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COLONIC RATHER THAN ILEAL EXPRESSION OF ITGA4/ITGB7 CORRELATES WITH LOCAL INTESTINAL INFLAMMATION IN IBD

Anna Strömbeck 1, Eszter Csomor 2, Ulf Gehrmann 1, Sue Monkley 1, Sun Tian 2, Junmei Cairns 1, Bastian Angermann 1, Emon Khan 2, Josquin Nys 2, Daniel Marks 2

Affiliations

1 AstraZeneca, Gothenburg, Sweden

2 AstraZeneca, Cambridge, United Kingdom

Summary

AI Generated

Gene expression analysis in 926 IBD patients shows differential upregulation of integrin α4β7 subunits in colonic versus ileal inflammation, potentially explaining vedolizumab's greater efficacy in colonic disease.

MADCAM1 expression increased significantly with inflammation across all bowel segments in both Crohn's disease and ulcerative colitis patients, while ITGA4 and ITGB7 expression increased predominantly in colonic but not ileal biopsies.
In Crohn's disease patients with moderate to severe disease, ITGA4 and ITGB7 showed increased expression in colonic biopsies but only minor changes in ileal biopsies despite comparable MADCAM1 upregulation.
In ulcerative colitis, ITGA4 and ITGB7 expression increased in inflamed sigmoid colon biopsies and correlated with modified Mayo endoscopic score, but not in cecal biopsies.
The authors suggest these findings may mechanistically explain why vedolizumab demonstrates greater efficacy in colonic IBD compared to ileal Crohn's disease.
Relevant for researchers investigating IBD pathophysiology and clinicians considering vedolizumab therapy, particularly in patients with different disease locations.

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Abstract

Introduction

Background
Lymphocyte trafficking to the inflamed gut is one of the hallmarks of Inflammatory Bowel Disease (IBD) pathology. Integrin a4b7 and its ligand MADCAM1 play an important role in targeting immune cells in the bloodstream to mucosal tissues and blocking this pathway using the anti-a4b7 monoclonal antibody Vedolizumab (VDZ) proved to be an effective treatment in IBD. However, VDZ is most efficient in treatment of Ulcerative Colitis (UC) and of colonic rather than ileal Crohn’s Disease (CD), for which the reasons have not been completely understood.

Aims & Methods

Aim:
To compare the expression of ITGA4, ITGB7 and MADCAM1 in gut tissue biopsies from small and large bowel with respect to the underlying severity of tissue inflammation.

Methods:
Differential gene expression analysis was conducted using bulk RNA Sequencing data generated from gut tissue biopsies of the large and small intestine of 611 CD and 315 UC patients enrolled in a multicentred longitudinal Study of a Prospective Adult Research Cohort with IBD (SPARC IBD) obtained from the IBD Plexus program of the Crohn’s and Colitis Foundation. Gene expression levels of ITGA4, ITGB7 and MADCAM1 were compared across ileal, colonic and rectal segments of the intestine and data were then linked to available measures of local inflammation.

Results

Results:
ITGA4, ITGB7 and MADCAM1 were expressed at comparable levels in large vs small bowel biopsies. Expression of MADCAM1 was significantly increased in both ileal and colonic biopsies from patients with moderate to severe CD based on segmental or composite endoscopy score (SES-CD) across all bowel segments. Expression of both ITGA4 and ITGB7 was similarly increased in colonic biopsies of moderate/severe CD patients, whereas only minor changes were observed for both genes in ileal biopsies. Similar findings were obtained from UC patients, where expression of MADCAM1 was significantly increased in inflamed or ulcerated biopsies from both sigmoid colon and cecum as compared to normal appearing biopsies. Expression of ITGA4 and ITGB7 was only increased in inflamed/ulcerated biopsies of the sigmoid colon but not the cecum and correlated with the modified Mayo endoscopic score (MMES).

Conclusion

Conclusion:
Our analysis suggests that influx of leukocytes to inflamed tissue via ITGA4/ITGB7 and MADCAM1 interactions is more common in the distal colon compared to proximal colon or ileum. This provides a possible mechanistic explanation as to why VDZ is most effective in patients with colonic IBD. Further work is needed to understand the differential regulation of cell trafficking to different regions of the gut.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

New

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EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

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EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Vipul Jairath 1, Alessandro Armuzzi 2,3, Silvio Danese 4, Bruce E. Sands 5, Bogdan Ratiu-Duma 6, Phillip Levine 7, Rajendra Singh 8, Nicholas Gross 8, Ken Abrams 9, Walter Reinisch 10

Affiliations

1 Department of Medicine, Schulich School of Medicine & Dentistry I Western University, Room A10-219, University Hospital, London, Canada

2 Department of Biomedical Sciences, Humanitas University, Milan, Italy

3 IBD Center, Department of Gastroenterology, IRCCS Humanitas Research Hospital, Milan, Italy

4 IRCCS Ospedale San Raffaele - University Vita-Salute, Milan, Italy

5 Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, United States

6 Teva Pharmaceuticals S.R.L, Bucharest, Romania

7 Sanofi, Cambridge, United States

8 Teva Branded Pharmaceutical Products R&D, Inc., West Chester, United States

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

10 Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria

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Abstract

Introduction

Duvakitug is an anti-TL1A monoclonal antibody selected for its preferential inhibition of TL1A-DR3 signaling over DcR3 binding.¹ In the RELIEVE UCCD phase 2b induction study, duvakitug demonstrated significant evidence for endoscopic response vs placebo in patients with moderately to severely active CD at week 14.² Efficacy, safety and tolerability of duvakitug in patients who continued into the 44-week maintenance phase of the RELIEVE UCCD long-term extension (LTE) study are presented here.

