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CORTICOSTEROID SPARING EFFECTS OF TREATMENT WITH GUSELKUMAB IN PATIENTS WITH MODERATE TO SEVERELY ACTIVE ULCERATIVE COLITIS: PHASE 3 QUASAR MAINTENANCE STUDY RESULTS THROUGH WEEK 44

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Introduction

The Phase 3 QUASAR Maintenance Study (NCT04033445) evaluated the efficacy of maintenance treatment with SC guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor that binds to CD64 (a receptor on cells that produce IL-23), in patients with ulcerative colitis (UC). Here we report the corticosteroid sparing effects of maintenance treatment with GUS compared with GUS withdrawal (placebo [PBO]) through Week (Wk) 44.

Aims & Methods

At maintenance baseline, clinical responders to 12 weeks of GUS IV induction were randomized 1:1:1 to GUS 200 mg SC q4w, GUS 100 mg SC q8w, or GUS withdrawal (PBO). Patients who were receiving oral corticosteroids upon entry into the maintenance study were required to begin tapering their daily corticosteroid dose at Wk0, unless medically not feasible. Corticosteroid use and corticosteroid-free clinical remission at Wk44 were assessed.

Results

The primary analysis population included 568 patients (induction baseline: mean age, 40.7yr; mean UC duration, 7.8yr; mean modified Mayo score, 6.9 [63.9% with severe disease]; Mayo endoscopy subscore of 3, 66.4%). At maintenance baseline, 38.9% (221/568) of patients were receiving oral corticosteroids and the mean daily prednisone-equivalent corticosteroid dose (excluding budesonide and beclomethasone dipropionate) was similar across all treatment groups (17.3, 15.0, and 14.9mg/day, respectively, for GUS withdrawal, GUS 100mg, and GUS 200mg groups).

Among patients who were receiving oral corticosteroids (excluding budesonide and beclomethasone dipropionate) at maintenance baseline, the mean decreases from baseline in the average daily prednisone-equivalent corticosteroid dose at Wk44 were greater in the GUS 100mg and 200mg groups compared with the withdrawal group (-10.22 and -10.25 vs -7.35mg/day, respectively, both nominal p<0.001). As early as Wk8, higher proportions of patients in both GUS treatment groups had eliminated oral corticosteroid use through Wk44 compared with the withdrawal group (65.8% [48/73] and 64.4% [47/73] for GUS 100mg and GUS 200mg groups, respectively, vs 32.0% [24/75] for withdrawal group, both nominal p<0.001). At Wk44, higher proportions of patients in the GUS treatment groups vs withdrawal group had eliminated oral corticosteroid use (Table 1). Higher proportions of patients in the GUS treatment groups were in clinical remission at Wk44 and had eliminated oral corticosteroid use for at least 8 weeks prior to Wk44, compared with patients in the withdrawal group (Table 1).

Among GUS-treated patients, 180 achieved clinical remission at Wk44 and 178 (98.9%) of them had eliminated oral corticosteroids at least 8 weeks prior to Wk44.

