Treatment Adherence of Anti-TNF Drugs in the Patients with Inflammatory Bowel Disease: A Scale Development Study.

BACKGROUND: This work studies the validity and reliability of the Anti-TNF Alpha Treatment Adherence Scale, which has newly been developed to measure the compliance of inflammatory bowel disease patients using the anti-TNF alpha agents that are widely used in gastroenterology and rheumatology clinics. METHODS: The study group consisted of 165 irritable bowel disease patients aged 18 years and above who were using anti-TNF alpha drugs. After creating a question pool with 40 items, the pilot study was applied with 70 patients. SPSS 25.0 and AMOS programs were used. Item-total correlation coefficients, Cronbach's alpha and test-retest analysis, missing data, extreme value, normality, 27% sub- upper item discrimination analysis, and exploratory and confirmatory factor analyses were used. RESULTS: The factor structure of the scale was examined with exploratory and confirmatory factor analyses and the contribution of these components to the total variance was measured as 74.21%. The Anti-TNF Alpha Treatment Adherence Scale was found in relation to the scale structure consisting of 12 items and 4 sub-dimensions. According to the first level multifactorial analysis results, the goodness of fit identities of the scale were found at an acceptable level, with the following values: RMSEA 0.067; GFI 0.92; AGFI 0.87; CFI 0.95; andχ2 79.876 (P = .000). CONCLUSION: It was determined that the Anti-TNF Alpha Treatment Adherence Scale represents the area to be measured, measures the researched structure, has a high internal consistency between items, is interrelated, and is consistent over time. As a result of all mea- surements, it was determined that it is a valid and reliable scale.

The relevance between anti-rods/rings antibody and different treatment regimens in chronic hepatitis C virus infection.

The antibodies and other issues associated with immunity in chronic hepatitis C virus (HCV) have been widely investigated, especially non-organ-specific antinuclear antibodies. Rods-rings (RR) antibody patterns are frequently observed due to pegylated IFN-α (PEG-IFN)/ribavirin (RBV) treatment by indirect immunofluorescence (IIF). We evaluated the relevance between anti-RR and PEG-IFN/RBV and/or direct-acting antiviral (DAA) regimens in chronic HCV. Sampling was done after achieving a sustained virological response (SVR) for 178 patients (aged >18 years). Patients were grouped according to treatment protocols (Group 1 [G1]: PEG-IFN/RBV [n = 53], Group 2 [G2]: PEG-IFN/RBV and Telaprevir or Boceprevir [n = 31], Group 3 [G3]: second- and third-wave DAA and previously received PEG-IFN/RBV (n = 38), and Group 4 [G4]: second- and third-wave DAA [n = 56]). Anti-RR was investigated by IIF (Euroimmun AG) test. Overall, 27 (15.16%) patients were anti-RR positive and received PEG-IFN/RBV. The numbers of anti-RR positivity for G1/2/3/4 (%) were 16/3/8/0 (30.2/9.6/21/0), respectively (p < .001). The anti-RR positivity rate for G1/2/3 was 22.13% (27/122, p = .088). Anti-RR was positive in 17.5% (11/63) of G1/2/3 patients who did not achieve SVR after the first treatment. This rate was 27.1% (16/59) in patients with SVR after the first treatment in G1/2 and there was no difference between these two classified groups in terms of antibody titers (p = .915). Anti-RR was detected up to 172 months after SVR. In summary, anti-RR was positive in high rates in patients receiving PEG-IFN/RBV therapy. Frequent monitoring is needed during patient follow-up to get more data on the relationship between anti-RR titer, treatment regimens, and SVR.

Work Productivity Loss in Inflammatory Bowel Disease Patients in Turkey.

BACKGROUND: Beyond the medical treatment in inflammatory bowel disease (IBD), there are other issues which influence the quality of life adversely. The aim of this study was to determine the impact of the IBD patients' illness on working and education life. METHOD: The participants were invited to participate in the online survey from the Turkish Crohn's and Ulcerative Colitis Patient Association network. The data was analysed and then discussed to improve the health-related quality of working and education life. RESULTS: One hundred and fifteen patients had ulcerative colitis (UC) (57.2%), and 86 had Crohn's disease (CD) (42.8%). There was a statistically significant difference in UC between retirement age group 1 (<40 age) and groups 2 (40-49 ages) and 4 (60-65 ages) (p < 0.05). There was the same significant difference in CD. Even though the data did not have significant statistical difference, there was clustering around negative perceptions the patients have about their working and education lives. CONCLUSION: Our survey revealed a very strong causative relationship between work and IBD involving problems before, during, and at the end of employment. Young patients lower their career expectations, and that announces a clear need to support them and improve career guidance.

