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EFFICACY AND SAFETY OF OBEFAZIMOD IN UC PATIENTS AT WEEK 48 OF AN OPEN-LABEL MAINTENANCE STUDY AMONG CLINICAL NON-RESPONDERS AT WEEK 8 OF THE PHASE 2B INDUCTION TRIAL

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Introduction

Obefazimod is an investigational, oral, once-daily, small molecule which enhances expression of microRNA-124 and is currently in phase 3 clinical trials for the treatment of patients with moderately to severely active ulcerative colitis (UC) [1]. Obefazimod demonstrated efficacy and safety in patients with UC at week-8 in a placebo-controlled, Phase 2b induction trial and in the subsequent open-label maintenance (OLM) study [2]. Here we present efficacy and safety among patients who did and those that did not achieve clinical response at week 8 of the double-blind induction trial.

Aims & Methods

Patients received placebo or obefazimod 25mg, 50mg or 100mg once daily (od) during the Phase 2b, induction trial and, irrespective of their clinical response, could enter the optional 96-week OLM study with obefazimod 50mg od. Patients were followed monthly for safety and efficacy. This analysis evaluates efficacy (at week 48) and safety (through week 96) among patients who achieved and those who did not achieve clinical response (decrease from baseline in the Modified Mayo score (MMS) ≥ 2 points and ≥30% from baseline, plus a decrease in rectal bleeding sub-score (RBS) ≥ 1 or an absolute RBS ≤ 1) at week 8 of double-blind induction and continued treatment in the OLM.

Results

Among the 217 patients who participated in the OLM, 57% (124/217) achieved clinical response at week 8 of the induction trial (CR group), and 43% (93/217) did not (NCR group). Proportions of patients achieving efficacy endpoints were numerically higher within the CR group than those observed in NCR group. At week 48, 66% of CR patients and 40% of NCR patients achieved clinical remission; 86% of CR patients and 75% of NCR patients achieved clinical response; endoscopic improvement was achieved by 70% of CR patients and by 50% of NCR patients, and endoscopic remission was achieved by 38% of CR patients and 27% of NCR patients (Table 1). There was no significant difference in the safety profile between these two subpopulations.

Table 1: Efficacy at week 48 of open-label maintenance study among clinical responders and non responders at week 8 of induction trial

Efficacy Endpoint, % (n)	Patients with clinical response at week 8 (N=124)	Patients with no clinical response at week 8 (N=93)
Clinical remission	66.1 (82)	39.8 (37)
Clinical response	86.3 (107)	75.3 (70)
Endoscopic improvement	70.2 (87)	49.5 (46)
Endoscopic remission	37.9 (47)	26.9 (25)

Non-responder imputation (NRI) was used for missing efficacy data; clinical remission: stool frequency sub-score ≤1, RBS = 0 and endoscopic sub-score ≤1; clinical response: decrease from baseline in the Modified Mayo score (MMS) ≥ 2 points and ≥30% from baseline, plus a decrease in rectal bleeding sub-score (RBS) ≥ 1 or an absolute RBS ≤ 1; endoscopic improvement: endoscopic sub-score ≤1; endoscopic remission: endoscopic sub-score = 0

Conclusion

Substantial proportions of patients treated with obefazimod 50 mg od achieved clinical outcomes at week 48 of an open label maintenance study, irrespective of whether they achieved clinical response at week 8 of the prior induction trial. Patients achieving clinical response at week 8 of the induction trial consistently showed higher efficacy rates throughout the 48-week open-label maintenance trial. The safety profile remains consistent over time, regardless of treatment response at week 8.

References

Vermeire S, et al. J Crohns Colitis. 2023; 17: 1689-1697
Vermeire S, et al. The Lancet Gastroenterology & Hepatology. 2022; 7: 1024-1035.

