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DIFFERENCES IN CLINICAL HISTORY AND PRESENTATION IN PATIENTS WITH CHRONIC LIVER DISEASE UNDERGOING INPATIENT VERSUS OUTPATIENT LIVER TRANSPLANT EVALUATION

Katherine Cooper 1, Deepika Devuni 1

Affiliations

1 UMass Chan Medical School, Worcester, United States

Summary

AI Generated

Retrospective matched cohort study (n=318) comparing inpatient versus outpatient liver transplant evaluations found that inpatients had significantly higher MELD-Na scores, more prior decompensations, higher rates of malnutrition, and more frequent hospitalizations, with spontaneous bacterial peritonitis and hepatorenal syndrome showing the greatest differences.

Inpatients had significantly higher MELD-Na scores than outpatients (27.1 ± 8 vs. 13.3 ± 6; p<0.0001) at time of liver transplant evaluation.
Malnutrition was 5.6 times more common in inpatients (33.5%) than outpatients (8.2%) (OR 5.6, 95% CI 2.9-10.8, p<0.001).
Inpatients had significantly more prior decompensations than outpatients (3.2 ± 1.4 vs. 1.8 ± 1.1, p<0.001), with the greatest differences in spontaneous bacterial peritonitis (22.0% vs. 3.8%, p<0.0001) and hepatorenal syndrome (32.7% vs. 3.8%, p<0.0001).
Inpatients were three times as likely to have had one or more liver-related hospital admissions prior to evaluation (p<0.0001), with 65.8% of inpatients having more than one prior admission compared to 39.6% of outpatients.
Authors conclude that multiple liver-related hospitalizations, malnutrition, and particularly episodes of spontaneous bacterial peritonitis or hepatorenal syndrome may indicate need for urgent transplant evaluation referral.

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Abstract

Introduction

Liver transplant is the only definitive treatment for chronic liver disease (CLD). Referral to a hepatologist for consideration for liver transplant should be made when a patient with CLD experiences a hepatic decompensation or has a MELD score ≥ 15. Failure to refer in a timely manner can result needing a liver transplant evaluation (LTE) in the inpatient setting while a patient is experiencing acute decompensation.

Aims & Methods

We aimed to compare the clinical presentation of patients undergoing LTE in the inpatient setting versus the outpatient setting to identify potential risk factors for requiring urgent evaluation. A list of all LTEs performed at our institution between 10/2017-8/2021 was obtained. Medical records were preliminarily reviewed for evaluation setting (Inpatient vs. Outpatients); evaluations for re-transplantation and acute liver failure were excluded. After all Inpatients (n=159) were identified, Outpatients (n=159) were selected at random to create a sample matched for age, gender, race, and ethnicity (n=318). Data were collected using our institutions electronic medical record and outside health records as obtained during LTE process. “Prior decompensations” refers to the number of the following clinical decompensations experienced prior to the time of LTE: ascites, hepatic encephalopathy (HE), variceal/acute UGIB, SBP and HRS. Categorical variables and continuous were compared between using Fisher’s Exact test, and student’s T test, respectively.

Results

Alcohol was the most common CLD etiology (42.1% Inpatient, 48.4% Outpatient). Inpatients tended to live further from our center than Outpatients (p=0.079). Inpatients had significantly higher MELD-Na scores (27.1 ± 8 vs. 13.3 ± 6; p<0.0001). Malnutrition was more common in 5.6 times more common in inpatients than outpatients (OR 5.6, 95% CI 2.9-10.8, p<0.001).. A similar proportion of patients had 1 hospitalization. But inpatients were 3 times as likely to have had ≥ 1 liver-related hospital admission prior to LTE (p<0.0001). Inpatients had significantly more prior decompensations than Outpatients prior to inpatient LTE (3.2 ± 1.4 vs. 1.8 ± 1.1, p<0.001), with the greatest differences in SBP and HRS.

