Patients With Inflammatory Bowel Diseases Have Impaired Antibody Production After Anti-SARS-CoV-2 Vaccination: Results From a Panhellenic Registry.

BACKGROUND: Four EMA-approved vaccines against SARS-CoV-2 are currently available. Data regarding antibody responses to initial vaccination regimens in patients with inflammatory bowel diseases (IBD) are limited. METHODS: We conducted a prospective, controlled, multicenter study in tertiary Greek IBD centers. Participating patients had completed the initial vaccination regimens (1 or 2 doses, depending on the type of COVID-19 vaccine) at least 2 weeks before study enrolment. Anti-S1 IgG antibody levels were measured. Demographic and adverse events data were collected. RESULTS: We tested 403 patients (Crohn's disease, 58.9%; male, 53.4%; median age, 45 years) and 124 healthy controls (HCs). Following full vaccination, 98% of patients seroconverted, with mRNA vaccines inducing higher seroconversion rates than viral vector vaccines (P = .021). In total, IBD patients had lower anti-S1 levels than HCs (P < .001). In the multivariate analysis, viral vector vaccines (P < .001), longer time to antibody testing (P < .001), anti-TNFα treatment (P = .013), and age (P = .016) were independently associated with lower anti-S1 titers. Vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or anti-interleukin-12/IL-23 monotherapy (P = .023 and P = .032). All anti- SARS-CoV-2 vaccines were safe. CONCLUSIONS: Patients with IBD have impaired antibody responses to anti-SARS-CoV-2 vaccination, particularly those receiving viral vector vaccines and those on anti-TNFα treatment. Older age also hampers antibody production after vaccination. For those low-response groups, administration of accelerated or prioritized booster vaccination may be considered.

Thisis a multicenter study on IBD patients after COVID-19 vaccination and anti-S1 IgG antibody levels measurement. Patients with IBD have lower antibody responses than healthy controls, particularly those receiving viral vector vaccines and those on anti-TNFα or combination treatment.

Helicobacter pylori, gastric microbiota and gastric cancer relationship: Unrolling the tangle.

Helicobacter pylori infection (Hp-I) represents a typical microbial agent intervening in the complex mechanisms of gastric homeostasis by disturbing the balance between the host gastric microbiota and mucosa-related factors, leading to inflammatory changes, dysbiosis and eventually gastric cancer. The normal gastric microbiota shows diversity, with Proteobacteria [Helicobacter pylori (H. pylori) belongs to this family], Firmicutes, Actinobacteria, Bacteroides and Fusobacteria being the most abundant phyla. Most studies indicate that H. pylori has inhibitory effects on the colonization of other bacteria, harboring a lower diversity of them in the stomach. When comparing the healthy with the diseased stomach, there is a change in the composition of the gastric microbiome with increasing abundance of H. pylori (where present) in the gastritis stage, while as the gastric carcinogenesis cascade progresses to gastric cancer, the oral and intestinal-type pathogenic microbial strains predominate. Hp-I creates a premalignant environment of atrophy and intestinal metaplasia and the subsequent alteration in gastric microbiota seems to play a crucial role in gastric tumorigenesis itself. Successful H. pylori eradication is suggested to restore gastric microbiota, at least in primary stages. It is more than clear that Hp-I, gastric microbiota and gastric cancer constitute a challenging tangle and the strong interaction between them makes it difficult to unroll. Future studies are considered of crucial importance to test the complex interaction on the modulation of the gastric microbiota by H. pylori as well as on the relationships between the gastric microbiota and gastric carcinogenesis.

Prevalence of inflammatory bowel disease in young Greek Army male recruits from 2006 to 2018: a 13-year retrospective study from a tertiary center.

BACKGROUND: The prevalence and incidence of inflammatory bowel diseases (IBDs) vary among countries. Data regarding prevalence of IBD in Greece are limited or outdated. METHODS: We reviewed the medical records of IBD patients from a population of 551,808 Greek Army recruits in a 13-year period (2006-2018). Study population consisted of males 18-37 of age from Northwest, Central Greece (including Attica), Peloponnese, and Aegean Sea Islands. Age, disease distribution, pharmaceutical treatment and IBD-related surgery at the time of patients' admission were recorded. RESULTS: The prevalence of IBD among male recruits during the studied period was 0.15% (839/551 808, 95% confidence interval 0.14-0.16%). Of these, 448 (53.4%) had Crohn's disease (CD) and 391 (46.6%) ulcerative colitis (UC). Although 32.1% of CD patients had been treated with biologics, most often infliximab (60% of them), azathioprine was the most common as monotherapy (27% of patients). Among UC patients, mesalamine was the most often prescribed treatment (64.2%), whereas treatment with biologics as monotherapy or in combination with azathioprine was used in a ratio 1:2 compared to CD patients. A gradual reduction in steroid use was noted from 2006 to 2018, coinciding with the advent and increasing use of biologics. IBD-related surgery had been performed in 8% and 2.8% of CD and UC patients, respectively. CONCLUSION: The prevalence of IBD in Greek male recruits was 0.15% with a slight CD predominance. Remarkable changes in therapeutic trends were noted with an increasing use of biologics and reduced prescription of steroids, especially for CD.

Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort.

BACKGROUND: Optimization of treatment with biologics is currently an unmet need for patients with ulcerative colitis (UC). Real-world studies provide neutral estimates of drug efficacy and safety within unselected patient populations and allow for the recognition of specific characteristics that affect response to therapy. AIMS: We aimed to depict the efficacy of vedolizumab in patients with UC in a real-world setting and identify prognosticators of improved outcomes. METHODS: Patients with active UC who commenced treatment with vedolizumab were prospectively followed up. Patient-reported outcomes (PROs) and clinical/endoscopic-reported outcomes were recorded at baseline and at weeks 14 and 54. Predefined endpoints of early and persistent efficacy were analyzed against clinical characteristics to identify prognostic factors for response. RESULTS: We included 96 patients (anti-TNF-exposed = 38.5%). At week 14, 73 patients (76%) had clinical response and 54 (56.3%) clinical remission. At week 54, the primary endpoint of vedolizumab persistence was met by 72 patients (75%), whereas steroid-free clinical remission by 59.4%. Among patients who had endoscopy, rates for mucosal healing (Mayo endoscopic score of 0) were 29.8% at week 14 and 44.6% at week 54, respectively. Vedolizumab treatment led to significant improvements in quality of life. Corticosteroid-refractory or anti-TNF-refractory disease, articular manifestations, and high baseline UC-PRO2 were associated with decreased efficacy of vedolizumab in the primary and secondary outcomes. CONCLUSIONS: Vedolizumab is characterized by high efficacy and long-term treatment persistence in UC. More aggressive disease, as indicated by refractoriness to steroids or anti-TNFs and elevated baseline PROs, may predict suboptimal response and help pre-treatment prognostic stratification of patients.

Informed consent in inflammatory bowel disease: a necessity in real-world clinical practice.

In modern medicine, any medical intervention has to be supported by a patient's informed consent. Challenges to this process include the specificity and complexity of medical information being provided, the patient's ability to comprehend the information, the medical uncertainty of the outcomes, and the physician's legal concerns. Important elements of the consent process are respect for the patient's autonomy and self-determination, appropriate disclosure and verification of their understanding, and voluntariness. In inflammatory bowel disease (IBD), pharmaceutical treatment carries significant risks, making discussion and illustration of the treatment critical for decision making. This review aims to emphasize the importance of the informed consent process in routine IBD clinical practice, and suggests an appropriate way of informing patients about the medical treatment on offer. The information that has to be comprehensively presented before consent includes: i) treatment goal; ii) basic characteristics of treatment (route and timetable of drug administration, drug efficacy, adverse events); and iii) consequences of staying untreated. The IBD physician's main concerns must include ensuring not only that the information being provided is detailed and objective, but also that the decision-making process is shared with the patient. Ultimately, the process of obtaining informed consent in real-world clinical practice is undoubtedly of great importance, for both upholding the principles of medical ethics and avoiding legal conflicts.

Evaluation of the Direct Economic Cost per Eradication Treatment Regimen against Helicobacter pylori Infection in Greece: Do National Health Policy-Makers Need to Care?

Helicobacter pylori (Hp) management has undoubtedly resulted in a notable economic burden on healthcare systems globally, including Greece. Its cost has never been estimated so far, especially during the recent 10-year unprecedented financial crisis. Direct medical and procedural costs for one attempt "outpatient" Hp eradication treatment were estimated as the following: (I) first-line regimens: 10 and 14 days standard triple, 10 and 14 days sequential, 10 and 14 days concomitant non-bismuth quadruple, 14 days hybrid, (II) second-line salvage regimens: 10 and 14 days levofloxacin-containing triple regimens. Treatment costs using prototypes and/or generic drugs were calculated. Drug prices were collected and confirmed from two official online medical databases including all medicines approved by the Greek National Organization for Medicines. Regimens based on generics were more affordable than prototypes and those including pantoprazole yielded the lowest prices (mean: 27.84 €). Paradoxically, 10-day concomitant and 14-day hybrid regimens (currently providing good (90-94%) first-line eradication rates in Greece) cost the same (mean: 34.76 €). The expenditures for Hp eradication treatment regimens were estimated thoroughly for the first time in Greece. These data should be taken into account by Public Health policymakers both in Greece and the European Union, aiming for a better and less expensive therapeutic approach.

