrated the ability to improve Crohn’s related strictures
It has a favourable PK profile and was well tolerated in this study

Significance to clinical practice

Although additional studies are required to confirm safety and efficacy, this is a promising therapy for the treatment of fibrostenotic strictures in addition to baseline therapy.
Given the limited treatment options for fibrostenotic strictures and the associated morbidity, this would have a substantial impact for patients if the results are proven in larger phase 3 studies

Rieder F et al. ECCO 2026; (Abstract citation ID: jjaf231.020, OP20).

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Who benefits from endotherapy in Crohn’s disease strictures? Predictors of recurrence, need for reintervention, and surgery from the Balloon Dilation versus Endoscopic Stricturotomy for Crohn’s Disease (BEST-CD) randomised controlled trial (NCT05521867)

P. Pal, K. Pooja, R. Gupta, M. Tandan, D.N. Reddy

Slides compiled by Dr. Neeraj Narula

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Introduction

Background & Objectives

Endoscopic balloon dilation (EBD) is widely used for Crohn’s disease (CD) strictures but recurrence and reintervention rates are high
Endoscopic stricturotomy (ES) is a promising alternative; defining predictors of long-term benefit is key to identifying the right patients for ES.

CD, Crohn’s disease; EBD, endoscopic balloon dilation; ES, endoscopic stricturotomy.

Pal P et al. ECCO 2026; (Abstract citation ID: jjaf231.019, OP19).

Endoscopic Balloon Dilation (EBD):

Controlled Radial Expansion (CRE) balloon (Boston Scientific, USA)
Size of balloons were selected based on stricture characteristics (estimated diameter, ulceration etc.)
Inflated to a max diameter of 12-20mm (based on baseline diameter) over 60 seconds

Endoscopic Stricturotomy (ES)

Needle knife / Insulated-tip (IT) knife nano (Olympus, Tokyo, Japan)
Electrosurgical unit: Endo Cut 1 mod (ERBE VIO 300D/VIO 3; Erbe Elektromedizin, Germany) with standard settings (Effect 3, Cut Duration 1, Cut Interval 3). Radial incisions followed by circumferential current used in non-ulcerated area/circumferential incision and dissection technique.

Effect

Cut Duration

Cut Interval

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Introduction

CD, Crohn’s disease; EBD, endoscopic balloon dilation; ES, endoscopic stricturotomy.

Pal P et al. ECCO 2026; (Abstract citation ID: jjaf231.019, OP19).

Methods

Design: Single-centre randomized controlled trial (Asian Institute of Gastroenterology, 2022-2025)
Population: Adults 18–65 years with CD and symptomatic, predominantly fibrotic/mixed strictures <3 cm accessible by standard endoscopy(de novo or anastomotic)

Key exclusions: >2 strictures, strictures beyond endoscopic reach, or prior ES.
Arms: Randomized to EBD vs ES.

Primary endpoint: Clinical recurrence at 1 year.
Secondary outcomes: Reintervention, stricture-related surgery, emergency visits, hospitalisation, and adverse events.
Analyses:

Cox regression for time-dependent outcomes
Logistic regression to identify predictors of key outcomes

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Results:

101 patients were randomized (EBD n=50; ES n=51), with comparable baseline characteristics between groups
Procedural feasibility was high and similar: technical success was 88% in both arms, and clinical success was 92% (EBD) vs 96% (ES)
Over a median 12-month follow-up (range 3–36), ES was associated with fewer downstream stricture-related events than EBD:

EBD, endoscopic balloon dilation; ES, endoscopic stricturotomy; CD, Crohn’s disease; ICR, ileocaecal resection; IFX, infliximab; CI, confidence interval; IQR, interquartile range.

Pal P et al. ECCO 2026; (Abstract citation ID: jjaf231.019, OP19).

	ES	EBD	p-value
Recurrence	24.5%	54.3%	0.003
Reintervention	23.5%	52%	0.004
Emergency visits	17.6%	54%	<0.001
Hospitalisation	15.7%	38%	0.01
Surgery	3.9%	16%	0.051
Adverse Event	13.7%	22%	0.31
Bleeding Event	9.8%	8%	–

ES prolonged time to recurrence, reintervention, surgery, and stricture related ED visit

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Results

CD, Crohn’s disease; EBD, endoscopic balloon dilation; ES, endoscopic stricturotomy; HR, hazard ratio; OR, odds ratio; CI, confidence interval; GI, gastrointestinal.

Pal P et al. ECCO 2026; (Abstract citation ID: jjaf231.019, OP19).

Predictor	Clinical Recurrence – Univariate OR (95% CI), p	Clinical Recurrence – Multivariate OR (95% CI), p	Reintervention – Univariate OR (95% CI), p	Reintervention – Multivariate OR (95% CI), p	Surgery – Univariate OR (95% CI), p	Surgery – Multivariate OR (95% CI), p
Balloon dilation vs stricturotomy	3.4 (1.5–7.8), p=0.004	3.6 (1.5–8.6), p=0.003	3.6 (1.5–8.6), p=0.003	3.4 (1.5–7.8), p=0.004	–	–
Stricture length ≥2 cm	5.9 (2.1–16.3), p<0.001	13.5 (4.0–45.7), p<0.001	13.5 (4.0–45.7), p<0.001	5.9 (2.1–16.3), p<0.001	8.7 (2.1–36.7), p=0.003	8.7 (2.1–36.7), p=0.003
Younger age (per year)	–	–	–	–	0.91 (0.85–0.98), p=0.012	0.91 (0.85–0.98), p=0.012
Proximal/colonic location	–	–	–	–	3.8 (1.2–12.1), p=0.025	3.8 (1.2–12.1), p=0.025
Prior biologic therapy	0.47 (0.21–1.07), p=0.072	–	–	–	–	–

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Conclusions

Endoscopic stricturotomy associated with longer time to clinical recurrence and need for re-intervention when compared with EBD for short CD strictures (<3cm) with similar safety profile
Length of stricture strongly predictive of recurrence/need for re-intervention/surgery

Significance to clinical practice

These findings support endoscopic stricturotomy as first line endotherapy in selected patients with short <3cm strictures where expertise is available
Access to expertise is likely limited in most of Canada
Relevance for patients with strictures >=3cm uncertain

Pal P et al. ECCO 2026; (Abstract citation ID: jjaf231.019, OP19).