Variable		Outpatient	Inpatient	p
Nutritional status (%)	Malnutrition	8.2	33.5	<0.0001
Previous hospital admissions (%)	0 admissions	23.9	11.4	<0.0001
	1 admissions	36.5	22.8
	>1 admissions	39.6	65.8
History of Decompensation (%)	Ascites	71.1	91.8	<0.0001
	HE	50.3	71.1	0.0002
	UGIB	23.3	32.1	0.1029
	SBP	3.8	22.0	<0.0001
	HRS	3.8	32.7	<0.0001

Conclusion

Multiple liver-related hospitalizations and malnutrition may be considered a risk factor for ultimately needing inpatient LTE and should be taken seriously by health care providers caring for patients with CLD. Episodes of SBP and HRS should prompt providers to consider immediate or urgent LTE referral regardless of other factors.

References

Multiple liver-related hospitalizations may be considered a risk factor for ultimately needing inpatient LTE and should be taken seriously by health care providers caring for patients with CLD. Episodes of SBP and HRS should prompt providers to consider immediate or urgent LTE referral regardless of other factors.

Disclosure

D Devuni has received grant funding from Sequana Medical and receives grant support from the NIAAA (AA017986-11), both for research unrelated to this work.

Conference

UEG Week Copenhagen 2023

Topics

Hepatobiliary

Submission format

Abstract

Session

PP 07 Liver & biliary (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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Nutritional aspects: How to provide baseline therapy

Julia Mader 1

Affiliations

1 Medizinsiche Universität Graz, Graz, Austria

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Abstract

Event

UEG Week Barcelona 2026

Topics

Hepatobiliary Small Intestine & Nutrition Mechanisms & Personalised Medicine

Session

Therapy update: Anti-obesity

Citation

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

Published

2026

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CONTEMPORARY TEMPORAL TRENDS IN COLECTOMY AND RESTORATIVE SURGERY FOR ULCERATIVE COLITIS: AN ANALYSIS OF THE UK IBD BIORESOURCE

Ailsa L Hart

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Laurent Peyrin-Biroulet

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Eirini Dimidi

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CONTEMPORARY TEMPORAL TRENDS IN COLECTOMY AND RESTORATIVE SURGERY FOR ULCERATIVE COLITIS: AN ANALYSIS OF THE UK IBD BIORESOURCE

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CONTEMPORARY TEMPORAL TRENDS IN COLECTOMY AND RESTORATIVE SURGERY FOR ULCERATIVE COLITIS: AN ANALYSIS OF THE UK IBD BIORESOURCE

Itai Ghersin 1,2, Qian Zhang 3, Hashem Mahdi M. Saleh Al-Dujaily 4, Orestis E. Argyriou 5, Kapil Sahnan 5, Laura Fachal 3, Laura Hancock 6, Jonathan P Segal 7, Miles Parkes 8, Ailsa L Hart 5

Affiliations

1 Rambam Health Care Campus, Haifa, Israel

2 St. Mark's Hospital and Academic Institute, London, United Kingdom

3 Wellcome Sanger Institute, Hinxton - Saffron Walden, United Kingdom

4 Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom

5 St Mark’s Hospital and Academic Institute, London, United Kingdom

6 Manchester University NHS Foundation Trust, Manchester, United Kingdom

7 Royal Melbourne Hospital, Melbourne, Australia

8 Inflammatory Bowel Disease Research Group, Addenbrooke's Hospital, Cambridge, UK, Cambridge, United Kingdom

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Abstract

Introduction

The surgical landscape for ulcerative colitis (UC) is evolving alongside the expanding use of advanced medical therapies. Whether the introduction and widespread adoption of biologic and small-molecule therapies have altered the long-term need for colectomy in UC remains controversial. In addition, the surgical pathway following subtotal colectomy remains a point of clinical variation. Restoration of intestinal continuity can be achieved via ileal pouch-anal anastomosis (IPAA), traditionally considered the gold standard, or ileo-rectal anastomosis (IRA)¹. However, a significant proportion of patients opt for a permanent ileostomy. Recent data highlight considerable international and regional variability in these practices².