Plummer-Vinson Syndrome in a Crohn's disease patient.

Plummer Vinson Syndrome (PVS), a rare condition complicating iron deficiency anaemia, manifests as a classic triad of dysphagia, anaemia and oesophageal web. Iron deficiency is the commonest systematic complication of Crohn's disease with only one described case of a Crohn's disease patient combined with PVS in the literature. We present a case of PVS complicating Crohn's disease in a 38-years-old female patient under treatment with the biologic agent Ustekinumab (human interleukin 12/23 monoclonal antibody) suffering from a progressively worsening dysphagia.

Helicobacter pylori eradication regimens in an antibiotic high-resistance European area: A cost-effectiveness analysis.

INTRODUCTION: Helicobacter pylori infection (H pylori-I) affects more than half of the global population and consists an important burden to public health and healthcare expenditures, by contributing to many diseases' pathogenesis. AIM: This study aimed to evaluate the current nonbismuth quadruple eradication regimens in a high antibiotic resistance area, such as Greece, concerning their cost-effectiveness, especially during financial crisis period. MATERIALS AND METHODS: Eight hundred and nine patients who received eradication treatment against H pylori-I were included to evaluate five different regimens, using amoxicillin, clarithromycin, and metronidazole as antibiotics and one proton-pump inhibitor, based on their current eradication rates. Regimes compared 10-day concomitant use of (a) pantoprazole or (b) esomeprazole; 10-day sequential use of (c) pantoprazole or (d) esomeprazole; and 14-day hybrid using esomeprazole. Cost-effectiveness analysis ratio (CEAR) and incremental cost-effectiveness ratios were calculated taking into account all direct costs and cases who needed second-line treatment. Additionally, sensitivity analysis was performed to predict all potential combinations. RESULTS: Ten-day concomitant regimen with esomeprazole was characterized by the lowest CEAR (179.17€) followed by the same regimen using pantoprazole (183.27€). Hybrid regimen, although equivalent in eradication rates, was found to have higher CEAR (187.42€), whereas sequential regimens were not cost-effective (CEAR: 204.12€ and 216.02€ respectively). DISCUSSION: This is the first study evaluating the cost-effectiveness of H pylori-I treatment regimens in a high clarithromycin-resistance (≈26.5%) European area, suggesting the 10-day concomitant regimen with generics using esomeprazole 40 mg as the most appropriate one. National and regional guidelines should include cost-effectiveness in their statements, and further studies are required to clarify the necessity of a wide "test and treat" policy for H pylori-I.

Impact of occupational stress on irritable bowel syndrome pathophysiology and potential management in active duty noncombat Greek military personnel: a multicenter prospective survey.

INTRODUCTION: Irritable bowel syndrome (IBS) is one of the gut-brain axis interaction disorders. It has global distribution with varying prevalence and particular financial and psychological consequences. IBS has been associated with stress and anxiety, conditions that are usually prevalent in the army. There are scarce data investigating the impact of IBS on noncombat active duty military without reports of Greek military or stress in the occupational environment. MATERIALS AND METHODS: The main exclusion criteria in our noncombat military multicenter prospective survey were gastrointestinal pathologies, malignancies, hematochezia, recent infections and antibiotics prescription, and pregnancy. Questionnaires included a synthesis of baseline information, lifestyle, and diet, psychological and stress-investigating scales and the IBS diagnosis checklist. Hospital Anxiety and Depression Scale and Rome IV criteria were utilized. RESULTS: Among 1605 participants included finally, the prevalence of IBS was 8% and 131 cases were identified. Women were more vulnerable to IBS, although male sex was prevalent at a ratio of 3.5 : 1 (male:female) in the entire sample. The mean age of all participants was 23.85 years; most of the IBS patients were older than thirty. Abnormal anxiety scores and high levels of occupational stress were related to an IBS diagnosis. DISCUSSION: This prospective multicenter survey showed, for the first time, the potential impact of occupational stress on IBS in active duty noncombat Greek Military personnel. The diagnosis of IBS by questionnaire is a quick, affordable way that can upgrade, by its management, the quality of life and relieve from the military burden. Our results are comparable with previous studies, although large-scale epidemiological studies are required for the confirmation of a possible causative relationship.

Evaluation of four time-saving methods of reading capsule endoscopy videos.

