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HIGH-DIMENSIONAL SINGLE-CELL ANALYSIS IDENTIFIES CELLULAR SIGNATURES ASSOCIATED WITH RESPONSE TO VEDOLIZUMAB THERAPY IN ULCERATIVE COLITIS

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Introduction

Vedolizumab (VDZ), an anti-α4β7 integrin antibody that is thought to inhibit leukocyte trafficking to the inflamed gut mucosa, has emerged as an effective treatment for patients with moderate-to-severe ulcerative colitis (UC) who have failed conventional therapy, but around 50% of patients experience primary non-response, highlighting the need to understand its mechanism of action, and thereby the mechanism underlying therapy (non)response, to improve clinical care and to reduce patient burden.

Aims & Methods

To gain new insights into the basis of primary (non-)response to VDZ, we performed single-cell RNA sequencing and high-dimensional spectral flow cytometry of gut mucosal biopsies and peripheral blood mononuclear cells (PBMCs) collected from 25 UC patients with active inflammation 2 weeks prior and 14 weeks after the initiation of VDZ therapy. We generated 159.188 mucosal and 95.057 PBMC transcriptomes, and validated results using immunoprofiles of additional 797.670 CD45+ mucosal cells and 480.000 PBMCs.

Results

From a total of 25 UC patients (mean age 41±12.7 years, 52% female, 36% anti-TNFα naive), 15 patients (60%) reached response at week 14. Patients with no prior use of anti-TNFα were more likely to achieve remission with VDZ compared to anti-TNFα exposed patients (89% vs 44% response rate, respectively). We found that the surface presence of β7 was significantly diminished on circulating T cells in all patients after VDZ administration. However, non-responders still showed sustained presence of leukocytes in the mucosa with no evidence of alternative integrin pathways playing a role in their trafficking. Furthermore, non-responders to VDZ exhibited ongoing mucosal inflammation marked by an expansion of inflammatory fibroblasts, sustained presence of post-capillary venules, depletion of most epithelial subsets, and an unaltered composition of innate immune cell types. We identified an innate cellular signature that distinguished non-responders from responders prior to VDZ treatment (independently of the prior exposure to anti-TNFα medication, localisation of disease, and histological inflammatory scores). This innate signature consisted of highly abundant dendritic cells, NKs, ILCs, and inflammatory monocytes in the mucosa, and NKs, γδ-T cells, and CD16+ monocytes in the peripheral blood, which was in turn confirmed by high-dimensional flow cytometry. Strikingly, mucosal inflammatory monocytes in non-responders were not only highly abundant prior to VDZ treatment but also showed a dysregulated function that does not correspond to a known pro-inflammatory phenotype in UC and lacked communication with Tregs.

Conclusion

This is the largest prospective study that combines single-cell RNA sequencing and surface marker immunoprofiling to address the response to biological therapy in UC. We show that non-response to VDZ is marked by active, innate immune cell-mediated inflammation that is present prior to and persists throughout the treatment and can be detected in peripheral blood before the start of treatment.

Disclosure

This study was performed in collaboration with the Takeda Pharmaceuticals GI Drug Discovery Unit

HIGH-DIMENSIONAL SINGLE-CELL ANALYSIS IDENTIFIES CELLULAR SIGNATURES ASSOCIATED WITH RESPONSE TO VEDOLIZUMAB THERAPY IN ULCERATIVE COLITIS

Shiqiang Sun 1, Paola Pibiri 1, Naomi Karmi 1, Roy Oelen 1, Sofie de Jong 1, Amber Bangma 1, Johan Teunis 1, Marcela Ramello 1, Maria Paraskevopoulou 2, Saman Farahmand 2, Bleck Bertram 2, Guliang Xia 2, Rinse K. Weersma 1, Emilia Bigaeva 1, E.A.M. (Noortje) Festen 1

1 University Medical Center Groningen/University of Groningen, Groningen, Netherlands

2 Takeda Pharmaceuticals, Cambridge, United States

Event

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

IBD: From principles to therapy

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

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SMOKING HABITS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

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Introduction

Smoking is an environmental and conductual risk factor for the development of Chron’s Disease (CD) and is associated with a more severe course of CD. In contrast, a protective effect is shown in the development and a mild course of Ulcerative Colitis (UC). Smoking leads to cardiovascular disease, cancer and other chronic diseases, and social isolation, anxiety and depression. It is also a predictor of poorer adherence to treatment in young patients.