Aims & Methods

We aimed to describe the contemporary landscape of UC surgery using the UK IBD BioResource, a national platform recruiting from over 100 centres³.
We analysed patients with a confirmed diagnosis of UC undergoing a subtotal colectomy. Temporal trends in colectomy incidence and IPAA uptake were evaluated across two eras, using 2012 as a cut-off to reflect the period following the widespread availability of anti-TNF maintenance and newer agents. Risk of colectomy was assessed using Cox regression, and IPAA formation was evaluated using multivariable logistic regression.

Results

Our cohort included 14,248 patients with UC. Of those patients, 965 (6.8%) underwent a subtotal colectomy.
The risk of colectomy was significantly lower in the recent era (after 2012) compared with the earlier era (HR 0.81, 95% CI 0.67–0.98, p=0.028).
Among those with a colectomy and fully available surgical details (n=627), 333 (53%) had an ileo-anal pouch and 294 (47%) did not.
Most notably, patients undergoing colectomy after 2012 were significantly less likely to receive an ileo-anal pouch than those in the earlier era (OR 0.11, 95% CI 0.07–0.16, p<0.001).
Indications for colectomy have remained stable across eras.
Among patients who underwent a subtotal colectomy without a subsequent IPAA, 61.5% had the rectum remaining in situ, whereas 28.5% underwent completion proctectomy.

Conclusion

We demonstrate a previously unreported and significant decline in the uptake of restorative pouch surgery after colectomy for UC in the UK.
This trend may reflect shifts in surgical decision-making and/or evolving patient preferences.
Further research is needed to elucidate the underlying drivers of this marked shift in clinical practice.

References

1. Worley GHT, Vaughan-Shaw P, Sahnan K. Surgical management of ulcerative colitis. Br J Surg. 2023 Jul 17;110(8):885-887.
2. Worley G, Nordenvall C, Askari A, Pinkney T, Burns E, Akbar A, Olén O, Ekbom A, Bottai M, Myrelid P, Faiz O. Restorative surgery after colectomy for ulcerative colitis in England and Sweden: observations from a comparison of nationwide cohorts. Colorectal Dis. 2018 Sep;20(9):804-812.

3. Parkes M; IBD BioResource Investigators. IBD BioResource: an open-access platform of 25 000 patients to accelerate research in Crohn's and Colitis. Gut. 2019 Sep;68(9):1537-1540.

Event

UEG Week Barcelona 2026

Topics

Surgery IBD

Submission format

Abstract

Session

Real-world observations in IBD: Things we don't see in clinical trials

Citation

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

Published

2026

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

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

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The inflamed pouch: Pouchitis or something else?

Ailsa L Hart 1

Affiliations

1 St Mark’s, the National Bowel Hospital, London North-West University Healthcare NHS Trust, London, United Kingdom

Summary

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Abstract

Event

UEG Week Barcelona 2026

Topics

Surgery Primary Care

Session

The troublesome pouch

Citation

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

Published

2026

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Dan Turner

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STRIDE-III: UPDATED EVIDENCE-BASED TREATMENT TARGETS FOR INFLAMMATORY BOWEL DISEASE FROM THE INTERNATIONAL ORGANIZATION FOR THE STUDY OF IBD

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STRIDE-III: UPDATED EVIDENCE-BASED TREATMENT TARGETS FOR INFLAMMATORY BOWEL DISEASE FROM THE INTERNATIONAL ORGANIZATION FOR THE STUDY OF IBD

Axel Dignass 1, Amanda Ricciuto 2, Shira Bar-Asher 3, Sudheer K. Vuyyuru 4, Virginia Solitano 5, Nadine Bock 6, Maria Manuela Estevinho 7, Yuhong Yuan 8, Marietta Iacucci 9, Florian Rieder 10, Rupert W Leong 11, Walter Reinisch 12, Edward V Loftus Jr 13, Laurent Peyrin-Biroulet 14, Silvio Danese 15, Remo Panaccione 16, Takayuki Yamamoto 17, Stefan Schreiber 18, Marla C. Dubinsky 19, David T. Rubin 20, Gerassimos J. Mantzaris 21, Fernando Magro 22, Vipul Jairath 4, Iris Dotan 23, Dan Turner 24