Aims & Methods

This was a phase 2b, randomized, double-blind study without placebo control. Patients were eligible to enter the maintenance phase if they achieved clinical remission/response (CDAI) after 14 weeks of induction treatment, at which point they were re-randomized 1:1 to receive subcutaneous duvakitug 450 mg or 900 mg every 4 weeks. Efficacy analysis included duvakitug-treated patients who entered directly into the maintenance phase (total exposure of 58 weeks). The safety analysis included all patients who received ≥1 dose of duvakitug during the maintenance phase. Maintenance outcomes were assessed at week 44. The primary efficacy endpoint was endoscopic response (SES-CD). Secondary efficacy endpoints included clinical response and remission (CDAI). Safety and tolerability were assessed by adverse event (AE) reporting and laboratory monitoring.

Results

The CD efficacy analysis set included 58 patients (27 [450 mg]; 31 [900 mg]); the safety analysis set included 103 patients (50 [450 mg]; 53 [900 mg]). Demographics and baseline characteristics were generally similar between dose groups. At week 44, endoscopic response was achieved by 41% (450 mg) and 55% (900 mg) of patients receiving duvakitug (Table). High rates of clinical response and remission were observed in patients receiving 450 mg and 900 mg (Table). Treatment-emergent AEs occurred in 35 (70%) of patients receiving 450 mg and 41 (77%) receiving 900 mg. Most AEs were mild to moderate in severity, and the most common were upper respiratory infections. AEs leading to discontinuation occurred in 3 (6%) patients in each dose group.

Conclusion

Duvakitug maintenance therapy demonstrated high rates of endoscopic response and clinical response and remission at week 44 (total exposure of 58 weeks) in patients with moderately to severely active CD who had responded to duvakitug induction therapy. Duvakitug appeared to demonstrate a dose response. No new safety concerns observed. These findings support duvakitug maintenance therapy as a potentially effective and durable treatment option for patients with CD, which is being further evaluated in phase 3.

Table: Endoscopic and clinical outcomes following duvakitug treatment (week 14 of induction and week 44 of maintenance phase)
	*Week 14 induction¹*		Week 44 maintenance (58 weeks’ exposure)
	*Duvakitug 450mg* *q2w* *N=46*	*Duvakitug 900mg* *q2w* *N=46*	Duvakitug 450mg q4w N=27	Duvakitug 900mg q4w N=31
Primary endpoint: Endoscopic response, n (%)	12 (26)	22 (48)	11 (41) [95% CI: 25, 62]	17 (55) [95% CI: 39, 75]
Secondary endpoints:
Clinical remission (CDAI), n (%)	23 (50)	25 (54)	22 (81) [95% CI: 65, 95]	26 (84) [95% CI: 68, 96]
Clinical response (CDAI), n (%)	28 (61)	28 (62)*	22 (81) [95% CI: 63, 94]	27 (87) [95% CI: 70, 96]
Endoscopic response defined as ≥50% improvement in SES-CD; clinical remission defined as CDAI score <150; clinical response defined as ≥100 point decrease from baseline in CDAI score. CI, confidence interval. *n=45. 1. Jairath et al. J Crohns Colitis 2025;19:i77–8;doi: 10.1093/ecco-jcc/jjae190.0039A.

References

Clarke et al. MAbs 2018;10:664–77; doi: 10.1080/19420862.2018.1440164.
Jairath et al. J Crohn's Colitis 2025;19:i77–8; doi: 10.1093/ecco-jcc/jjae190.0039A.