Disclosure

Bruce E Sands has served as a consultant or received speaker’s fees from AbbVie, Abivax, Adiso Therapeutics, AgomAb, Alimentiv, Amgen, Arena Pharmaceuticals, Artizan Biosciences, Artugen Therapeutics, AstraZeneca, Bacainn Therapeutics, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celltrion, ClostraBio, Connect Biopharm, Cytoki Pharma, Eli Lilly and Company, Enthera, Evommune, Ferring, Fresenius Kabi, Galapagos, Gilead Sciences, Genentech, Glaxo SmithKline, Gossamer Bio, HMP Acquisition, Imhotex, Immunic, InDex Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Ironwood Pharmaceuticals, Janssen, Johnson & Johnson, Kaleido, Kalyope, Merck, MiroBio, Morphic Therapeutic, MRM Health, OSE Immunotherapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, RedHill Biopharma, Sun Pharma Global, Surrozen, Synlogic Operating Company, Takeda, Target RWE, Theravance Biopharma R&D, TLL Pharmaceutical, USWM Enterprises, Ventyx Biosciences, Viela Bio, and stock options from Ventyx Biosciences.
Séverine Vermeire has received grants from AbbVie, J&J, Pfizer, Takeda and Galapagos; SV has received consulting and/or speaking fees from: AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, 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.
Laurent Peyrin-Biroulet has received grants from Celltrion, Fresenius Kabi, Takeda; LPB has served as a consultant or received speaker’s 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, Gilea, Gossamer Bio, GSK, Hac Pharm, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopa, 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.
Silvio Danese has served as consultant or received speaker’s fees from AbbVie, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Takeda, Mundipharma, Pfizer Inc, Tigenix, UCB Pharma, Vifor, Biogen, Celgene, Allergan, Celltrion, Sandoz, Boehringer Ingelheim.
Parambir Dulai received speaker’s fees from Abbvie, Abivax, Adiso, Bristol Meyer Squibb, Geneoscopy, GSK, Janssen, Lilly, Pfizer, Takeda.
Herbert Tilg has served as a consultant or received speaker’s fees from Abbvie, Abivax, Dr Falk Pharma, ferring, Galapagos, Microbiotica, MSD, Pfizer, Takeda.
Britta Siegmund has served as consultant for Abbvie, Abivax, Arena, BMS, Boehringer, CED Service GmbH, Celgene, CT Scout, Endpoint Health, Falk, Forga Software, Galapagos, Janssen, Lilly, Materia Prima, Pfizer, Takeda, Pharma Insight, Predictimmune, PsiCro; Speaker fees: AbbVie, BMS, CED Service GmbH, Chiesi, Falk, Ferring, Gilead, Janssen, Lilly, Materia Prima, Takeda, Pfizer and grant support by Arena/Pfizer (served as representative of the Charité).

EFFICACY AND SAFETY OF OBEFAZIMOD IN UC PATIENTS AT WEEK 48 OF AN OPEN-LABEL MAINTENANCE STUDY AMONG CLINICAL NON-RESPONDERS AT WEEK 8 OF THE PHASE 2B INDUCTION TRIAL

Bruce E. Sands 1, Laurent Peyrin-Biroulet 2, Silvio Danese 3, Parambir Singh Dulai 4, Herbert Tilg 5, Britta Siegmund 6, Josianne Nitcheu 7, Sheldon Sloan 7, Christopher Rabbat 7, Severine Vermeire 8

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

2 University of Lorraine, Vandoeuvre-les-Nancy, France

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

4 Feinberg School of Medicine Northwestern University, Chicago, United States

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

6 Charité - Universitätsmedizin Berlin, Berlin, Germany

7 Abivax, Paris, France

8 University Hospital Leuven, Leuven, Belgium

Event

UEG Week Vienna 2024

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

IBD: New horizons in medical treatment - Part 2

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

Real-world data on the speed of onset of ustekinumab (UST) in patients with ulcerative colitis (UC) are limited. Current information regarding early response in these patients comes from the UNIFI trial.

