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DUAL THERAPY WITH CAROTEGRAST (AJM300: ORAL Α4 INTEGRIN ANTAGONIST) AND BIOLOGICS FOR REFRACTORY ULCERATIVE COLITIS

Toshimitsu Fujii 1, Shuji Hibiya 1, Hiromichi Shimizu 1, Ami Kawamoto 1, Kento Takenaka 1, Eiko Saito 1, Masakazu Nagahori 1, Kazuo Ohtsuka 1, Ryuichi Okamoto 1

Affiliations

1 Tokyo Medical and Dental University, Tokyo, Japan

Summary

AI Generated

A small case series from Tokyo Medical and Dental University examined dual therapy combining carotegrast with other biologics in six patients with treatment-refractory ulcerative colitis.

All five patients who continued treatment achieved pMayo score of 0 at 2 weeks and maintained it through 6-8 weeks, then transitioned to biologic maintenance therapy.
The six patients had median pMayo score of 5.0 at baseline, with half being steroid-refractory and half steroid-dependent, and all had prior inadequate response or loss of response to biologics.
Carotegrast was combined with ustekinumab in four cases and infliximab in two cases, with median 14.5 days between last biologic dose and carotegrast initiation.
One patient discontinued carotegrast due to epigastric pain; no other side effects were observed during mean 38.8 days of carotegrast administration.
The authors conclude dual therapy may be effective and safe in biologics-failure ulcerative colitis, though this reflects a very small sample with short-term follow-up.

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Abstract

Introduction

A diverse variety of biologics and small molecules have been developed for the treatment of refractory ulcerative colitis; however, it is still reported that 10% of these patients will undergo surgery within a decade for inadequate induction and maintenance of remission due to reasons such as drug ineffectiveness, loss of response, and side effects. Dual therapy using a combination of biologics has been attempted for rheumatoid arthritis with lack of success, owing to insufficient efficacy and increase in side effects. In inflammatory bowel disease, biologics have been developed against adhesion molecules, which are considered to have high intestinal selectivity and safety, with potential for safe co-administration with other drugs. Carotegrast (AJM300), an oral α4 integrin antagonist, has been developed and approved as a novel therapy for ulcerative colitis, however there have been no reports so far on the dual use of carotegrast with other biologics.

Aims & Methods

We investigated the efficacy and safety of carotegrast in combination with other biologics in treating refractory ulcerative colitis. Six patients (3 males, median age 27 years) who underwent dual therapy with carotegrast and another biologic (4 cases of ustekinumab and 2 cases of infliximab) for treatment refractory ulcerative colitis at the Advanced Clinical Center for Inflammatory Bowel Diseases, Tokyo Medical and Dental University after May 2022 were included, Patient background, short-term efficacy, and safety profile were investigated.

Results

The median pMayo at induction was 5.0 (3-6). 50% of patients were steroid-refractory, 50% were steroid-dependent. 5 patients had inadequate or no response to previous biologics and 1 patient had a loss of response to biologics. The median time between the last dose of biologic and the start of carotegrast was 14.5 days, and the mean duration of carotegrast administration was 38.8 days. Carotegrast was discontinued in one patient due to epigastric pain. All 5 patients who were eligible for continued treatment achieved pMayo0 at 2 weeks, and also maintained pMayo0 at the end of the 6-8 week treatment period, and were placed on maintenance therapy with biologics. No side effects other than epigastric pain were observed.

Conclusion

Dual therapy with carotegerast and another biologic may be effective and safe in ulcerative colitis patients with biologics failure.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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OUTCOMES OF ENDOSCOPIC MANAGEMENT OF SIGMOID VOLVULUS: COHORT OF 404 PATIENTS – VOLVOR STUDY

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OUTCOMES OF ENDOSCOPIC MANAGEMENT OF SIGMOID VOLVULUS: COHORT OF 404 PATIENTS – VOLVOR STUDY

Karine Louvion 1, Hadrien Alric 2, Charles Houdeville 1, Marie Goudot 1, Aïmene KHIARI 1, Salome Ouazana 1, Nelson Lourenço 3, Maximilien Barret 4, Sara Lemoinne 5, Aymeric Becq 6, Nils Steuer 7, Jean Charles Nault 8, Antoine Guilloux 1, Xavier Dray 1, Marine Camus 1

