Introduction PBC patients can experience severe morbidity and extrahepatic symptoms leading to impaired HRQoL; it is proposed that this is due to symptom burdens rather than disease morbidity. There are few medical interventions for PBC symptoms. Many patients rely on self-management strategies to improve symptom burden. However, there is limited research exploring the prevalence and impact of PBC symptom burden on HRQoL. Study aims: 1. analyse the influence of extrahepatic symptoms on HRQoL; 2. measure the effect of self-management strategies on symptom burden and HRQoL. Methods PBC patients in Germany completed a survey on self-management and impact on HRQoL for the symptoms fatigue, pruritus, arthralgia, and sicca syndrome. In addition, the 12-Item short-form health survey and the 10-item PBC quality of life survey were used. Data were collected from January 2021 to January 2022. All data were patient self-reported; no clinical validation data was collected. Descriptive data analysis aimed to identify significant differences in influence on HRQoL, and clusters of self-management strategies. Results Of the 1032 surveys, all four symptom burdens were found to have a statistically significant influence on HRQoL. Data didn’t allow evaluation of symptom burden and its link to biochemical disease activity, disease stage and UDCA dosages. Three clusters of reported symptom improvement were identified. A large variety of strategies were reported to improve a respective symptom. Conclusion The study showed significant positive associations between use of self-management strategies and improved HRQoL. Clinicians should support patients in finding the best self-management strategy for their personal disease experience.
Introduction: Most trials studying advanced therapies for ulcerative colitis (UC) adopted a responder re‑randomization design. By contrast, a treat-through design was utilized in the ELEVATE UC 52 trial to assess etrasimod, an oral, once-daily, selective sphingosine 1 phosphate (S1P) receptor modulator. It is therefore important to contextualize the efficacy of etrasimod given this different study design. We evaluated the efficacy of etrasimod versus placebo at week 52 among induction clinical responders. Methods: In this post hoc analysis of ELEVATE UC 52, selected efficacy endpoints were evaluated at week 52 among all week 12 clinical responders (induction responders), defined as a ≥ 2‑point and ≥ 30% decrease from baseline in modified Mayo score, with a ≥ 1‑point decrease from baseline in rectal bleeding subscore (or an absolute value ≤ 1). Results: In total, 182 patients receiving etrasimod and 52 patients receiving placebo were induction responders. Of these patients, a greater proportion who received etrasimod versus placebo met the criteria for clinical remission (48.9% vs 19.2%; p < 0.001) and all other endpoints assessed at week 52 (p < 0.05). Greater proportions of induction responders compared with the total trial population treated with etrasimod met criteria for clinical remission (48.9% vs 32.5%), endoscopic improvement (56.6% vs 39.1%), and all other endpoints. Conclusion: Greater efficacy was observed among etrasimod induction responders for all assessed endpoints at week 52 when compared with the total ELEVATE UC 52 population, contextualizing the efficacy of etrasimod given the treat-through design of the study. ClinicalTrials.gov identifier: NCT03945188.
Background: Gastrointestinal (GI) cancers account for a substantial cancer burden, yet contemporary incidence trends and future projections across cancer sites and demographic subgroups remain incompletely characterized. We aimed to analyze incidence trends from 2000–2022 and forecast rates through 2032 for eight major GI cancers in the United States. Methods: Using SEER Research Data (17 registries, 2000–2022), we identified patients with esophageal, gastric, liver, gallbladder, pancreatic, small intestine, and colorectal cancer. Age-adjusted incidence rates were calculated and stratified by sex, age group (<60 vs. ≥60 years), and race (White, Black, Asian/Pacific Islander, American Indian/Alaska Native). Time-series forecasting models (linear regression, ARIMA, ETS, NNAR) were applied to project incidence through 2032. Results: Incidence trends varied markedly by cancer site. Pancreatic cancer showed sustained increases across most subgroups, with projected rates rising from 4.41 to 5.11 per 100,000 by 2032. Colorectal cancer demonstrated divergent age-specific patterns: incidence among individuals ≥60 years is projected to decline (25.48 to 14.89 per 100,000), while early-onset disease (<60 years) is expected to increase (5.35 to 5.84 per 100,000). Liver cancer incidence is forecast to decline (2.18 to 1.42 per 100,000). Esophageal and gastric cancers showed modest increases, while gallbladder cancer remained stable. Substantial disparities persisted by sex (male predominance for most sites, female predominance for gallbladder) and race (highest burden among Asian/Pacific Islander populations). Conclusions: GI cancer incidence trajectories are highly heterogeneous. The projected rise in pancreatic and early-onset colorectal cancers signals urgent needs for targeted prevention, risk-factor modification, and improved early detection strategies in at-risk populations.