Aims & Methods

The primary outcome of this study was to evaluate the response to UST in patients with moderate-to-severe UC by assessing PRO2 at 14 days after the first intravenous dose (6mg/kg).
Methods: A multicenter, prospective observational study was designed in patients ≥18 years old with moderate-to-severe UC (partial Mayo score ≥6) who initiated UST 6mg/kg between June 2023 and September 2024. Patients received a diary to record the stool frecuency and rectal bleeding during first 14 days after first dose of induction. The proportion of patients achieving the combined outcome of rectal bleeding score = 0 and stool frequency score ≤ 1 (PRO-2: patient-reported outcome 2 remission) was assessed. FC was measured at baseline and at day 7 and 14. Health-Related Quality of Life was evaluated using the disease-specific shortened Spanish version of the IBDQ (SIBDQ-9) at baseline and at 4 weeks. Patients with previous panproctocolectomy with ileostomy or pouch and those who had received cyclosporine within one month prior to starting UST were excluded. Descriptive statistics are presented as frequencies with percentages for categorical variables.

Results

A total of 54 patients were included across 14 hospitals in Spain. Of these, 29 (53.7%) were men, with a mean age of 54 (± SD 16.1) years. Thirty (55.6%) patients had pancolitis, 20 (37%) had left-sided colitis, and 4 (7.4%) had proctitis. Five (9.3%) patients were bio-naïve, 32 (59.3%) had previously received one biological therapy, 10 (18.5%) had received two, and 7 (13%) had received three biologics prior to starting UST. By day 14, 26% of patients had achieved clinical remission. No significant differences in clinical remission were observed based on disease extent (p = 0.11) or the number of prior biologics (p = 0.39). By day 7, 12/31 (38.7%) patients with baseline bloody stools had achieved a rectal bleeding score = 0. A reduction in FC >50% was observed in 14/48 (29%) patients by day 7 and in 20/47 (43%) patients by day 14. The SIBDQ9 average score was 54.9 (± SD 6.2) at baseline and 61.3 (± SD 7.4) at week 4.

Conclusion

One-quarter of patients with moderate-to-severe UC achieved clinical remission by day 14 following the first induction dose of UST. Nearly 40% of patients achieved a rectal bleeding score = 0 (PRO2) by day 7. A reduction in FC >50% was observed in 43% of patients by day 14.

Disclosure

Manuel Barreiro de Acosta: speaker, consultant and advisory member for or have received research funding from AbbVie, Janssen, Takeda, Pfizer, Lilly, Alphasigma, Sandoz and Oncostellae

RAPID ONSET OF ACTION OF USTEKINUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (RAUCU STUDY)

Iria Bastón-Rey 1, María García-Alvarado 2, Natalia Garcia Morales 3, Brais Fernández Suárez 4, Irene Latras Cortés 5, Rocío Ferreiro-Iglesias 1, Javier Santos Fernández 6, Coral Tejido Sandoval 7, Maria Teresa Vázquez Rey 8, Francisco Javier Garcia-Alonso 9, Alberto Guerrero Montañés 10, Gema Molina Arriero 11, Benito Velayos Jiménez 12, Maria Jesús Ruiz Barcia 13, Mercedes Ibáñez García 14, María del Sol Porto-Silva 15, Laura Tejerizo García 2, Patricia Ucha Abal 3, Eva Marti Marques 4, Laura Nieto-Garcia 15, María García-Alvarado 2, Jose Fernando Muñoz Nuñez 2, Manuel Barreiro de Acosta 16

1 University Hospital of Santiago de Compostela, Santiago de Compostela, Spain|||Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