Table 1. Corticosteroid use and corticosteroid-free clinical remission at Week 44: Primary analysis population
	GUS Withdrawal (Placebo)	GUS 100mg SC q8w	GUS 200mg SCq4w
Primary analysis population, N	190	188	190
Clinical remission at Wk44 (multiplicity-controlled), ^a1,bn (%) Adjusted treatment difference (95% CI) ^c P-value^d	36 (18.9%)	85 (45.2%) 25.2 (16.4, 33.9) P<0.001	95 (50.0%) 29.5 (20.9, 38.1) P<0.001
Clinical remission at Wk44 and not receiving corticosteroids for ≥8 wks prior to Wk44 (multiplicity-controlled) ^a1,b Adjusted treatment difference (95% CI)^c P-value^d	35 (18.4%)	85 (45.2%) 25.7% (17.0%, 34.5%) <0.001	93 (48.9%) 29.0% (20.5%, 37.6%) <0.001
Clinical remission at Wk44 and not receiving corticosteroids for ≥12 wks prior to Wk44 ^a1,b Adjusted treatment difference (95% CI)^c Nominal P-value^d	35 (18.4%)	85 (45.2%) 25.7% (17.0%, 34.5%) <0.001	93 (48.9%) 29.0% (20.5%, 37.6%) <0.001
Patients receiving oral corticosteroids at maintenance baseline, n (%)	75 (39.5%)	73 (38.8%)	73 (38.4%)
Eliminating oral corticosteroids ≥12 wks prior to Wk44,^a2,^bn (%) Adjusted treatment difference (95% CI) ^c Nominal P-value ^d	27 (36.0%)	51 (69.9%) 33.5% (19.0%, 48.0%) <0.001	48 (65.8%) 29.2% (14.4%, 44.0%) <0.001
Eliminating oral corticosteroids ≥8 wks prior to Wk44 and in clinical remission at Wk44,^a2,^bn (%) Adjusted treatment difference (95% CI) ^c Nominal P-value ^d	10 (13.3%)	35 (47.9%) 34.2% (21.4%, 47.1%) <0.001	29 (39.7%) 25.8% (13.1%, 38.6%) < 0.001
*Primary analysis population: Randomized and treated patients with a modified Mayo score 5-9 at induction baseline.* ^a1 Clinical remission is defined as a stool frequency subscore of 0 or 1 that has not increased from induction baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present. ^a2Eliminating oral corticosteroids by a designated time point is defined as not requiring any oral corticosteroid treatment from that time point until maintenance Wk44. ^b Patients who had an ostomy or colectomy, a dose adjustment, a prohibited change in UC medications, or discontinued study agent due to lack of efficacy or an AE of worsening of UC or other reasons except for COVID-19 related reasons (excluding COVID-19 infection) or regional crisis in Russia and Ukraine prior to Wk44 were considered not to have achieved the endpoint. ^c The adjusted treatment difference and confidence intervals were based on the Wald statistic with Cochran-Mantel-Haenszel (CMH) weight. ^d The p-values were based on the CMH test, stratified by clinical remission status at maintenance baseline (Yes/No), and induction treatment (guselkumab 400 mg IV, guselkumab 200 mg IV, placebo IV crossover to guselkumab 200 mg IV).

Conclusion

In patients with UC, maintenance treatment with GUS 100mg SC q8w and GUS 200mg SC q4w sustained clinically meaningful efficacy through Wk44 and allowed successful elimination of concomitant corticosteroids.

Disclosure

BB is an advisor/speaker for Abbvie, BMS, Ferring, Janssen, Merck, Novartis, Organon, Pfizer, Sandoz, Takeda; advisor for Alimentiv, Allergan, AMT, Bausch Health, BMS, Celgene, Celltrion Healthcare, Eupraxia, Fresenius Kabi, Genentech, Gilead, Iterative Scopes, Jamp Pharma, Merck Amgen, Microbiome Insights, Mylan, Pendopharm, Protagonist, Viatris; received research support from Abbvie, Amgen, BI, BMS, Genentech, GSK, Janssen, Merck, Qu Biologic; and reports stock options for Qu Biologic.
JA is a consultant for Finch Therapeutics, Artugen, Pfizer, Takeda, Janssen, and Iterative Scopes and receives research support from Merck. Consultant and speaker for BMS.
DTR reports research funding from Takeda, and has served as a consultant to AbbVie, Altrubio, Allergan, Inc., Arena Pharmaceuticals, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Ltd., Bristol Myers Squibb, Celgene Corp/Syneos, Connect BioPharma, GalenPharma/Atlantica, Genentech/Roche, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Eli Lilly, Materia Prima, Pfizer, Prometheus Biosciences, Reistone, Takeda, Techlab, Inc and is a co-founder of Cornerstones Health, Inc.
NS is an employee of Johnson & Johnson and owns company stock/stock options.
KGH is an employee of Johnson & Johnson and owns company stock/stock options.
MG is an employee of Johnson & Johnson and owns company stock/stock options.
RW is an employee of Johnson & Johnson and owns company stock/stock options.
HZ is an employee of Johnson & Johnson and owns company stock/stock options.
AA reports consulting/advisory board fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Mylan, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda, Tillots Pharma; speaker’s fees from AbbVie, AG Pharma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals; research grants from MSD, Takeda, Pfizer, Biogen
SF clinical investigator for Janssen
YW clinical investigator for Janssen
JP received consultancy fees/honorarium from AbbVie, Alimentiv, Athos, Atomwise, Boehringer Ingelheim, Celsius, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Nimbus, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Sanofi, Sorriso, Surrozen, Takeda, and Wasserman, and has served on a data safety monitoring board for Alimentiv, Mirum, Sorriso, Sanofi, and Surrozen.
GRL discloses relationships with Abbvie (Consultant), Allergan (Consultant), American College of Gastroenterology (Honorarium for Associate Editor of American Journal of Gastroenterology), American Gastroenterological Association (CME), American Regent (Consultant, Honorarium [CME Program]), Celgene (Research, Consultant), Chemed (CME), Eli Lilly (Consultant, Data Safety Monitoring Board), Endo Pharmaceuticals (Consultant), Ferring (Consultant), Gastroenterology and Hepatology (Gastro-Hep Communication, Editor-Honorarium), Gilead (Consultant), IMEDEX (CME), Ironwood (CME), Janssen/ Janssen Orthobiotech (Consultant, Research, Funding to University of PA [IBD Fellow Education]), MedEd Consultants (Consultant), Merck (Consulting, Honorarium [CME Program]), Morphic Therapeutics (Consultant), Pfizer Pharmaceuticals (Consultant, Funding to University of PA [IBD Fellow Education]), Professional Communications, Inc. (Royalty for writing Textbook), Prometheus Laboratories, Inc (Consultant), Romark (Consultant, Honorarium for CME), Sandoz (Consultant), Salix Pharmaceuticals/Valeant (Consultant), Shire Pharmaceuticals (Consultant), SLACK, Inc (Book Royalty), Springer Science and Business Media (Editor [Honorarium]), Takeda (Consultant, Funding to University of PA [IBD Fellow Education], Research), University of Kentucky (CME), UCB (Consultant, Research), Up-To-Date (Author [Honorarium]), Vindico (CME), and Virgo (Consultant [Stock options]).
LPB reports personal fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Enterome, Enthera, Ferring, Fresenius, Genentech, Gilead, Hikma, Index Pharmaceuticals, Janssen, Lilly, MSD, Mylan, Nestlé, Norgine, Oppilan Pharma, OSE Immunotherapeutics, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Tillots and Vifor; grants from AbbVie, MSD and Takeda; stock options from CTMA.