OBJECTIVE: Review of wireless capsule endoscopy recordings is time consuming. The aim of this study was to evaluate four time-saving methods offered with Rapid Software. METHODS: A total of 100 wireless capsule endoscopy videos with abnormal findings were evaluated using five different ways of viewing: (a) manual mode at a speed of 10 frames per second (fps), (b) manual mode at a speed of 20 fps, (c) manual mode with a simultaneous display of two images at a speed of 20 fps, (d) automatic mode at a speed of 10 fps, and (e) quickview mode at a speed of 3 fps. Then, we calculated the concordance of abnormal findings between each one of the four time-saving methods using method A. RESULTS: The mean reading time with time-saving methods was significantly shorter than with method A (method A: 59.8 min, method B: 30 min, method C: 30.2 min, method D: 32.2 min, method E: 16.3 min). The agreement in finding abnormal lesions between method A and the four evaluated methods was excellent and almost perfect (κ>0.8), except for quickview in recognizing polyps. Diagnostic miss rate was 1% for method D, 2% for B and C, and 12% for E. No tumors and cases of celiac or Crohn's disease were lost by all four methods. CONCLUSION: We conclude that manual mode/20 fps, the simultaneous projection of two images/20 fps, and automatic mode/10 fps have minimal diagnostic miss rates and can safely replace slower modes in clinical practice. The quickview mode is a safe diagnostic tool only when larger or diffuse lesions are suspected, such as Crohn's or celiac disease.

A study comparing an endoscopy nurse and an endoscopy physician in capsule endoscopy interpretation.

OBJECTIVE: Complete review of wireless capsule endoscopy (WCE) recordings by a physician is time-consuming and laborious and may be perceived as a limitation to perform WCE. The aim of this study was to evaluate the efficacy of a nurse in interpreting WCE. METHODS: A total of 102 WCE videos were evaluated by a single gastroenterologist and a nurse experienced as an assistant in diagnostic and interventional endoscopy and trained in WCE. After independently reviewing WCE videos, the two readers discussed their findings and came to a consensus. RESULTS: The mean capsule reading time was significantly longer for the nurse compared with the gastroenterologist (117.3+/-24.8 vs. 63.8+/-8.5 min, P<0.001). No statistical differences were observed regarding the correct recognition of first gastric, duodenal and caecal images between the two readers. For the gastroenterologist, both sensitivity and specificity in detecting abnormal findings were 100% except for angiodysplasia [sensitivity 88.5%, 95% confidence interval (CI): 70-97.4]. For the nurse, the lowest sensitivity rates were in detecting polyps (70%, 95% CI: 34.9-92.3) and angiodysplasias (92.3%, 95% CI: 74.8-98.9). The interobserver agreement as determined by Cohen's κ coefficient was excellent except for polyps (k=0.71, 95% CI: 0.46-0.96). CONCLUSION: A trained nurse is highly accurate in detecting abnormal findings and interpreting WCE recordings. Physician's role could be limited to consider and confirm thumbnails created by a nurse.

Efficacy of brimonidine in preventing intraocular pressure spikes following phacoemulsification in glaucoma patients.

PURPOSE: To measure intraocular pressure (IOP) elevation 6 and 24 hours after phacoemulsification in patients with glaucoma and to investigate the efficacy of brimonidine tartrate 0.2% in preventing IOP rise on the first postoperative day following cataract surgery. METHODS: In this prospective randomized single-masked study, 86 eyes of 78 patients with well-controlled open-angle glaucoma were scheduled for phacoemulsification surgery. Patients were randomly assigned into 2 groups. Group A received 1 drop of brimonidine tartrate 0.2% and group B, which served as a control group, received 1 drop of artificial tears. Intraocular pressure was measured at baseline, before surgery, and 6 and 24 hours postoperatively. RESULTS: Within each group, we found a statistically significant difference in IOP between baseline and 6 hours postoperatively (p<0.01) and between 6 and 24 hours (p<0.01). There was no statistically significant difference between baseline IOP and 24-hour values. Comparing the 2 groups, there was no statistically significant difference in preoperative and 24-hour postoperative IOP. Six hours after surgery, the mean IOP in the brimonidine group was 18.52±4.58 mmHg, compared with 20.86±3.79 mmHg in the control group. Treatment with brimonidine tartrate 0.2% significantly reduced postoperative IOP elevation 6 hours following cataract extraction (p=0.009). CONCLUSIONS: Patients with medically well-controlled glaucoma may experience a substantial increase in IOP shortly after phacoemulsification surgery. Instillation of brimonidine tartrate 0.2%, although it significantly reduced IOP elevation following cataract operation, did not completely prevent IOP spikes.