Results & Findings

50% were women, 52 years old (SD: 12.6). 58.6% suffered CD, 39.7% more than 10 years from onset of disease, 60.7% with biologics; 54.4% in remission and 29.8% mild activity. 24% were active smokers, 60% ex-smokers and 15.5% has never smoked. 60.3% were regular exercisers, and 66% consume alcoholic beverages regularly.
Of those who smoked, 64% were women, 57% suffered CD, 46% was in remission. 85.7% with anxiety and 52.7% with depression, 61.5% perceived their health status as suboptimal. 64.3% consumed alcoholic beverages, 57.1% no physical exercise.
The mean anxiety score was 9 (SD: 3.6), depression score was 5.76 (SD: 3.7). 67.2% had anxiety levels and 32.8% depression. Perceived health status as optimal was 57.9%.
In the bilateral analysis between smoking and the independent variables, only depression and anxiety was associated.

Summary & Discussion

Smoking is an environmental risk factor for the development and course of CD. The aim of this study iis to determine smoking habits and associated factors in patients with Inflammatory Bowel Disease (IBD) in Hospital Universitario del Henares (Madrid).
A transversal study was carried out. Data were collected in a questionnaire ad-hoc and HADS.
Patients with IBD are active smokers, and their percentage is bigger to regular population in Comunidad de Madrid (21.9%). On the other hand, the percentage of ex-smokers with IBD (60%) is much higher than with no IBD; it may be related to IBD development.
It is well known the relationship between IBD and psicosocial aspects. In this study we show the high prevalence of anxiety and depression, which is higher than in general population.
Nurses can play an important role in the psychological care of patients with IBD, especially in prevention and early detection.

Conclusion

Patients with IBD showed a high tobacco consumption, most of which were women and with no healthy habits.
Smoking in patients with IBD is associated with anxiety and depression.

References

(1) Bisgaard TH, Allin KH, Keefer L, Ananthakrishnan AN, Jess T. Depression and anxiety in inflammatory bowel disease: epidemiology, mechanisms and treatment. Nat Rev Gastroenterol Hepatol. 2022;19(11):717-726.
(2) Feng L, Cai X, Zou Q, et al. Exploring the management and treatment of IBD from the perspective of psychological comorbidities. Therap Adv Gastroenterol. 2024;17:17562848241290685.
(3) Barreiro-de Acosta M, Marín-Jiménez I, Panadero A, et al. Recommendations of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) and the Association of Crohn's Disease and Ulcerative Colitis Patients (ACCU) in the management of psychological problems in Inflammatory Bowel Disease patients. Gastroenterol Hepatol. 2018;41(2):118-127.
(4) Herrero MJ, Blanch J, Peri JM, et al. A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003;25(4):277-83.
(5) Comunidad de Madrid. Dirección de Salud Pública. Resultados del Sistema de Vigilancia Integral del Tabaquismo (VITa). Informe 2023.

SMOKING HABITS IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Dania Rocio Diaz-Rodriguez 1, Monica Granados Martin 2, Liliana La Rosa-Huertas 3, Inés Constanze Hammel 4

1 Hospital Universitario del Henares, Madrid, Spain

2 Hospital de Fuenlabrada, Fuenlabrada, Spain

3 Universidad Señor de Sipán, Lims, Peru

4 Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Spain

Event

UEG Week Berlin 2025

Topics

Nurses

Submission format

Abstract

Session

Abstracts II: Patient care and endoscopic techniques

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

Guselkumab (GUS) intravenous (IV) induction followed by subcutaneous (SC) maintenance with 200mg q4w or 100mg q8w was effective in the GALAXI 2 & 3 phase 3 treat-through studies of participants (pts) with moderately to severely active Crohn’s disease (CD), with similar efficacy between both maintenance doses in the overall study populations. Here, we evaluated the efficacy of maintenance doses in subgroups by baseline disease activity and severity and inflammatory burden at Week (Wk) 12 to determine if some pts may receive additional benefit from the higher maintenance dose.