Portal Hypertensive Polyps as Gastroscopic Finding in Liver Cirrhosis.

BACKGROUND: Portal hypertensive polyps in patients with portal hypertension are described. AIMS: The most significant and serious complication in liver cirrhosis proves to be portal hypertension. Polypoid lesions, which can be seen in the stomach as endoscopic finding in patients with portal hypertension, have not quite been defined in the literature. The aim of this study, therefore, was to define polypoid lesion formation due to portal hypertension in the upper gastrointestinal system in patients with portal hypertension. Study Design. Cross-sectional study. METHODS: The study covered a group of patients with liver cirrhosis and a healthy control group that did not have portal hypertension. All individuals covered by the study received upper GI endoscopy, while the endoscopic features and pathological characteristics of the identified polypoid lesions were defined. Standard histological criteria were used in polyp diagnosis. RESULTS: A total of 400 individuals were included in the study. Upper GI endoscopy was performed for 200 patients with liver cirrhosis and another 200 healthy individuals with no portal hypertension in the control group. When the cases were gastroscopically assessed with regard to polypoid lesion presence, it was seen that a total of 87 (21.8%) individuals had polyps. While 67 (33.5%) cirrhotic patients were identified to have polyps, 20 (10%) individuals in the healthy control group had polyps. When the results of those with liver cirrhosis who received esophageal variceal endoscopic band ligation (EVL) and who did not were compared, it was observed that a higher number of individuals in the group with EVL had polypoid lesions. When the patient and control groups were compared as to Helicobacter pylori presence, the results showed that it was slightly higher in the dyspepsia group but the difference was not statistically significant (p > 0.05). CONCLUSION: Portal hypertension-associated polypoid lesions are common in advanced liver cirrhosis cases. The pathological analyses of these polyps pointed out that they were all benign and no malignant cases were detected. It was argued that these polypoid lesions, referred to as portal hypertensive polyps, were associated with elevated angiogenesis in the gastric mucosa.

Serum Syndecan-1 Levels and Its Relationship to Disease Activity in Patients with Crohn's Disease.

Background. Syndecan-1 (SDC-1), a member of the family of heparan sulfate proteoglycans, plays an important role in the resolution of inflammation. This study aimed to investigate the relationship between SDC-1 and disease activity in Crohn's disease (CD). Methods. Serum samples of 54 patients with CD and 30 healthy controls were obtained. First, SDC-1 levels of the CD patients were compared to the control group. Subsequently, SDC-1 levels were analyzed in patients with CD in active and remission periods. Finally, SDC-1 efficacy in predicting disease activity was evaluated by performing correlation analysis between SDC-1 and C-reactive protein (CRP) and Crohn's disease activity index (CDAI). Results. SDC-1 level was higher in the CD group (61.9 ± 42.6 ng/mL) compared with the control group (34.1 ± 8.0 ng/mL) (p = 0.03). SDC-1 levels were higher in active CD patients (97.1 ± 40.3 ng/mL) compared with those in remission (33.7 ± 13.5 ng/mL) (p < 0.001). A significant positive correlation was found between SDC-1 and CRP (r = 0.687, p < 0.001) and between SDC-1 and CDAI (r = 0.747, p < 0.001). Conclusion. Serum levels of SDC-1 are higher in CD compared to the normal population and can be an effective marker of disease severity.

The effect of intravenous iron treatment on quality of life in inflammatory bowel disease patients with nonanemic iron deficiency.