2 University Hospital of Salamanca, Salamanca, Spain

3 University Hospital of Vigo CHUVI, Vigo, Spain|||Galicia Sur Health Research Institute ISS Galicia Sur, Vigo, Spain

4 University Hospital Lucus Augusti, Lugo, Spain

5 University Hospital of León, León, Spain

6 Hospital Río Carrión, Palencia, Spain

7 University Hospital of Ourense CHOU, Ourense, Spain

8 University Hospital of A Coruña CHUAC, A Coruña, Spain

9 University Hospital Río Hortega, Valladolid, Spain

10 Hospital Virxe da Xunqueira, Cee, Spain

11 University Hospital of Ferrol CHUF, Ferrol, Spain

12 University Hospital of Valladolid HCUV, Valladolid, Spain

13 Hospital da Costa, Burela, Spain

14 Hospital Medina del Campo, Valladolid, Spain

15 Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

16 University Hospital of Santiago, Santiago de Compostela, Spain|||Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Metabolic dysfunction-associated steatotic liver disease (MASLD) has a global prevalence of 30%, with 10-30% progressing to advanced liver fibrosis in 5 years. It is essential to assess advanced liver fibrosis – a predictor of liver-related outcomes. FIB-4 is a good screening test, but its low specificity leads to unnecessary referrals to hospital, especially in individuals over 65 years and with type 2 diabetes (T2D). To address these limitations, machine-learning techniques are developing scores like FIB-6 (validated for Hepatitis B and C).

Aims & Methods

We aimed to assess the performance of FIB-6 score in screening for advanced fibrosis in a Portuguese cohort of MASLD patients.
A retrospective-cohort study was conducted with MASLD patients who had undergone liver vibration-controlled transient elastography (VCTE) between January-October 2024. inclusion criteria: adult patients (age >18years) diagnosed with MASLD; undergone liver VCTE; complete biochemical and hematological data. Exclusion criteria: coexistence of other liver diseases; decompensated cirrhosis; hepatocellular carcinoma; hematological/bone‑related diseases. We used liver stiffness measurement by VCTE as a reference standard for liver fibrosis. Fibrosis was staged on a 0–4 scale: F0, F1 and F2, patients without advanced fibrosis; F3 and F4, patients with advanced fibrosis/cirrhosis.
Non invasive tests (FIB-6, FIB‑4, APRI, NFS) were calculated using blood results available within the month of the VCTE. Statistical analysis was performed using R version 4.2.3. AUC-ROC curve analysis with cutoff points were calculated using the Youden index.

Results

115 MASLD patients (58 males (50.43%),57 females (49.57%), median age of 62years) where included. 41 (35.65%) had diabetes mellitus type 2 (T2D) (10 of those insulin-treated), 74 (64.35%) arterial hypertension, 76 (66.09%) dyslipidemia and with a median body mass index of 29.9mg/Kg/m². Regarding hepatic fibrosis, 79 patients had F0-2 and 17 patients had F3-4.
In the general sample, AUC-ROC curve analysis showed an AUC 0.771 (CI 95% :0.662, 0.88) for FIB-4, AUC 0.788 (CI 95% :0.686, 0.889) for APRI, AUC 0.709 (CI 95% :0.595, 0.823) for NFS and AUC 0.695 (CI 95% :0.571, 0.819) for FIB-6.
A subanalysis of the sample over 65 years old revealed AUC 0.807 (CI 95% : 0.665, 0.949) for FIB4; AUC 0.788 (CI 95% : 0.686, 0.889) for APRI; AUC 0.788 (CI 95% : 0.65, 0.926) for NFS; AUC 0.663 (CI 95% : 0.475, 0.852) for FIB-6. A subanalysis of the sample of T2D patients revealed AUC 0.747 (CI 95% :0.584, 0.911) for FIB4; AUC 0.811 (CI 95% :0.676, 0.946) for APRI; and AUC 0.765 (CI 95% : 0.612, 0.918) for FIB6.
Using the optimal cut‑offs of FIB6 (cutoff= 1.8992) for the diagnosis of F3+F4 indicated a reliable performance of FIB‑6 score (sensitivity was 70%, specificity was 52.6%).
The cutoff values of FIB-6 for the general sample was 2.4420 (sensitivity 53%, specificity 87%); for the subset of patients over 65 years was 2.7668 (sensitivity 40%, specificity 96%); for the subset of T2D patients was 2.2230 (sensitivity 55%, specificity 90%).