CORTICOSTEROID SPARING EFFECTS OF TREATMENT WITH GUSELKUMAB IN PATIENTS WITH MODERATE TO SEVERELY ACTIVE ULCERATIVE COLITIS: PHASE 3 QUASAR MAINTENANCE STUDY RESULTS THROUGH WEEK 44

Brian Bressler 1, Jessica Allegretti 2, David T. Rubin 3, Nicole Shipitofsky 4, Gary KH Huang 4, Matthew Germinaro 4, Rebbecca Wilson 4, Hongyan Zhang 4, Alessandro Armuzzi 5, Sigal Fishman 6, Yufang Wang 7, Julian Panés 8, Gary Lichtenstein 9, Laurent Peyrin-Biroulet 10

1 University of British Columbia, Vancouver, Canada

2 Brigham and Women´s Hospital, Boston, United States

3 University of Chicago Medicine, Chicago, United States

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

5 Humanitas Research Hospital, Milan, Italy

6 Tel Aviv Sourasky Medical Center Tel Aviv University, Tel Aviv, Israel

7 West China Hospital, Sichuan University, Chengdu, China

8 Hospital Clínic Barcelona, Barcelona, Spain

9 University of Pennsylvania School of Medicine, Merion Station, United States

10 Nancy University Hospital, Université de Lorraine, Nancy, France

Event

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

Expanding treatment response in IBD

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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A NOVEL MULTI-EPITOPE BASED VACCINE AGAINST HELICOBACTER PYLORI

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Introduction

Helicobacter pylori infection affects approximately half of the global population and may lead to sever complications, including gastric cancer. Current antibiotic-based therapies face the challenge of rising resistance rates. Therefore, there is urgent medical need for an effective vaccine. Despite extensive research efforts, no H. pylori vaccine has yet made it to clinical application. Aim of our study is the development of a novel multi-epitope-based H. pylori vaccine

Aims & Methods

Sixteen selected B- and T-cell epitopes from six key virulence factors were fused to create the Multi-Epitope-Unit (MEU) antigen. Two vaccine formulations were evaluated: MEU combined with flagellin as adjuvant, and MEU incorporated into the Modified Vaccinia virus Ankara (MVA) genome for enhanced antigen delivery. The efficacy was assessed in murine models using H. pylori SS1 infection, with evaluation in both prophylactic and therapeutic settings. To explore the possible clinical relevance, crude antigens from 48 human clinical isolates of H. pylori obtained from international healthcare centers were tested for binding capacity with anti-MEU antibodies generated from immunized mice.