Background. Iron deficiency is the prevalent complication of inflammatory bowel disease (IBD). Herein, we investigated the effect of intravenous iron treatment on quality of life (QoL) in nonanemic and iron deficient IBD patients. Methods. Eighty-five IBD patients were recruited for this study. The patients were intravenously administered 500 mg iron sucrose in the first week of the study. Hematologic parameters and QoL were evaluated before to iron treatment and during the 12th week of treatment. The Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36) Health Survey were used to assess QoL. Results. Prior to intravenous iron administration, the IBDQ, SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were 152.3 ± 30.6, 46.7 ± 7.3, and 45.7 ± 9.8, respectively. In the 12th week of iron administration, those scores were 162.3 ± 25.5 (P < 0.001), 49.3 ± 6.4 (P < 0.001), and 47.6 ± 8.9 (P = 0.024), respectively, which were all significantly different from the scores prior to iron administration. The mean changes in the IBDQ scores for ulcerative colitis and Crohn's disease were 8.7% and 3.0% (P = 0.029), were 6.4% and 4.7% (P = 0.562) for the SF-36 PCS, and were 4.6% and 3.2% (P = 0.482) for the SF-36 MCS, respectively. Conclusion. Intravenous iron treatment may improve QoL in nonanemic, but iron deficient, IBD patients.

An Evaluation of the Correlation between Hepcidin Serum Levels and Disease Activity in Inflammatory Bowel Disease.

Aim. While there are many well-defined serological markers for inflammatory bowel disease (IBD), there is limited evidence that they positively affect clinical outcomes. This study aimed to evaluate the correlation between hepcidin serum levels and disease activity in IBD. Materials and Methods. Eighty-five consecutive IBD patients were enrolled in the study. Hepcidin serum levels were assessed using an enzyme-linked immunosorbent assay (ELISA) and were compared with disease activity as well as the interleukin-6 (IL-6) and C-reactive protein (CRP) levels. Results. The mean hepcidin serum levels in Crohn's disease (CD) patients in remission and in the active phase were 3837 ± 1436 and 3752 ± 1274 pg/mL, respectively (P = 0.613). The mean hepcidin serum levels in ulcerative colitis (UC) patients in remission and in the active phase were 4285 ± 8623 and 3727 ± 1176 pg/mL, respectively (P = 0.241). Correlation analysis between inflammatory markers and hepcidin serum levels indicated that there was no correlation between hepcidin levels and IL-6 (P = 0.582) or CRP (P = 0.783). Conclusion. As an acute-phase protein, hepcidin seems to have a lower efficacy than other parameters in the detection of activation in IBD.

The prevalence of IgG4-positive plasma cell infiltrates in inflammatory bowel disease patients without autoimmune pancreatitis.

BACKGROUND/AIMS: IgG4-related autoimmune disease can exist in other organs even when there is no evidence of autoimmune pancreatitis. The aim of our study was to determine the prevalence of IgG4-positive plasma cells in the histopathological evaluations of colon biopsy specimens in IBD patients. MATERIALS AND METHODS: The number of IgG4-positive plasma cells with strong cytoplasmic immunoreactivity was counted in each colon biopsy from inflammatory bowel disease patients who had no evidence of autoimmune pancreatitis. Five high power fields (HPFs) in the highest density plasma cell infiltration area were counted and were then averaged. An average >10 cells/HPF was considered significant for IgG4-related disease. RESULTS: We detected IgG4-positive plasma cell staining in the colon of 21 of 119 patients (17.6%). Of these 21 patients, 5 had elevated serum IgG4 levels (>140 mg/dL). Of the total, 4.2% (5/119) had both IgG4-immunstaining and elevated IgG4 serum levels. The demographic features, disease type and activity, and response to treatment (especially to steroid treatment) were similar between the IgG4-negative and IgG4-positive groups. CONCLUSION: In our study, 4.2% of patients with the diagnosis of IBD had elevated IgG4 serum levels and significant IGg4 immunostaining. Together, these two parameters indicate the possible diagnosis of an IgG4-related systemic disease.

Use of direct, endoscopic-guided measurements of mucosal impedance in diagnosis of gastroesophageal reflux disease.