Disclosure

Duvakitug is being developed in partnership by Teva and Sanofi.
VJ: consulting/advisory board fees from Abbvie, Alimentiv, Amgen, Anaptys Bio, Asahi Kasei, Asieris, AstraZeneca, Attovia, Blackbird Labs, BMS, Boehringer Ingleheim, Biomebank, Cabaletta, Caldera, Calluna, Catalytic Health, Celltrion, Ensho, Enthera, Equillium Exeliome Biosciences, Ferring, Fresenius Kabi, Gilead, Granite Bio, GSK, Janssen, Lilly, Merck, Mountainfield, MRM Health, Nxera, Organon, OSE Immunotherapeutics, Palisade Bio, Pendopharm, Pioneering Medicine, Pfizer, Prometheus, Roche/Genentech, Sanofi, SCOPE, Shattuck Labs, Sorriso, Spyre, Synedgen, Takeda, Teva, Throne Scientific, Tillotts, Union Therapeutics, Ventus, Ventyx, Vividion, Xencor, Zealand Pharma; payment for lectures, presentations, speakers bureaus, manuscript writing or educational events from AbbVie, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Pfizer, Takeda, Tillotts; and participation on Data Safety Monitoring Board or Advisory Board for Abbvie, Takeda, Janssen, Fresenius Kabi, Gilead, Roche.
AA: Consulting fees: AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Johnson & Johnson, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, and Tillots Pharma; Speaker’s fees: AbbVie, Abivax, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Johnson & Johnson, Lionhealth, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals; Research support: Biogen, MSD, Takeda, Pfizer; non-financial support: AbbVie, Johnson & Johnson, MSD, Pfizer, Takeda.
SD: consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor; and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
BES: reports consulting fees from AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Celltrion, Ensho Therapeutics, Enthera, Enveda Biosciences, Equillium, Evommune, Ferring, Fzata, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Immunyx Therapeutics, Index Pharmaceuticals, Innovation Pharmaceuticals, Kaleido, Kallyope, Merck & Co., Microba, Microbiotica, Mitsubishi Tanabe Pharma, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Palisade Bio, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biotherapeutics, Sanofi, Sorriso Pharmaceuticals, Surrozen, Target RWE, Teva, TLL Pharmaceutical, TR1X, Union Therapeutics; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees, and other support from Bristol Myers Squibb, Janssen/J & J Innovative Medicine, Pfizer, Takeda; research grants and consulting fees from Theravance Biopharma; and consulting fees, stock, and stock options from Ventyx Biopharma.
BR-D, RS, NG, KA: Teva employees.
PL: employee of Sanofi – may hold stock and/or stock options in the company.
WR: served as speaker for AbbVie, Celltrion, Ferring, Galapagos, Janssen, Merck Sharp & Dohme, Pfizer, Roche, Sobi, 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, Takeda, Teva; served as an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, Pfizer, Teva; and has received research funding from AbbVie, Janssen, Sandoz, Sanofi, Takeda.

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine IBD

Submission format

Abstract

Session

Looking into the future: Novel therapeutics in IBD (Part 2)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

New

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

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

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LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bruce E. Sands 1, Silvio Danese 2, Parambir Dulai 3, Laurent Peyrin-Biroulet 3, Marla C. Dubinsky 4, Herbert Tilg 5, Britta Siegmund 6, Geert R. D'Haens 7, Raja Atreya 8, David T. Rubin 9, Tadakazu Hisamatsu 10, Kejia Shan 11, Pascaline Ploncard 11, Douglas Jacobstein 11, Fabio Cataldi 11, Christopher Rabbat 11, Alessandro Armuzzi 12, Bram Verstockt 13

Affiliations

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

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

3 Northwestern Medicine, Digestive Health Institute, Chicago, IL, Chicago, United States

4 Mount Sinai Hospital, Mount Sinai, New York City, United States

5 Innsbruck Medical University - Department of Medicine, Innsbruck Medical University; Innsbruck/AT, Innsbruck, Austria

6 Charité - Universitätsmedizin Berlin, Berlin, Germany

7 AMC Amsterdam Inflammatory Bowel Disease Centre - Academic Medical Center, AMC Amsterdam Inflammator, Amsterdam, Netherlands

8 University Erlangen-Nuremberg, Erlangen, Germany

9 University of Chicago Medicine, Chicago, United States

10 Kyorin University School of Medicine, Tokyo, Japan

11 Abivax, Paris, France

12 IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

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

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Abstract

Introduction

Obefazimod (Obe) is an oral, once-daily (QD), small molecule that enhances the expression of microRNA-124, thereby restoring mucosal immune balance through regulation of Th17 cells and macrophages. Obe has shown efficacy in patients (pts) with moderately to severely active ulcerative colitis (UC) in two Phase 2 induction trials and subsequent open-label maintenance studies [1-3], as well as in the Phase 3 ABTECT-1 and ABTECT-2 induction trials [4].

Aims & Methods

Pts with UC receiving Obe 50mg QD (Obe-50) who completed a prior phase 2 open-label study and achieved endoscopic improvement (Mayo Endoscopic subscore = 0 or 1), were eligible to enroll in an open label study in which they received Obe 25mg QD (Obe-25) for up to an additional 78 months. This interim analysis (cut-off date: January 5, 2026) reports efficacy endpoints (clinical remission, endoscopic improvement/remission, symptomatic remission) in the portion of pts who completed the W144 visit (as observed analysis) including analyses of subgroups with and without prior exposure to advanced therapies (AT-Yes, AT-No).

Results

Patients with UC received Obe-50 for approximately 4 years in the Phase 2a open-label maintenance (OLM) study and approximately 2 years in the Phase 2b OLM. Among the 174 completers, 130 enrolled and received Obe-25 in the OLM extension. At the cutoff date, 104 completed the W144 visit. Following dose de-escalation, rates of clinical remission were 85% from W48 through W144, while symptomatic remission rates ranged from 88 to 90%. Consistent trends were observed across other efficacy endpoints (Table 1). Among W144 completers, 45.2% (47/104) were AT-Yes, and 54.8% (57/104) were AT-No. In the AT-Yes subgroup of W144 completers, rates of clinical remission ranged from 77% to 79% and rates of symptomatic remission ranged from 83% to 85% from W48 to W144 (Table 1). The AT-No subgroup consistently showed numerically higher rates across all efficacy endpoints, particularly for endoscopic remission.