Affiliations

1 Agaplesion Markus Krankenhaus, Frankfurt/ Main, Germany

2 Hospital for Sick Children, Toronto, Canada

3 Zare, Jerusalem, Israel

4 Alimentiv Inc., London, Canada

5 IRCCS Ospedale San Raffaele, Milan, Italy

6 Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany

7 Vila Nova de Gaia Espinho Hospital Center, Vila Nova de Gaia, Portugal, Porto, Portugal

8 McMaster University, Ancaster, Canada

9 University of Birmingham, Birmingham, Ireland

10 Cleveland Clinic Foundation, Cleveland Heights, United States

11 Concord Hospital Dept. of Gastroenterology, Sydney, Australia

12 Medical University of Vienna, Wien, Austria

13 Mayo Clinic College of Medicine and Science, Rochester, United States

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

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

16 University of Calgary, Calgary, Canada

17 Yokkaichi Social Insurance Hospital, Yokkaichi, Japan

18 University Hospital Schleswig-Holstein, Kiel, Germany

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

20 University of Chicago Medicine, Chicago, United States

21 Evangelismos Hospital, Athens, Greece

22 Centro Hospitalar São João, Porto, Portugal

23 Rabin Medical Center, Petah Tikva, Israel

24 Shaare Zedek Medical Center, Jerusalem, Israel

Summary

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Abstract

Introduction

Treat-to-target (T2T) has become a central principle of inflammatory bowel disease (IBD) management, but evidence supporting individual treatment targets has evolved substantially since STRIDE-II.

Aims & Methods

We aimed to update evidence-based treatment targets for Crohn’s disease (CD) and ulcerative colitis (UC), distinguish targets that should trigger treatment change from measures that primarily guide optimization and monitoring, and define practical timelines for target achievement. MEDLINE, Embase and Cochrane CENTRAL were systematically searched for studies published after the STRIDE-II search period through April 18, 2025, while retaining evidence considered in STRIDE-II. Evidence was integrated with structured surveys of International Organization for the Study of IBD (IOIBD) members and pediatric gastroenterologists from the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Porto Group. Consensus statements were developed by the steering committee and voted on by IOIBD members using a modified Delphi process; consensus required ≥75% rating a statement 7–10 on a 10-point scale. Final voting was completed on June 25, 2026.

Results

Of 13,071 unique records identified, 1,021 studies were included, comprising 683 CD-relevant and 558 UC-relevant studies. Surveys were completed by 60/79 (76%) IOIBD and 23/30 (77%) ESPGHAN members. All 26 recommendations achieved consensus, with 77–100% agreement. STRIDE-III establishes three conceptually distinct categories of treatment targets. Actionable targets, supported by T2T evidence, should generally prompt treatment changes when not achieved despite adequate treatment optimization and include clinical response and remission, C-reactive protein and fecal calprotectin (FC), and endoscopic remission. Adjunctive targets, associated with favorable outcomes but lacking sufficient evidence that target-guided treatment switching improves outcomes, should guide treatment optimization and tighter monitoring without necessarily changing therapeutic class. These include bowel urgency, growth in children, histological remission in UC, and transmural remission in CD. Patient-centered targets comprise quality of life, disability, and fatigue. Impairment should prompt assessment of inflammatory and non-inflammatory causes and management through shared decision-making. Clinical response is positioned as an immediate target (<1–2 months), clinical remission as a short-term target (2–3 months), biochemical remission as an intermediate target (3–6 months), and endoscopic remission as the principal long-term actionable target (7–12 months), with treatment-specific timelines. FC <200 µg/g is the actionable biochemical target, while values <100 µg/g support deeper inflammatory control. Serial multidimensional assessment and pragmatic adaptations for resource-limited settings are emphasized.

Conclusion

STRIDE-III redefines T2T management in IBD by distinguishing targets that warrant treatment change from measures that guide optimization, monitoring, and integrating patient-centered care. This evidence-based hierarchy provides a practical framework for serial multi-dimensional therapeutic decision-making while reducing the risk of both undertreatment of persistent inflammation and unnecessary treatment escalation.

