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Stricturing Crohn's disease: Surgery and medical therapy

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Stricturing Crohn's disease: Surgery and medical therapy

Christianne Johanna Buskens 1, Krisztina Barbara Gecse 2

1 Academic Medical Center, Amsterdam, Netherlands

2 Amsterdam University Medical Center, Amsterdam, Netherlands

Event

UEG Postgraduate Teaching Programme Vienna 2024

Topics

Education & Training IBD Immunology Mechanisms & Personalised Medicine Surgery

Session

Decision time in IBD: Difficult cases

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

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Introduction

Although endoscopic balloon dilation (EBD) remains the standard intervention for Crohn’s disease (CD)-associated strictures, its efficacy is limited by high recurrence and surgery rates. Retrospective analyses suggest endoscopic stricturotomy (ES) may offer superior outcomes, particularly in anastomotic strictures. However, no randomized trials have directly compared EBD and ES for short CD-related strictures.

Aims & Methods

This single-center, randomized controlled trial (August 2022–March 2025) enrolled adult CD patients (18–65 years) with symptomatic, predominantly fibrotic or mixed, short strictures (<3 cm), including both de novo and anastomotic types, accessible via standard endoscopy. Patients with multiple (>2) strictures, strictures beyond endoscopic reach, or prior stricturotomy were excluded. Participants were randomized to undergo either EBD or ES. The primary outcome was clinical recurrence at 1 year. Secondary outcomes included re-intervention, surgery, emergency visits, hospitalization, technical success, and adverse events.

Results

Out of 70 randomized patients, 69 were analyzed (EBD: 35; ES: 34). Baseline characteristics were comparable between groups. Technical success was similar (EBD: 91.4%, ES: 94.1%). On time to event analysis, clinical recurrence was significantly lower in the ES group (OR=0.343, 95% CI: 0.134–0.881; p=0.026). Re-intervention rates favored ES (EBD: 25.7%, ES: 8.8%; OR=0.337, 95% CI: 0.131–0.870; p=0.025). Surgery rates were numerically lower with ES (EBD: 11.4%, ES: 5.9%) but not statistically significant (p=0.581). Hospitalization was significantly more frequent in the EBD arm (OR=0.276, 95% CI: 0.091–0.840; p=0.023). ED visits also trended lower with ES, though not statistically significant (p=0.062) (see table). Adverse events occurred in 25.7% of EBD patients (bleeding n=3 [1 hemoclip], pain with admission n=3, micro-perforation n=1, post-procedure pain n=2) and 14.7% of ES patients (bleeding n=3 [1 self-limited, 1 coagrasper, 1 hemoclip], none required transfusion, suspected perforation n=1, mild pain n=1).

Outcome	EBD (n=35)	ES (n=34)	p-value	Odds Ratio (95% CI)
Technical Success (%)	91.4% (32/35)	94.1% (32/34)	0.70	-
Clinical Recurrence (%)	48.6%	23.5%	0.026	0.343 (0.134–0.881)
Re-intervention Rate (%)	25.7%	8.8%	0.025	0.337 (0.131–0.870)
Surgery (%)	11.4%	5.9%	0.581	0.707 (0.207–2.422)
Stricture-related ED Visits (%)	20.0%	11.8%	0.062	0.404 (0.156–1.047)
Stricture-related Hospitalizations (%)	25.7%	8.8%	0.023	0.276 (0.091–0.840)
Any Adverse Event (%)	25.7% (9/35)	14.7% (5/34)	0.45	-

Conclusion

In this interim analysis, ES was associated with significantly lower clinical recurrence, re-intervention, and hospitalization compared to EBD for short CD-related strictures, with similar safety outcomes. These findings support ES as a potentially superior first-line endoscopic strategy over EBD in selected patients with Crohn’s disease strictures. (NCT05521867)

References

Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085. PMID: 29546384.

RANDOMIZED CONTROLLED TRIAL COMPARING ENDOSCOPIC BALLOON DILATION VERSUS ENDOSCOPIC STRICTUROTOMY FOR SHORT STRICTURES (&LT; 3 CM) RELATED TO CROHN’S DISEASE (THE BEST-CD TRIAL) (NCT05521867)

Partha Pal 1, Kanapuram Pooja 1, Rajesh Gupta 1, Manu Tandan 1, D. Nageshwar Reddy 1

1 Asian Institute of Gastroenterology, Hyderabad, India

Event

UEG Week Berlin 2025

Topics

Endoscopy Radiology & Imaging IBD

Submission format

Abstract

Session

Advances in the investigation of the small bowel

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Long-term outcome post-LTx in adults

Patrizia Burra 1

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

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Surgery

Session

New developments in liver transplantation

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Biologic drugs

Luc Biedermann 1

1 USZ Zürich, Zürich, Switzerland

Event

UEG Week Berlin 2025

Topics

Mechanisms & Personalised Medicine Small Intestine & Nutrition Oesophagus Paediatrics

Session

Therapy update: EoE

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Psychology

Laurie Keefer 1

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

Event

UEG Week Vienna 2024

Topics

Neurogastroenterology & Motility Primary Care

Session

The patient with a challenging functional disorder

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL

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Introduction

Mirikizumab, an anti-IL-23p19 antibody, has demonstrated efficacy and safety in moderately-to-severely active ulcerative colitis (UC) Phase 3 trials (LUCENT-1 and -2; NCT03518086, NCT03524092). A treatment goal for patients with UC is corticosteroid (CS)-free remission. We assessed the CS-sparing effect of mirikizumab among the extended induction patient population receiving CS at induction baseline.

