关键词： Aminosalicylates   Annualized medical cost   Anti-tumor necrosis factor alpha   Claims database   Corticosteroids   Crohn's disease   Gastroenterology   Healthcare resource utilization   Ulcerative colitis  

摘要： Introduction Conventional pharmaceutical interventions for inflammatory bowel disease (IBD) provide limited disease/symptom control and are associated with an increased risk of adverse events (AEs). These limitations increase patient morbidity, medical resource utilization (MRU), and costs. Methods The IQVIA (TM) Real-World Data Adjudicated Claims-US database was leveraged to identify adult patients (> 18 years) with Crohn's disease (Crohn's) or ulcerative colitis (UC), who were new and chronic users (>= 60 days) of oral corticosteroids (OCS), immunosuppressants (IS), anti-tumor necrosis factor agents (anti-TNF) or combinations thereof. Using aminosalicylate-treated patients as a reference, we compared AE incidence, MRU, and medical costs across drug classes. Results The analysis included 30,676 patients (Crohn's: n = 14,528;UC: n = 16,148). OCS monotherapy was the strongest predictor of any AE occurring [Crohn's: hazard ratio 1.62 (1.51-1.73);UC: hazard ratio 1.57 (1.49-1.66)]. A similar pattern was observed for severe infection and bone-related conditions. Patients with UC or Crohn's receiving OCS or IS plus OCS were more likely to have emergency department visits, IBD-related hospitalizations/visits/procedures, and gastrointestinal surgery than were patients receiving other therapies. Annualized total medical costs (pharmacy plus hospital service costs) were greatest for anti-TNF plus IS or anti-TNF therapy in both Crohn's and UC. Annualized medical service costs (excluding IBD drug costs) were highest for patients initiating OCS-containing therapies [Crohn's: OCS, $27,041 (24,882-29,200) and OCS plus IS, $23,332 (19,889-26,775);UC: OCS, $19,659 (17,977-21,340)]. Conclusion Although biologic therapies have higher pharmacy costs, treatment decisions should consider the increased AE risks and long-term MRU costs associated with chronic use of OCS-containing therapies. Funding This study was funded by F. Hoffmann-La Roche Ltd. The journal's Rapid Service Fee and Ope

关键词： Adverse childhood experiences   Attachment   Illness anxiety   Irritable bowel syndrome   Mentalizing   Somatic symptom disorder  

摘要： Objective: Irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD) have similar symptoms and are affected by psychological factors via gut-brain-interactions. However, previous studies on IBS and IBD showed inconsistent results regarding psychological factors, potentially because they failed to consider the impact of symptom activity. The aim of this study was 1) to compare psychological distress and psychological risk factors among patients with IBS, IBD and healthy controls (HC), and 2) to assess the impact of symptom activity. Methods: A controlled cross-sectional study was conducted. Patients with IBS and IBD were recruited in several primary, secondary, and tertiary medical care units between 02 and 12/2017 in Germany. Overall, 381 matched participants (127/group, 63% female) were included. For the second analyses, patients with IBD were distinguished in patients with active (n = 93) and non-active (n = 34) symptoms. Psychological distress (somatization, depression, anxiety, and illness anxiety) and risk factors (adverse childhood experiences, attachment style, and mentalizing capacity) were measured. Results: Patients with IBS showed higher psychological distress and more psychological risk factors than patients with IBD and HC. However, patients with IBD and active symptoms showed similar psychological distress than patients with IBS, except for lower illness anxiety (p < .001, eta(2) = 0.069). Conclusion: With the exception of higher illness anxiety in IBS patients, differences in psychological factors between patients with IBS and IBD were more strongly associated with symptom activity than with the underlying diagnosis. Therefore, this study challenges previous concepts of distinguishing functional and organic gastrointestinal diseases, but highlights the role of symptom activity and illness anxiety.

关键词： adherence   educational intervention   medical knowledge   transition readiness  

摘要： Objectives:Among adolescents with inflammatory bowel disease (IBD), nonadherence rates are 50 to 88% across medications. Improving education in adults with IBD has been shown to improve coping and adherence to treatment in adults with IBD. Therapeutic patient education (TPE) has been used in patients with chronic diseases to train patients in skills to support treatment adaptation and condition management. This study tested the feasibility and preliminary efficacy of a novel TPE intervention in adolescents with ***:In this pilot, mixed-methods study, we evaluated the feasibility and preliminary efficacy of TPE with the IBD Pocket Guide on medication adherence, IBD knowledge, and transition readiness in adolescents ages 11 to 18 years. Medication adherence was monitored using a MedMinder Pill Dispensing system. Participants who were <90% adherent during a 4-week pre-intervention monitoring period were randomized to either a usual care group or an educational intervention (EI) group. Participants were followed for an additional 4 weeks after ***:Trends were found in the EI group indicating improved medication adherence and IBD knowledge compared with the usual care group, though differences between groups did not reach statistical significance. Qualitative data showed that participants perceived that they had improved knowledge after the educational ***:Therapeutic patient education may be beneficial for improving patient medication adherence and IBD knowledge. Future directions include testing the effects of the intervention with a larger sample.