Conclusion

FIB-6 demonstrated good performance in screening advanced fibrosis in MASLD patients, when compared to those of FIB‑4, APRI, and NFS, surpassing FIB-4, particularly in individuals with T2D. This study is the first to evaluate the applicability of FIB-6 in a Portuguese MASLD cohort. Although the findings warrant validation in larger and more diverse populations, they suggest that FIB-6 may be more efficient to evaluate liver fibrosis in MASLD and offer a more efficient tool to identify patients that need specialized care.

References

Anushiravani A, et al. 2023.
Alswat K, et al. 2024.
Shiha G, et al. 2022
Tacke, Frank et al. 2023
Boursier, Jerome et al. 2022
Papatheodoridi, Margarita et al. 2021
Hannes Hagström et al. 2024.
Rinella, Mary E. et al.2023

FIB-6 OVER FIB-4: SCORING HIGHER IN LIVER FIBROSIS EVALUATION IN MASLD: EVIDENCE FROM A PORTUGUESE COHORT

Ana Catarina Garcia 1, Patrícia Pires 1, Mónica Francisco 1, Sofia Bragança 1, Mariana Cardoso 1, Joana Carvalho e Branco 1, Mariana Nuno Costa 1, Rita Carvalho 1, Alexandra Martins 1, Gonçalo Alexandrino 1

1 Unidade Local de Saúde Amadora/Sintra, Lisbon, Portugal

Conference

UEG Week Berlin 2025

Topics

Hepatobiliary

Submission format

Abstract

Session

LIVER (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

While three JAK inhibitors are now available in Ulcerative Colitis (UC), the hierarchy of these treatments according to their effectiveness, remains to be determined.

Aims & Methods

In the JAKARTA study, we aimed to compare the effectiveness of the three available JAK inhibitors (tofacitinib/TOFA, filgotinib/FILGO and upadacitinib/UPA) in bio-exposed patients with UC.
In this retrospective multicenter study (12 centres), we included all consecutive patients with UC ≥18 years-old, partial Mayo score > 2 who had started TOFA, FILGO or UPA after receiving ≥ 1 biologic between JAN2019 and JUN2022. Acute severe UC were excluded.
Following regimen were applied for TOFA (10mg b.i.d until W8 and 5mg or 10 mg b.i.d according to physician’s judgement), FILGO (200mg q.d) and UPA (45mg q.d until W8 and 45mg, 30 mg or 15 mg q.d according to physician’s judgement).
The primary endpoint was symptomatic remission (partial Mayo score ≤ 2) without corticosteroids (CFREM) at W16. Secondary endpoints were clinical and endoscopic remission (CFREM + endoscopic Mayo score ≤ 1), histological and endoscopic mucosal improvement (HEMI) (= clinical-endoscopic and histological remission (Nancy index ≤ 1)), drug retention (treatment discontinuation-free survival using Kaplan-Meier curve), time to colectomy, time to UC-related hospitalization and secondary loss of response among patients in CFREM at W16.
All the comparisons were performed using propensity scores adjustment (IPTW).

Results

A total of 290 patients were included: 150, 79 and 61 in TOFA, FILGO, and UPA arms, respectively. The 3 groups were comparable except for higher proportion of patients with previous exposure to > 3 biologics in UPA group (p < 0.001). TOFA 10 mg b.i.d was continued until W16 in 47.0% of patients. FILGO was maintained at 200 mg in 97.5%. UPA was diminished at 30 mg and 15 mg at W8 in 55.6% and 3.3% of patients, respectively.
After IPTW, CFREM at W16 was higher in UPA (60.1%) compared to TOFA (38.9%) or FILGO groups (36.0%) (p = 0.026 and 0.016, respectively). No predictive factor of efficacy/ failure was identified with these 3 JAK inhibitors.
We failed to show any significant difference regarding clinical-endoscopic remission (UPA:16.5%, TOFA:16.5%, FILGO:12.8%) or HEMI (UPA:11.9%, TOFA: 4.4, FILGO: 12.7%) at W16.
Among patients who reduced the dose to the recommended maintenance regimen (TOFA 5 mg b.i.d and UPA 30 or 15 mg q.d) between W8 and W16, the need for dose re-escalation to the induction dose was 33.8% (27/80) for TOFA, 14.7% (5/34) for UPA30mg and 50.0 % (1/2) for UPA 15 mg. After adjustment, drug retention was longer for UPA compared to TOFA (HR = 0.38 [0.17-0.85], p = 0.019) and FILGO groups (HR = 0.17 [0.08-0.65], p < 0.001) and shorter in FILGO than in TOFA group (HR = 1.57[1.02-2.41], p = 0.038).
No difference was demonstrated in terms of time to hospitalization or surgery between the 3 groups.
Among patients achieving CFREM at W16 (regardless of the dose), secondary loss of response (symptomatic relapse) was similar for TOFA:12.8% (N=47 patients), FILGO: 19.2% (N = 26 patients) and UPA: 10.3% (N = 29 patients) (p=ns after IPTW).

