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Combining therapies in ulcerative colitis

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Combining therapies in ulcerative colitis

Joana Torres 1

Affiliations

1 Division of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal

Summary

AI Generated

Advanced combination therapy (ACT) in ulcerative colitis—combining two biologics or a biologic with a small molecule—shows promise for refractory disease and extra-intestinal manifestations, with no major safety signals in early studies, though the approach remains off-label and largely empirical.

The speaker reported that current monotherapies achieve clinical remission at one year in under 50% of advanced-therapy-naive patients and even lower rates in bio-exposed patients, according to data from Mount Sinai.
The Vega trial randomised patients to golimumab monotherapy, guselkumab monotherapy, or combination; the speaker stated that combination was numerically better than guselkumab and significantly better than golimumab for the primary endpoint of clinical response at week 12, and outperformed monotherapy for stricter endpoints like endoscopic improvement.
Real-world evidence from retrospective studies shows roughly 60% clinical remission and 30% endoscopic remission with ACT, with infections reported but serious infections not occurring at higher rates than with monotherapy, the speaker stated.
The speaker noted that ACT has been used mostly for refractory disease or concomitant extra-intestinal manifestations, with ustekinumab, IL-23 inhibitors, or vedolizumab as common backbones, and that recycling previously failed agents is attempted with reasonable success.
The speaker suggested that ACT could be considered for patients with partial responses to achieve deeper remission, for high-risk patients via co-induction strategies, and potentially earlier to prevent therapeutic resistance, though this should be done in centres with adequate monitoring and safety resources.
The speaker stated that ACT remains off-label and largely empirical, as validated biomarkers to guide combination therapy do not exist, and emphasised the need for appropriately powered randomised controlled trials and large observational studies to assess long-term safety including malignancy risk.

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Paediatrics Surgery

Session

What's new in ulcerative colitis 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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UEG Presentation

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... for medical therapy in inflammatory bowel diseases

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... for medical therapy in inflammatory bowel diseases

Chris Lamb 1

Affiliations

1 Newcastle Hospitals NHS Foundation Trust, Newcastle, United Kingdom

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Colorectal IBD Surgery

Session

Predicting patient outcomes...

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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LINERIXIBAT SIGNIFICANTLY IMPROVES CHOLESTATIC PRURITUS IN PRIMARY BILIARY CHOLANGITIS: RESULTS OF THE PIVOTAL PHASE 3 GLISTEN TRIAL

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LINERIXIBAT SIGNIFICANTLY IMPROVES CHOLESTATIC PRURITUS IN PRIMARY BILIARY CHOLANGITIS: RESULTS OF THE PIVOTAL PHASE 3 GLISTEN TRIAL

Gideon M. Hirschfield 1, Christopher L. Bowlus 2, David Jones 3, Andreas E. Kremer 4, Marlyn J. Mayo 5, Atsushi Tanaka 6, Pietro Andreone 7, Jidong Jia 8, Qinglong Jin 9, Ricardo Macias-Rodriguez 10, Alexander R. Cobitz 11, Brooke M. Currie 11, Ciara Gorey 12, Ivana Lazic 12, Danielle J. Podmore 12, Andrea Ribiero 13, Jennifer B. Shannon 14, Brandon Swift 14, Megan M. McLaughlin 11, Cynthia Levy 15

Affiliations

1 Toronto General Hospital, Toronto, Canada

2 University of California Davis School of Medicine, Sacramento, United States

3 Newcastle University, Newcastle Upon Tyne, United Kingdom

4 University Hospital Zurich, Zurich, Switzerland

5 University of Texas Southwestern Medical School, Dallas, United States

6 Teikyo University School of Medicine, Tokyo, Japan

7 Azienda Ospedaliero-Universitaria di Modena and Università di Modena e Reggio Emilia, Modena, Italy

8 Capital Medical University, Beijing, China

9 The First Hospital of Jilin University, Changchun, China

10 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico

11 GSK, Collegeville, United States

12 GSK, London, United Kingdom

13 GSK, Madrid, Spain

14 GSK, Durham, United States

15 University of Miami, Miami, United States

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Abstract

Introduction

Cholestatic pruritus is common, debilitating and undertreated in patients with primary biliary cholangitis (PBC). Here, we describe the results of GLISTEN (NCT04950127), a Phase 3 study investigating the efficacy and safety of the ileal bile acid transporter inhibitor linerixibat for pruritus in PBC.