Aims & Methods

Eligible pts had moderately to severely active CD (CDAI 220–450 and mean daily stool frequency score >3 or abdominal pain score >1), SES-CD ≥6 (≥4 for isolated ileal disease), and inadequate response or intolerance to oral corticosteroids, AZA, 6-MP, MTX, or biologics. Pts were randomly assigned to GUS 200mg IV at Wks 0, 4, and 8, followed by GUS SC 100mg q8w (N=286) or 200mg q4w (N=296). The studies also included placebo and ustekinumab arms, but this analysis focused on differences between GUS maintenance doses. Wk48 endpoints included clinical remission (CDAI <150) and endoscopic response (≥50% improvement in SES-CD or SES-CD ≤2). Analyses of subgroups by baseline disease activity (CDAI >300 or SES-CD >12), and inflammatory burden (CRP >5) or endoscopic response at Wk 12 were prespecified but not multiplicity controlled.

Results

In the pooled GALAXI 2 & 3 dataset, pts with baseline high disease activity (CDAI >300 or SES-CD >12) had numerically greater clinical and endoscopic outcomes at Wk 48 with 200mg q4w compared with 100mg q8w. Pts with baseline CDAI >300 had numerically greater percentages of clinical remission (200mg: 68.0% [83/122] vs 100mg: 55.1% [65/118], respectively) and endoscopic response (52.5% [64/122] vs 44.1% [52/118]) at Wk 48. Pts with baseline SES-CD >12 also had numerically greater percentages of these outcomes (clinical remission: 77.0% [94/122] vs 65.1% [82/126] and endoscopic response 67.2% [82/122] vs 58.7% [74/126]). Pts with baseline CDAI ≤300 or SES-CD ≤12 had similar Wk 48 outcomes for both maintenance doses. Pts with greater inflammatory burden (CRP >5mg/L) at Wk 12 or who were not in endoscopic response at Wk 12 also had numerically greater clinical and endoscopic outcomes at Wk 48 with 200mg compared with 100mg (Table). Pts with CRP ≤5mg/L or who were in endoscopic response at Wk 12 had similar clinical and endoscopic outcomes for both maintenance doses. Results for individual GALAXI 2 & 3 studies generally trended in the same direction for all subgroups.

Table. Week 48 Outcomes by CRP and Endoscopic Response Status at Week 12
Week 48 outcome by status at Week 12	Guselkumab 200 mg q4w (N=278)	Guselkumab 100 mg q8w (N=268)
CRP>5mg/L at Week 12	107/278 (38.5%)	85/268 (31.7%)
Clinical remission at Week 48	76/107 (71.0%)	46/85 (54.1%)
Endoscopic response at Week 48	54/107 (50.5%)	31/85 (36.5%)
Not in endoscopic response at Week 12	177/278 (63.7%)	156/268 (58.2%)
Clinical remission at Week 48	120/177 (67.8%)	97/156 (62.2%)
Endoscopic response at Week 48	79/177 (44.6%)	50/156 (32.1%)
Clinical remission was defined as CDAI score <150; endoscopic response was defined as ≥50% improvement from baseline in SES-CD or SES-CD ≤2

Conclusion

Pts with high clinical or endoscopic disease severity at baseline, greater inflammatory burden after induction, or who had not achieved endoscopic response after induction showed greater clinical and endoscopic outcomes at Wk 48 with GUS 200mg SC q4w compared with 100mg SC q8w.