关键词： vancomycin   antibiotics   primary sclerosing cholangitis   inflammatory bowel disease   ulcerative colitis   Crohn's disease   microbiome  

摘要： The authors conducted a systematic review and meta-analysis to assess the effect of antibiotic therapy in primary sclerosing cholangitis (PSC). Effect of antibiotic therapy on Mayo PSC Risk Score (MRS), serum alkaline phosphatase (ALP), total serum bilirubin (TSB), and adverse events (AEs) rates were calculated and expressed as standardized difference of means or proportions. Five studies including 124 PSC patients who received antibiotics were included. Overall, antibiotic treatment was associated with a statistically significant reduction in ALP, MRS, and TSB by 33.2, 36.1, and 28.8%, respectively. ALP reduction was greatest for vancomycin (65.6%, p < 0.002) and smallest with metronidazole (22.7%, p = 0.18). Overall, 8.9% (95% confidence interval: 3.9-13.9) of patients had AEs severe enough to discontinue antibiotic therapy. In PSC patients, antibiotic treatment results in a significant improvement in markers of cholestasis and MRS. Antibiotics, particularly vancomycin, may have a positive effect on PSC either via direct effects on the microbiome or via host-mediated mechanisms.

关键词： Crohn disease   inpatient   mental health   parenteral nutrition   ulcerative colitis  

摘要： Objective:Few studies report the impact of depression on inflammatory bowel disease (IBD)-related hospitalizations. We evaluated the association between depression and pediatric IBD-related hospitalizations. Our primary aim was to test the hypothesis that depression is associated with hospital length of stay (LOS);our secondary goal was to evaluate if patients with depression are at higher risk for undergoing additional imaging and ***:Data were extracted from the 2012 Kids Inpatient Database (KID), the largest nationally representative publicly available all-payer pediatric inpatient cross-sectional database in the United States. Hospitalizations for patients less than 21 years with a primary diagnosis Crohn disease (CD) or ulcerative colitis (UC) by ICD-9 code were included. Multivariable logistic regression was used to predict long LOS controlling for patient- and hospital-level variables and for potential disease ***:For primary IBD-related hospitalizations (N=8222), depression was associated with prolonged LOS (odds ratio [OR] 1.50;95% confidence interval [CI] 1.19-1.90) and total parenteral nutrition use (OR 1.54;95% CI 1.04-2.27). Depression was not associated with increased likelihood of surgery (OR 0.97;95% CI 0.72-1.30), endoscopy (OR 0.91;95% CI 0.74-1.14), blood transfusion (OR 0.85;95% CI 0.58-1.23), or abdominal imaging (OR 1.15;95% CI 0.53-2.53).Conclusions:Depression is associated with prolonged LOS in pediatric patients with IBD, even when controlling for gastrointestinal disease severity. Future research evaluating the efficacy of standardized depression screening and early intervention may be beneficial to improving inpatient outcomes in this population.

关键词： Calprotectin   Saliva   Inflammatory bowel disease  

摘要： Objectives: To assess the concentration of calprotectin, a heterodimer of S100A8 and S100A9 implicated in inflammatory bowel disease (IBD), in saliva of IBD patients compared to controls. Methods: Unstimulated and stimulated saliva, and serum was collected from 23 IBD patients with active intestinal inflammation, verified by endoscopy. Fifteen patients were re-sampled after treatment. Saliva was collected from 15 controls for protocol validation and group comparisons. Calprotectin concentrations were measured by enzyme-linked immunosorbent assay, correlated to clinical data/indexes and routine laboratory parameters. Results: Calprotectin was 4.0-fold (median) elevated in stimulated saliva of IBD patients compared to controls and tended to be elevated in unstimulated saliva (P = 0.001, P = 0.090). Crohn's (CD) patients had significantly elevated calprotectin in both unstimulated and stimulated saliva compared to controls (P = 0.011, P = 0.002). Newly diagnosed, treatment naive CD patients had 8.2-fold (median) higher calprotectin concentrations in unstimulated saliva and 1.5-fold in stimulated saliva, compared to CD patients with established disease (P = 0.059, P = 0.019). Calprotectin decreased in serum of IBD patients after treatment (P = 0.011), and in unstimulated saliva of newly diagnosed, treatment naive CD patients (P = 0.046, P = 0.028). Conclusion: Salivary calprotectin is elevated in IBD, which suggests subclinical inflammatory responses in the oral cavity as a manifestation of IBD.