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Randomised controlled trial of withdrawal of thiopurines in patients with IBD switching from intravenous to subcutaneous infliximab: Results of the MINIMISE study

P.M. Irving, A. Centritto, X.Y. Choon, J.H. Yeo, W. Blad, A. Talbot, A.L. Fitzgerald, E. Whitehead, A. Elford, M. Colwill, S. Baillie, R. Pramanik, S. Ayis, A. Goubar, M. Arenas Hernandez, J. Cordle, C. Lees, R. Pollok, S. Sebastian, R. Dart, M. Samaan, P. Harrow

Slides compiled by Dr. Sally Lawrence

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Introduction

Background & Objectives

Combination IV infliximab (IFX) + thiopurine (TP) reduces immunogenicity risk and increases efficacy.
Registration study sub-analyses suggest SC IFX may have lower anti-drug antibody (ADAb) risk vs IV IFX. However, immunogenicity and the need for and the effect of combination therapy with SC IFX has not been evaluated in a randomized controlled setting.
Objective: In IBD patients in stable remission switching IV to SC IFX, to compare TP continuation vs TP withdrawal on immunogenicity.

TP, thiopurines; IFX, infliximab; ADAb, anti-drug antibody; IV, intravenous; SC, sub-cutaneous; HBI, Harvey-Bradshaw index; SCCAI, simple clinical colitis activity index; FC, fecal calprotectin; CRP, C-reactive protein

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

Methods

Primary endpoint: free ADAb in the absence of detectable drug at w24
Key secondary endpoints: disease activity at w24 (HBI >4, SSCI >2), IFX drug levels at w8, 16, 24

Multicenter investigator initiated RCT of TP continuation vs. TP withdrawal after switch from IV to SC IFX (non inferiority design)

CD / UC in stable remission

IV IFX +TP ≥22 weeks

Stable dosing

Therapeutic IFX drug level

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Results: Subject flow through trial

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

Randomized

n = 102

Continue

n = 52

Stop

n = 50

Week 24

n = 45

Week 24

n = 43

2 – Lost to FU

1 – Non compliance

4 – Outside 1 week window @ week 24

1 – Reversion to IV IFX

6 – Outside 1 week window @ week 24

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Baseline Demographics

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

Characteristic	Overall (n=102)	Continue (N=52)	Stop (N=50)
Patient demographics
Female n (%)	38 (37.3)	22 (42.3)	16 (32)
Male n (%)	64 (62.7)	30 (57.7)	34 (68)
Weight - Kg (med [range])	80.6 [51.3, 147.0]	83.5 [51.3, 147.0]	76.9 [52.3, 115.4]
Disease demographics
Crohn’s disease n (%)	63 (62)	35 (67.3)	28 (56)
HBI (median [range])	0.0 [0.0, 6.0]	0.0 [0.0, 6.0]	0.0 [0.0, 3.0]
Ulcerative colitis/IBD-U* n (%)	39 (38)	17 (32.7)	22 (44.0)
SCCAI (median [range])	0.0 [0.0, 2.0]	0.0 [0.0, 2.0]	0.5 [0.0, 2.0]
Disease duration - years (med [range])	7.1 [0.5 to 38.0]	7.4 [0.5 to 35.0]	7.0 [1.0 to 38.0]
HLA DQA1*05 status n (%)
Negative	63 (61.8)	32 (61.5)	31 (62)
Positive	39 (38.2)	20 (38.5)	19 (38)
Time on IV IFX - years	2.26 [0.3 to 19.0]	2.41 [0.3 to 19.0]	2.2 [0.3 to 16.2]
Immunomodulator
Azathioprine n (%)	93 (91.2)	47 (90.4)	46 (92)
Mercaptopurine n (%)	9 (8.8)	5 (9.6)	4 (8)
Biomarkers (median [range])
CRP - mg/L	1.0 [0.0, 7.0]	1.0 [0.0, 7.0]	1.0 [0.0, 6.0]
Faecal calprotectin - µg/g	38.0 [4.0, 4690]	40.5 [6.0, 1840]	29.0 [4.0, 4690]

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Results

TP, thiopurines; IFX, infliximab; ADAb, anti-drug antibody

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

Primary Outcome: Free antibody positivity at w24

Patients with free antibodies

ITT cohort

N = 88

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Results: Secondary outcomes

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

Drug levels

Total antibodies

Disease activity

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Conclusions

Discontinuation of thiopurine therapy was not associated with an increased incidence of free antibody production at 6 months following transition from maintenance IV to SC IFX in stable patients in clinical and biochemical remission.
Withdrawal of combination therapy did not appear to influence total antibody formation, SC IFX drug concentrations or clinical disease activity over 6 months.

Significance to clinical practice

These findings suggest that SC IFX monotherapy may be a reasonable strategy following transition from maintenance IV combination therapy in clinically stable IBD patients.
Further prospective evaluation is warranted to characterize the pharmacokinetic, immunogenic and clinical implications of transitioning to SC IFX monotherapy during the induction phase of IFX therapy.

Irving PM et al. ECCO 2026; (Abstract citation ID: jjaf231.145, DOP108).

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Faecal microbiota transplantation for active Crohn’s disease: The MIRO (Microbial Restoration) randomised placebo-controlled trial

S. Fehily, E.K. Wright, D. Bogatic, A. Wilson-O’Brien, C. Basnayake, A. Stanley, E. Marks, E. Russell, Y. Rong, I. Gory, Z. Ardalan, A. Hamilton, M. Morrison, A. Thompson, R.V. Bryant, S.P. Costello, M.A. Kamm

Slides compiled by Dr. Neeraj Narula

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Introduction

Background & Objectives

The enteric microbiota is an antigenic driver of Crohn’s disease (CD), allowing faecal microbiota transplantation (FMT) as a potential therapy, but evidence of it’s use in active CD is lacking
Objective: Assess the therapeutic efficacy and safety of FMT vs placebo in active Crohn’s disease.