Affiliations

1 Sorbonne University, Saint Antoine Hospital, Paris, France

2 Hôpital Européen Georges-pompidou, Paris, France

3 Université Paris Cité, Paris, France

4 Cochin Hospital, Paris, France

5 INSERM, UMRS 938, Université Pierre et Marie Curie, Paris, France

6 Henri Mondor Hospital, Créteil, France

7 Montfermeil, Montfermeil, France

8 Inserm U, Paris, France

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Abstract

Introduction

Sigmoid volvulus is usually managed by endoscopic detorsion in the absence of complications, while surgery is reserved for severe cases. However, recurrence rates remain high, ranging from 18% to 90% (1). The guidelines from the American Society of Colon and Rectal Surgeons (1) recommend prophylactic surgery, although the optimal timing is not defined. In Europe, most cases are sporadic and affect elderly patients with comorbidities. However, large studies mainly originate from endemic regions, which limits their applicability to Western settings. Moreover, there is a lack of large-scale data focusing specifically on the endoscopic management of sigmoid volvulus.

Aims & Methods

The study aimed to evaluate the outcomes of patients with sigmoid volvulus managed by endoscopic detorsion during out-of-hours emergency endoscopy shifts across multiple centers.
We conducted a retrospective, multicenter study (8 centers), including all patients who underwent endoscopy for suspected sigmoid volvulus during on-call digestive endoscopy shifts between March 2016 and December 2023. Procedures were performed by the POET group (Parisian On-call Endoscopy Team), a mobile unit composed of an endoscopist and a nurse, covering urgent endoscopy during nights and weekends in Paris and suburbs (6.9 million inhabitants), using a portable system (2).

Results

A total of 404 patients were included. Median age was 72 years (IQR 59; 83), 69% were male, 19% institutionalized, 40% had neurocognitive disorders, 26% had anatomical abnormalities of the colon and 45% had constipation. The most common presenting symptoms were abdominal pain (53%), bowel obstruction (17%), and constipation (20%). Endoscopic detorsion was successful in 92% of cases, with a 2% perforation rate and 89% of clinical success. Predictors of technical failure included ischemia at endoscopy (OR 0,16 [0,07-0,37], p<0,0001) and history of abdominal surgery (OR=0,44 [0,2;0,99], p=0,0463). Ischemia was independently associated with initial CRP ≥ 27 mg/L (OR=2,24 [1,11-4,54], p=0,0253), time to endoscopy ≥ 10h (OR=2,38 [1,28-4,39], p=0,0058), and radiological signs of severity (OR=4,13 [1,82-9,36], p=0,0007). All 24 patients with colonic necrosis at endoscopy died without emergency surgery, regardless of the success of detorsion (58% in this subgroup). In 28% of cases, endoscopy was performed for recurrence. Among patients with a first episode, recurrence occurred in 40%, with 50% occurring within 12 days. Endoscopic success was associated with a higher risk of recurrence (OR=4,39 [1,18-16,32], p=0,0271). In-hospital and 30-day mortality was <10%; overall mortality at the latest follow-up was 31% (median follow-up : 9 months, IQR 2-31).

Conclusion

Emergency endoscopic detorsion is highly effective with low morbidity. However, in the presence of colonic necrosis, endoscopic treatment is ineffective and uniformly fatal without surgical intervention. Optimal patient selection is therefore critical, and relies on early identification of predictive factors for ischemia. Volvulus recurrence is frequent and early, highlighting the need for systematic prophylactic treatment following successful detorsion. Elective surgery during the same hospitalization should be considered whenever possible. For patients with surgical contraindications, endoscopic sigmoidopexy may offer a viable alternative.

References

Alavi K, Poylin V, Davids JS, Patel SV, Felder S, Valente MA, Paquette IM, Feingold DL; Prepared on behalf of the Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Colonic Volvulus and Acute Colonic Pseudo-Obstruction. Dis Colon Rectum. 2021 Sep 1;64(9):1046-1057. doi: 10.1097/DCR.0000000000002159. PMID: 34016826.
Camus M, Becq A, Jaïs B; Parisian On-Call Endoscopy Team; Dray X. Resource-sparing urgent endoscopies by a mobile on-call team in the Paris area during the COVID-19 outbreak. Gastrointest Endosc. 2020 Aug;92(2):447-448. doi: 10.1016/j.gie.2020.04.021. Epub 2020 Apr 16. PMID: 32305344; PMCID: PMC7161514.