Disclosure

Dan Turner: Janssen, Pfizer,Ferring, Abbvie, Takeda, Lilly, SorrisoPharma, Boehringer Ingelheim, BMS, AlfaSigma, Merck, Genentech; Sudheer K. Vuyyuru: Alimentiv Inc, Takeda; Virginia Solitano:J&J, Celltrion, Pfizer, Takeda, Giuliani, Tillotts, Alfasigma, Lilly and Abbvie; Maria Manuela Estevinho: Celltrion, Dr Falk, J&J, and Lilly; Fernando Magro: Abbvie, Abivax, Adacyte, Alfasigma, Amgen, Bristol Myers Squibb (BMS), Celltrion, Ferring, FalK, Fresenius Kabi, Gilead, GSK , Janssen, Lilly, Laboratorios Vitoria, MSD, OM Pharma, Pfizer, Roche, Sandoz, Sanofi, Takeda, Teva, Tillotts; Marietta Iacucci: J&J, Takeda, Eli Lilly, Olympus, Pentax; Florian Rieder: AbbVie, Abivax, Adiso, Adnovate, Agomab, Alimentiv, Allakos, Allergan, Anaptys, Astra Zeneca, Bausch & Lomb, Boehringer-Ingelheim, Cabaletta, Cage, Cellarity, BMS, Celltrion, CDISC, Celsius, Chemomab, Cowen, 89Bio, Empress, Enveda, Equillium, Eugit, Falk, Ferring, Flow Therapeutics, Forth Therapeutics, Frequency Therapeutics, Horizon Therapeutics, Image Analysis Limited, Imidomics, Index Pharma, JT Pharma, Koutif, Landos, Lassen, Lilly, Medbiopharma, Merck, Mestag, Metacrine, Mirador, Mirum, Mobius, Mopac, Morphic, Myka Labs, Nxera, Ono, Organovo, Origo, Palisade, Pfizer, Roche, Rubix, Samsung, Sanofi, Sironax, SRT, Surmodics, Surrozen, Takeda, Techlab, Tentarix, Teva, Thabor, Theravance, Thetis, Tillerts, Transcenta, Ventus, Versant, Viatris, Virgo, Xencor, Ysios; Rupert W. Leong: AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, J&J, Lilly, MSD, Novartis, Pfizer, Prometheus, Takeda, SPYRE; Walter Reinisch: AbbVie, Alfasigma, Celltrion, Ferring, JNJ, Lilly, MSD, Roche, Pfizer, Sobi, Takeda, Agomab, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Medahead, Microbiotica, MSD, Pfizer, Redex, Sanofi,; Edward V. Loftus: AbbVie, Abivax, Astellas, Biocon, Celltrion, Eli Lilly, Gilead, Iota Bioscience, Iterative Health, J&J, Kymera, Merck, Takeda, Eli Lilly, Morphic; Exact Science and Moderna.; Laurent Peyrin-Biroulet: AbbVie, Abivax, Alfasigma, Alimentiv, Amgen, Apini, BMS, Celltrion, Cytoki Pharma, Enthera, Ferring, Fresenius, GSK, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Iterative Health, Johnson & Johnson, LifeMine, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, ONO Pharma, OSE Immunotherapeutics, Par' Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta, and Ventyx, Gilead, Iterative Health, Johnson & Johnson, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots.; Vipul Jairath: Abbvie, Alimentiv, Amgen, Anaptys Bio, Asahi Kasei, Asieris, Astra Zeneca, Attovia, Blackbird Labs, BMS, Boehringer, Biomebank, Cabaletta, Caldera, Calluna, Campfield, Catalytic Health, Celltrion, Ferring, Fresenius Kabi, Gilead, Granite Bio, GSK, Janssen, Lilly, Merck, Mobius, MRM Health, Pfizer, PharmaNest, Pioneering Medicine, PIPr Therapeutics, Roche, Sanofi, SCOPE, Shattuck Labs, Sorriso, Spyre, Synedgen, Takeda, Teva, Tillotts, Ventus, Ventyx; Silvio Danese: AbbVie, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Inotrem, Johnson & Johnson, MSD, Pfizer, Roche, Sandoz, Takeda, Vifor; Remo Panaccione: Abbott, AbbVie, Abbivax, Alimentiv, Alentics Therapeutics, Amgen, AnaptysBio, AstraZeneca, Biogen, Boehringer, BMS, Caldera, Candid Therapeutics, Celltrion,, Eisai, Elan, Eli Lilly, Enthera, Ferring, Galapagos, Inviva,Fresenius, Glaxo-Smith Kline, JAMP Bio, Merck, Mirador, Novartis, Organon, Oruka Therapeutics, Prometheus, Roche, Sandoz, Sanofi, Satisfai Health, Shire, Soriso;Iris Dotan:Abbvie, AstraZeneca, Athos, Agomab, BMS, Lilly, Falk, Ferring, Gilead, Institut des MICI, Roche, Janssen, Mirador, MSD, Nestle, Pfizer, Prometheus, Sandoz, Sangamo, Spyre Therapeutics, Takeda, Harp Dx: Takayuki Yamamoto: AbbVie GK; EA Pharma, Gilead Sciences K.K.; Celltrion Takeda, Mitsubishi, BMS, J&J; Stefan Schreiber:AbbVie, Amgen, Arena, Biogen, BMS, Celltrion, Falk, Ferring, Fresenius, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, and Ventyx. SS is a co-inventor of IP owned by CONARIS; Marla Dubinsky: Abivax, Abbvie, AstraZeneca, Boehringer, BMS, Celltrion, Lilly, J&J, Merck & Co., Novartis, Pfizer, Prometheus, Sanofi, Spyre, Takeda; David T. Rubin:Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Lilly, Roche, Gilead, Iterative Health, J&J, Merck, Mirador, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda, Throne, Vedanta Biosciences, and Ventyx; Axel Dignass: Abivax, AbbVie, Falk, J&J, Pfizer and Takeda, Alfasigma, Amgen, J&J, Lilly, MSD, Pfizer, Pharmacosmos, Roche, Sandoz, Stada, Takeda; Celltrion, Fresenius Kabi, Ferring