CD, Crohn’s disease; FMT, faecal microbiota transplantation; CDAI, Crohn’s Disease Activity Index.

Fehily S et al. ECCO 2026; (Abstract citation ID: jjaf231.015, OP15).

Methods

Design: Randomized , double-blind, placebo-controlled trial in patients with active CD (CDAI 220–450).
Run-in / optimisation: 3-week “optimisation” of wholefood diet, 1-week antibiotic therapy
Intervention: Single-donor, anaerobically-prepared FMT or placebo (2:1); route of delivery:

Disease proximal to splenic flexure: Gastroscopic FMT infusion at Week 0/2/6
Left-sided colonic disease: Colonoscopy infusion followed by weekly enemas

Primary endpoint (Week 8): Clinical response defined as CDAI decrease ≥100 points or CDAI <150.
Analysis populations:

Modified ITT (mITT): patients receiving ≥1 dose of FMT/placebo
Per protocol (PP): patients who completed 8 weeks of treatment

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Results

Patient disposition:

103 patients enrolled; 70 received FMT and 33 received placebo (Route of delivery: predominantly upper GI (95 upper; 8 lower GI delivery))
Before randomization, diet + antibiotics produced a CDAI response in 21% of all patients, highlighting a large pre-treatment effect.

FMT, faecal microbiota transplantation; CDAI, Crohn’s Disease Activity Index; mITT, modified intention-to-treat.

Fehily S et al. ECCO 2026; (Abstract citation ID: jjaf231.015, OP15).

Baseline characteristics

Characteristic	Active FMT (n=70) n, frequency (%) or median (IQR)	Placebo (n=33) n, frequency (%) or median (IQR)
Male	37 (52.9%)	14 (42.4%)
Age (mean years, SD)	40.7 (13.7)	37.7 (9.7)
Current Disease Location
Ileal (L1)	23 (32.9%)	9 (27.3%)
Colonic (L2)	25 (35.7%)	15 (45.5%)
Ileocolonic (L3)	22 (31.4%)	9 (27.3%)
Disease Duration (median years, IQR)	8 (14)	9 (15)
Previous Surgical Resection
1	7 (10%)	2 (6.1%)
≥2	5 (7.1%)	6 (18.2%)
Stricture present at baseline	20 (28.6%)	15 (45.4%)
Disease activity at Enrolment
Crohn’s Disease Activity Index (CDAI)	256 (90)	247 (53.9)
Median total SES-CD week 0	9 (8)	9 (7)
CRP (mg/L)	5 (12)	6 (8.4)
Faecal Calprotectin (µg/g)	378.5 (649)	459 (698)
Medication at Enrolment
Biological agent, small molecule inhibitor	36 (51%)	17 (51%)
No medication	27 (38.6%)	10 (30.3%)
Past Medications
Past Biologic Drugs (any)	35 (50%)	15 (45.5%)
Past Small Molecules (any)	3 (4.3%)	2 (6.1%)

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Results

Clinical response appears higher in bio-naïve / 1 AT failure as compared to patients with 2+ AT failures

FMT, faecal microbiota transplantation; CDAI, Crohn’s Disease Activity Index; mITT, modified intention-to-treat.

Fehily S et al. ECCO 2026; (Abstract citation ID: jjaf231.015, OP15).

Primary endpoint (Week 8):

Analysis set	FMT	Placebo	p-value
mITT	40/70 (57.1%)	15/33 (45.5%)	0.296
Per-protocol	40/63 (63.5%)	14/30 (46.7%)	0.177

At Week 8, clinical response rates numerically favored FMT, but did not reach statistical significance in either analysis set

Despite the between-group endpoint not meeting significance, CDAI decreased significantly only in the FMT group (p<0.001)

Subgroups:
No prior biologic or small molecule inhibitor FMT 66% vs placebo 34%
1 prior biologic or small molecule inhibitor FMT 77% vs placebo 23%
2+ prior biologic or small molecule inhibitor FMT 50% vs placebo 50%

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Results

Safety

Adverse events were described as mostly mild transient gut symptoms and liver function test abnormalities.

CD, Crohn’s disease; FMT, faecal microbiota transplantation; SES-CD, Simple Endoscopic Score for Crohn’s Disease; CRP, C-reactive protein; FCP, faecal calprotectin; AE, adverse event; LFT, liver function test.

Fehily S et al. ECCO 2026; (Abstract citation ID: jjaf231.015, OP15).

Donor Effect

Outcome	FMT	Placebo	p-value
Endoscopic response (SES-CD ↓ ≥25% or SES-CD ≤2)	24/45 (53.3%)	4/17 (23.5%)	0.047

Endoscopic response & biomarkers (Week 8)

Endoscopic response was more likely with FMT vs placebo at Week 8
Inflammatory biomarkers decreased, but CRP and faecal calprotectin reductions did not differ between treatment groups

Clinical Response According to Donor

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Conclusions

No significant difference in inducing clinical response of CD with FMT vs placebo
Trends observed including higher rate of endoscopic response, higher rates of clinical response in more treatment-naïve patients, and donor effect, suggest potential of microbiota-based therapies in CD and future research will be needed

Significance to clinical practice

FMT not ready for clinical use in IBD management, as many unanswered questions remain
Ultimately, the reproducibility and standardization of FMT is challenging, even when positive effects in studies are seen
FMT studies will inform rationally designed bacterial consortia, engineered microbes, and targeted interventions and expect to see more studies examining Live Biotherapeutic Products (LBPs) and Postbiotics like short-chain fatty acids (SCFAs, e.g., butyrate)

Fehily S et al. ECCO 2026; (Abstract citation ID: jjaf231.015, OP15).

