Introduction

Potassium-competitive acid blockers (P-CABs) offer prolonged acid suppression and are promising agents for Helicobacter pylori eradication. Prospective studies evaluating the efficacy of tegoprazan-based triple therapy according to dosage differences have been scarce.

Aims & Methods

This study aimed to assess the efficacy and safety of tegoprazan-based versus lansoprazole-based standard triple therapy (STT). This multicenter randomized controlled study enrolled treatment-naïve adults with H. pylori infection in 18 institutions from February 2023 to April 2024. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC1), tegoprazan 100 mg (TAC2), or lansoprazole 30 mg (LAC) with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 14 days. The primary endpoint was the eradication rate, analyzed in the full analysis set (FAS) and per-protocol set (PPS). Secondary endpoints included eradication rates stratified by clarithromycin resistance, as determined by 23S rRNA genotyping. Non-inferiority was established if the lower bound of the 95% confidence interval (CI) for the difference in eradication rates was greater than -10%.

Results

A total of 382 patients were randomized, of whom 364 completed the study. The FAS included 372 participants after excluding those who did not receive any study medication, lacked safety data, or violated eligibility criteria. The PPS comprised 355 participants after excluding 17 protocol violators. In the FAS analysis, eradication rates were 85.95% for TAC1, 85.48% for TAC2, and 78.74% for LAC. Both TAC1 (p = 0.0002 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) demonstrated non-inferiority. In the PPS analysis, eradication rates were 88.50% for TAC1, 87.39% for TAC2, and 81.30% for LAC, with TAC1 (p < 0.0001 vs. LAC) and TAC2 (p = 0.0003 vs. LAC) maintaining non-inferiority. Among 275 clarithromycin-susceptible patients in the PPS, eradication rates were 96.74% (TAC1), 98.88% (TAC2), and 94.68% (LAC). Among 80 clarithromycin-resistant patients, eradication rates were 52.38% (TAC1), 53.33% (TAC2), and 37.93% (LAC). In both subgroups, there were no significant differences between either TAC1 or TAC2 and the LAC group. Adverse event rates were comparable across groups, and no serious adverse events were reported. No significant differences in adverse event rates were observed across groups, and no serious adverse events occurred.

Conclusion

Tegoprazan-based STT demonstrated non-inferiority to lansoprazole-based STT, achieving eradication rates above 80% in the FAS population. Given its efficacy and safety profile, tegoprazan-based triple therapy may serve as an effective first-line treatment option for H. pylori eradication.

Disclosure

This study was funded in full by HK inno.N Corp., Seoul, Republic of Korea. HK inno.N Corp. contributed to the study design, data management, statistical analysis, and approval of publication in co-operation with all the authors. No other potential conflicts of interest relevant to this article were reported.

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) 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

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

Global rise in primary Helicobacter pylori (H. pylori) antibiotic resistance has led to a decrease in the treatment efficacy. Understanding the rates of clarithromycin (ClaR), metronidazole (MetR) and levofloxacin (LevR) resistance in H. pylori management is essential for determining the optimal eradication therapy and achieving successful clinical outcomes.

Aims & Methods

To evaluate the prevalence and geographical distribution of H. pylori primary ClaR, MetR and LevR in Europe. Bibliographical searches were conducted in PubMed until March 2024, with no language restrictions. Studies focused on children only or non-European countries were excluded.

Results

A total of 218 studies published since 1990 were included, of which 188 provided information on ClaR, 138 on MetR, and 77 on LevR (Table 1). The average ClaR in Europe, considering all studies and years, was 17%, showing an increase from 7.3% in the 1990s to 26% in the period 2010–2019, with a slight decrease to 22% in the period 2020–2024. The highest values were reported in Switzerland (66%), Ireland (50%), and Israel (44%). Southern European countries presented higher resistance rates (over 15–20%) compared to those in the north (under 10–15%). MetR remained consistently high (with a European average of 34%), particularly in Poland (66%), Turkey (67%), and Switzerland (60%). As for LevR, it was low in the 1990s but experienced a progressive increase over time, reaching approximately 15% during 2010–2019, and fluctuating between 20% and 25% in recent years.

Conclusion

In Europe, since the 1990s, primary ClaR has fluctuated but always remaining above 15%; MetR has remained consistently high; and LevR has shown a progressive increase throughout the study periods. These data highlight the urgent need for region-specific antibiotic stewardship and updated treatment guidelines to ensure H. pylori eradication success.

Disclosure

Javier P. Gisbert has served as speaker, consultant, and advisory member for or has received research funding from: Mayoly, Allergan/Abbvie, Diasorin, Richen, Juvisé and Biocodex.
Olga P. Nyssen received research funding from: Mayoly, Allergan/Abbvie, Richen, Juvisé and Biocodex.

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.