Event

UEG Week Berlin 2025

Topics

Colorectal Endoscopy Surgery

Submission format

Abstract

Session

Lower GI: Surgical considerations

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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RISANKIZUMAB, BUT NOT USTEKINUMAB OR VEDOLIZUMAB, DOWNREGULATES IL-23-INDUCED MUCOSAL PATHOGENIC TH17 CELLS IN PATIENTS WITH CROHN’S DISEASE

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RISANKIZUMAB, BUT NOT USTEKINUMAB OR VEDOLIZUMAB, DOWNREGULATES IL-23-INDUCED MUCOSAL PATHOGENIC TH17 CELLS IN PATIENTS WITH CROHN’S DISEASE

Daniele Noviello 1, Irene Dusetti 1, Valerie Pivorunas 2, Ambra Eleonora Lovati 3, Clorinda Ciafardini 3, Chiara Amoroso 3, Francesco Conforti 3, Nicole Piazza O Sed 3, Maurizio Vecchi 1, Federica Facciotti 4, Moira Paroni 1, Flavio Caprioli 1

Affiliations

1 University of Milan, Milano, Italy

2 AbbVie, Chicago, United States

3 Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

4 University Of Milano Bicocca, Milan, Italy

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Abstract

Introduction

We recently described an interleukin(IL)-23-inducible pathogenic subset of CCR6⁺CXCR3^-CCR5⁺mucosal T helper (Th)17 cells (pTh17) infiltrating Crohn’s disease (CD) inflamed mucosa and specifically activated in response to Adherent-Invasive Escherichia Coli. pTh17 cells are functionally and phenotypically distinct from CCR6⁺CXCR3^-CCR5^-Th17 cells (cTh17) and from IL-12-induced CCR6⁺CXCR3⁺Th1/17 subset. Here, we investigated pTh17 cells' recirculation into the bloodstream, localization into the intraepithelial lymphocyte (IEL) compartment, and in-vivo modulation by different biological therapies.

Aims & Methods

Adult patients with active CD initiating either vedolizumab as per clinical practice or ustekinumab and risankizumab during the SEQUENCE trial were prospectively recruited at Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano. In vedolizumab-treated patients, peripheral blood and intestinal biopsies were collected at baseline and at the end of induction. In ustekinumab- and risankizumab-treated patients, intestinal biopsies were collected outside study protocol assessments at baseline and week 24. Endoscopic response was defined as a greater than 50% decrease in the Simple Endoscopic Score from baseline. Peripheral blood mononuclear cells, lamina propria mononuclear cells (LPMC), and IEL were isolated and analyzed through flow cytometry.

Results

Overall, 34 CD patients were assessed. Demographic and baseline disease characteristics are summarized in Table 1. At baseline, as compared with cTh17, pTh17 cells: 1. are rarely found in the peripheral blood and express low levels of CCR9 and α4β7, 2. express high levels of tissue-resident markers CD69⁺CD103⁺ in the mucosa, and 3. infiltrate the IEL layer upon binding of CD103 with E-cadherin. Baseline pTh17 cells were upregulated in patients not achieving vedolizumab-induced endoscopic response. Upon vedolizumab treatment, a selective downregulation of mucosal cTh17 cells but not pTh17 was observed. Remarkably, risankizumab induced a specific downregulation of pTh17 cells, but not cTh17, in both LPMC and IEL layers. Conversely, ustekinumab reduced Th1/17 mucosal subsets, but not pTh17 cells (Figure 1).

Conclusion

pTh17 cells are largely unable to recirculate through the bloodstream, express markers of gut-tissue residency, and infiltrate the IEL compartment. IL-23 neutralization by risankizumab specifically downregulates mucosal pTh17 cells, as compared with vedolizumab and ustekinumab. Our immunologic results might provide mechanistic clues to vedolizumab latency effect in CD, and potentially explain early signs of risankizumab superiority over ustekinumab in the SEQUENCE study in terms of endoscopic response at 24 weeks.