Table 1: Efficacy at baseline, weeks 48, 96 and 144 among patients who completed W144, and stratified by prior advanced therapies experience (Yes/No)

Efficacy Endpoint, % (n/N1)		Baseline	Week 48	Week 96	Week 144
Clinical remission	*W144 completers (N1=104) AT-Yes (N1=47)* AT-No (N1=57)	91.3 (95) 85.1 (40) 96.5 (55)	84.6 (88) 76.6 (36) 91.2 (52)	83.6 (87) 78.7 (37) 87.7 (50)	84.6 (88) 78.7 (37) 89.5 (51)
Symptomatic remission	*W144 completers (N1=104) AT-Yes (N1=47)* AT-No (N1=57)	92.3 (96) 87.2 (41) 96.5 (55)	90.4 (94) 83.0 (39) 96.5 (55)	87.5 (91) 83.0 (39) 91.2 (52)	90.4 (94) 85.1 (40) 94.7 (54)
Endoscopic improvement	*W144 completers (N1=104) AT-Yes (N1=47)* AT-No (N1=57)	99.0 (103) 97.9 (46) 100 (57)	92.3 (96) 91.5 (43) 93.0 (53)	92.3 (96) 89.4 (42) 94.7 (54)	92.3 (96) 89.4 (42) 94.7 (54)
Endoscopic remission	*W144 completers (N1=104) AT-Yes (N1=47)* AT-No (N1=57)	66.3 (69) 44.7 (21) 84.2 (48)	66.3 (69) 53.2 (25) 77.2 (44)	71.2 (74) 55.3 (26) 84.2 (48)	72.1 (75) 61.7 (29) 80.7 (46)
Clinical remission: stool frequency sub-score (SFS) ≤1, rectal bleeding sub-score (RBS) = 0 and endoscopic sub-score ≤1; symptomatic remission: SFS≤1 and RBS=0; endoscopic improvement: endoscopic sub-score ≤1; endoscopic remission: endoscopic sub-score = 0; As observed analysis: includes patients with non-missing outcome available for each endpoint at the respective visit. N1: number of subjects who have non-missing assessment. *One subject had RB/SF subscores at W96 but was missing endoscopy assessment

Conclusion

Following 2-4 years of open-label treatment with Obe-50, a high proportion of W144 completer pts have maintained efficacy outcomes through 3 years of treatment with the lower maintenance dose of Obe-25. Maintained and persistent improvements in clinical, endoscopic, and symptomatic measures were observed regardless of prior AT status.

References

Vermeire S, et al. J Crohns Colitis. 2023; 17: 1689-1697
Vermeire S, et al. The Lancet Gastroenterology & Hepatology. 2022; 7: 1024-1035.
Vermeire S, et al. J Crohns Colitis. 2025; 19 : jjaf074
Sands BE, et al. UEG Journal, 2025; 13: 1818-1820

Disclosure

BES: Abbvie, Abivax, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, BMS, Celltrion, Equillium, Enthera, Enveda Biosciences, Evommune, Ferring, Fzata, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Kaleido, Kallyope, Lilly, Merck, Microba, Microbiotica, Mitsubishi Tanabe, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, OSE Immunotherapeutics, Janssen, Palisade Bio, Pfizer, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Therapeutics, Spyre Therapeutics, Takeda, Target RWE, Teva, TLL Pharmaceutical, Tr1X, Trex Bio, Union Therapeutics, Ventyx Biosciences; SV: AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma AG, Zealand Pharma; SD: AbbVie, Ferring, Hospira, J&J, Merck, MSD, Takeda, Mundipharma, Pfizer, Tigenix, UCB Pharma, Vifor, Biogen, Celgene, Allergan, Celltrion, Sandoz, Boehringer Ingelheim; LPB: Abbvie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, BMS, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, Ysopia; HT: Abbvie, Abivax, Dr Falk Pharma, Ferring, Galapagos, Microbiotica, MSD, Pfizer, Takeda ; US: AbbVie, Abivax, Amgen, Galapagos, Janssen, Lilly ; DR: Abbvie, Abivax, Altrubio, Athos Therapeutics, BMS, Celltrion, Connect BioPharma, Eli Lilly, Genentech, Iterative Health, Janssen, J&J, Merck, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda, Vedanta Biosciences, Ventyx ; PSD : Abbvie, Abivax, Adiso, Alimentiv, BMS, Celltrion, Genentech, Geneoscopy, Janssen, Pfizer, Takeda ; MD : Abbvie, Abivax, Arena, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Hoffmann-La-Roche, Genentech, Gilead, Janssen, Merck, Pfizer, Prometheus Biosciences, Takeda; BS: AbbVie, AltruBio, Abivax, Boehringer Ingelheim, BMS, Dr. Falk Pharma, Eli Lilly, Endpoint Health, Falk, Galapagos, Gilead, Janssen, Landos, Materia Prima, PredictImmune, Pfizer, and Takeda; TH: Mitsubishi Tanabe Pharma Corporation, EA pharma Co., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer, Eli Lilly, Gilead Sciences, BMS, Abivax ; RA : AbbVie, Abivax, AstraZeneca, BMS, Celltrion Healthcare, Galapagos, J&J, Lilly, MSD, Pfizer, Takeda; AA: AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, BMS, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma; GDH : Abbvie, Abivax, Agomab, Alimentiv, Anaptys Bio, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Galapagos, Glaxo Smith Kline, Dr Falk Pharma, Pfizer, J&J, Merck, Mirador, Polpharma, Procise Diagnostics, Prometheus Biosciences, Sorriso Pharma, Spyre, Takeda, Ventyx; BV : Abbvie, Agomab, Alfasigma, Biogen, BMS, Celltrion, Eli Lily, Falk, Ferring, Galapagos, Materia Prima, J&J, Pfizer, Sandoz, Takeda, Tillots Pharma, Truvion and Viatris, Alimentiv, Anaptys Bio, Applied Strategic, Astrazeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, BMS, Domain Therapeutics, Guidepont, Landos, Merck, Mirador Therapeutics, Mylan, Nxera, Inotrem, Ipsos, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Viatris