Disclosure

AA: AbbVie, Bristol Myers Squibb/Celgene, DiaSorin, Eli Lilly, Gilead, IBD Horizons, Johnson & Johnson, Pfizer, Takeda, and TLL Pharmaceuticals
TH: grants from AbbVie GK, Boston Scientific Corporation, EA Pharma Co. Ltd., JIMRO Co. Ltd., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Pfizer Inc., Takeda Pharmaceutical Co. Ltd., and Zeria Pharmaceutical Co. Ltd.; consulting fees from AbbVie GK, Abivax, Bristol Myers Squibb, EA Pharma Co. Ltd., Gilead Sciences, Janssen Pharmaceutical K.K., Lilly, Mitsubishi Tanabe Pharma Corporation, and Pfizer Inc.; lecture fees from AbbVie GK, EA Pharma Co. Ltd., Janssen Pharmaceutical K.K., JIMRO Co., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Pfizer Inc., and Takeda Pharmaceutical Co. Ltd.
DTR: consulting/speaker fees/advisory board for AbbVie, Altrubio, Apex, Avalo, Bristol Myers Squibb, Buhlmann Diagnostics, Celgene, Connect BioPharma, Intouch Group, Iterative Health, Johnson & Johnson, Lilly, Pfizer, Samsung Neurologica, and Takeda; Altrubio, Datos Health, and Iterative Health stock options; grants from Takeda; membership on Board of Directors of Cornerstones Health, Inc and Crohn’s & Colitis Foundation’s Board of Trustees.
NAT, RVR, JY, KYYW, and ZY: employees of and may own Johnson & Johnson stock.
WR: speaker for AbbVie, Celltrion, Ferring, Johnson & Johnson, Galapagos Medice, MSD, Roche, Pfizer, Sobi, Takeda; consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Johnson & Johnson, Medahead, Microbiotica, Pfizer, Takeda; advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Johnson & Johnson, Pfizer; funding from AbbVie, Johnson & Johnson, Sandoz, Sanofi, Takeda.
BES: consulting fees from AbbVie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Celltrion, Equillium, Enthera, Enveda Biosciences, Evommune, Ferring, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Microba, Mirador Therapeutics, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Pharmaceuticals, Spyre Therapeutics, Sun Pharma, Surrozen, Target RWE, Teva, TLL Pharmaceutical, Tr1X, Union Therapeutics, Ventyx Biosciences, and Vividion Therapeutics; consulting /speaking fees from Abivax; consulting/speaking fees/other support from Lilly; research grants/consulting/speaking fees/other support from Bristol Myers Squibb, Johnson & Johnson, Pfizer, and Takeda; stock/options from Ventyx Biopharma.
SD: consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Hospira, Inotrem, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity, Takeda, TiGenix, UCB, and Vifor; lecture fees from AbbVie, Amgen, Ferring, Gilead, Janssen, Mylan, Pfizer, and Takeda.
RP: consulting fees from Abbivax, Abbott, AbbVie, Alimentiv, Amgen, AnaptsyBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Spyre Therapeutics, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, and UCB; speaker’s fees from AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Johnson & Johnson, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals; Advisory Boards for AbbVie, Alimentiv, Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, and Ventyx.

GUSELKUMAB MAINTENANCE DOSE REGIMENS IN PATIENTS WITH HIGH DISEASE ACTIVITY AND SEVERITY: SUBGROUP ANALYSIS OF PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE IN THE GALAXI PHASE 3 STUDIES

Anita Afzali 1, Tadakazu Hisamatsu 2, David T. Rubin 3, Natalie Terry 4, Rian Van Rampelbergh 5, Jacqueline Yee 6, Kitty Yuen Yi Wan 7, Zijiang Yang 8, Walter Reinisch 9, Bruce E. Sands 10, Silvio Danese 11, Remo Panaccione 12

1 University of Cincinnati College of Medicine, Cincinnati, United States

2 Kyorin University School of Medicine, Tokyo, Japan

3 University of Chicago Medicine, Chicago, United States

4 Johnson And Johnson, Philadelphia, United States

5 Johnson & Johnson, Beerse, Belgium

6 Johnson & Johnson, Bedminster, United States

7 Johnson & Johnson, Allschwil, Switzerland

8 Johnson & Johnson, Spring House, United States

9 Medical University of Vienna, Wien, Austria

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

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

12 University of Calgary, Calgary, Canada

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

New treatments on the horizon for Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Mesenchymal stem cell therapy: All just rubbish?

