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PSC: From principals to clinic

Samuel Huber 1

1 University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany

Event

UEG Week Berlin 2025

Topics

Endoscopy Hepatobiliary IBD Paediatrics

Session

Cross-cutting: Primary sclerosing cholangitis and IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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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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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.

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

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

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

UEG Presentation

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Radiological approach in unresectable disease

Christoph Zech 1

1 University Hospital Basel, Basel, Switzerland

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Hepatobiliary Mechanisms & Personalised Medicine Radiology & Imaging

Session

Advancement in management of primary liver tumors

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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ACLF: When to be concerned?

Christiana Graf 1

1 LMU Klinikum, Munich, Germany

Event

UEG Week Berlin 2025

Topics

Colorectal Hepatobiliary Pancreas

Session

Predicting disease severity

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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THERAPEUTIC AND HOSPITALISATION OUTCOMES AFTER FIRST-LINE ANTI-TNF IN INFLAMMATORY BOWEL DISEASE: INSIGHTS FROM THE EPITHERA STUDY USING DATA FROM THE FRENCH NATIONAL HEALTH DATA (SNDS)

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Introduction

Following anti-TNF therapy, treatment options include switching between different anti-TNF agents or swapping to therapies with distinct mechanisms of action. It is essential to evaluate these treatment pathways in real-world settings to improve inflammatory bowel diseases (IBD) management.

Aims & Methods

This retrospective study analyzed data from the French National Health Data System and included all adult patients meeting at least one of the following criteria between 2014 and 2023: i) long-term disease related to IBD ii) at least 2 hospitalizations for IBD iii) one hospitalization for IBD coupled with 3 or more IBD treatment deliveries. The study assessed treatment discontinuation (short-term: 1 year; long-term: 5 years), and hospitalizations for IBD, IBD-related surgeries and serious infections among patients initiating a second line treatment (2L) between 2014 and 2022 following a first anti-TNF therapy. All outcomes were evaluated one year post switching between anti-TNF agents (reference) versus swapping to vedolizumab (VDZ) or ustekinumab (UST) using a propensity score (PS)-matched Cox proportional hazards model. Covariates used to estimate PS were age, gender, and medical history (see full list in Table 1). Covariate balance was assessed through standardized mean difference (SMD).

Results

The cohort consisted of 151,999 CD patients and 152,367 UC patients, with 14.5% of CD patients and 9.3% of UC patients undergoing 2L treatment. After PS matching, the profiles of IBD patients who switched to a 2^nd anti-TNF were comparable to those who swapped to UST or VDZ (SMD<0.1 for all covariates). Main outcomes are summarized in Table 1.
CD patients who swapped to VDZ had higher risks of treatment discontinuation compared to those who switched to a 2^nd anti-TNF (short-term: adjusted hazard ratio (aHR)=1.23 95%CI [1.11-1.36]; long-term: aHR=1.14 95%CI [1.06-1.23]). Conversely, patients who swapped to UST showed lower risks of treatment discontinuation (short-term: aHR=0.76 95%CI [0.70-0.81]; long-term: aHR=0.72 95%CI [0.68-0.76]), and experienced fewer hospitalizations due to IBD (aHR=0.77 95%CI [0.71-0.83]) and serious infections (aHR=0.74 95%CI [0.59-0.93]).
UC patients who swapped to VDZ had lower risks of treatment discontinuation (short-term: aHR=0.81 95%CI [0.75-0.87]; long-term: aHR=0.83 95%CI [0.78-0.87]), but a higher risk of IBD-related hospitalizations (aHR=1.11 95%CI [1.02-1.20]) compared to those who switched to another anti-TNF. In contrast, UC patients who swapped to UST showed decreased risks of treatment discontinuation (short term: aHR=0.58 95%CI [0.49-0.69]; long-term: aHR=0.62 95%CI [0.54-0.71]). For all other outcomes, the results were statistically non-significant and are presented in Table 1.

	CD patients		UC patients
	Switch vs. Swap to vedolizumab N=1,987	Switch vs. Swap to ustekinumab N=5,317	Switch vs. Swap to vedolizumab N=4,324	Switch vs. Swap to ustekinumab N=815
	aHR [95%CI]	aHR [95%CI]	aHR [95%CI]	aHR [95%CI]
Short-term IBD treatment discontinuation (1 year after switching/swapping)	1.23 [1.11-1.36] *	0.76 [0.70-0.81] *	0.81 [0.75-0.87] *	0.58 [0.49-0.69] *
Long-term IBD treatment discontinuation (5 years after switching/swapping)	1.14 [1.06-1.23] *	0.72 [0.68-0.76] *	0.83 [0.78-0.87] *	0.62 [0.54-0.71] *
IBD-related hospitalizations	1.06 [0.94-1.19]	0.77 [0.71-0.83] *	1.11 [1.02-1.20] *	0.84 [0.68-1.03]
IBD-related surgeries	0.94 [0.66-1.32]	1.14 [0.93-1.39]	1.29 [0.89-1.87]	1.08 [0.42-2.79]
Hospitalizations for serious infection	1.20 [0.87-1.67]	0.74 [0.59-0.93] *	0.96 [0.74-1.23]	0.58 [0.30-1.14]
*p-value <0.05; aHR: adjusted hazard ratios; CD: Crohn’s disease; CI: confidence interval; UC: ulcerative colitis Covariates used to estimate propensity score: age, gender, previous infections, clostridium difficile infections, cardiovascular diseases, end stage kidney disease/kidney transplant, chronic liver diseases, chronic pulmonary diseases, venous thromboembolism, diabetes mellitus, nature of 1L anti-TNF, time to first line of anti-TNF from diagnosis date, disease duration, hospitalisation at induction of new treatment. Additional covariate for CD patients only: history of major IBD-related surgery (colectomy or intestinal resection).

Conclusion

In this large cohort of patients, swapping to UST led to better treatment persistence in both CD and UC while reducing the risks of hospitalizations and serious infections in CD compared to switching between anti-TNF agents. Swapping to VDZ offered better treatment persistence than switching to another anti-TNF agent in UC.

Disclosure

LV received fees from abbvie, amgen, MSD, Ferring, Takeda, Pfizer, Janssen, Lilly, Galapagos, Celltrion, Viatris
LPB received fees from Abbvie, Abivax, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS,
Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK,
Hac Pharma, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD
Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus,
Protagonist, Roche, Roivant, Samsung, Sandoz, Sanofi, Takeda, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vifor, Vectivbio,
Ventyx, Ysopia.
JK received fees from Janssen, Takeda, Lilly, Abbvie, Pfizer, Tillots, Amgen, Celltrion, Roche, Gilead, Galapagos.
SC, VC, HO, LG, KS, LC works for Johnson&Johnson Innovative Medicine.
PR, GB, AH, TN works for IQVIA Operations France.