Conclusion

In this real-world evidence multicenter study, UPA was the most effective JAK inhibitor in UC at short and long-term but the large use of off-label maintenance doses in current practice needs further safety investigations.

Disclosure

Consulting fees from: Abbvie, Amgen, Arena, Biocon, Biogen, Celltrion Healthcare, CTMA, Ferring, Galapagos/AlfaSigma, GutyCare/Resilience Janssen, Lilly, MSD, Nexbiome, Pfizer, Roche, Sandoz, Takeda et Tillotts
Lecture fees from : Abbvie, Amgen, Biogen, Celltrion Healthcare Galapagos/AlfaSigma, Ferring, Janssen, Lilly, Mayoli-Spindler, MSD, Nordic Pharma, Norgine, Pfizer, Roche, Takeda, Tillotts and Vifor Pharma
Research grants/fundings from: Abbvie, Celltrion Healthcare, Janssen, Lessaffre, Lilly, Pfizer, Sandoz and Takeda

SHORT AND LONG-TERMS EFFECTIVENESS COMPARISONS BETWEEN TOFACITINIB, FILGOTINIB AND UPADACITINIB IN BIO-EXPOSED PATIENTS WITH ULCERATIVE COLITIS: RESULTS FROM THE JAKARTA REAL-WORLD EVIDENCE MULTICENTER STUDY

Anthony Buisson 1, Maria Nachury 2, Mathieu Uzzan 3, Guillaume Bouguen 4, Aurelien Amiot 5, Amira Banana Hamadidi 1, Mélanie Serrero 6, Xavier Treton 7, Mathurin Fumery 8, Marianne Hupé 9, Ludovic Caillo 10, Guillaume Le Cosquer 11, Bruno Pereira 1, Romain Altwegg 12

1 CHU Estaing Clermont-Ferrand, Clermont-ferrand, France

2 CHRU Lille, Courbevoie Cedex, France

3 Hôpital Mondor, Paris, France

4 CHU Pontchaillou, Rennes, France

5 KB, APHP Dept. of Gastroenterology, Creteil, France

6 Hopital Nord, Marseille, France

7 Paris IBD center, Neuilly, France

8 Amiens University Hospital, Amiens, France

9 CHU de Grenoble, Grenoble, France

10 CHU DE NIMES, Nîmes, France

11 CHU Toulouse, Toulouse, France

12 Hopital Saint Eloi Hepatologie Gastro Enterologie, Montpellier cedex 5, France

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Advanced IBD therapies: Lessons over time (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Combining therapies in ulcerative colitis

Joana Torres 1

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

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

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.