Aims & Methods

In this double-blind, randomised, placebo-controlled study, patients with PBC and moderate-to-severe pruritus received oral linerixibat 40 mg or placebo twice daily. Pruritus severity and pruritus-related sleep interference were assessed using a 0–10 numerical rating scale. The primary endpoint was change from baseline in worst itch over 24 weeks. Secondary endpoints included: at Week 2, change in worst itch; over 24 weeks, change in sleep interference; at Week 24, proportion of responders (≥ 2-, ≥ 3-, ≥ 4-point reduction in worst itch) and analysis of responses to 2 patient global impression items (itch severity and change). Safety endpoints included adverse event (AE) reporting.

Results

238 patients were randomised; 95% were female, itch severity was mean (standard deviation [SD]) 7.34 (1.54), 52% had alkaline phosphatase < 1.67 times upper limit of normal, and 47% were receiving stable therapy for pruritus. Pruritus improvement over 24 weeks was significantly greater with linerixibat than placebo: least-squares (LS) mean change -2.86 versus -2.15, adjusted mean difference -0.72; p = 0.001. At Week 24, the observed mean (SD) difference from baseline in pruritus was -3.66 (2.50) with linerixibat and -2.82 (2.32) with placebo. The effect of linerixibat was rapid and superior to placebo at Week 2: LS mean change -1.78 versus -1.07, adjusted mean difference -0.71; p < 0.001. Linerixibat also significantly improved pruritus-related sleep interference over 24 weeks versus placebo: LS mean change ‑2.77 versus -2.24, adjusted mean difference -0.53; p = 0.024. At Week 24, more patients on linerixibat than placebo achieved a ≥ 2-point (68% vs 64%), ≥ 3-point (56% vs 43%) or ≥ 4-point (41% vs 29%) reduction in pruritus and a higher proportion of linerixibat than placebo-treated patients reported their pruritus was very much improved (55% vs 37%) or absent (21% vs 9%). AEs reported more frequently with linerixibat than placebo were predominantly gastrointestinal (GI), including diarrhoea (61% vs 18% of patients) and abdominal pain (18% vs 3% of patients); 4% of patients in the linerixibat group discontinued treatment due to diarrhoea.

Conclusion

In patients with PBC and moderate-to-severe pruritus, linerixibat rapidly and significantly improved pruritus and pruritus-related sleep interference versus placebo. While GI AEs were more common with linerixibat than placebo, they rarely led to treatment discontinuation.

Disclosure

Funded by GSK. Various authors declare conflicts of interest as consultants, employee, recipients of grants and stockholders. These will be reported in full during the presentation.

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Immunology Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Advances in management of immune-mediated biliary disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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UEG Presentation

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Nutritional management of small intestinal enteropathies

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Nutritional management of small intestinal enteropathies

Francisca Joly 1

Affiliations

1 Beaujon Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Immunology Small Intestine & Nutrition

Session

Coeliac or non-coeliac enteropathy?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Cynthia Levy

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UEG Presentation

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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

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UEG Presentation

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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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Long-term outcome post-LTx in adults

Patrizia Burra 1

Affiliations

1 University of Padua-Multivisceral Transplant Unit- Gastroenterology, Padova, Italy

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Abstract

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Surgery

Session

New developments in liver transplantation

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Francisca Joly

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Andrea Severino

UEG Presentation

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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FMT: Established and emerging indications

Andrea Severino 1

Affiliations

1 Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Rome, Italy

Summary

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Abstract

Event

UEG Week Berlin 2025

Topics

Gut Microbiota

Session

FMT: What’s new?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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