Christianne Johanna Buskens 1

1 Academic Medical Center, Amsterdam, Netherlands

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Surgery

Session

Focus on fistulising Crohn’s disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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USTEKINUMAB FOR FISTULIZING PERIANAL CROHN’S DISEASE: WEEK-12 RESULTS FROM THE USTAP RANDOMIZED PLACEBO CONTROLLED GETAID TRIAL

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Introduction

Fistulizing perianal Crohn’s disease (CD) remains a significant therapeutic challenge, with limited randomized controlled trials to date, restricted so far to infliximab and, more recently, filgotinib. The USTAP (NCT04496063) trial aimed to evaluate the efficacy and safety of UST in patients with actively draining perianal fistulas through a multicenter randomized controlled design.

Aims & Methods

This double-blind, placebo-controlled, multicenter trial enrolled adult patients with active draining fistulizing perianal CD. Between April 2020 and June 2024, eligible patients with persistent fistula drainage were randomized 1:1, after seton placement when necessary, to receive either UST (6 mg/kg IV at baseline followed by 90 mg SC at week 8, then every 8 weeks) or placebo. Steroids were allowed at baseline with a standardized steroid taper. Seton removal was planned at week 6. The primary endpoint was combined clinical remission (absence of drainage from all external fistula openings) and radiological remission (defined as the absence of abscesses >2 cm confirmed by blinded central pelvic MRI) at week 12. Secondary endpoints included clinical remission, radiological remission, changes in disease activity (CDAI, PDAI), IBD-DI, and safety. Endpoints were independently reviewed by a blinded adjudication committee. Randomization was stratified by prior anti-TNF exposure and study center. The intended sample size was 73 patients per group to detect a 20% difference in remission rates (power 80%, alpha 5%). Due to slow recruitment, the study was discontinued in June 2024 after randomizing 32 patients, without unblinding the study data. Patients were subsequently followed until week 48.

Results

Thirty-three patients consented to participate with 32 patients (women: 41%; median age: 42) ultimately randomized (UST: 16; placebo: 16) across 10 French centers. Seventy percent had prior anti-TNF exposure (50% in UST arm, 50% in placebo arm), and 23% had previously failed two or more anti-TNF therapies. At baseline, 84% had one draining fistula, 16% had two, and 25% had associated abscesses. At week 12, combined remission was achieved in 62% in the UST group versus 25% in the placebo group (Table). Clinical remission was observed in 69% in the UST group vs. 31% in the placebo group, while radiological remission rates were 87.5% in the UST group and 75% in the placebo group. In the UST arm, mean change in CDAI, PDAI and IBD-DI from baseline to week 12 was -56.3, -2.2 and -4.9, (vs. -9.8, -1.6 and +4.9, in the placebo arm, respectively). Adverse events (AE) and serious adverse events (SAE) were similar in both treatment groups: 23 AE (62%) occurred in the placebo group, and 14 AE (38%) in the UST group. Six SAEs were reported overall, including two gastrointestinal events, one renal disorder, and one anal abscess. Two patients in the placebo group discontinued study by week 6 due to SAEs (an anal abscess and a peri-ileal abscess).

Endpoints	Overall (N=32)	Placebo (N=16)*	Ustekinumab (N=16)	OR (IC 95%)
Primary endpoints, n (%)
Combined Remission	14 (44%)	4 (25%)	10 (62%)	5.1 [1.07-24.4]
Secondary endpoints, n (%)
Clinical Remission (100% of the fistulas tracts showing no drainage)	16 (50%)	5 (31%)	11 (69%)	0.27 [0.06-1.17]
Radiological Remission (absence of collections >2 cm confirmed by masked central MRI)	26 (81.2%)	12 (75%)	14 (87.5%)	2.7 [0.34-21.1]
Absence of abscess at pelvic MRI	22 (69%)	11 (69%)	11 (68%)	1.51 [0.3-7.46]

*Two patients discontinued study by week 6 in the placebo group

Conclusion

In this trial, where the majority of patients had prior anti-TNF exposure, the observed short-term clinical benefit of UST supports its use in fistulizing perianal CD.