Event

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Long-term outcomes of interventional trials in IBD

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

New

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

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

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INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Finn Hinrichsen 1,2, Joana P. Bernardes 1, Víctor A. López-Agudelo 1, Neha Mishra 1, Lina Wehkamp 1,2, Florian Tran 1,2, Konrad Aden 1,2, Stefan Schreiber 1,2, Philip Rosenstiel 1,2

Affiliations

1 University Hospital Schleswig-Holstein UKSH, Kiel, Kiel, Germany

2 University Hospital Schleswig-Holstein UKSH, Campus Kiel, Kiel, Germany

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Abstract

Introduction

In the last decennary treatment goals in ulcerative colitis (UC) have progressed beyond simple symptom relief toward achieving deeper, multidimensional forms of remission. This evolution has led to a critical re-evaluation of traditional single endpoints in accurately reflecting disease activity and therapeutic response. A recent Delphi consensus introduced the concept of comprehensive disease control (CDC) in UC, by integrating clinical, endoscopic, and patient-reported outcomes to characterize a state of true disease quiescence. We proposed that this stringent combination of endpoints might correspond to a distinct molecular signature indicating minimal residual inflammation. To test this, we analyzed mRNA and mucosa-associated microbiota signatures in a cohort of UC patients across different remission states.

Aims & Methods

A total of 211 colonic biopsies were obtained from 173 UC patients at Kiel University Hospital between 2010 and 2020. Bulk mRNA sequencing and mucosal 16S rRNA profiling were conducted. Patients were classified according to established remission domains: Biomarker Remission: CRP < 5mg/dL and leukocytes 2.5-9/nL; Clinical Remission: Partial Mayo Score 0-1; Histological Remission: Nancy Index 0-1; Endoscopic Remission: Endoscopic Mayo Score 0. Individuals meeting all 4 criteria were designated as achieving CDC. To identify molecular features predictive of CDC, we applied an iterative random forest model using an 80% training and 20% testing split.

Results

Microbial and transcriptomic profiles mirrored inflammation gradients. Analyses revealed overlapping but distinct signatures across remission domains, exemplified by enrichment of Dorea formicigenerans in endoscopic, histological, and clinical -but not biomarker- remission. None of the 31 CDC patients CDC required IBD-related hospitalization or surgery over 2 years, highlighting CDC as a clinically meaningful state of profound disease inactivity. Linear mixed modeling showed differential abundance of IBD-associated taxa Lachnoclostridium and Lachnospiraceae FC020 in CDC. Transcriptomic profiling revealed a molecular gradient between CDC and non-CDC patients, with enrichment of fatty acid metabolism and suppression of immune programs. A random forest classifier identified 19 transcriptomic markers predictive of CDC (AUC 0.856), including known IBD-associated genes (CXCL1, KRT7, SLC6A14, ESRRA, FGFR3, ITPKA) and novel markers (ATP5PBP8, CHPT1, CPVL-AS2, CTDSPL, GRIK2, MAZ, MCM9, MED7, RIMKLA, RND1, TIGD5, TMEM115, ZDHHC23).

Conclusion

CDC reflects a biologically profound state of disease quiescence in UC, extending to both the molecular and microbial landscape of the intestinal mucosa. The observed molecular gradient suggests a continuum of mucosal healing and highlights the potential for objective biomarkers capable of quantifying minimal residual disease activity. Importantly, such molecular signatures might help identify patients with low disease activity who are in a molecularly inactive state of disease, even if they do not fulfill all Comprehensive Disease Control criteria. External validation of this molecular signature will determine its prognostic value for long-term clinical outcomes.

