UEG's educational platform for gastroenterology education bringing recordings, courses, guidelines, and more together in one place.

UEG Week Berlin 2025 Recordings Gut Guide online

Rate for better recommendations!

Your feedback helps us show you more of what you like and less of what you dislike!

More of this!

We will show you more similar content.

Not for me!

We won't suggest this again.

Bookmark!

Save this content for later!

New to myUEG? Create an account! Log In with myUEG account

UEG Poster

Standard Poster

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

Free for all myUEG account holders. Your access level is set automatically based on your occupation. Medical professionals get full access to all content. If you are a non-medical user, you can only access UEG Week content from congresses you attended.

Not sure what you can access? Learn more about account types.

Introduction

Mirikizumab (miri), an anti-IL-23p19 antibody, has shown efficacy and safety in treatment of patients (pts) with moderately-to-severely active Crohn's disease (CD) up to Week 52 (W52) in a Phase 2 study (NCT02891226). We further assessed efficacy and safety, extending to W104.

Aims & Methods

At baseline, pts (N=191) were randomized 2:1:1:2 allocation across 4 treatment arms (1000, 600, 200mg miri and placebo (PBO), intravenously (IV) every 4 weeks (Q4W) at W0, W4, and W8). Pts who received miri and achieved ≥1 point improvement in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at W12 were rerandomized 1:1 into double-blind maintenance to either continue IV treatment assignment Q4W (IV-C; N=41) or to 300mg miri subcutaneous (SC) Q4W (IV-SC; N=46) up to W52. W12 endoscopic non-improvers and pts receiving PBO during induction received IV 1000mg miri Q4W from W12-W52. Subjects reported to experience clinical benefit received 300 mg SC from W52 to W104. For analysis purposes, all IV and SC arms were pooled. The clinical and symptom endpoints [Crohn’s Disease Activity Index (CDAI) remission (CDAI Total Score <150) and patient-reported outcomes (PRO) remission (defined as SF ≤2.5 and AP ≤1 and no worse than baseline)] were evaluated among endoscopic improvers at W12 who were rerandomized into maintenance and went onto the extension period (W52-W104) (Table 1). Results were summarized by descriptive statistics with non-responder imputation (NRI).

Results

Of the 127 pts randomized to miri for induction, 68.5% (87/127) achieved endoscopic improvement at W12 and were rerandomized into maintenance. Of the W12 endoscopic improvers, 74 finished W52 maintenance and entered the extension period (W52 - W104) where 68 went on to complete treatment through W104. Among the W12 miri induction endoscopic improvers, CDAI remission rates were 39.0% (16/41) (IV-C) and 56.5% (26/46) (SC) and PRO remission rates were 46.3% (19/41) (IV-C) and 45.7% (21/46) (SC) at W52. One year later, (W104), CDAI remission rates were 66.7% (22/33) (IV-C) and 61.0% (25/41) (SC) and PRO remission rates were 63.6% (21/33) (IV-C) and 46.3% (19/41) (SC). Of the 74 endoscopic improvers who finished W52 maintenance, 6 discontinued between W52 to W104 (1 due to adverse events (AEs), 2 due to lack of efficacy, 1 due to lost to follow-up, and 2 due to withdrawal by subject). Among endoscopic improvers at W12, 4 pts were hospitalized due to CD in the SC group (2 from W12-W52 and 2 from W52-W104) as reported in Table 1. In all pts who received any miri treatment from W52 to W104 (endoscopic improvers, non-improvers, and PBO treated pts), 79.4% (108/136) experienced ≥ 1 treatment-emergent AEs.

Table 1. Week 52 and Week 104 Efficacy and Safety Results in Week 12 endoscopic improvers.

Table 1	Week 12 Endoscopic Improvers^c
	Week 52	Week 104	Week 52	Week 104
	Miri IV-C N=41	Miri IV-C N=33	Miri SC N=46	Miri SC N=41
PRO remission^a, n (%)	19 (46.3)	21 (63.6)	21 (45.7)	19 (46.3)
CDAI remission^b, n (%)	16 (39.0)	22 (66.7)	26 (56.5)	25 (61.0)
Hospitalization events due to CD, n (%)	0 (0)	0 (0)	2 (4.3)	2 (4.9)
^aPRO remission: defined as SF ≤2.5 and AP ≤1, and no worse than baseline; ^bCDAI remission: A CDAI score of <150 points; ^cEndoscopic improvement: ≥1 point improvement in SES-CD at Week 12 Abbreviations: CD = Crohn’s disease; SF = stool frequency; AP = abdominal pain; CDAI = Crohn’s Disease Activity Index; PRO = patient-reported outcomes

Conclusion

Miri demonstrated durable effectiveness among pts with moderately-to-severely active CD who showed early endoscopic improvement with continued miri dosing up to W104, and with no unexpected safety events. CDAI and PRO remission were sustained through W104, with no differences observed in pts who received either IV-C and SC miri treatments during maintenance and continued into the extension period.