Disclosure

This work was supported by a grant from Johnson & Johnson
Pauline Wils : Johnson & johnson, Takeda, Amgen, Abbvie, Celltrion, Ferring
S Nancey: Abbvie, Johnson and Johnson, Fresenius Kabi, Biogen, Takeda, Medac, Celltrion, MSD, Pfizer, Sandoz, Lilly,Ferring, Amgen
E. Messmer: No conflict of interest for this study
A Bourreille: Johnson and Johnson
A Buisson: Consulting fees from: Abbvie, Amgen, Arena, Biocon, Biogen, Celltrion Healthcare, CTMA, Ferring, Galapagos/AlfaSigma, GutyCare/Resilience Janssen, Lilly, MSD, Nexbiome, Pileje, 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
L Caillo: No conflict of interest for this study
L Vuitton: abbvie amgen J&J Pfizer Takeda Lilly MSD Mayoli Ferring Dr Falk Alpha Sigma
R Altwegg: Abbvie, Johnson ans Johnson, Takeda, Pfizer, Lilly, Alphasigma, Celltrion, Amgen, Biogen, Sandoz, Ferring
X Hébuterne reports clinical research funding from Abbvie, Abivax, Amgen, Celltrion, Lilly, Fresenius-Kabi, J&J, InDex Pharmaceuticals, Pfizer, Prometheus, MSD, Roche, Takeda, serving on advisory boards for Abbvie, Biogen, Celltrion, Lilly, J&J, and participating in lectures and educational activities for Abbvie, Amgen, Celltrion, Lilly, Fresenius-Kabi, Galapagos, J&J, MSD, Nestlé Health Sciences, Nutricia, Pfizer, Tillots, Takeda.
O Ernst: No conflict of interest for this study
P Meunier: No conflict of interest for this study
V Laurent: No conflict of interest for this study
D Laharie: received board and lecture fees from: Abbvie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Fresenius-Kabi, Janssen, Lilly, MSD, Pfizer, Roche, Sandoz, Takeda
E Vicaut: No conflict of interest for this study
L Peyrin-Biroulet: Consulting : Abbvie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, BMS, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, Ysopia ; lecture : Abbvie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Janssen, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots, Viatris

USTEKINUMAB FOR FISTULIZING PERIANAL CROHN’S DISEASE: WEEK-12 RESULTS FROM THE USTAP RANDOMIZED PLACEBO CONTROLLED GETAID TRIAL

pauline wils 1, Stephane NANCEY 2, Elodie Messmer 3, Arnaud Bourreille 4, Anthony Buisson 5, Ludovic Caillo 6, Lucine Vuitton 7, Romain Altwegg 8, Xavier Hebuterne 9, Olivier Ernst 1, Paul Meunier 10, Valérie Laurent 11, David Laharie 12, Eric Vicaut 13, Laurent Peyrin-Biroulet 14

1 Lille university hospital, Lille, France

2 Lyon hospital, Pierre Benite, France

3 Roubaix Hospital, Roubaix, France

4 Hopital Hotel Dieu Et Hme - Hge Aile Sud, Nantes Cedex 1, France

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

6 CHU DE NIMES, Nîmes, France

7 Besançon university hospital, Courbevoie, France

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

9 Hospital Archet 2, Nice, Nice, France

10 Liege hospital, Liege, Belgium

11 Nancy hospital, Nancy, France

12 CHU de Bordeaux Hopital Haut-Leveque Dept. de Gastroenterologie, Pessac cedex, France

13 Hôpital Lariboisière, APHP, Paris, France

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

Event

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Treatment of fistulas in Crohn's disease

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Will there be pathologists in 2030 or only AI?