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Combination treatment with adalimumab and partial enteral nutrition compared with adalimumab monotherapy in adults with active Crohn’s disease: The BIOPIC study

B. White, I. Campbell, C. Fandinga, C. Kerbiriou, J. Clowe, A. Jatkowska, E. Brownson, S. Milling, G.T. Ho, C. Mowat, E. Robertson, D. Gaya, A. Kefayat, S. Din, J.P. Seenan, J. Macdonald, K. Gerasimidis

Slides compiled by Dr. Sally Lawrence

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Introduction

Background & Objectives

50-60% of Crohn’s Disease (CD) patients achieve clinical remission with anti-TNF therapy.
Exclusive enteral nutrition is an effective induction strategy for CD, but tolerability limits it’s use.
Objective: Compare efficacy of adalimumab (ADA) + 50% partial enteral nutrition (PEN) vs ADA alone in biologic-naïve adults with active ileocolonic CD.

CD, Crohn’s Disease; PEN, partial enteral nutrition; ADA, adalimumab; CDAI, Crohn’s Disease Activity Index; RCT, randomized controlled trial.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

Methods

Primary Outcome:

W12 clinical response: CDAI decrease ≥70 points from baseline

W12 clinical remission: CDAI <150

RCT: 7 sites

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Results: Flow Diagram

ADA, adalimumab; PEN, partial enteral nutrition; CDAI, Crohn’s Disease Activity Index.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

266 patients assessed for eligibility

3 withdrawn prior to active participation

2 withdrew consent in first 48 hours
1 found to be ineligible prior to commencing active participation

198 eligible patients approached by the research team

101 underwent randomisation

ADA + PEN

n = 51

48 commenced active participation

43 completed full study participation

ADA

n = 50

41 commenced active participation

37 completed full study participation

5 discontinued the study:

1 exited due to palatability issues
1 exited due to difficulties committing time to the study
3 exited due to symptom deterioration

3 excluded from primary outcome analysis due to protocol violations

9 withdrawn prior to active participation

5 withdrew consent in first 48 hours
4 found to be ineligible prior to commencing active participation

4 discontinued the study:

1 lost to follow-up
3 exited due to symptom deterioration

4 excluded from primary outcome analysis due to protocol violations

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Results: Baseline characteristics

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

Characteristic	All participants	ADA + PEN	ADA
Number of patients, n	89	48	41
Age, years (Q1, Q3)	41.0 (27.0, 55.0)	40.0 (28.0, 53.25)	43.0 (24.0, 55.0)
Females, n (%)	48 (53.9)	26 (54.2)	22 (53.7)
Ethnicity, n (%)
White British	79 (88.8)	41 (85.4)	38 (92.7)
White Irish	5 (5.62)	2 (4.17)	3 (7.32)
White Other	3 (3.37)	3 (6.25)	0
Pakistani	2 (2.25)	2 (4.17)	0
Alcohol units per month (Q1, Q3)	10.0 (0, 31.0)	6.00 (0, 23.0)	14.0 (0.5, 34.0)
Smoking Status, n (%)
Non-smoker	54 (60.7)	29 (60.4)	25 (61.0)
Former smoker	21 (23.6)	13 (27.1)	8 (19.5)
Current smoker	14 (15.7)	6 (12.5)	8 (19.5)
Disease duration, months (Q1, Q3)	10.3 (3.30, 105)	12.3 (3.50, 108.0)	7.5 (2.70, 118)
Weight, kg (Q1, Q3)	76.3 (63.2, 91.4)	74.1 (59.9, 90.2)	77.7 (67.4, 92.1)
BMI, kg/m² (Q1, Q3)	25.4 (21.8, 30.2)	24.8 (21.3, 29.2)	26.8 (22.0, 31.8)
CDAI, (Q1, Q3) ∞	242 (188, 286)	224 (186, 279)	252 (203, 297)
HBI, (Q1, Q3)	8.00 (6.00, 10.00)	8.00 (6.00, 10.0)	8.00 (6.00, 11.0)
FC mg/kg (Q1, Q3) ×	504 (159, 1101)	466 (163, 1070)	595 (154, 1260)
CRP, mg/L (Q1, Q3)	5.00 (2.00, 19.5)	5.00 (2.00, 20.8)	4.00 (2.00, 16.5)
ALB, g/L (Q1, Q3)	40.0 (35.5, 42.0)	40.0 (36.0, 42.0)	39.0 (35.0, 42.0)

Data presented as median (Q1, Q3) unless stated otherwise. ∞ CDAI data excluded from n = 3 ADA+PEN arm and n = 4 ADA arm due to presence of normal CDAI (<150) at baseline. × FC data missing for n = 1 ADA arm. * p ≤ 0.05 for comparisons between study arms.

Abbreviations: ADA+PEN, Adalimumab with 50% partial enteral nutrition; ADA, adalimumab; SIMD, Scottish Index of Multiple Deprivation; BMI, Body mass index; CDAI, Crohn’s Disease Activity Index; HBI, Harvey-Bradshaw Index; FC, Fecal calprotectin; CRP, C-reactive protein; ALB, Albumin.

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Results: Primary outcome

ADA, adalimumab; PEN, partial enteral nutrition; CDAI, Crohn’s Disease Activity Index; ITT, intention-to-treat; FC, fecal calprotectin; CRP, C-reactive protein.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

Similar reductions in FC and CRP between the cohorts over 12 weeks

Clinical response

Clinical remission

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Results: subgroup analyses

ADA, adalimumab; PEN, partial enteral nutrition; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; FC, fecal calprotectin.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

Baseline CRP >5mg/L & FC >100ug/g Clinical Response

Clinical Response by Disease Location

Detectable anti-drug antibodies

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Results: Endoscopic subgroup

ADA, adalimumab; PEN, partial enteral nutrition; SES-CD, Simple Endoscopic Score for Crohn’s Disease.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

n=7

n=9

SES-CD over time

>50% reduction in SES-CD at w 12

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Conclusions

The addition of 50% PEN to ADA was not associated with detectable differences in short-term clinical outcomes through week 12. However, signals of benefit were observed, including higher rates of mucosal endoscopic response and numerically lower frequency of anti-drug antibody formation (in a subset of patients).
Exploratory analysis suggested that this combination strategy may have differential effects in subgroups with greater inflammatory burden and those with an ileal CD phenotype.