Disclosure

DN received research grant from Pfizer, consulting fees from Dr. Falk, lecturer fees from Ferring. VP is employee of AbbVie. MV served as a consultant for Abbvie, MSD, Takeda, Janssen-Cilag, and Celgene. He received lecturer fees from Abbvie, Ferring, Takeda, MSD, Janssen-Cilag, and Zambon. FCa has served as consultant for Mundipharma, AbbVie, MSD, Takeda, Janssen, Roche, and Celgene; received lecture fees from AbbVie, Ferring, Takeda, Allergy Therapeutics, and Janssen; and received unrestricted research grants from Giuliani, SOFAR, MS&D, Takeda, Pfizer, and AbbVie.

Event

UEG Week Vienna 2024

Topics

Histopathology IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Ameliorating acute disease through novel treatment in IBD: Part 2

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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SAFETY AND TOLERABILITY OF MH002, A LIVE BIOTHERAPEUTIC PRODUCT, IN INFLAMMATORY BOWEL DISEASE: SUMMARY OF DATA FROM TWO PHASE 2 CLINICAL TRIALS

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SAFETY AND TOLERABILITY OF MH002, A LIVE BIOTHERAPEUTIC PRODUCT, IN INFLAMMATORY BOWEL DISEASE: SUMMARY OF DATA FROM TWO PHASE 2 CLINICAL TRIALS

Severine Vermeire 1, Silvio Danese 2, Fernando Magro 3, Sam Possemiers 4, Selin Bolca 4, Ludo Haazen 4

Affiliations

1 University Hospital Leuven, Leuven, Belgium

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

3 Faculty of Medicine of the University of Porto, Porto, Portugal

4 MRM Health, Ghent, Belgium

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Abstract

Introduction

Inflammatory bowel diseases (IBD) have an ongoing, unmet medical need for new medicinal products with a different mode of action and a favourable safety profile. MH002 is a live biotherapeutic product (LBP) consisting of 6 commensal bacteria and is entering phase 3 clinical development as a therapeutic treatment developed to restore dysbiosis and depletion of butyric acid producing-bacteria that are associated with IBD. The non-pathogenic nature of the MH002 strains and absence of systemic bioavailability are expected to result in a particularly favourable safety profile.

Aims & Methods

To assess the safety of MH002 in ulcerative colitis (UC) and pouchitis (PC).
Safety data from 45 UC patients randomized (2:1) to double-blind treatment with 400mg MH002 or placebo daily for up to 16 weeks (MH002-UC-201), and from 14 PC patients treated open label with 400mg MH002 daily for 8 weeks (MH002-PC-201) were collected prospectively, the primary endpoint being occurrence of treatment emergent adverse events (AEs). UC patients were on stable 5-ASA treatment with or without low-dose corticosteroid throughout the study. Concomitant and recent antibiotic use was prohibited in all, as was treatment with advanced therapies. Placebo-treated UC patients who did not have a clinical response after 8 weeks were switched to MH002 treatment for 8 weeks.

Results

A total of 52 patients were exposed to MH002 with a total of about 136 patient-months of exposure. At baseline, the mean (range) modified Mayo score in UC patients was 5.76 (4.0-8.0) and the modified mean (range) Pouchitis Disease Activity Index score in PC patients was 6.91 (5.3-9.3). In UC patients, 20% were on stable, low dose corticosteroid, none was in the PC study. In both studies, no deaths, no severe AEs, no related serious AEs were reported in MH002-treated subjects, and no discontinuation occurred for an AE in MH002-treated participants. In particular, no bacteremia or sepsis was reported. Most AEs were mild and unrelated. Numerically less patients experienced an AE with MH002 than with placebo in UC.