Valerie Paradis 1

1 INSERM - Hôpital Beaujon, Clichy, France

Event

UEG Week Berlin 2025

Topics

Histopathology IBD Nurses

Session

The art of making clinical research precise: AI – friend or foe?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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ENDOSCOPIC AND HISTOLOGIC IMPROVEMENTS WITH PRA023 IN ARTEMIS-UC, A PHASE 2 PLACEBO-CONTROLLED STUDY ON MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

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Introduction

Tumor necrosis factor–like cytokine 1A (TL1A) promotes inflammation and fibrosis. PRA023 is an anti-TL1A monoclonal antibody in development for multiple inflammatory/fibrotic diseases. ARTEMIS-UC was a phase 2 multicenter, double-blind, placebo-controlled trial of PRA023 in adults with moderately to severely active ulcerative colitis (UC). The primary endpoint of clinical remission was statistically significantly higher in the PRA023 arm compared with the placebo arm. Here, we report the impact of PRA023 on endoscopic and histologic outcomes.

Aims & Methods

Adults with a modified Mayo score of 4 to 9, centrally read endoscopy subscore of ≥2, rectal bleeding subscore of ≥1, and history of insufficient response, loss of response, and/or intolerance to conventional and/or advanced therapies (≤4 advanced agents from ≤3 classes allowed) were randomized 1:1 to receive placebo or intravenous PRA023 (1000 mg on day 1, and 500 mg at weeks 2, 6, and 10). Endoscopic improvement (defined as a Mayo endoscopic subscore ≤1 with no friability), endoscopic remission (defined as a Mayo endoscopic subscore of 0), histologic improvement (defined as Geboes score ≤3.1), and mucosal healing (defined as Geboes score ≤2B.1 and endoscopy subscore ≤1) were measured after 12 weeks of induction therapy. Improvements in other histologic parameters were assessed by changes in Geboes scores.

Results

Of 135 randomized patients, 60/67 (89.6%) in the placebo arm and 68/68 (100%) in the PRA023 arm completed the 12-week induction period. Baseline characteristics were similar between treatment groups. Among alpha-controlled secondary endpoints, endoscopic improvement was observed in 36.8% of PRA023-treated vs 6.0% of placebo-treated patients (Δ30.8%, p<0.0001) at week 12. Histologic improvement occurred in 46.2% of patients receiving PRA023 vs 17.5% receiving placebo (Δ28.6%, p=0.0009) and mucosal healing in 30.8% vs 3.5% (Δ27.3%, p<0.0001), respectively. The mean change (SD) from baseline in the Mayo endoscopic subscore was −0.8 (0.93) for PRA023 vs −0.2 (0.54) for placebo. Furthermore, in a post hoc analysis, a significantly greater proportion of patients who received PRA023 achieved endoscopic remission (11.8% PRA023 vs 0% placebo, Δ11.8%, p=0.004). Of the patients with eosinophils in the lamina propria (LP) at baseline, 21.8% receiving PRA023 and 5.8% receiving placebo experienced complete resolution. Similarly, the resolution rates in those with neutrophils in the LP at baseline were 41.2% and 15.4% in PRA023-treated and placebo-treated patients, respectively; and of those with neutrophils in the epithelium at baseline, values were 40.4% vs 11.3%, respectively.

Conclusion

In patients with moderately to severely active UC, PRA023 resulted in a significantly greater proportion of patients achieving endoscopic remission, endoscopic improvement, histologic improvement, and mucosal healing, endpoints associated with an improved prognosis. Resolution of eosinophil and neutrophil infiltration suggests a reduction in the inflammation associated with UC.