Significance to clinical practice

These findings should be considered hypothesis- generating and require confirmation in adequately powered prospective studies with robust objective endpoints.

White B et al. ECCO 26; (Abstract citation ID: jjaf231.137, DOP100).

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Ustekinumab for Fistulizing Perianal Crohn’s Disease: week-48 results from the USTAP Randomized Placebo-Controlled Trial

P. Wils, S. Nancey, E. Messmer, A. Bourreille, A. Buisson, L. Caillo, L. Vuitton, R. Altwegg, X. Hebuterne, O. Ernst, P. Meunier, V. Laurent, D. Laharie, E. Vicaut, L. Peyrin-Biroulet, GETAID group

Slides compiled by Dr. Cynthia Seow

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Introduction

Background & Objectives

Fistulizing perianal Crohn’s disease (CD) remains a major therapeutic challenge, with limited therapeutic options
USTAP (NCT04496063) evaluated the efficacy and safety of ustekinumab (UST) in adults with active draining perianal fistulas

CD, Crohn’s disease; UST, ustekinumab; MRI, magnetic resonance imaging; anti-TNF, anti–tumor necrosis factor.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

Methods

Design: Double-blind, placebo-controlled, multicenter GETAID randomized controlled trial.
Population: Adults with active draining fistulizing perianal CD; seton placement when needed prior to randomization.
Randomization (1:1):

UST: 6 mg/kg IV (baseline) → 90 mg SC (Week 8), then q8w
Placebo
Stratified by prior anti-TNF exposure and study centre�(notably, 70% had prior anti-TNF exposure)

Primary endpoint (Week 12): Combined remission =

Clinical remission: absence of drainage from all external fistula openings AND
Radiological remission: absence of abscesses >2 cm confirmed by blinded central MRI

Secondary endpoints: Clinical remission, radiological remission, and safety.
Blinded adjudication: Week-12 before Open-label phase: (post–Week 12): Placebo non-responders could switch to UST; UST non-responders could be intensified.

Assessments

Background: Fistulizing perianal Crohn’s disease (CD) remains a significant challenge, with few randomized controlled trials. The USTAP

(NCT04496063) trial aimed to evaluate the efficacy and safety of ustekinumab (UST) in patients with active draining perianal fistulas in a multicenter

randomized controlled design.

UEGW 12 week data: In this trial, where two-thirds of patients had prior anti-TNF exposure, the observed short-term clinical benefit of UST supports its use in fistulizing perianal CD.

First randomized, placebo-controlled evidence suggesting efficacy of UST in fistulizing perianal CD, including those who have been previously exposed to anti-therapy.

The trial was terminated early, leaving results underpowered, prevents definitive conclusions.

Conclusions

The observed short-term clinical benefit of ustekinumab (UST) support it use in fistulizing perianal Crohn’s disease.

Notably, two-thirds of patients had prior anti-TNF exposure.

Significance to clinical practice

First randomized, placebo-controlled trial of UST for the management of perianal fistulizing disease.

Small study with premature termination. The observed effect of UST for perianal disease is promising but the study is inadequately powered (lack of statistical confidence).

Individuals received 4 weeks of antibiotics +/- concurrent seton placement prior to UST; Reinforces the need for multidisciplinary perianal management with radiology, colorectal surgery, and IBD services.

Await long term (week 48) data for the efficacy and durability of UST for perianal disease.

Current data is insufficiently robust to to determine positioning of advanced therapies for the treatment of perianal disease.

How would you sequence therapies for the management of perianal fistulizing CD?

Methods: This double-blind, placebo-controlled, multicenter GETAID trial enrolled adult patients with active draining fistulizing perianal CD. Eligible

patients were randomized 1:1, after seton placement when needed, to receive UST (6 mg/kg IV at baseline followed by 90 mg SC at week 8, then every

8 weeks) or placebo. The primary endpoint was combined clinical remission (absence of drainage from all external fistula openings) and radiological

remission (absence of abscesses >2 cm confirmed by blinded central MRI) at week 12 (1). At week 12, placebo non-responders could switch to UST,

and UST non-responders could be intensified during the open-label phase. Secondary endpoints included clinical remission, radiological remission,

and safety. Endpoints at week 12 were independently reviewed by a blinded adjudication committee. Randomization was stratified by prior anti-TNF

exposure and study center. The intended sample size was 73 patients per group to detect a 20% difference in remission rates (power 80%, alpha 5%).

Due to slow recruitment, the study was discontinued in June 2024, without unblinding the study data.

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Study Design

CDAI, Crohn’s Disease Activity Index; IBD-DI. Inflammatory Bowel Disease Disability Index; IBDQ, Inflammatory Bowel Disease Questionnaire; IV, intravenous; MRI, Magnetic resonance imaging; PDAI, Perianal Disease Activity Index; SC, subcutaneous; TL, trough levels’ UST, ustekinumab; W, week.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

UNBLINDING

RANDOMIZATION 1:1

SELECTION

Steroid course were allowed to treat flares of luminal disease during the study with a starting dose of 40 mg tapered over a maximum of 12 weeks.