	MH002-UC-201		MH002-PC-201	Total
Nr (%) of subjects	MH002 (n=31)	Placebo (n=14)	MH002 (n=14)	MH002 (n=45)
with a severe Adverse Event (AE)	0	0	0	0
discontinuing for an AE	0	1 (7%)	0	0
with at least 1 AE	11 (35%)	8 (57%)	11 (79%)	22 (49%)
with a Serious AE (not related)	1 (3%)	1 (7%)	1 (7%)	2 (4%)
with a possibly related AE	1 (3%)	1 (7%)	3 (21%)	4 (9%)
with an AE of gastro-intestinal disorders	2 (6%)	4 (29%)	4 (29%)	6 (13%)

Possibly related AEs reported with MH002 included rash (UC) and abdominal pain, diarrhoea, flatulence and nausea (PC), while abdominal distension was reported with placebo (UC). Type 2 diabetes, arterial hypertension (MH002) and Clostridioides difficile infection (placebo) were the unrelated serious AEs that were reported. No clinically significant changes were observed during physical examination, vital signs assessment and in routine laboratory safety analyses (biochemistry, hematology and urinalysis) with MH002 or placebo. Efficacy data showed positive trends for clinical and endoscopic improvement and have been reported previously.

Conclusion

MH002 was well tolerated and safe in the first-in-disease phase 2 clinical trials conducted in UC and PC. MH002 may exhibit a particularly favourable safety profile if these results are confirmed in larger, late-stage clinical studies.

Disclosure

SV: financial support for research from AbbVie, J&J, Pfizer, Takeda and Galapagos; speakers’ and/or consultancy fees from AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, Mestag Therapeutics, MiroBio, Morphic, MRM Health, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Surrozen, Takeda, Theravance, Tillots Pharma AG, VectivBio, Ventyx, Zealand Pharma.
SD: consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor; reports lecture fees from Abbvie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
FM: served as speaker and received honoraria from: Abbvie, Arena, Biogen, Bristol-Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, Sandoz, Takeda, UCB, Vifor.
SP, SB & LH: employee, paid consultant and/or shareholder of MRM Health.

Event

UEG Week Vienna 2024

Topics

Gut Microbiota IBD

Submission format

Abstract

Session

Microbiome: Bench to the future

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Marine Camus

RISANKIZUMAB, BUT NOT USTEKINUMAB OR VEDOLIZUMAB, DOWNREGULATES IL-23-INDUCED MUCOSAL PATHOGENIC TH17 CELLS IN PATIENTS WITH CROHN’S DISEASE

Flavio Caprioli

SAFETY AND TOLERABILITY OF MH002, A LIVE BIOTHERAPEUTIC PRODUCT, IN INFLAMMATORY BOWEL DISEASE: SUMMARY OF DATA FROM TWO PHASE 2 CLINICAL TRIALS

Silvio Danese

The carbon footprint of endoscopy

Bu Hayee

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Paul Meunier

Is IBS a gut-specific disease or a multisystemic disorder?

Magnus Simrén

UEG Presentation

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

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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The carbon footprint of endoscopy

Bu Hayee 1

Affiliations

1 Kings College Hospital, London, United Kingdom

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Abstract

Event

UEG Week Berlin 2025

Topics

Endoscopy Nurses

Session

Is your GI-practice sustainable?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Marine Camus

RISANKIZUMAB, BUT NOT USTEKINUMAB OR VEDOLIZUMAB, DOWNREGULATES IL-23-INDUCED MUCOSAL PATHOGENIC TH17 CELLS IN PATIENTS WITH CROHN’S DISEASE

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SAFETY AND TOLERABILITY OF MH002, A LIVE BIOTHERAPEUTIC PRODUCT, IN INFLAMMATORY BOWEL DISEASE: SUMMARY OF DATA FROM TWO PHASE 2 CLINICAL TRIALS

Silvio Danese

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Bu Hayee

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

Paul Meunier

Is IBS a gut-specific disease or a multisystemic disorder?

Magnus Simrén

UEG Presentation

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

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

This content is part of Gutflix. Log in with your myUEG account, or create one free, to watch it.

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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

Affiliations

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

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Abstract

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

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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Is IBS a gut-specific disease or a multisystemic disorder?

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Is IBS a gut-specific disease or a multisystemic disorder?

Laurie Keefer 1, Magnus Simrén 2

Affiliations

1 Icahn School of Medicine, New York, United States of America

2 Sahlgrenska University Hospital - Dept of Internal Medicine, Sahlgrenska University Hospital ; Gothe, Gothenburg, Sweden

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Abstract

Event

UEG Week Vienna 2024

Topics

Primary Care

Session

Is IBS a gut-specific disease or a multisystem disorder?

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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