关键词： Crohn's Disease   Ulcerative Colitis   Inflammation   Short-Chain Fatty Acid  

摘要： BACKGROUND & AIMS: Altered interactions between the mucosal immune system and intestinal microbiota contribute to pathogenesis of inflammatory bowel diseases (IBD). It is not clear how inhibitors of cytokines, such as antagonists of tumor necrosis factor (anti-TNF), affect the intestinal microbiome. We investigated the effects of anti-TNF agents on gut microbe community structure and function in a longitudinal 2-step study of patients with IBD. We correlated our findings with outcomes of treatment and investigated patterns of metabolites in fecal samples before and after anti-TNF therapy. METHODS: We performed a prospective study of 2 cohorts of patients in Germany;the discovery cohort comprised 12 patients with IBD, 17 patients with rheumatic disease, and 19 healthy individuals (controls);fecal samples were collected at baseline and 2, 6, and 30 weeks after induction of anti-TNF therapy. The validation cohort comprised 23 patients with IBD treated with anti-TNF or vedolizumab (anti-alpha 4 beta 7 integrin) and 99 healthy controls;fecal samples were collected at baseline and at weeks 2, 6, and 14. Fecal microbiota were analyzed by V3-V4 16S ribosomal RNA gene amplicon sequencing. Clinical response and remission were determined by clinical disease activity scores. Metabolic network reconstruction and associated fecal metabolite level inference was performed in silico using the AGORA (Assembly of Gut Organisms through Reconstruction and Analysis) resource. Metabolomic analyses of fecal samples from a subset of patients were performed to validate metabolites associated with treatment outcomes. RESULTS: Anti-TNF therapy shifted the diversity of fecal microbiota in patients with IBD, but not with rheumatic disease, toward that of controls. Across timepoints, diversity indices did not vary significantly between patients with IBD who did or did not achieve clinical remission after therapy. In contrast, in silico modeling of metabolic interactions between gut microbes found

关键词： Inflammatory bowel disease   Crohn's disease   Ulcerative colitis   Thromboembolism   Transfusion   Bleeding  

摘要： Background Inflammatory bowel disease (IBD) exacerbation requiring hospitalization increases the risk of venous thromboembolism (VTE), and current guidelines recommend pharmacologic VTE prophylaxis (PVTEP). Aims Bleeding risks with PVTEP in this population are poorly defined, and no study has investigated packed red blood cell (PRBC) transfusion requirements in this population. Methods We conducted a chart review of all adult hospitalizations for IBD exacerbation within the Northwell Healthcare system. Patient characteristics recorded included demographics, disease type ulcerative colitis or Crohn's disease, severe disease defined by inpatient corticosteroid or biologic use, and admission hemoglobin. Inpatient use of PVTEP and antiplatelet therapies were identified. The primary outcome was the occurrence of any packed red blood cell (PRBC) transfusion. Results In total, 717 patients met inclusion criteria, accounting for 891 admissions. PVTEP was used during 60.4% of admissions, and 11.1% of patient admissions included a transfusion event. Severe disease patients receiving PVTEP had an 18.6% transfusion risk, versus 11.1% for those not receiving PVTEP, OR 1.82, CI (1.04-3.17). One multivariable analysis transfusion was associated with PVTEP, OR 2.11, 95% CI 1.18, 3.77, p=0.0120, disease severity OR 3.17, 95% CI 1.81,5.54, p<0.0001, anti-platelet therapies OR 2.46, 95% CI 1.23-4.90, p=0.0107, bowel resection OR 3.88, 95% CI 1.97,7.63, p<0.0001 and decreased admission hemoglobin OR 2.01, 95% CI 1.73-2.32, p<0.0001, but not disease type ulcerative colitis OR 0.71, 95% CI 0.42-1.20. Conclusion PVTEP during IBD exacerbation is associated with increased PRBC transfusions. Our findings do not constitute a contraindication to PVTEP, but may be incorporated into patient counseling during inpatient IBD management.

关键词： children   Crohn disease   home infusions   infliximab   infusion services   ulcerative colitis  

摘要： Objectives:We used a quality improvement (QI) approach to improve access and reduce barriers to care by increasing the number of external infliximab infusions at our pediatric inflammatory bowel disease ***:Using an iterative QI strategy, pediatric patients >= 12 years of age with inflammatory bowel disease were offered the opportunity to receive infliximab infusions at home/an external infusion center. They were required to first have >5 infusions at the hospital without any significant infusion reactions. Data were collected and tracked monthly using P-charts. Comparisons between control chart centerlines were analyzed using the Fisher exact ***:Fifty-four patients received external infusions, 87% had Crohn disease, 63% boys, average age 17.62.9 years, and 89% with private insurance. From September 2016 to January 2018, the percentage of eligible patients receiving external infusions was approximately 7%, increasing to approximately 30% by January 2018. A centerline shift, representing a statistically significant change, occurred in October 2016 and June 2017 (P<0.001). No serious safety concerns have ***:Through a multidisciplinary team of stakeholders using QI strategies, we now offer external infusion service options to all appropriate patients as routine practice. Home infusions are a viable option to reduce barriers to care, and our patients did not experience any safety events.