Event

UEG Week Barcelona 2026

Topics

Standards & Guidelines Paediatrics Mechanisms & Personalised Medicine Immunology IBD Endoscopy

Submission format

Late-Breaking Abstract

Session

Late-Breaking: IBD Trials

Citation

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

Published

2026

More Like This:

Nutritional aspects: How to provide baseline therapy

Julia Mader

CONTEMPORARY TEMPORAL TRENDS IN COLECTOMY AND RESTORATIVE SURGERY FOR ULCERATIVE COLITIS: AN ANALYSIS OF THE UK IBD BIORESOURCE

Ailsa L Hart

The inflamed pouch: Pouchitis or something else?

Ailsa L Hart

STRIDE-III: UPDATED EVIDENCE-BASED TREATMENT TARGETS FOR INFLAMMATORY BOWEL DISEASE FROM THE INTERNATIONAL ORGANIZATION FOR THE STUDY OF IBD

Dan Turner

EFFICACY AND SAFETY OF GUSELKUMAB IN PERIANAL FISTULIZING CROHN’S DISEASE: WEEK 48 RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED FUZION TRIAL

Laurent Peyrin-Biroulet

The role of lifestyle changes and diet

Eirini Dimidi

UEG Presentation

New

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

EFFICACY AND SAFETY OF GUSELKUMAB IN PERIANAL FISTULIZING CROHN’S DISEASE: WEEK 48 RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED FUZION TRIAL

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EFFICACY AND SAFETY OF GUSELKUMAB IN PERIANAL FISTULIZING CROHN’S DISEASE: WEEK 48 RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED FUZION TRIAL