Disclosure

Hinrichsen, Finn: Received travel support from Pfizer.
P. Bernardes, Joana: I have no conflict of interest to declare
Lopez Agudelo, Victor Alonso: No conflicts
Mishra, Neha: none
Welz, Lina: Received support from Celltrion for independent reporting from scientific congresses.
Tran, Florian: Grant: Sanofi/Regeneron Personal Fees: Speaker’s fees: Abbvie, Bristol-Myers-Squibb, Celltrion Healthcare, Dr Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, J & J, Sanofi, Takeda Consulting honoraria: AbbVie, J & J, Takeda Non-financial Support: Sanofi for statistical analysis
Aden, Konrad: Personal Fees: Lecture fee: Takeda, Janssen, Lilly, Abbvie
Consulting fee: Takeda, Jannsen, Lilly, Guidepoint
Schreiber, Stefan Wolfgang: Personal Fees: AbbVie, Alfasigma, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance
Rosenstiel, Philip: stock ownership Gerion

Event

UEG Week Barcelona 2026

Topics

Mechanisms & Personalised Medicine Immunology IBD

Submission format

Abstract

Session

Immunologic pathways of disease and drug response in IBD

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

New

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

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

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EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Silvio Danese 1, Millie Long 2, Laurent Peyrin-Biroulet 3, Aline Charabaty 4, Gil Melmed 5, Iris Dotan 6, Axel Dignass 7, Tim Raine 8, Alex Song 9, Jasmina Kalabic 10, Javier Zambrano 9, Fernando Aponte 9, Xi Yang 9, Feng Zeng 9, Rachel Duan 9, Miguel Regueiro 11, Remo Panaccione 12

Affiliations

1 IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy

2 University of North Carolina at Chapel Hill, Chapel Hill, NC, United States

3 McGill University Health Centre, Montreal, QC, Canada

4 University of Maryland Medical Center, Baltimore, MD, United States

5 Cedars Sinai Health Sciences University, Los Angeles, CA, United States

6 Rabin Medical Center, Beilinson Campus, and Gray Faculty of Health and Medical Sciences, Tel Aviv University, Petah Tikva, Israel

7 Agaplesion Markus Krankenhaus, Frankfurt/ Main, Germany

8 Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom

9 AbbVie Inc., North Chicago, IL, United States

10 AbbVie Deutschland GmbH Co. KG, Ludwigshafen am Rhein, Germany

11 Cleveland Clinic, Cleveland, OH, United States

12 University of Calgary, Calgary, AB, Canada

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Abstract

Introduction

Risankizumab (RZB) is an interleukin-23 p19 subunit inhibitor currently approvedas intravenous induction followed by subcutaneous (SC) maintenance therapy in patients with moderately to severely active Crohn’s disease (CD).^1-4 Here we report 12-week results from the AFFIRM study that evaluated the efficacy and safety of RZB SC induction therapy in patients with moderately to severely active CD.

Aims & Methods

AFFIRM (NCT06063967) is a phase 3, randomised, placebo (PBO)-controlled, double-blind study that enrolled adult patients (≥ 18 years) with a confirmed CD diagnosis ≥ 3 months prior to baseline (BL), a BL CD Activity Index (CDAI) of 220–450, a BL Simple Endoscopic Score for CD (excluding the presence of narrowing component) of ≥ 6 (or ≥ 4 for isolated ileal disease), and prior intolerance/inadequate response (IR) to conventional and/or advanced therapies (ATs; ie biologics and Janus kinase [JAK] inhibitors). Enrolment of patients who were ustekinumab (UST)-IR or ≥ 3 AT-IR were each capped at 20%. Patients were randomised 2:1 to receive either SC RZB 720 mg or matching PBO at BL and weeks 2, 4, and 8 of the induction period. Co-primary endpoints were CDAI clinical remission and endoscopic response at week 12. All co-primary and secondary efficacy endpoints were multiplicity controlled for overall type-I error rate at a two-sided significance level of 0.05. Treatment-emergent adverse events (TEAEs) were assessed through week 12.

Results

This analysis included 289 patients (RZB, N = 191; PBO, N = 98). Patient demographics and BL characteristics were similar between treatment arms; 64.9% and 66.3% were AT-IR in RZB and PBO arms, respectively. At week 12, significantly greater proportions of the overall population treated with RZB vs PBO achieved CDAI clinical remission (55.0% vs 29.6%; P < .0001) and endoscopic response (44.0% vs 14.3%; P < .0001) (Table). For these endpoints, numerically higher rates were achieved at week 12 with RZB vs PBO in the AT-naïve subpopulation, with the RZB arm reaching 73.1% (vs 27.3% for PBO) for CDAI clinical remission and 61.2% (vs 15.2% for PBO) for endoscopic response. Numerically higher rates were also achieved at week 12 in the AT-IR subpopulation with RZB vs PBO for CDAI clinical remission (45.2% vs 30.8%) and endoscopic response (34.7% vs 13.8%). TEAEs were reported in 81 (42.4%) and 58 (59.2%) patients in the RZB and PBO arms, respectively (Table). No deaths were reported.