Aims & Methods

In LUCENT-1, patients in the modified intention to treat mirikizumab group (n=868) received mirikizumab 300 mg intravenously (IV) at Week (W)0, W4, and W8. Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Patients not achieving clinical response (≥2-point and ≥30% decrease in Modified Mayo Score from baseline; and rectal bleeding=0 or 1, or ≥1-point decrease from baseline) at W12 (n=272) entered LUCENT-2 open label (OL) extended induction and received 300 mg mirikizumab IV at W12, W16, and W20. Extended induction responders at W24 (n=144) entered OL maintenance and received 200mg mirikizumab subcutaneously (SC) Q4W until W52. CS taper was initiated if clinical response was achieved at W24 or earlier based on investigator discretion if symptomatic improvement was evident. Patients who discontinued CS and remained off throughout the study were considered “discontinued.” Descriptive statistics for efficacy outcomes were summarized. Missing data were imputed as non-response.

Results

Of the 272 mirikizumab patients in the extended induction population, 118 received CS at induction baseline. The mean prednisone equivalent dose was 15mg. At W24, among the 62/118 (52.5%) who achieved clinical response and continued with maintenance, 8 (12.9%) discontinued CS, 2 (3.2%) achieved clinical remission off CS, and 8 (12.9%) achieved symptomatic remission off CS. At W52, 43/62 (69.4%) of the extended induction responders discontinued CS, 18 (29.0%) achieved clinical remission off CS, and 37 (59.7%) achieved symptomatic remission off CS. Among patients with non-missing data who completed W52 of mirikizumab treatment, 89.6% had discontinued CS (Table).
Table. Corticosteroid-Sparing Effect of Mirikizumab in Extended Induction Population Receiving Corticosteroids at Induction Baseline

		Mirikizumab Extended Induction Responders^a (N=62)
		Observed n/Nx (%)	NRI n (%)
Week 24	Clinical remission^b and off CS	2/62 (3.2)	2 (3.2)
	Symptomatic remission^c and off CS	8/62 (12.9)	8 (12.9)
	Discontinued CS^d	8/53 (15.1)	8 (12.9)
Week 52	Clinical remission^b and off CS	18/50 (36.0)	18 (29.0)
	Symptomatic remission^c and off CS	37/52 (71.2)	37 (59.7)
	CS-free remission^e	16/49 (32.7)	16 (25.8)
	Discontinued CS^d	43/48 (89.6)	43 (69.4)
Abbreviations: CS=corticosteroid; N =number of patients in analysis population; n=number of patients in the specified category; NRI=non-responder imputation; Nx=number of patients with non-missing values ^a Patients without response at week 12 treated with mirikizumab extended induction and responded at week 24. Clinical response defined as ≥2-point and ≥30% decrease in Modified Mayo Score from baseline; and rectal bleeding=0 or 1, or ≥1-point decrease from baseline ^b Defined as stool frequency subscore=0 or 1 with ≥1-point decrease from induction baseline, a rectal bleeding subscore=0, and an endoscopic subscore=0 or 1 (excluding friability) ^c Defined as stool frequency subscore=0 or 1 with ≥1-point decrease from induction baseline, a rectal bleeding subscore=0 ^d Patients discontinued CS and remained off through Week 52 ^eClinical remission at Week 52 + symptomatic remission at Week 40 + off CS for ≥12 weeks

Conclusion

Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation.

Disclosure

DL declares counseling, boards, transports or fees from Abbvie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, Tillots.
CS reports advisory board and consultant fees for Abbvie, BMS, Lilly, Janssen, Pfizer, Prometheus, Takeda and Trellus Health; speaker for CME activities for Abbvie, Janssen, Pfizer and Takeda; received grant support from Abbvie, Janssen, Pfizer and Takeda; intellectual property for a “System and Method of Communicating Predicted Medical Outcomes”; co-founder of MiTest Health, LLC (software company) that has technology (PROSPECT/CDPATH) that has been licensed to Takeda.
PD reports consulting fees from Johnson and Johnson, Gilead, Lilly, BMS, Novartis, Pfizer, and Takeda; financial support for research from Takeda and Pfizer; stock options for DigbiHealth; and licensing royalties from PreciDiag.
KM has received speaker fees and research grants from AbbVie, EA Pharma, Mochida, Mitsubishi-Tanabe, ZERIA, Nippon Kayaku, and JIMRO; speaker fees from Takeda, Janssen, Pfizer, Kyorin, Kissei, Gilead, Eli Lilly, and Celltrion Healthcare.
JPG has served as speaker, consultant, and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine and Vifor Pharma.
KHS, IR,SB are employees and minor shareholders of Eli Lilly and Company
JP is an employee of Syneos Health and contractor for Eli Lilly and Company
VJ has received consulting/advisory board fees from AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Asieris, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Reistone Biopharma, Roche, Sandoz, Takeda and TopiVert, and speaker’s fees from AbbVie, Ferring, Galapagos, Janssen, Pfizer, Shire and Takeda.

CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL

David Laharie 1, Corey A Siegel 2, Parambir Singh Dulai 3, Matsuoka Katsuyoshi 4, Javier P. Gisbert 5, Karen Samaan 6, Isabel Redondo 6, Simin K. Baygani 6, Jerome Paulissen 7, Vipul Jairath 8

1 CHU de Bordeaux Hopital Haut-Leveque Dept. de Gastroenterologie, Bordeaux, France

2 Dartmouth-Hitchcock Medical Center, Lebanon, United States

3 Northwestern Medicine Digestive Health Center, Chicago, United States

4 Tokyo Medical and Dental University, Tokyo, Japan

5 Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-Princesa], Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBEREHD], Madrid, Spain

6 Eli Lilly and Company, Indianapolis, United States

7 Syneos Health, Morrisville, United States

8 University of Western Ontario, London, Canada