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)

Julien Kirchgesner 1, Laurent Peyrin-Biroulet 2, Laurène Gautier 3, Katia Sosnowiez 3, Samira Chaalal 3, Lucien Clevy 3, Hanane Omichessan 3, Vanessa Cohignac 3, Pascaline Rabiéga 4, Geoffray Bizouard 4, Tiffany Nishikawa 4, Alice Huguet 4, Lucine Vuitton 5

1 Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne University, Saint-Antoine Hospital, Paris, France

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

3 Johnson&Johnson Innovative Medicine, Issy-les-Moulineaux, France

4 IQVIA Operations France, Courbevoie, France

5 Besançon university hospital, Besançon, France

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD

Submission format

Abstract

Session

Tackling IBD in clinics

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

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Introduction

Colectomy is the primary treatment for dysplastic lesions in inflammatory bowel disease (IBD). Since the development of advanced endoscopic techniques, the management of dysplasia is evolving. Endoscopic submucosal resection (ESD) could be used in selected cases at referral centres as an alternative to colectomy. However, the feasibility and safety in IBD remains limited.

Aims & Methods

To evaluate en-bloc resection rate and the need of colectomy due to ESD failure in IBD.
Secondary aims: to assess the complications of ESD, the local recurrence of dysplastic lesions, the presence of synchronous and metachronous lesions and the risk of IBD relapse following the procedure.
Multicentre, retrospective study of IBD patients who underwent ESD for suspected colonic dysplastic lesions at least one month before the inclusion date. Patients with total colectomy before ESD, invisible dysplasia at the time of ESD, or pregnancy were excluded. En-bloc resection rate and colectomy due to ESD failure at the short term were evaluated by logistic regression analysis. The risk of IBD relapse was evaluated by Cox regression analysis.

Results

Sixty patients from 22 centres were included: 47 with ulcerative colitis, 11 with Crohn’s disease and 2 with IBD-unclassified. The mean age at ESD was 64 years (SD 13). The majority of the lesions (n=33, 55%) were located in rectum. Fifty lesions (83%) were located in areas previously inflamed. En-bloc and R0 were achieved in 58 (97%) and 50 patients (83%), respectively. Colectomy due to ESD failure was required in 5 patients (8.3%), all of them occurred within 6 months after ESD. No risk factors were associated with colectomy in multivariable analysis, including inflammatory activity, IBD treatments or characteristics of the lesions. Complications occurred in 17 patients (28%): 3 did not required any treatment, 6 required pharmacologic therapy, 6 needed endoscopic or radiologic intervention, and 2 underwent surgery (Table 1). No deaths were reported.
At least one surveillance colonoscopy after ESD was performed in 42 patients (70%). Local recurrence was observed in 2 patients (4.7%) while other dysplastic lesions were detected in 11 (26%) during the follow-up (median 1.5 years, IQR 0.5-3.4). All these lesions were removed endoscopically. Synchronous and metachronous lesions were identified in 4 (20%) and 9 patients (19%), respectively. IBD relapse occurred in 8 patients during the follow-up, with an incidence rate of 7% person-year (CI 95%:3-13). The occurrence of relapses was gradually throughout the follow-up period.

Table 1. Complications of endoscopic submucosal dissection

	Frequency, n (%)	Time of onset: during the ESD, n (%)	Serious complication, n (%)	Resolution with endoscopy, n (%)	Resolution with no sequelae, n (%)
Perforation	9 (15)	8 (13)	2 (3.3)	6 (10)	8 (13)
Bleeding	3 (5)	1 (1.6)	0 (0)	3 (5)	3 (5)
Post polypectomy syndrome	4 (6.7)	0 (0)	0 (0)	0 (0)	4 (6.7)
Other complication	1 (1.6)	0 (0)	0 (0)	0 (0)	1 (1.6)

Other complication: fever with no evidence of infection.
n: number, ESD: endoscopic submucosal infection.

Conclusion

ESD avoids colectomy in 90% of IBD patients with dysplastic lesions. One-third of the patients experienced complications, all of them resolved with no sequelae. Given the risk of new dysplastic lesions, ongoing monitoring with surveillance colonoscopies is recommended.