Ailsa L Hart 1, Axel Dignass 2, Vipul Jairath 3, Tadakazu Hisamatsu 4, Bruce E. Sands 5, Antonino Spinelli 6,7, Susan Connor 8, André D'Hoore 9, Walter Reinisch 10, Silvio Danese 11, David Schwartzhttps://www.marriott.com/reservation/rateListMenu.mi# 12, Julian Panés 13, Bram Verstockt 14, Anton Stift 15, Maciek Nazar 16, Jacqueline van Denderen 17, Takehiko Sakamoto 18, Koji Masuda 18, Stephen Xu 19, Ivana Bravatà 20, Geert R. D'Haens 21, Laurent Peyrin-Biroulet 22

Affiliations

1 St Mark’s, the National Bowel Hospital, London North-West University Healthcare NHS Trust, London, United Kingdom

2 Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany

3 Department of Medicine, Schulich School of Medicine & Dentistry I, Western University, London, ON, Canada

4 Kyorin University School of Medicine, Tokyo, Japan

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

6 Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

7 IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy

8 Department of Gastroenterology, Liverpool Hospital, Liverpool, New South Wales and South West Sydney Clinical Campuses, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia

9 Department of Abdominal Surgery, University Hospitals Leuven, KU Leuven, Leuven, Belgium

10 Clinical Department for Gastroenterology and Hepatology, Internal Medicine Clinic III, Medical University of Vienna, Vienna, Austria

11 IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy

12 Inflammatory Bowel Disease Center, Vanderbilt University Medical Center, Nashville, United States

13 Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

14 Department of Gastroenterology and Hepatology, University Hospitals Leuven and Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium

15 Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, Vienna, Austria

16 Johnson & Johnson, Warsaw, Poland

17 Johnson & Johnson, Breda, Netherlands

18 Johnson & Johnson, Tokyo, Japan

19 Johnson & Johnson, Spring House, United States

20 Johnson & Johnson, Milan, Italy

21 Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, Netherlands

22 Northwestern Medicine Digestive Health Institute, Chicago, United States

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Abstract

Introduction

Perianal fistulizing Crohn’s disease (PFCD) is a difficult-to-treat complication of Crohn’s disease (CD) that impairs patients’ quality of life. Effective long-term treatment options for PFCD remain limited. In the Phase 3, randomized, placebo-controlled, double-blind, multicenter FUZION study (NCT05347095), guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor approved for moderately-to-severely active CD, met the primary endpoint, with both dose regimens achieving significantly higher combined clinical and radiological fistula remission rates vs placebo (PBO) at Week (W) 24, with no new safety signals.¹ Here, we report efficacy and safety outcomes through W48.

Aims & Methods

Eligible adults had ≥1 active draining perianal fistula confirmed by blinded central magnetic resonance imaging (MRI), CD Activity Index [CDAI] <350, and prior inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, antibiotics, or ≤2 advanced-therapy classes. Participants (pts) were randomized (2:2:1) to GUS 200mg intravenous induction at W0/4/8 followed by GUS 100mg subcutaneous (SC) every 8W (Q8W) or GUS 200mg SC Q4W for maintenance, or PBO. Randomization was stratified by baseline (BL) bionaïve status and proctitis confirmed by MRI status.
At W24, clinically assessed fistula responders continued their assigned dose regimen through W48. Non-responders (NRs) underwent a blinded dose adjustment: NRs initially assigned to PBO (N=40) received GUS 400mg SC Q4W at W24/28/32 and GUS 200mg SC Q4W from W36-W48; NRs initially assigned to GUS 100mg SC Q8W (N=55) received GUS 200mg SC Q4W; and NRs assigned to GUS 200mg SC Q4W (N=67) received sham escalation dose adjustment through W48. Combined fistula remission, clinically assessed fistula remission, and clinically assessed fistula response were evaluated at W24 and W48 (See Table 1 footnote for endpoint definitions). Adverse events (AEs) through W48 were reported.