OPEN-LABEL

Study drug

1st IV

If present, azathioprine (AZA), �6- mercaptopurine (6-MP), or methotrexate (MTX) maintained at the same dose during the study

Study drug �1st SC

≥1 perineal fistula confirmed by MRI

Examination under

anesthesia, fistula

curettage, and seton placement if

indicated

USTEKINUMAB 6 mg/kg IV – 90 mg/8w SC

USTEKINUMAB SC 90 mg/8 weeks

USTEKINUMAB SC 90 mg/4 weeks

USTEKINUMAB 6 mg/kg IV-90 mg/8w

NO TREATMENT

Ciprofloxacin + metronidazole

4 weeks

PLACEBO

Seton removed

PDAI, CDAI

UST TL antibodies against UST IBDQ

PDAI, CDAI
UST TL antibodies against ustekinumab
IBDQ
Pelvic MRI

Responders

Non-Responders

Responders

Non-Responders

W-3	W0	W6	W8	W12		W24		W48

VS	V0	V1		V2		V3		V4

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Baseline Characteristics

IQR, Interquartile range; MAGNIFI-CD, Magnetic-Assisted General Navigation Index for Fistula Imaging in Crohn's Disease; TNF, tumour necrosis factor.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

Key Baseline demographic and clinical characteristics of patients	Overall N=32	Placebo N=16	Ustekinumab N=16
Female, n (%)	13 (41%)	9 (56%)	4 (25%)
Median age (IQR)	42 (34–56)	40 (35–56)	45 (34–56)
Median disease duration (IQR), months	56 (12–195)	56 (12–188)	85 (12–223)
Current smoking, n (%) n=30	9 (30%)	3 (19%)	6 (43%)
Anti-TNF exposure, n (%)	22 (69%)	11 (69%)	11 (69%)
Infliximab	15 (47%)	6 (38%)	9 (56%)
Clinical disease activity
Number of fistula tracts
One	25 (78%)	12 (75%)	13 (81%)
Two	7 (22%)	4 (25%)	3 (19%)
Clinical abscess, n (%)	8 (25%)	3 (19%)	5 (31%)
Fistula curettage	22 (71%)	11 (69%)	11 (73%)
Fistula tract seton been placed, n=22	21 (95%)	11 (100%)	10 (91%)
MRI scores (central reading)
Median MAGNIFI-CD (min-max)	15 (6–30)	15.5 (9–29)	14 (6–30)
Median Van Assche (min-max)	10 (3–19)	9.5 (3–18)	11 (3–19)

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Key Results

*Two patients discontinued study by Week 6 in the placebo group.

CI, confidence interval; MRI, magnetic resonance imaging; OR, odds ratio; SAEs, serious adverse events; W, week.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

Secondary Endpoints

Secondary Endpoints �at W12, n(%)	Overall (n=32)	Placebo (n=16)*	Ustekinumab (n=16)	OR (95% CI)
Clinical Remission (100% of the fistula tracts showing no drainage)	16 (50%)	5 �(31%)	11 �(69%)	0.27 [0.06–1.17]
Radiological Remission (absence of collections �>2 cm confirmed by masked central MRI)	26 (81.2%)	12 �(75%)	14 �(87.5%)	2.7 �[0.34–21.1]
Absence of abscess �at pelvic MRI	22 (69%)	11 �(69%)	11 �(68%)	1.51 �[0.3–7.46]

Combined clinical remission (absence of drainage from all external fistula openings) + radiological remission (defined as the absence of abscesses >2 cm confirmed by blinded central pelvic MRI) at Week 12.

OR=5.1 [1.07–24.4]

Primary Endpoint at Week 12

Trend to higher levels of ustekinumab with combined remission.

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Results: Efficacy & Safety

CD, Crohn’s disease; UST, ustekinumab; MRI, magnetic resonance imaging; AE, adverse event; SAE, serious adverse event.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

Week 48 outcomes:

Treatment persistence from randomization was higher in the ustekinumab (UST) arm than the placebo arm
During the open-label phase, 9 placebo patients required escalation to active therapy.
At Week 48, combined remission (clinical + radiologic) was observed in:

50% (7/16) in the “placebo → UST” arm
31% (5/16) in the UST arm

Safety: 14 SAEs were reported (11 in the placebo group and 3 in the UST group), leading to study discontinuation by week 6 in two placebo-treated patients (anal abcess and peri-ileal abscess).

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Conclusions

The authors concluded short term clinical benefit of ustekinumab for the treatment of fistulizing perianal Crohn’s disease in the presence of prior anti-TNF exposure.

Significance to clinical practice

This is the first randomized, placebo-controlled study of ustekinumab for fistulizing perianal Crohn’s disease, including individuals who had been previously exposed to anti-TNF therapy.
The trial was terminated early, and is underpowered, preventing definitive conclusions for short and long term outcomes.
This underscores the difficult nature of this disease to maintain people in long-term remission.

Wils P et al. ECCO 2026; (Abstract citation ID: jjaf231.044, DOP007).

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NORDTREAT: a randomised, multicentre, biomarker-strategy design, open-label, controlled trial of top-down versus clinical management in newly diagnosed IBD

D. Bergemalm, D. Füchtbauer, M. Rejller, L. Davíðsdóttir, A. Fejrskov, C.R. Hedin, C. Bache-Wiig Mathisen, G. Hupperz-Hauss, A. Carstens, V. Kristensen, H. Hjortswang, T.B. Aabrekk, M. Carlson, S.O. Frigstad, J.D. Söderholm, R. Christensen, V.C. Andersen, D. Repsilber, J. Kjeldsen, M. Høivik, J. Halfvarson

Slides compiled by Dr. Neeraj Narula

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Introduction

Background & Objectives

Early IBD management varies widely; prognostic biomarkers may enable personalized treatment.
NORDTREAT compared biomarker-guided “top-down” therapy vs standard clinical care in patients identified as high-risk by a NORDTREAT protein signature (13 proteins found to be associated with more aggressive disease course).
Objective: Determine whether biomarker-guided early anti-TNF–based “top-down” therapy improves 52-week corticosteroid-free clinical and endoscopic remission vs standard care.

IBD, inflammatory bowel disease; CD, Crohn’s disease; UC, ulcerative colitis; anti-TNF, anti–tumour necrosis factor

Bergemalm D et al. ECCO 2026; (Abstract citation ID: jjaf231.004, OP04).