Disclosure

SD has received consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr. Falk Pharma, Eli Lilly and Company, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, and Vifor and lecture fees from AbbVie, Amgen, Ferring, Gilead, Janssen, Mylan, Pfizer, and Takeda.
BES has served as a consultant for or received speaker’s fees from AbbVie, Abivax, Adiso Therapeutics, Alimentiv, Amgen, Arena Pharmaceuticals, Artizan Biosciences, Artugen Therapeutics, AstraZeneca, Bacainn Therapeutics, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celltrion Healthcare, ClostraBio, Connect Biopharma, Cytoki Pharma, Eli Lilly and Company, Entera, Evommune, Ferring, Fresenius Kabi, Galapagos, Gilead, Genentech, GSK, Gossamer Bio, HMP Acquisition, Imhotex, Immunic, InDex Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Ironwood Pharmaceuticals, Janssen, Johnson & Johnson, Kaleido, Kallyope, 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, Takeda, Target RWE, Theravance Biopharma R&D, TLL Pharmaceutical, USWM Enterprises, Ventyx Biosciences, and Viela Bio and has received stock options from Ventyx Biosciences.
LPB has served as a consultant for or has received fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Eli Lilly and Company, Enterome, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, Hikma, Index Pharmaceuticals, Inotrem, Janssen, MSD, Mylan, Oppilan Pharma, OSE Immunotherapeutics, Nestlé, Norgine, Roche, Pandion Therapeutics, Pfizer, Pharmacosmos, Samsung Bioepis, Sandoz, sterna biologicals, Sublimity Therapeutics, Takeda, Theravance Biopharma, Tillotts Pharma, and Vifor; has received grants from AbbVie, Fresenius Kabi, MSD, and Takeda; and has stock options from CTMA.
DTR has served as a consultant for AbbVie, AltruBio, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Chronicles, Corp/Syneos, ClostraBio, Connect Biopharma, Eco R1, Eli Lilly and Company, Genentech/Roche, Gilead Sciences, Iterative Health, Janssen Pharmaceuticals, Kaleido, Pfizer, Prometheus Biosciences, Reistone Biopharma, Seres Therapeutics, Takeda, Target RWE, and Trellus Health and has received grant support from Takeda, Helmsley Charitable Trust, and the Gastro-Intestinal Research Foundation.
DDN, QD, AM, JL and BD are employees and shareholders of Prometheus Biosciences.
RK has received grants from Janssen and Takeda.
TER has been a speaker for Takeda Pharmaceuticals, Janssen, Pfizer, Bristol Myers Squibb, and Abbvie; has served on advisory boards for AbbVie, Ardelyx, Arena, Boehringer Ingelheim, Bristol Myers Squibb/Celgene, Eli Lilly and Company, Ferring, Genentech/Roche, Gilead, Intercept, Iterative Scopes, Janssen, Pfizer, Prometheus Biosciences, Sanofi, and Takeda; and has been a shareholder for Iterative Scopes.
RP has been a consultant for Abbott, AbbVie, Abivax, Alimentiv (formerly Robarts), Amgen, Arena, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly and Company, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, GSK, BIOJAMP, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda, Theravance Biopharma, Trellus, Viatris, Ventyx, and UCB; has received speakers fees from AbbVie, Amgen, Arena, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda; and has served on advisory boards for AbbVie, Alimentiv (formerly Robarts), Amgen, Arena, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, GSK, BIOJAMP, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Shire, Sublimity Therapeutics, Takeda, and Ventyx.

ENDOSCOPIC AND HISTOLOGIC IMPROVEMENTS WITH PRA023 IN ARTEMIS-UC, A PHASE 2 PLACEBO-CONTROLLED STUDY ON MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Silvio Danese 1, Bruce E. Sands 2, Laurent Peyrin-Biroulet 3, David T. Rubin 4, Deanna Nguyen 5, Quinn Dinh 5, Alina Melnyk 5, J. D. Lu 5, Bin Dong 5, Radoslaw Kempinski 6, Timothy Ritter 7, Remo Panaccione 8

1 Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milano, Italy

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

3 Last Inserm U954 and CHU de Nancy, Lorraine University, Nancy, France

4 University of Chicago Medicine, Chicago, United States

5 Prometheus Biosciences, Inc., San Diego, United States

6 Wroclaw Medical University, Wroclaw, Poland

7 GI Alliance, Southlake, United States

8 University of Calgary, Calgary, Canada

Event

UEG Week Copenhagen 2023

Topics

Endoscopy Histopathology IBD

Submission format

Abstract

Session

The new kids on the block in IBD: Part 2

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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