Disclosure

María José García has received financial support for travelling and educational activities from Janssen, Pfizer, AbbVie, Takeda, Kern Pharma, Faes Farma and Ferring.
Edoardo Vincenzo Savarino has served as speaker for Abbvie, Abivax, Agave, AGPharma, Alfasigma, Apoteca, Biosline, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Galapagos, Johnson&Johnson,consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Dr. Falk, Eli Lilly, Fenix Pharma, Ferring, Giuliani, Grunenthal, Johnson&Johnson, JB Pharmaceuticals, Merck & Co, Nestlè, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Takeda, Unifarco; he received research support from Bonollo, Difass, Pfizer, Reckitt Benckiser, Sanofi/Regeneron, SILA, Sofar, Unifarco, Zeta Farmaceutici.
Irene González-Partida has received support for conference attendance and speaker fees from AbbVie, Dr. Falk Pharma, Ferring Pharmaceuticals, Janssen, MSD, Kern, Pfizer, Shire, Takeda, Teva and Tillotts Pharma AG.
Alicia López has served as speaker for Chiesi, Takeda, ABBVIE, Lilly. I have received support for conference attendance from Pfizer, Lilly, Kern Pharma, Falk, Ferring, and Janssen
Jordina Llao has received educacional suport from Abbvie, Tillots, Ferring and Lilly.

FEASIBILITY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION IN INFLAMMATORY BOWEL DISEASE (ESDEUR-IBD): AN INTERIM ANALYSIS OF EUROPEAN RETROSPECTIVE STUDY

María José García 1, Miguel Fraile López 1, Georgios Katinios 2, Alessandro Gubbiotti 3, Konstantinos Argyriou 4, Benedetto Neri 5, Irene Gonzalez Partida 6, Aleksandar Gavric 7, Jean Philippe Loly 8, Maria Luisa De Castro Parga 9, Fotios Fousekis 10, Laura Cudero 11, Stepan Suchanek 12, Bénédicte Caron 13, Jordina Llaó 14, Álvaro Terán Lantarón 1, Laura Arranz Hernández 15, Alicia López-García 16, Daniel Sebastian Ceballos Santos 17, Pedro de María Pallarés 18, Ainara Elorza 19, Olga Bednarska 2, Edoardo Vincenzo Savarino 20, Anastasios Manolakis 4, Roberto Mancone 21, Diego de Frutos 6, Antonio Rodríguez 9, Alexandros Skamnelos 10, Marion Schaefer 13, Diana García Romero 15, Raúl Honrubia-López 16, Carlos Rodríguez Pérez 17, Cristina Suárez Ferrer 18, Montserrat Rivero 1

1 Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain

2 University Hospital in Linköping, Linkoping, Sweden

3 Azienda Ospedale Università Padova, Padua, Italy|||University of Padua, Padua Italy, Padua, Italy

4 University Hospital of Larissa, Larissa, Greece

5 Fondazione Policlinico Campus Bio Medico di Roma, Rome, Italy|||University 'Tor Vergata' of Rome, Rome, Italy

6 Hospital Universitario Puerta de Hierro, Majadahonda, Spain

7 University Medical Center Ljubljana, Ljubljana, Slovenia|||Ljubljana Digestive Endoscopy Research Group (LuDERG), Ljubljana, Slovenia

8 CHU Liège, Liège, Belgium

9 Complexo Hospitalario Universitario de Vigo (CHUVI), Sergas, Grupo de Investigación en Patología Digestiva, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia), Vigo, Spain

10 University Hospital of Ioannina, Ioannina, Greece

11 Hospital Universitario 12 de Octubre, Madrid, Spain

12 1st Faculty of Medicine, Charles University, Military University Hospital, Prague 6, Czechia|||1st Faculty of Medicine, Charles University, Military University Hospital, Prague, Czechia

13 Université de Lorraine, CHRU, Inserm, INFINY Institute, NGERE, Nancy, France

14 Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

15 Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain

16 Hospital Universitario Infanta Sofía, Madrid, Spain

17 Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain

18 Hospital Universitario La Paz, Madrid, Spain

19 Hospital de Galdakao, Bilbao, Spain

20 University of Padua, Padua Italy, Padua, Italy

21 University 'Tor Vergata' of Rome, Rome, Italy

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Scoping IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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