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GUSELKUMAB VERSUS RISANKIZUMAB AS MAINTENANCE TREATMENT FOR MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: NETWORK META-ANALYSES OF CLINICAL REMISSION AND ENDOSCOPIC OUTCOMES

Elise Wu 1, Dominik Naessens 2, Mario Alberto Gomez Camacho 3, Ashley Bonner 4, Maxwell Jones 4

Affiliations

1 Johnson & Johnson, Horsham, PA, United States

2 Janssen Pharmaceutica, Beerse, Belgium

3 Johnson & Johnson, Spring House, PA, United States

4 EVERSANA Value & Evidence Services, Burlington, ON, Canada

Summary

AI Generated

A network meta-analysis comparing guselkumab and risankizumab for maintenance therapy in moderate to severely active ulcerative colitis found that guselkumab 200 mg every 4 weeks was significantly more efficacious than risankizumab 360 mg every 8 weeks on clinical remission and endoscopic improvement.

Guselkumab 200 mg every 4 weeks showed statistically significant superiority over risankizumab 360 mg every 8 weeks for clinical remission (odds ratio 2.38; 95% CI 1.25, 4.52) and endoscopic improvement (odds ratio 2.26; 95% CI 1.21, 4.22).
Guselkumab 200 mg every 4 weeks demonstrated numerical but not statistically significant benefits over risankizumab 360 mg every 8 weeks for endoscopic remission (odds ratio 1.53; 95% CI 0.74, 3.16) and histologic endoscopic mucosal improvement (odds ratio 1.89; 95% CI 0.98, 3.63).
The network meta-analysis used data from the QUASAR trial of guselkumab and the COMMAND trial of risankizumab, with maintenance endpoints assessed at 44 weeks and 52 weeks, respectively.
Both guselkumab and risankizumab are monoclonal antibodies targeting interleukin 23 approved for moderate to severely active ulcerative colitis in the United States, but have not been directly compared in a controlled setting.
This analysis may be relevant to clinicians making treatment decisions between these two IL-23 inhibitors for ulcerative colitis maintenance therapy.

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Abstract

Introduction

Guselkumab and risankizumab are monoclonal antibody treatments targeting interleukin 23 that are approved for the treatment of moderate to severely active ulcerative colitis (UC) in the United States. However, these agents have not been directly compared in a controlled setting.

Aims & Methods

A network meta-analysis (NMA) was conducted to compare guselkumab and risankizumab as maintenance therapy for UC, based on key outcomes from pivotal Phase 3 randomised controlled trials (RCTs). The COMMAND trial of risankizumab and the QUASAR trial of guselkumab were identified through systematic literature review. Frequentist, fixed-effect NMAs were conducted for key efficacy endpoints at the end of maintenance (52 weeks in COMMAND and 44 weeks in QUASAR) as reported by the trials: clinical remission, endoscopic improvement, endoscopic remission, and histologic endoscopic mucosal improvement (HEMI). Analyses included populations of variable advanced therapy (ADT) failure status (i.e., mixed). Data from these re-randomized RCTs were used directly, rather than normalising to mimic treat-through designs, given these trials are for same-class therapies and were similarly designed.

Results

NMAs found that guselkumab 200 mg every 4 weeks (Q4W) was significantly more efficacious than risankizumab 360 mg every 8 weeks (Q8W) on clinical remission (odds ratio [OR] 2.38; 95% confidence interval [CI] 1.25, 4.52) and endoscopic improvement (OR 2.26; 95% CI 1.21, 4.22). Guselkumab 200 mg Q4W had numerical benefits on endoscopic remission (OR 1.53; 95% CI 0.74, 3.16) and HEMI (OR 1.89; 95% CI 0.98, 3.63) compared with risankizumab 360 mg Q8W. Numerically higher benefits of guselkumab compared with risankizumab were also observed at lower doses (ie, guselkumab 100 mg Q8W and risankizumab 180 mg Q8W).

Conclusion

Results of this NMA suggest that guselkumab 200 mg Q4W is superior to risankizumab 360 mg Q8W for maintenance treatment of moderate to severely active UC on multiple efficacy endpoints including endoscopic improvement.