Results

Among 286 randomized pts, 113 received GUS 100mg SC Q8W, 115 received GUS 200mg SC Q4W, and 58 received PBO. Overall, 57% of pts received blinded dose adjustment at W24; 90% of pts completed treatment through W48.
At W48, efficacy was maintained or improved across all endpoints (Table 1). Combined fistula remission rates were consistent from W24 (28%) to W48 (31%) in the combined GUS group (GUS 100mg SC Q8W, W24: 28%; W48: 35%; GUS 200mg SC Q4W, W24: 27%; W48: 26%). Similar findings were observed for clinically assessed fistula remission rates. Clinically assessed fistula response rates increased from W24 (34%) to W48 (41%) in the combined GUS group (GUS 100mg SC Q8W, W24: 33%; W48: 47%; GUS 200mg SC Q4W, W24; W48: 36%).
Through W48, AEs occurred in 71%, 77%, and 83% of pts in the GUS 100mg SC Q8W, GUS 200mg SC Q4W, and PBO arms, respectively; serious AEs occurred in 16%, 8%, and 14%. Infections occurred in 46%, 36%, and 48% of pts, respectively, with rates of serious infections of 12%, 2%, and 3%. Two pts with 3 unrelated malignancies were reported in the GUS 200mg SC Q4W arm.

Table 1. Fistula endpoints at W24 and W48

	W24^a				W48^b,c
	GUS 100mg SC Q8W	GUS 200mg SC Q4W	Combined GUS	PBO		GUS 100mg SC Q8W^d	GUS 200mg SC Q4W	Combined GUS
Combined fistula remission, n/N (%) P value	32/113 (28) 0.007	31/115 (27) 0.013	63/228 (28) -	6/58 (10)		40/113 (35) -	30/115 (26) -	70/228 (31) -
Clinically assessed fistula remission, n/N (%) P value	32/113 (28) 0.007	31/115 (27) 0.013	63/228 (28)	6/58 (10)		41/113 (36) -	30/115 (26) -	71/228 (31) -
Clinically assessed fistula response, n/N (%) P value	37/113 (33) 0.008	41/115 (36) 0.003	78/228 (34) -	8/58 (14)		53/113 (47) -	41/115 (36) -	94/228 (41) -
P values are multiplicity controlled and based on CMH test. Combined fistula remission defined as: 100% closure of all external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression and absence of collections >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results. Clinically assessed fistula remission defined as: 100% closure of all external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression. Clinically assessed fistula response defined as: a ≥50% reduction from BL in number of open or draining perianal fistulas. NRs defined as <50% reduction from BL in the number of open or draining fistulas. ^aMissing data imputation: After applying the ICE strategy, missing data were imputed as not having achieved binary endpoints. ^bPts in the GUS groups who met the criteria for dose adjustment at W24 are included in this analysis in their randomized treatment group. Nonresponder imputation for dose adjustment was not applied at W48 for these pts. However, other ICE and missing data rules were applied. ^cBeyond W24, PBO data were truncated as NR PBO pts received induction and maintenance GUS from W24 through W48. ^dAt W48, GUS 100mg SC Q8W group includes pts on 100mg SC Q8W (R), and those (NRs) with dose adjusted to 200mg SC Q4W at W24. BL: baseline. CMH: Cochran-Mantel-Haenszel. GUS: guselkumab. ICE: intercurrent event. MRI: magnetic resonance imaging. NRs: non-responders. PBO: placebo. Pts: participants. Q4W: every 4 weeks. Q8W: every 8 weeks. R: responders. SC: subcutaneous. W: week.

Conclusion

GUS was superior to PBO at W24, and demonstrated sustained efficacy through W48, supporting its continued use for durable fistula remission. GUS was well tolerated through W48, with no new safety signals identified.

References

1. Peyrin-Biroulet. DDW. 2026

Disclosure

Aisla Hart: Lecturer and/or advisory board member for AbbVie, BMS, Celltrion, DrFalk, Galapagos, GSK, Johnson & Johnson, MSD, Pfizer, and Takeda.

Event

UEG Week Barcelona 2026

Topics

Standards & Guidelines Paediatrics Mechanisms & Personalised Medicine Immunology IBD Endoscopy

Submission format

Late-Breaking Abstract

Session

Late-Breaking: IBD Trials

Citation

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

Published

2026

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The role of lifestyle changes and diet

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Affiliations

1 King's College London, London, United Kingdom

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Neurogastroenterology & Motility Surgery Primary Care Small Intestine & Nutrition

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