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.

Introduction

Minocycline is considered the most potent semi-synthetic tetracycline, demonstrates promising pharmacokinetic and antimicrobial properties against Helicobacter pylori (H. pylori). While previous studies suggested the efficacy of minocycline-containing bismuth quadruple therapy for H. pylori eradication, real-world evidence remains limited.

Aims & Methods

his study aimed to evaluate the clinical efficacy, safety, and cost-effectiveness of minocycline-containing bismuth quadruple therapy in routine clinical practice.This multicenter, real-world observational study was conducted at 25 hospitals in Fujian China between January and March 2025. Patients diagnosed with H. pylori infection received one of three 14-day bismuth-containing quadruple regimens with b.i.d. esomeprazole 20 mg and bismuth 220 mg, plus amoxicillin 1000 mg b.i.d. and clarithromycin 250 mg b.i.d. (PBAC), or minocycline 100 mg b.i.d. and clarithromycin 250 mg b.i.d. (PBMC), or minocycline 100 mg twice b.i.d. and levofloxacin 500mg q.d. (PBML). The primary outcome was the H. pylori eradication rate, secondary outcomes included the frequency of adverse events, patient compliance, and cost-effectiveness.

Results

A total of 347 patients were enrolled, with 110 patients completing treatment in each group. In the intention-to-treat (ITT) analysis, eradication rates were 77.4% (PBAC), 85.5% (PBMC), and 84.3% (PBML). In the per-protocol (PP) analysis, eradication rates were 80.9%, 90.9%, and 88.2%, respectively. Although the differences among the three regimens were not statistically significant, minocycline-based regimens achieved numerically higher eradication rates. Adverse event incidence was 32.73%, 20.91%, and 23.64% in the three groups, respectively. Compliance rates exceeded 94% across all groups. Cost-effectiveness analysis showed PBML had the lowest cost-effectiveness ratio (5.38 CNY per 1% eradication), followed by PBAC (5.41 CNY) and PBMC (6.06 CNY).

Conclusion

H. pylori eradication, with favorable patient compliance and pharmacoeconomic profiles. These regimens present a viable alternative to traditional amoxicillin-or tetracycline-based therapies. Further large-scale randomized controlled trials are warranted to confirm these findings.

Introduction

Helicobacter pylori (Hp) infection is highly prevalent in Portugal, affecting over 60% of the population. Antibiotic resistance poses a significant challenge to Hp treatment; however, empirical regimens remain the standard of care over susceptibility-guided approaches. This study aims to evaluate the most recommended therapeutic options for Hp eradication and to identify risk factors associated with treatment failure.

Aims & Methods

Prospective cohort study conducted in a single centre, including all patients treated for Hp infection between 2013 and 2024. We analysed four eradication regimens: triple therapy (Tri), bismuth quadruple therapy (QuadB), concomitant quadruple therapy (QuadC) and sequential quadruple therapy (QuadS). We collected data on patient demographics and clinical characteristics and compared adherence rates, treatment effectiveness and incidence of adverse events.

Results

Included 591 patients, with a median age of 57 years (IQR 47-66) and female sex 57.2%. The main indication for Hp testing was dyspeptic symptoms (61.1%). The prescribed therapeutic regimens were QuadC in 34.0% of patients, QuadB in 32.8%, Tri in 23.2% and QuadS in 10.0%. According to the intention-to-treat analysis, QuadC (92.9%) and QuadB (90.4%) showed significantly higher eradication rates compared with Tri (73.9%, p<0.001), with no difference observed for QuadS (84.2%, p=0.30 vs QuadC; p=0.61 vs QuadB). Adverse events were significantly less frequent with Tri (0.06%) and QuadS (0.02%) compared to QuadC (0.18%, p<0.01) and QuadB (0.17%, p<0.05), but overall adherence to treatment was 97.1%, with no significant difference among regimens (p=0.19). Logistic regression identified predictive factors for treatment failure: prior eradication attempts (OR 2.31; 95% CI 0.3-1.4), poor adherence (OR 14.5; 95% CI 0.7-4.7) and absence of statin use (OR 2.33; 95% CI 0.07-1.6), with an AUC of 0.72.

Conclusion

QuadC and QuadB therapies are more effective for Hp eradication but are associated with increased rates of adverse events, without a negative impact on overall treatment adherence. Therapeutic failure is more likely in non-naive patients, those with poor adherence to treatment and without statin use.

Introduction

It remains uncertain if the addition of Saccharomyces boulardii (S. boulardii) to Vonoprazan-amoxicillin dual therapy as a first-line treatment can enhance the Helicobacter pylori (H. pylori) eradication rate and decrease the incidence of adverse events. Therefore, we conducted the randomized controlled trials (RCTs) to address this issue.

Aims & Methods

This is a single-center, prospective randomized controlled study. A total of 150 eligible patients, recruited from December 2023 to November 2024, were randomly assigned to the VA (vonoprazan 20 mg twice daily, amoxicillin 750 mg 3 times daily for 10 days) and VAS groups (vonoprazan 20 mg twice daily, amoxicillin 750 mg 3 times daily, and S. boulardii 250 mg twice daily for 10 days). The eradication rates, adverse events, safety, and compliance were compared between the two groups. Factors associated with eradication rate were explored.

Results

The eradication rates of VA and VAS were 89.3% and 93.3%, respectively, by intention-to-treat analysis (P = 0.384); 93.1%, and 94.6%, respectively, by per-protocol analysis (P=0.966). The incidence of adverse events significantly lower in the VAS group (5.4%) than in the VA group (22.2%; P=0.003). There was no significant difference in compliance between the VA (96%) and VAS groups (98.7%, P = 0.612). Body surface area (BSA) was found to be a influencing factor for eradication rate in both VA and VAS groups. Serum chemistry tests revealed no significant differences in liver and kidney function before and after treatment in both groups.