	PBO (N = 98)	RZB SC (N = 191)	Treatment difference vs PBO
CDAI clinical remission,^a % [95% CI] Overall AT-naïve AT-IR Endoscopic response,^b % [95% CI] Overall AT-naïve AT-IR TEAEs (safety analysis population), n (%) Severe AE Serious AE AE with reasonable possibility of being drug related^c AE leading to discontinuation of study drug Deaths AESIs (safety analysis population), n (%)^e Serious infections Adjudicated MACE Malignant tumours Malignancies excluding NMSC Adjudicated anaphylactic reaction Hepatic events Injection site reaction	29.6 [20.55, 38.63] 27.3 [12.08, 42.47] 30.8 [19.55, 41.99] 14.3 [7.36, 21.21] 15.2 [2.92, 27.38] 13.8 [5.45, 22.24] 58 (59.2) 5 (5.1) 3 (3.1) 21 (21.4) 1 (1.0) 0 0 0 0 0 0 5 (5.1) 1 (1.0)	55.0 [47.92, 62.03] 73.1 [62.52, 83.75] 45.2 [36.40, 53.92] 44.0 [36.94, 51.02] 61.2 [49.53, 72.86] 34.7 [26.30, 43.05] 81 (42.4) 5 (2.6) 1 (0.5)^d 21 (11.0) 0 0 0 0 0 0 0 1 (0.5) 4 (2.1)	26.6 [15.57, 37.60], P < .0001 45.9 [27.33, 64.40] 14.4 [0.16, 28.63] 29.4 [19.94, 38.92], P < .0001 46.0 [29.14, 62.95] 20.8 [8.97, 32.69] NA NA
Table. Summary of coprimary endpoints, TEAEs, and AESIs during the 12-week induction period AE, adverse event; AESI, adverse event of special interest; AT, advanced therapy; BL, baseline; CDAI, Crohn’s Disease Activity Index; IR, inadequate response; MACE, major adverse cardiovascular events; NMSC, nonmelanoma skin cancer; NRI-MI, nonresponder imputation while incorporating multiple imputation; PBO, placebo; RZB, risankizumab; SC, subcutaneous; TEAE, treatment-emergent adverse event. Overall population included all patients who were randomised and received ≥ 1 dose of study drug during the 12-week induction period. Randomisation was stratified by number of prior ATs failed (0, 1, > 1), prior ustekinumab failed (yes, no), and BL steroid use (yes, no). AT-naïve patients included those without prior AT failure. AT-IR patients included those with prior failure to ≥ 1 AT for CD. The safety analysis population included all patients who received ≥ 1 dose of study drug during the 12-week induction period. Statistically significant difference between RZB vs PBO for the coprimary endpoints was determined using a fixed-sequence multiple testing procedure at significance level of 0.05 (two-sided). Handling of missing data was based on NRI-MI for binary endpoints. 95% CIs were calculated using Student's t-distribution if there were missing data that can be reasonably assumed to be missing at random or normal approximation to the binomial distribution if there were no missing data that are missing at random. Treatment differences were based on Mantel-Haenszel estimation for binary endpoints. Statistical testing was not performed for the AT-naïve/AT-IR subgroup analyses; thus, no P values are provided herein. ^aCDAI < 150. ^bDecrease in SES-CD > 50% from baseline (or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by central reviewer. ^cAs assessed by investigator. ^dWorsening of Crohn’s disease. ^eThere were no reports of active tuberculosis, opportunistic infections, or herpes zoster.

Conclusion

In the overall AFFIRM population, patients with moderately to severely active CD treated with 12-weeks of RZB SC induction therapy achieved the coprimary endpoints of CDAI clinical remission and endoscopic response at significantly higher rates than those receiving PBO. Approximately three quarters of AT-naïve patients achieved clinical remission at this early timepoint. Both AT-naïve and AT-IR (which included UST-IR, and JAK-IR) achieved high rates of efficacy at numerically higher rates with RZB SC induction than PBO. Safety results of SC induction were consistent with the known safety profile of RZB.

References

Singh S, et al. mAbs. 2015;7(4):778–91.
SKYRIZI® (risankizumab-rzaa) prescribing information. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf
D’Haens G, et al. Lancet. 2022;399(10340):2015–30.
Ferrante M, et al. Lancet. 2022;399(10340):2034–46.

Funding
AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.

Acknowledgements
Mahesh Chemudupati, PhD, and Jeanie K. Meckes, PhD, of AbbVie, provided medical writing support. Angela T. Hadsell, of AbbVie, provided editorial support.