BACKGROUND & AIMS: Diagnostic tests for gastroesophageal reflux disease (GERD) are constrained because measurements are made at a single time point, so the long-term effects on the mucosa cannot be determined. We developed a minimally invasive system to assess changes in esophageal mucosal impedance (MI), a marker of reflux. We measured the extent of changes in MI along the esophagus and show that the device to assess MI can be used to diagnose patients with GERD. METHODS: A single-channel MI catheter composed of a unique sensor array was designed to easily traverse the working channel of an upper endoscope. We performed a prospective longitudinal study of patients with erosive esophagitis (n = 19), nonerosive but pH-positive GERD (n = 23), and those without GERD (n = 27). MI was measured at the site of esophagitis as well as 2, 5, and 10 cm above the squamocolumnar junction. The MI values were compared among groups, at different levels along the esophageal axis. RESULTS: Median MI values were significantly lower at the site of erosive mucosa (811 Ω; range, 621-1272 Ω) than other nonerosive regions (3723 Ω; range, 2421-4671 Ω; P = .001), and were significantly lower at 2 cm above the squamocolumnar junction in patients with GERD (2096 Ω; range, 1415-2808 Ω), compared with those without GERD (3607 Ω; range, 1973-4238 Ω; P = .008). There was a significant and graded increase in MI along the axis of the distal to proximal esophagus in patients with GERD that was not observed in individuals without reflux (P = .004). CONCLUSIONS: Measurements of MI along the esophagus can be used to identify patients with GERD. ClinicalTrials.gov, number NCT01194323.

Extraesophageal manifestations of gastroesophageal reflux disease: cough, asthma, laryngitis, chest pain.

GER is a common condition affecting many patients in different parts of the world. It usually presents with the classic manifestations of heartburn and regurgitation; however, in some it can also present with extraesophageal manifestations such as chronic cough, laryngitis, asthma or chest pain. Commonly employed diagnostic tests such as EGD and ambulatory pH or impedance monitoring in GER, are less useful in extraesophageal syndromes due to their poor sensitivity and specificity. In contrast, empiric trials of PPI's are shown to be cost effective; however, patients may require long-term treatment to establish effectiveness. Diagnostic testing with pH and impedance monitoring are commonly reserved for patients with partial or poor response to the initial treatment with PPI's. Poor response to PPI therapy may be an important indicator for non-GER causes for patients' symptoms and should initiate a search for other potential causes.

Rapid salivary pepsin test: blinded assessment of test performance in gastroesophageal reflux disease.

OBJECTIVE/HYPOTHESIS: Pepsin lateral flow device (LFD) is a rapid noninvasive test to detect salivary pepsin as a surrogate marker for gastroesophageal reflux disease (GERD). We aimed to establish the test sensitivity, specificity, positive and negative predictive values (PPV, NPV) in patients with symptomatic and objective evidence of GERD compared to healthy controls. STUDY DESIGN: Prospective, blinded, controlled cohort study. METHODS: A total of 230 samples were analyzed. In vitro bench testing was conducted on 52 gastric juice and 54 sterile water samples to assess test sensitivity and specificity. Saliva was collected from 58 patients with GERD and 51 controls. All patients with GERD underwent esophagogastroduodenoscopy (EGD) and wireless 48-hour pH monitoring off acid suppressive therapy. PPV and NPV were calculated based on disease definition of esophagitis and/or abnormal pH monitoring. RESULTS: Receiver operating characteristics analysis of in vitro samples found assay sensitivity and a specificity of 87%. There were 6/51 (12%) control subjects and 13/58 (22%) patients with GERD who tested positive for salivary pepsin (P = .25). There was a step-wise increase in the prevalence of positive salivary pepsin: esophagitis (55%), abnormal pH monitoring (43%), GERD symptoms only (24%) (P < .001). Salivary pepsin test showed a PPV of 81% and NPV of 78% for those with objective evidence of GERD (abnormal pH and/or esophagitis). CONCLUSIONS: Rapid LFD for salivary pepsin has acceptable test characteristics in patients with GERD. A positive salivary pepsin test in this group may obviate the need for more expensive diagnostic testing by EGD or pH monitoring.

New developments in extraesophageal reflux disease.

Gastroesophageal reflux disease (GERD) can present with a wide variety of extraesophageal symptoms that are usually difficult to diagnose because of the absence of typical GERD symptoms (ie, regurgitation or heartburn). The diagnostic process is further complicated by the lack of a definitive test for identifying GERD as the cause of extraesophageal reflux symptoms. Due to the low predictive value of upper endoscopy and pH testing-as well as the lack of reliability of the symptom index and symptom association probability-extraesophageal reflux disease is still an area of investigation. This paper discusses recent developments in this field, with special emphasis on new diagnostic modalities and treatment options.