Results

Both vaccine formulations elicited robust MEU-specific antibody and CD4+ T-cell responses. The vaccines generated a balanced Th1/Th2 immune response profile and significantly elevated CD4+NKT-like cell levels. Complete bacterial clearance was achieved with protein-based vaccination followed by MVA boost or two doses of MVA vaccine in both prevention and treatment models. Binding assays revealed that anti-MEU antibodies demonstrated positive binding capacity to crude antigens from all 48 tested human clinical isolates (100% reactivity), confirming broad-spectrum recognition across diverse H. pylori strains from different geographical origins.

Conclusion

This study represents groundbreaking research, presenting a novel promising H. pylori vaccine candidate. The comprehensive testing against 48 human clinical isolates from international healthcare units provides unprecedented evidence of functional immune responses. Our data demonstrate 100% binding reactivity of anti-MEU antibodies to crude antigens from ALL tested clinical isolates, representing diverse geographical origins and strain variations. This finding demonstrates for the first time that a H. pylori vaccine can generate immune responses effective against a vast spectrum of human pathogenic strains, which has eluded all previous vaccine approach failures and poses high expectation for a successful clinical application. Our multi-epitope vaccine represents a novel H. pylori vaccine development, being the first to demonstrate both complete bacterial clearance in preclinical models as well as a broad-spectrum reactivity against human clinical isolates. These results provide strong scientific rationale for advancing to toxicology studies and clinical evaluation, offering the first genuine hope for both prevention and treatment of H. pylori infections in human populations worldwide.

Disclosure

BK, HM and VW are employed by Iguana Biotechnology. The remaining authors declare no conflicts of interest.

A NOVEL MULTI-EPITOPE BASED VACCINE AGAINST HELICOBACTER PYLORI

Behnam Kalali 1, Hassan Moeini 1, Amrollah Mostafazadeh 2, Abbas Yadegar 3, Volker Wedershoven 4, Christian Schulz 5, Peter Malfertheiner 5

1 Iguana Biotechnology, Munich, Germany|||Ludwig Maximilian University, Munich, Germany

2 Babol University of Medical Sciences, Babol, Iran, Islamic Republic of

3 Shahid Beheshti Medical University, Tehran, Iran, Islamic Republic of

4 Iguana Biotechnology, Munich, Germany

5 Ludwig Maximilian University, Munich, Germany

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Endoscopy Neurogastroenterology & Motility Oesophagus Stomach & H. Pylori

Submission format

Late-Breaking Abstract

Session

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Panel discussion: Therapy update - EoE

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

UEG Presentation

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THE MEDITERRANEAN DIET FOR IRRITABLE BOWEL SYNDROME

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Introduction

Patients with irritable bowel syndrome (IBS) frequently seek dietary advice. However, few evidence-based options exist. Societal guidelines recommend traditional dietary advice (TDA) as first-line therapy, with the cumbersome and resource-intensive low FODMAP diet reserved as second-line therapy.
Recent pilot data suggests that the Mediterranean diet (MD), renowned for its general health benefits, improves the symptoms of IBS. Whether it can be considered another first-line dietary option is not known.

Aims & Methods

This randomized non-inferiority clinical trial assigned 139 individuals with IBS, from across the United Kingdom, to follow the MD (n=68) or TDA (n=71) for six weeks. The primary endpoint was the proportion of participants achieving clinical response, defined as a ≥50-point reduction in the IBS Symptom Severity Scale (IBS-SSS). Secondary outcomes included changes in IBS-SSS, psychological health, somatic symptom reporting, quality of life, diet satisfaction, and the Mediterranean Diet Adherence Screener (MEDAS).

Results

Baseline characteristics (mean age 40.4 [range 19-65] years, 80% female) and IBS-SSS (mean 309, SD 90) were similar between groups. On modified intention-to-treat analysis, the primary endpoint was met by 62% (95% CI 50%-73%) taking a MD versus 42% (95% CI 31%-55%) taking TDA. The difference in clinical response between the groups was in favor of the MD (20%, 95% CI 4%-36%), demonstrating it to be non-inferior based on the a priori defined requirement for the CI to exclude -5%. Rather, the MD was superior to TDA (odds ratio 2.3 [95% CI: 1.16-4.64], p = 0.017). There was a greater reduction in the mean IBS-SSS following a MD than TDA (-101.2 vs. -64.5, ∆-36.7 [95% C.I. -70.5 to -2.8], p=0.034). No significant differences were observed between the groups with regards to changes in mood, somatic symptoms, quality of life or diet satisfaction. The MEDAS significantly increased following a MD compared with TDA (p< 0.001).

Conclusion

The MD is non-inferior (rather, it demonstrated superiority) to TDA in managing the symptoms of IBS, and can be considered as another first-line dietary option.
Clinical trials registration: NCT05985018