Table. Results summary for NMAs comparing guselkumab and risankizumab on clinical and endoscopic outcomes in UC.*

	Clinical remission		Endoscopic improvement		Endoscopic remission		HEMI
	GUS 100 mg Q8W	GUS 200 mg Q4W	GUS 100 mg Q8W	GUS 200 mg Q4W	GUS 100 mg Q8W	GUS 200 mg Q4W	GUS 100 mg Q8W	GUS 200 mg Q4W
RIS 180 mg Q8W	1.76 (0.92, 3.35)	2.13 (1.12, 4.06)^†	1.88 (1.00, 3.53)	2.04 (1.09, 3.83)^†	1.71 (0.82, 3.55)	1.64 (0.79, 3.41)	1.55 (0.81, 3.00)	1.85 (0.96, 3.56)
RIS 360 mg Q8W	1.96 (1.03, 3.74)^†	2.38 (1.25, 4.52)^†	2.07 (1.11, 3.88)^†	2.26 (1.21, 4.22)^†	1.59 (0.77, 3.29)	1.53 (0.74, 3.16)	1.59 (0.83, 3.06)	1.89 (0.98, 3.63)
PBO	3.53 (2.22, 5.61)^†	4.28 (2.70, 6.78)^†	4.19 (2.64, 6.65)^†	4.56 (2.87, 7.23)^†	2.93 (1.79, 4.82)^†	2.82 (1.72, 4.63)^†	3.82 (2.37, 6.15)^†	4.54 (2.82, 7.30)^†
GUS = guselkumab, HEMI = histologic endoscopic mucosal improvement, NMAs = network meta-analyses, PBO = placebo, Q4W = every four weeks, Q8W = every 8 weeks, RIS = risankizumab, UC = ulcerative colitis. *Data are presented as odds ratio (95% confidence interval). ^†Significantly favours GUS (ie, confidence interval does not include 1). Note: clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy. Endoscopic remission is defined as an endoscopic subscore of 0, and HEMI is defined as a combination of histologic and endoscopic improvement

Disclosure

Elise Wu, Dominik Naessens, and Mario Gomez are employees of and may hold stock/stock options in Johnson & Johnson. Ashley Bonner and Maxwell Jones are employees of EVERSANA.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Treatment outcomes in IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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The treatment

Judith Wellens 1

Affiliations

1 University Hospitals Leuven, Leuven, Belgium

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Primary Care

Session

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

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Jonas Halfvarson

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UEG Presentation

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

Innovations in IBD Therapy: The Story of TL1A - from Discovery to Potential Future Care (F. Hoffmann-La Roche Ltd) (Complete Session)

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Innovations in IBD Therapy: The Story of TL1A - from Discovery to Potential Future Care (F. Hoffmann-La Roche Ltd) (Complete Session)

Jean-Frédéric Colombel 1, Beatriz Gros 2, Remo Panaccione 3

Affiliations

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

2 Hospital Universitario Reina Sofia, Cordoba, Spain

3 University of Calgary, Calgary, Canada

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Abstract

Publisher

F. Hoffmann La Roche

Event

UEG Week Berlin 2025

Session

Innovations in IBD Therapy: The Story of TL1A - from Discovery to Potential Future Care (F. Hoffmann-La Roche Ltd)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Judith Wellens

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Remo Panaccione

Introduction: The Crohn´s disease journey

Ailsa L Hart

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Jonathan Landy

How to handle the frail

Jonas Halfvarson

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Nurulamin Noor

UEG Presentation

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

Introduction: The Crohn´s disease journey

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Introduction: The Crohn´s disease journey

Ailsa L Hart 1

Affiliations

1 St Mark’s Hospital and Academic Institute, Harrow, United Kingdom

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Abstract

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

IBD Surgery

Session

The Crohn´s disease journey

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Judith Wellens

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Jonas Halfvarson

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Nurulamin Noor

UEG Presentation

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

SPATIALLY DIFFERENTIATED MEASUREMENT OF INFLAMMATORY CELLS WITH DEEP LEARNING REVEALS THE HETEROGENEITY OF CHANGES IN ULCERATIVE COLITIS

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SPATIALLY DIFFERENTIATED MEASUREMENT OF INFLAMMATORY CELLS WITH DEEP LEARNING REVEALS THE HETEROGENEITY OF CHANGES IN ULCERATIVE COLITIS

Dylan Windell 1, Alastair Magness 1, Rongqi Li 1, Paul Aljabar 1, Eve Fryer 2, Robert D. Goldin 3, Phil Wakefield 1, Caitlin Langford 4, Jonathan Landy 5

Affiliations

1 Perspectum Ltd., Oxford, United Kingdom

2 John Radcliffe Hospital, Oxford, United Kingdom

3 Centre for Pathology, London, United Kingdom

4 Perspectum, Cambridge, United States

5 London North West University Healthcare NHS Trust, London, United Kingdom

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Abstract

Introduction

Histological assessment in Inflammatory Bowel Disease (IBD) is often required with endoscopic diagnoses to establish disease activity. This is evident in patients where histological healing is a major therapeutic goal and when endoscopic healing can also exhibit microscopic disease. IBD can manifest in numerous landmark features which are structural and inflammatory related. Histological activity is determined through erosion/ulceration, architectural changes in tissue morphology, mucin depletion and presence of varied inflammatory cells the colonic crypts, Muscularis Mucosae (MM) and Lamina Propria (LP). Histological scoring systems vary in complexity and methodology and subject to discrepancies in inter-rater consensus. Our model aims to provide accurate measurements of key histological features in Ulcerative Colitis (UC) used in scoring systems as both a decision support tool for improving pathologist scoring alignment and sensitive quantitative metrics of inflammatory cells to evaluate disease activity.