Conclusion

Although the addition of S. boulardii to VA dual therapy could not increase the eradication rate, it could decrease the incidence of adverse events. Low-BSA patients are more suitable candidates for this regimen.

Introduction

Helicobacter pylori (HP) has been designated as a Grade I Carcinogen by the WHO and remains an important factor in the pathogenesis of intestinal-type gastric cancer. Gastric cancer was the fifth most common malignant disease in the world in 2022 (Globocan) with 968,784 new cases(1), after lung, breast, colorectal and prostate cancers. The incidence of gastric cancer has changed significantly since the first estimates in 1975, when stomach cancer was the leading cancer, and one of the most important factors has been the eradication of HP.(2)

Aims & Methods

The purpose of this study was to determinate the trends in the incidence of HP in our region, and also of the precancerous lesions.
There have been included in the study a group of 12541 patients from the years 2014-2018 and a group of 7138 patients from more recently years 2020-2024.
All the patients had dyspeptic syndrome and in all the patients upper digestive endoscopy has been performed in the Gastroenterology Clinic from Târgu Mureș, Emergency Clinical Hospital. Patients with haemorrhage were excluded from the study. In all the patients gastric biopsies and histopathological exam were made, OLGA classification was used.

Results

From the first group, in 2131 patients (52,9% males and 47,1% females) were found gastric changes. Histopathological, 32,7% of the patients had atrophic gastritis, 43,1% intestinal metaplasia (23,7% complete metaplasia and 19,4% incomplete metaplasia) and 0,7% dysplasia. Active gastritis/pangastritis with HP was identified in 59,3% of the patients. In 4,8% of cases there were revealed polyps (hyperplastic, adenomatous) and were removed.
In the second group from 2560 patients (54,4% males and 45,6 females) that underwent upper gastrointestinal with biopsy sampling, HP was present in 442 patients (17,26%.) Histopathological, 14,50% of the patients had atrophic gastritis, 23,8% intestinal metaplasia and 2,58% dysplasia.

Conclusion

HP incidence is decreasing, as it has been treated by the gastroenterologist and also by the general practitioner. The decreasing in incidence of HP is corelating with the decreasing of the precancerous lesions and gastric cancer, so ​it is worth to treat it.

References

1. Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: Inter- national Agency for Research on Cancer Available from: http://globocan.iarc.fr. Accessed 27.03.2025
2. Malfertheiner P, Megraud F, Rokkas T, et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report, Gut 2022;71:1724–1762.

Disclosure

no conflict of interest

Introduction

Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction affecting 5 to 10% of the population, combining chronic abdominal pain and altered bowel transit. Its varied and complex mechanisms make management difficult and can be responsible for impaired quality of life. Patient education is recommended for managing chronic diseases. As part of a patient education program, the first step is to assess patients' knowledge and needs by conducting a shared educational assessment. Experiments conducted in various countries have shown that therapeutic patient education (TPE) can be effective, reducing severity, improving quality of life, and reducing care seeking. These studies have also shown that patients often have a lack of knowledge and/or misconceptions about IBS (1).

Aims & Methods

This study aimed to assess the baseline knowledge level of patients enrolled in a patient education program. Patients with IBS were selected for participation in a TPE program following a multidisciplinary day hospital for IBS. All patients had to have seen a general practitioner and/or a gastroenterologist outside the team without sufficient improvement in their condition. The TPE was based on a document developed in collaboration with a patient organisation (APSSII). This program was divided into five 1-hour sessions (training and discussion time) conducted by different professionals (neurogastroenterologists, clinical psychologist, dietitian) covering the following points:
1) understanding my illness (epidemiology, diagnosis, mechanisms),
2) talking about my illness and expressing my needs (interaction with loved ones, work, doctor, school, rights and support);
3) organizing my daily life, improving my quality of life (impact of IBS on QoL, work, exercise, intimate life);
4) taking advantage of different treatments and care options (placebo, adverse effects, symptomatic and long-term treatment, alternative treatments);
5) the role of eating and diets (balanced diet, lactose-free, gluten-free, low-FODMAP, food allergies, risks of diets). Before the start of each session, questionnaires testing participants' knowledge on the session topic were completed.

Results

From November 2023 to September 2024, 135 questionnaires completed by 43 patients with IBS were included. 70% were women, mean age 45 ± 18 years, subtypes based on IBS transit: IBS-C 55%, IBS-D 33%, IBS-M 12%, with a mean severity (IBS-SSS) of 331 ± 72 points, EQ5D health score of 50 ± 21. Among the most common misconceptions, 25% believed that a diagnosis by endoscopy was possible, 48% believed the disease could be complicated by IBD, and 13% by colon cancer. Regarding treatments, 11% of patients believed that the placebo effect only concerned medications, 58% believed that faecal microbiota transplantation could currently be offered in clinical routine for IBS care, 78% believed that hypnotherapy was only effective if you believe in it, and 68% believed that multi-strain probiotics were more effective than single-strain ones.

Conclusion

This study, conducted in France on patients with moderate or severe forms of IBS, shows a highly variable level of knowledge about their disease depending on the questions, with some significant misconceptions that need to be addressed. These results justify the implementation of therapeutic education for these patients. A study is underway to verify the improvement in patients' knowledge and the existence of a positive impact of this strategy on symptom severity and quality of life.

References

(1) Halpert et al. What Patients Know About Irritable Bowel Syndrome (IBS) and What They Would Like to Know. National Survey on Patient Educational Needs in IBS and Development and Validation of the Patient Educational Needs Questionnaire (PEQ). Am J Gastroenterol 2007; 102:1972-82.

Disclosure

Nothing to disclose