Disclosure

Arthur Kaser: Scientific advisor to AstraZeneca, Janssen J&J, Pfizer, Novartis, Boehringer Ingelheim, Ferring, GlaxoSmithKline, Imhotex, Pandion, Merck, MiroBio, Applied Molecular Transport, Eli Lilly, Glenmark, Galapagos
Bruce E Sands: Received fees for consulting and speaking from Abivax, Bristol Myers Squibb, Janssen, Lilly Pfizer, and Takeda; for consulting from AbbVie; Adiso Therapeutics; Alimentiv; Amgen; Arena Pharmaceuticals; Artizan Biosciences; Artugen Therapeutics; AstraZeneca; Bacainn Therapeutics; Boehringer-Ingelheim; Boston Pharmaceuticals; Calibr; Celltrion Healthcare; ClostraBio; Cytoki Pharma; Connect Biopharma; Entera; Evommune; Fresenius Kabi; Galapagos; Genentech; Gilead Sciences; GlaxoSmithKline; Gossamer Bio; Imhotex; Immunic; Index Pharmaceuticals; Inotrem; Innovation Therapeutics; Ironwood Pharmaceuticals; Kaleido; Kallyope; MiroBio; Morphic Therapeutics; MRM Health; OSE Immunotherapeutics; Progenity; Prometheus Biosciences; Protagonist Therapeutics; Q32 Bio; Redhill Biopharma; Sun Pharma; Surrozen; Synlogic; Target RWE; Teva; Theravance Biopharma; TLL Pharmaceutical; USWM Enterprises; VielaBio: VTA Labs; and personal fees and stock options for consulting from Ventyx Biosciences.
Laurent Peyrin-Biroulet: Personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Pharmacosmos, Celltrion, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, and Theravance; grants from Abbvie, MSD, and Takeda; and stock options from CTMA.
Vipul Jairath: Consulting/advisory board fees: AbbVie, Alimentiv Inc, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus, Reistone Biopharma, Roche, Sandoz, Second Genome, Sorriso pharmaceuticals, Takeda, Teva, Topivert, Ventyx, Vividion; speaker’s fees: Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda, Fresenius Kabi
Monika Fischer: Advisor for Abbvie, Eli Lilly, BMS, Pfizer, Ferring, Seres, Speaker for Janssen and BMS, DSMB for Rebiotix/Ferring
Marijana Protic, Zhantao Lin, Rebecca Hozak, Hilde Carlier, and Emily Hon: employees and shareholders of Eli Lilly and Company.

EFFICACY AND SAFETY OF MIRIKIZUMAB IN PATIENTS WITH CROHN’S DISEASE: 104-WEEK EXTENSION RESULTS FROM A PHASE 2 RANDOMIZED CONTROLLED TRIAL

Arthur Kaser 1, Bruce E. Sands 2, Marijana Protic 3, Laurent Peyrin-Biroulet 4, Zhantao Lin 3, Rebecca Hozak 3, Vipul Jairath 5, Hilde Carlier 3, Emily Hon 3, Monika Fischer 6

1 University of Cambridge Gastroenterology and Hepatology, Cambridge, United Kingdom

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

3 Eli Lilly and Company, Indianapolis, United States

4 University Hospital of Nancy, University of Lorraine, Vandoeuvre-les-Nancy, France

5 Western University & London Health Sciences Centre, London, Canada

6 Indiana University, Indianapolis, United States

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

IL-23: Many but different? (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Standards and Guidelines

Clinical Practice Guideline

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

Not sure what you can access? Learn more about account types.

Main recommendations

Prophylaxis

1 ESGE recommends routine rectal administration of 100mg of diclofenac or indomethacin immediately before endoscopic retrograde cholangiopancreatography (ERCP) in all patients without contraindications to nonsteroidal antiinflammatory drug administration.

Strong recommendation, moderate quality evidence.

2 ESGE recommends prophylactic pancreatic stenting in selected patients at high risk for post-ERCP pancreatitis (inadvertent guidewire insertion/opacification of the pancreatic duct, double-guidewire cannulation).

Strong recommendation, moderate quality evidence.

3 ESGE suggests against routine endoscopic biliary sphincterotomy before the insertion of a single plastic stent or an uncovered/partially covered self-expandable metal stent for relief of biliary obstruction.

Weak recommendation, moderate quality evidence.

4 ESGE recommends against the routine use of antibiotic prophylaxis before ERCP.

Strong recommendation, moderate quality evidence.

5 ESGE suggests antibiotic prophylaxis before ERCP in the case of anticipated incomplete biliary drainage, for severely immunocompromised patients, and when performing cholangioscopy.

Weak recommendation, moderate quality evidence.

6 ESGE suggests tests of coagulation are not routinely required prior to ERCP for patients who are not on anticoagulants and not jaundiced.

Weak recommendation, low quality evidence.

Treatment

7 ESGE suggests against salvage pancreatic stenting in patients with post-ERCP pancreatitis.

Weak recommendation, low quality evidence.

8 ESGE suggests temporary placement of a biliary fully covered self-expandable metal stent for post-sphincterotomy bleeding refractory to standard hemostatic modalities.

Weak recommendation, low quality evidence.

9 ESGE suggests to evaluate patients with post-ERCP cholangitis by abdominal ultrasonography or computed tomography (CT) scan and, in the absence of improvement with conservative therapy, to consider repeat ERCP. A bile sample should be collected for microbiological examination during repeat ERCP.

Weak recommendation, low quality evidence.

ERCP-related adverse events:European Society of Gastrointestinal Endoscopy (ESGE) Guideline

Jean-Marc Dumonceau

Publisher

European Society of Gastrointestinal Endoscopy

Guideline

Clinical Practice Guideline

Topics

Endoscopy

Citation

Endoscopy. 2020 Feb;52(2):127-149

Published

2019

UEG Mistakes In Articles

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

Not sure what you can access? Learn more about account types.

Cholangioscopy is a minimally invasive, endoscopic technique that allows direct visualisation of the bile ducts, facilitating both diagnostic and therapeutic interventions. It is a useful tool in managing biliary diseases, allowing characterisation and tissue acquisition for strictures of undetermined aetiology, facilitating extension assessment for biliary cancer and providing intraductal lithotripsy for complex biliary stones.