Aims & Methods

We developed an ensemble of convolutional neural networks to identify cell types, tissue foreground, crypts, MM, and haemorrhage in H&E images of IBD biopsy data. Models were trained with expert-labelled annotations comprising 34,289 image-annotation pairs (80% training, 20% validation) from in-house and publicly available data. Model accuracy was assessed with 6,464 held-out image-annotation pairs from 26 Whole Slide Images (WSIs) from all sites of the large intestine commonly sampled during endoscopic investigation, while ground truth annotations were reviewed by GI-trained pathologists to certify accuracy. We used geospatial methods to derive boundaries of the LP from other predicted domains, associate cells to delineated regions, measure architectural changes and derive spatially differentiated metrics of inflammatory burden in 66 patients with confirmed UC.

Results

The AI model spatially differentiates and segments cell types and tissue compartments. This produces metrics for inflammatory cell counts in regions of interest such as crypts, LP, and MM. Goblet cell segmentation within crypts allows for measurement of mucin depletion. This can be visualized for pathologists where each inflammatory cell type across the WSI is represented as density metrics. Automated quantification of inflammatory cells across AI-identified tissue domains throughout the bowels of UC patients revealed large intra- and inter-patient variability.

Conclusion

Our AI model can measure histological healing by detecting architectural change, inflammatory cell number, goblet cell reduction and erosions and ulceration. This allows for metrics and visual overlays to assist with pathologist reading and quantifying changes in mucosal biopsies in a clinical trial setting which requires extremely sensitive tools only AI can provide.

Disclosure

DW/AM/RL/PA/PW and CL are employees at Perspectum Ltd. EF and RG are consultants for Perspectum Ltd. All other co-authors have no conflicts of interest to declare relevant to this work.

Event

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Artificial intelligence in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Judith Wellens

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Remo Panaccione

Introduction: The Crohn´s disease journey

Ailsa L Hart

SPATIALLY DIFFERENTIATED MEASUREMENT OF INFLAMMATORY CELLS WITH DEEP LEARNING REVEALS THE HETEROGENEITY OF CHANGES IN ULCERATIVE COLITIS

Jonathan Landy

How to handle the frail

Jonas Halfvarson

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Nurulamin Noor

UEG Presentation

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.

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How to handle the frail

Jonas Halfvarson 1

Affiliations

1 Örebro University, Örebro, Sweden

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Nurses Paediatrics Primary Care

Session

IBD across all ages

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

The treatment

Judith Wellens

Innovations in IBD Therapy: The Story of TL1A - from Discovery to Potential Future Care (F. Hoffmann-La Roche Ltd) (Complete Session)

Remo Panaccione

Introduction: The Crohn´s disease journey

Ailsa L Hart

SPATIALLY DIFFERENTIATED MEASUREMENT OF INFLAMMATORY CELLS WITH DEEP LEARNING REVEALS THE HETEROGENEITY OF CHANGES IN ULCERATIVE COLITIS

Jonathan Landy

How to handle the frail

Jonas Halfvarson

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Nurulamin Noor

UEG Presentation

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

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

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Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Joline de Groof 1, Nurulamin Noor 2

Affiliations

1 Haaglanden Medical Center, The Hague, Netherlands

2 Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

Summary

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Abstract

Event

UEG Postgraduate Teaching Programme Berlin 2025

Session

The Crohn´s disease journey

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

The treatment

Judith Wellens

Innovations in IBD Therapy: The Story of TL1A - from Discovery to Potential Future Care (F. Hoffmann-La Roche Ltd) (Complete Session)

Remo Panaccione

Introduction: The Crohn´s disease journey

Ailsa L Hart

SPATIALLY DIFFERENTIATED MEASUREMENT OF INFLAMMATORY CELLS WITH DEEP LEARNING REVEALS THE HETEROGENEITY OF CHANGES IN ULCERATIVE COLITIS

Jonathan Landy

How to handle the frail

Jonas Halfvarson

Getting out of the block early in Crohn´s disease: Gastroenterologist vs surgeon perspective

Nurulamin Noor

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