Introduction: More than ten years after its introduction into clinical practice, we aimed to assess the current real-life effectiveness and safety of bismuth-containing quadruple therapy in patients infected with H. pylori. Methods: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients received Pylera® 3 capsules four times daily plus omeprazole 20 mg or esomeprazole 40 mg bid for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of treatment). We assessed effectiveness and safety in these patients. Results: One thousand and eighteen consecutive patients were included in the study, 648 (63.7%) treated as first-line and 370 (36.3%) treated after failure of at least one previous eradication course. The vast majority of patients were fully compliant, except 18 (1.8%) subjects, who discontinued treatment due to severe adverse events. H. pylori eradication was achieved in 959/1,000 (95.9%, CI 94.7-97.1%) patients, higher in naïve than in previously treated patients (97.3%, CI 96.1-98.6%, vs 93.3%, CI 90.8-95.9%; p=0.002). Overall, the eradication rate remains significantly high during the observational period. In particular, it was 100% in 2020, 97.8% (CI 95.7-99.9%) in 2021, 100% in 2022, 98.8% (CI 97.3-100%) in 2023, 89.1% (CI 84.6-93.6%) in 2024, and 97.8% (CI 95.5-100%) in 2025: the failures, although minimal, were more present in 2024 (P<0.001). Finally, the eradication rate remained constant from 2020 to 2025. Conclusions: Pylera® remains an effective and safe therapeutic option for curing H. pylori infection in both naïve and previously treated patients.
INTRODUCTION:Biologic therapy options for ulcerative colitis (UC) have increased in recent years. Although predicting treatment response may support personalized treatment strategies, the predictive value of histopathological features in UC remains unclear. This exploratory study aimed to evaluate the association between ustekinumab effectiveness and pre-treatment histopathological findings. METHODS:This single-center, retrospective, observational pilot study included patients with moderate-to-severe UC who were administered ustekinumab at the Kitasato University Hospital between April 2020 and March 2024. The endpoints were the relationship between pre-treatment histopathological findings, assessed using the Geboes score, and clinical efficacy at weeks 8 and 52, stratified by prior exposure to advanced therapies. RESULTS:The study enrolled 33 patients. Among advanced therapy-naïve (AT-naïve) patients, responders at week 8 were significantly more likely to have low neutrophilic infiltration in the lamina propria than non-responders (66.7% vs. 0%, p = 0.03). Among advanced therapy-exposed (AT-exposed) patients, the degree of neutrophilic or eosinophilic infiltration in colonic tissue at week 8 did not differ significantly between responders and non-responders. Among AT-naïve patients, those who achieved clinical remission at week 52 tended to have mild eosinophilic infiltration in the lamina propria compared with non-responders (80.0% vs. 33.3%, p = 0.07). Among AT-exposed patients, the degree of neutrophilic or eosinophilic infiltration in colonic tissue at week 52 did not differ significantly between responders and non-responders. CONCLUSION:In moderate-to-severe UC, pre-treatment mucosal histopathological assessment may serve as a treatment response marker. This information can guide development of personalized treatment strategies.