Methods

Design / Population: Randomised, multicentre, biomarker-strategy, open-label, controlled trial. Eligible adults with newly diagnosed IBD (screened, then randomized) from 15 Nordic Hospitals
Randomization (1:1):

Access arm: Protein signature result available; high-risk patients received “top-down” anti-TNF ± immunomodulator; low-risk patients were excluded.
Non-access arm: Protein signature unknown to clinician/patient; treated with standard care using stepwise escalation at investigator discretion (“clinical management”)

Primary endpoint (Week 52): Corticosteroid-free clinical + endoscopic remission (surgery = treatment failure)
Secondary endpoints: Endoscopic remission; cumulative corticosteroid exposure; serious adverse events

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Results

IBD, inflammatory bowel disease; CD, Crohn’s disease; UC, ulcerative colitis; IBD-U, IBD-unclassified; anti-TNF, anti–tumour necrosis factor; CI, confidence interval.

Bergemalm D et al. ECCO 2026; (Abstract citation ID: jjaf231.004, OP04).

High-risk cohort	Achieved primary endpoint	Rate
Top-down	10/24	42%
Clinical management	8/29	27%

Trial population / Risk stratification

313 newly diagnosed IBD patients were randomized (CD n=133; UC/IBD-U n=180); median of 7 days from diagnosis to enrolment
Only a minority were classified as “high-risk” by the NORDTREAT protein signature:

Access arm: 24/157 (15%) high-risk (10 were CD)
Non-access arm (post-hoc): 29/156 (19%) were high-risk In the non-access arm, advanced therapy was commonly initiated quickly among high-risk patients: 16/29 (55%) received advanced therapy after a median of 15 days. 9/29 of the participants had CD

Primary endpoint (Week 52; corticosteroid-free clinical + endoscopic remission)

At Week 52, the biomarker-guided “top-down” strategy did not significantly increase the primary endpoint versus clinical management in patients at high-risk per NORDTREAT signature

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Results

Key safety events through Week 52

IBD, inflammatory bowel disease; CD, Crohn’s disease; UC, ulcerative colitis; CI, confidence interval.

Bergemalm D et al. ECCO 2026; (Abstract citation ID: jjaf231.004, OP04).

	Top-down (N=24)	Clinical management (N=29)
Hospital admissions, n	7	13
Death, n	0	1*

Key secondary outcomes at Week 52

Endoscopic remission were identical between groups at week 52 (53% vs 53% (p=0.99))
Cumulative corticosteroid exposure was numerically lower with top-down, though this did not reach statistical significance.

Median cumulative cortisone equivalents: 1232 mg vs 1651 mg (p=0.07)

Serious adverse events were driven mainly by hospital admissions, which were more frequent in the clinical management arm

*Death after colectomy in a patient with ulcerative colitis.

Post-hoc subgroup

Post-hoc analyses suggested achieving primary endpoint at numerically higher rates in Crohn’s disease, while outcomes were similar in UC:

CD: 50% vs 11% (p=0.09)
UC: 36% vs 35% (p=0.97)

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Conclusions

Biomarker-guided ‘top-down’ therapy did not lead to improved rates of CSF clinical and endoscopic remission at week 52 compared to standard care
A possible benefit was observed in patients with CD, suggesting early top-down therapy may be effective in this cohort of patients when deemed at high risk of aggressive disease (no signal observed in UC)

Significance to clinical practice

This is another trial which suggests benefit of early top-down therapy in moderate-severe CD patients (like PROFILE), but may be that UC patients do not experience disease progression in the same way
Although reimbursement criteria in Canada don’t permit a ‘top-down’ strategy as used in NORDTREAT or PROFILE 7 to 14 days from diagnosis, initiating early effective therapy as soon as possible in moderate-severe patients with CD does seem to have tangible short and long-term benefit
Further work still needed to look at NORDTREAT protein signature with larger sample size of CD patients and use of this biomarker is not ready for clinical practice

Bergemalm D et al. ECCO 2026; (Abstract citation ID: jjaf231.004, OP04).

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Poster #: P1049�Real-world effectiveness and safety of etrasimod in Ulcerative Colitis: interim analysis of the EFFECT-UC study�

P.M. Irving, R. Battat, S. Mehta, P. Harrow, D. Gaya, A. Walsh, T. Kucharzik, C. Maaser, E. Jörgensen, Y. Leung, E. Binder, M. Kudela, B. Sahin, T. Meng, A. Falsafi, K. Wosik, S. Hahne, U. Helwig

Slides compiled by Dr. Waqqas Afif

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Introduction

Background & Objectives

Etrasimod is an oral, once-daily, selective S1P receptor modulator for the treatment of UC
To report an interim analysis of the first prospective real-world data for etrasimod up to 24 weeks of treatment

Methods

EFFECT-UC is an ongoing, prospective, non-interventional study enrolling adults with active UC starting etrasimod in routine care
Descriptive analyses are presented as observed up to Week 24 with no imputation for missing data

UC, ulcerative colitis; S1P, sphingosine 1-phosphate; PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; NRS, numerical rating scale; CRP, C-reactive protein.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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Results

121 patients (UK n: 59, Germany n:57: Canada n=5) had enrolled in the study

CD, Crohn’s disease; UC, ulcerative colitis; NRS, numerical rating scale; PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; TNF, tumor necrosis factor; JAKi, Janus kinase inhibitor; S1P, sphingosine 1-phosphate.�Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

Demographics and baseline characteristics
Demographics (N=121)
Age (years), mean (SEM)	40.2 (1.1)
Median (range)	38.0 (19.0–64.0)
Female, n (%)	49 (40.5)
BMI (kg/m²), mean (SEM)	26.5 (0.5)
Disease activity
Duration of UC (years), mean (SEM) (N=115)	7.8 (0.8)
Median (range)	5.0 (0.0–36.0)
Extent of disease, n (%) (N=49)
Ulcerative proctitis	6 (12.2)
Proctosigmoiditis	6 (12.2)
Left-sided colitis	22 (44.9)
Pancolitis	15 (30.6)
MMS, mean (median) (N=36)	4.9 (5.0)
Mayo ES, mean (median) (N=39)	2.3 (2.0)
Mayo ES of 3, n (%)	11 (28.2)