Disclosure

SD has received 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.
MDL has served as a consultant for AbbVie, Takeda, Pfizer, Janssen, UCB, Target PharmaSolutions, Salix, Valeant, and Prometheus.
LPB has received consulting fees from AbbVie, Abivax, Adacyte, Alimentiv, Alfasigma, Amgen, Apini, Banook, BMS, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, GSK, Hemay, Iterative Health, Janssen, Eli Lilly, LifeMine, Medac, Mirador, Morphic, MSD, Nordic Pharma, Novartis, Oddifact, Oncodesign Precision Medicine, Onco3R, ONO Pharma, OSE Immunotherapeuthics, Palisade Bio, Par' Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta, Ventyx; stock options from Iterative Health, Oragen, Pharmanest, Thetis; and lecture fees from AbbVie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Eli Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche, Sandoz, Takeda, and Tillots.
AC has received advisory board and/or consulting fees from AbbVie, Celltrion, Eli Lilly, Janssen, Pfizer, and Sanofi.
GYM has served as a consultant and/or on advisory Board for AbbVie, Arena Biopharmaceuticals, Boehringer-Ingelheim, Bristol-Meyers Squibb / Celgene, Cristcot, Diasorin, Dieta, Entasis, Fresenius Kabi, Ferring, Genentech, Janssen Immunology, Lilly, Medtronic, Merck, Oshi Health, Pfizer, Prometheus Labs, Samsung Bioepis, Shionogi, Gilead, Takeda, Techlab, Viatris; received speaking fees from AbbVie and Janssen; and has stock options in Harp Diagnostics and Oshi Health.
ID has received consultation fees, research grants, or honoraria from AbbVie, Altman, Arena Pharmaceuticals, AstraZeneca, Athos, Celgene/Bristol Myers Squibb, Celltrion, Dr Falk Pharma, Ferring, Galapagos, Genentech, Gilead, Iterative Scopes, H5MD, Friedevents AG, Janssen, Lilly, Materia Prima, Mirador, Pfizer, Prometheus, Sandoz, Sangamo, Spyre, Sublimity, Takeda. She is a shareholder in Gutreat and Harp Diagnostics.
AD reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from AbbVie, Abivax, Falk, Galapagos, Gilead, J&J, Pfizer and Takeda; consultancy fees from AbbVie, Alfasigma, Amgen, Biogen, Boehringer Hexal, J&J, Lilly, MSD, Pfizer, Pharmacosmos, Roche, Sandoz, Stada, Takeda, and Vifor Pharma; payment from lectures including service on speakers bureaus from AbbVie, Alfasigma, Biogen, CED Service GmbH, Celltrion, Falk, Fresenius Kabi, Ferring, Galapagos, Gilead, Hexal, High5MD, J&J, Materia Prima, MedToday, MSD, Pfizer, Sandoz, Streamed-Up, Takeda, and Vifor Pharma; payment for manuscript preparation from AbbVie, Falk, J & J, Takeda, Thieme, and UniMed Verlag.
TR has received research/educational grants and/or speaker/consultation fees from AbbVie, Alfasigma, Arena, Aslan, AstraZeneca, Boehringer-Ingelheim, BMS, Domain Therapeutics, Eli Lilly, Ferring, Galapagos, Gilead, GSK, Heptares, LabGenius, MonteRosa, Novartis, Numab, Janssen, Pfizer, Roche, Scientia, Takeda, UCB, and XAP therapeutics.
AS, JK, JZ, FA, XY, FZ, and WRD are full-time employees of AbbVie and may hold AbbVie stock and/or stock options.
MR served as an advisory board member and consultant (both) for AbbVie, Johnson and Johnson, UCB, Takeda, Pfizer, BMS, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, Boehringer Ingelheim Pharmaceuticals Inc. (BIPI), Celltrion, Roche, Merck, Sanofi, Biocon, and Abivax.
RP has received consulting fees, speaker fees, and research support from Abbott, AbbVie, Abivax, Alimentiv, Amgen, AnaptysBio, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corporation, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Sanofi, Satisfai Health, Sublimity Therapeutics, Takeda, Theravance Biopharma, Trellus, Viatris, UCB, and Ventyx.

Event

UEG Week Barcelona 2026

Topics

IBD

Submission format

Abstract

Session

Teaching an old dog new tricks: New implementations of current IBD drugs

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

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The gut microbiome in cardiometabolic disorders

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The gut microbiome in cardiometabolic disorders

Francesco Asnicar 1

Affiliations

1 University of Trento, Trento, Italy

Summary

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Summary is not available for this content yet.

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Abstract

Event

UEG Week Barcelona 2026

Topics

IBD Gut Microbiota

Session

Gut microbiome in non-communicable disorders

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol

UEG Presentation

New

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

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

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

The gut microbiome in IBD

Harry Sokol 1

Affiliations

1 Saint-Antoine Hospital, Paris, France

Summary

AI Generated

Summary is not available for this content yet.

Download PDF

Was this helpful?

Thanks for your feedback.

Abstract

Event

UEG Week Barcelona 2026

Topics

IBD Gut Microbiota

Session

Gut microbiome in non-communicable disorders

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

More Like This:

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY

Walter Reinisch

LONG-TERM EFFICACY AND PERSISTENCE WITH OBEFAZIMOD AFTER DOSE DE-ESCALATION TO 25 MG: 3-YEAR INTERIM ANALYSIS IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS COMPLETING WEEK 144, STRATIFIED BY PRIOR ADVANCED THERAPY EXPERIENCE: RESULTS F

Bram Verstockt

INTEGRATING MUCOSAL TRANSCRIPTOMIC AND MICROBIAL SIGNATURES TO DEFINE COMPREHENSIVE DISEASE CONTROL IN ULCERATIVE COLITIS AT MOLECULAR RESOLUTION

Philip Rosenstiel

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY

Remo Panaccione

The gut microbiome in cardiometabolic disorders

Francesco Asnicar

The gut microbiome in IBD

Harry Sokol