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ENDOSCOPIC PATIENT CLUSTERING TO INVESTIGATE DIFFERENTIAL TREATMENT EFFECTS OF GUSELKUMAB AND USTEKINUMAB IN CROHN’S DISEASE: POST-HOC ANALYSIS OF GALAXI AND GRAVITI TRIALS

Dylan Richards 1, Loqmane Seridi 1, Klebea Sohn 1, Bradford McRae 1, Natalie Terry 1, Marion Vetter 1, Daniel Cua 1, Patrick Branigan 1, Walter Reinisch 2, Raja Atreya 3

Affiliations

1 Janssen Research & Development, LLC, Spring House, United States

2 Medical University of Vienna, Wien, Austria

3 University Erlangen-Nuremberg, Erlangen, Germany

Summary

AI Generated

Endoscopic clustering identified seven Crohn's disease subtypes with differential treatment responses, showing guselkumab demonstrated superior endoscopic efficacy over ustekinumab, particularly in ileal and strictured disease.

Seven endoscopic Crohn's disease subtypes were identified using segmental Simple Endoscopic Score clustering in 1758 patients from Phase 3 GALAXI trials, revealing heterogeneity beyond Montreal classification.
Guselkumab showed higher overall endoscopic remission rates than ustekinumab at Week 12 and Week 48 across all patients.
In 38% of patients with ileum-only disease or strictured right colon, guselkumab achieved endoscopic remission rates of 19-20% at Week 12 while ustekinumab showed placebo-like efficacy at 2-7%.
In the mixed ileocolonic/colonic group representing 62% of patients, guselkumab and ustekinumab showed similar Week 12 remission rates (26% versus 27%), but guselkumab was superior at Week 48 (39-44% versus 30%).
Guselkumab responders with baseline stricturing showed greater reduction in narrowing than non-responders, contributing to 21% versus 5% reduction in total endoscopic scores, suggesting potential effects on stricture biology.

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Abstract

Introduction

Differences in endoscopic response and biological features across ileal, ileocolonic, and colonic Crohn’s disease (CD) suggest distinct mechanisms for healing. We developed an endoscopic clustering method using segmental intestinal endoscopic scores in patients with moderately to severely active CD to investigate the potential influence of regional mucosal heterogeneity on treatment effect. We then evaluated endoscopic outcomes across subtypes between placebo (PBO), guselkumab (GUS), and ustekinumab (UST) in the Phase 3 GALAXI 2 and 3 studies.

Aims & Methods

Endoscopic clustering was established using baseline segment Simple Endoscopic Score for CD (SES-CD) values from terminal ileum, right colon, transverse colon, left/sigmoid colon, and rectum from cohort 1 (1233 patients, GALAXI 1, GALAXI 2, GRAVITI trials) and cohort 2 (525 patients, GALAXI 3). Patient clusters were identified using consensus hierarchical clustering, and a machine learning classification model was developed for patient cluster assignment of cohort 2. GALAXI 2 and GALAXI 3 patients were combined to evaluate Week (WK) 12 and WK48 endoscopic outcomes between PBO, GUS, and UST.

Results

We identified 7 CD endoscopic subtypes (ileum only, ileum dominant, right colon dominant, mid-colon, colonic, ileocolonic, rectum dominant), highlighting heterogeneity within Montreal classification. In total, GUS showed higher endoscopic remission rates than UST at WK12 and at WK48. Patient clusters were used with baseline stricturing data (SES-CD narrowing > 0) to consolidate groups with differential treatment effects: Group 1 (62% of patients, mixed ileocolonic/colonic) showed similar endoscopic remission rates at WK12 between GUS (26%) and UST (27%) with higher rates for GUS at WK48 (39-44% GUS, 30% UST); Group 2 (ileum only) and Group 3 (characterized by strictured right colon), totaling 38% of patients, showed higher endoscopic remission rates with GUS at WK12 (19%, 20%), where UST showed placebo-like efficacy (7%, 2%), with higher rates with GUS at WK48 (Group 2: 20-26% GUS, 18% UST; Group 3: 28-30% GUS, 12% UST). Endoscopic responders to GUS, and not UST, at WK12 in Group 2 and 3 patients with baseline stricturing showed greater reduction in narrowing than non-responders, contributing to 21% vs 5% reduction in total SES-CD.

Conclusion

Endoscopic patient clustering provides higher resolution of CD subtypes to delineate differential treatment effects. GUS demonstrated endoscopic efficacy across all patients at WK12, where UST showed placebo-like efficacy in 38% of patients, supporting superior endoscopic efficacy over UST across all patients by WK48. Reductions in narrowing with GUS proposes a role of GUS in affecting stricture biology in addition to broader segment-specific molecular treatment effects that will be explored in future research.

Disclosure

Dylan Richards, Loqmane Seridi, Klebea Sohn, Brad Mcrae, Natalie A. Terry, Marion Vetter, Daniel Cua, Patrick Branigan are employees of Janssen and may hold stock in Johnson & Johnson.
Walter Reinisch reports serving as a speaker for AbbVie, Celltrion, Ferring, Janssen, Galapagos Medice, MSD, Roche, Pfizer, Sobi, Takeda; serving as a consultant for AbbVie, Amgen, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Janssen, Medahead, Microbiotica, Pfizer, and Takeda; serving as an advisory board member for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, and Pfizer; and receiving research funding from AbbVie, Janssen, Sandoz, Sanofi, and Takeda.
Raja Atreya has served as a speaker or consultant, or received research grants from AbbVie, Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, DrFalk Pharma, Galapagos, Gilead, InDex Pharmaceuticals, Janssen-Cilag, Lilly, Merck Sharp & Dohme, Novartis, Pandion Therapeutics, Pfizer, Roche, Samsung Bioepis, Takeda, and Viatris.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Scoping IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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POST-INFECTION DISORDERS OF GUT BRAIN INTERACTION: RESULTS OF THE ROME FOUNDATION GLOBAL STUDY

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POST-INFECTION DISORDERS OF GUT BRAIN INTERACTION: RESULTS OF THE ROME FOUNDATION GLOBAL STUDY

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Affiliations

1 University of Bologna, Bologna, Italy

2 Universidad Nacional Autónoma de México (UNAM), Mexico City, Mexico

3 Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India

4 McMaster University, Hamilton, Canada|||McMaster University, Hamilton, Canada

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