PROs (N=113)
PRO2, mean (median)	2.5 (2.0)
SFS	1.6 (2.0)
RBS	0.9 (1.0)
Bowel urgency NRS, mean (median)	5.4 (6.0)
Abdominal pain NRS, mean (median)	2.8 (2.0)
Biomarkers
fCAL (µg/g), median (range) (N=67)	560.0 (9.0–8000.0)
hsCRP (mg/L), median (range) (N=93)	1.8 (0.1–72.0)
Prior/Concomitant therapies (N=121)
Line of therapy, n (%)
No previous advanced therapy	73 (60.3%)
1 previous advanced therapy	21 (17.4%)
≥2 previous advanced therapies	27 (22.3%)
Prior advanced therapies for UC, n (%)
Biologics	45 (37.2%)
TNFα inhibitor	35 (28.9%)
Integrin inhibitor	25 (20.7%)
Interleukin-12/23 inhibitor	13 (10.7%)
JAKi	14 (11.6%)
S1P receptor modulator	1 (0.8%)
Concomitant CS use, n (%)	40 (33.1%)
Concomitant 5-ASA, n (%)	56 (46.3%)

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Results

PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; NRS, numerical rating scale; CRP, C-reactive protein; UC, ulcerative colitis.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

Safety was consistent with the known profile of etrasimod, with no new safety signals identified

Effectiveness outcomes

Patient-reported outcomes over time

Note: Data at the bottom of each data bar are n/N; data in brackets are 95% CI.

Note: Bowel urgency and abdominal pain are assessed using an 11-point NRS. Scores ranged from 0 (“no urgency” and “none”, respectively) to 10 (“worst possible urgency” and “worst possible pain”, respectively).z

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Conclusions

Etrasimod demonstrated clinically meaningful improvements for up to 24 weeks of treatment in patients with active UC
Similar results to those observed in randomised, placebo-controlled clinical trials

Significance to clinical practice

Real world evidence supporting the use of etrasimod in clinical practice
Only clinical data presented in this interim results with no biomarkers or endoscopy
Only as observed data presented with no imputation for missing data

UC, ulcerative colitis.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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Poster #: P1007�Evaluation of transmural healing in patients with moderately to severely active Crohn’s disease shows early efficacy of vedolizumab: VECTORS week 14 interim analysis

V. Jairath, S.K. Vuyyuru, C. Ma, G. Zou, B. Neustifter, C. Agboton, I. Romo Bautista, J.J. Wu, H.J. Jiang, M. Allocca, Y.K. An, J. Begun, R.V. Bryant, S. Danese, M.C. Dubinsky, M. Freire, K.L. Novak, R. Panaccione, A. Pudipeddi, D.T. Rubin, B.E. Sands, M.P. Sparrow, S.A. Taylor, K.B. Gecse, C. Maaser, B.G. Feagan, R.L. Wilkens

Slides compiled by Dr. Jeffrey McCurdy

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Introduction

Background & Objectives

The optimal treat-to-target strategy for Crohn’s disease (CD) remains unknown
Transmural healing (TMH) may improve outcomes compared with clinical and endoscopic healing
Objective: This interim analysis of the VECTORS clinical trial program evaluated week 14 IUS outcomes in patients with CD treated with vedolizumab (VDZ).

CD, Crohn’s disease; TMH, transmural healing; VDZ, vedolizumab; IUS, intestinal ultrasound; CS, corticosteroids.�Jairath V et al. ECCO 2026; (Abstract citation ID: jjaf231.1188, P1007).

Methods

Design: Multicenter, randomized trial comparing two treat-2-target strategies in patients with CD treated with VDZ :
TMH + clinical + biochemical remission
Clinical + biochemical remission

Follow-up: Weeks 22, 30, and 38. Treatment optimization (CS, VDZ optimization or switch to alternate therapy) if target not achieved.
Primary outcome: Week 48 CS-free endoscopic remission
Outcome for this interim analysis is week 14 TMH (group 1)

Follow-up & Assessments

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Methods

CD, Crohn’s disease; VDZ, vedolizumab; CS, corticosteroids; IUS, intestinal ultrasound; TMH, transmural healing.�Jairath V et al. ECCO 2026; (Abstract citation ID: jjaf231.1188, P1007).

Week 14 IUS outcomes

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Results:

54 of planned 304 participants were randomised and treated with VDZ

41/54 reached week 14

Analysis will assess the patients who underwent week 14 IUS from group 1

VDZ, vedolizumab; CDAI, Crohn’s Disease Activity Index; SES-CD, Simple Endoscopic Score for Crohn’s Disease; CRP, C-reactive protein; FCP, faecal calprotectin; CS, corticosteroids.�Jairath V et al. ECCO 2026; (Abstract citation ID: jjaf231.1188, P1007).

	Treatment Target Groups
Characteristics	Group 1^a (N=28)	Group 2^b (N=26)
Male, n (%)	20 (71.4)	18 (69.2)
Age (y), mean (SD)	38 (17)	38 (16)
CDAI score, mean (SD)	296 (60)	295 (58)
SES-CD score, mean (SD)	10.8 (6.4)	11.0 (5.6)
Disease duration (y), median (min, max)	2.3 (0.4, 39.6)	5.6 (0.2, 23.4)
Disease location
Ileal only or ileocolonic, n (%)	23 (82.1)	21 (80.8)
Colonic only, n (%)	5 (17.9)	5 (19.2)
CRP (mg/L), median (min, max)	6 (0, 97)	6 (0, 93)
FCP (µg/g), median (min, max)	921 (139, 6685)	848 (81, 10581)
Baseline CS use, n (%)	5 (17.9)	6 (23.1)
Prior advanced therapy use, n (%)	7 (25.0)	7 (26.9)