Background Intravenous (IV) steroids remain the first-line treatment for patients with acute ulcerative colitis (UC). However, 30% of patients do not respond to steroids, requiring second-line therapy and/or surgery. There are no existing indices that allow physicians to predict steroid nonresponse at admission. We aimed to determine if admission biochemical and endoscopic values could predict response to IV steroids. Methods All admissions for acute UC (ICD-10 K51) between November 1, 2011, and October 31, 2016 were identified. Case note review confirmed diagnosis; clinical, endoscopic, and laboratory data were collected. Steroid response was defined as discharge home with no further therapy for active UC. Nonresponse was defined as requirement for second-line therapy or surgery. Univariate and binary logistic regression analyses were employed to identify factors associated with steroid nonresponse. Results Two hundred and thirty-five acute UC admissions were identified, comprising both acute severe and acute nonsevere UC; 155 of the 235 patients (66.0%) responded to steroids. Admission C-reactive protein (CRP) (P = 0.009, odds ratio [OR] 1.006), albumin (P < 0.001, OR 0.894) and endoscopic severity (P < 0.001, OR 3.166) differed significantly between responders and nonresponders. A simple UC severity score (area under the curve [AUC] 0.754, P < 0.001) was derived from these variables; 78.1% (25 of 32) of patients with concurrent CRP ≥50 mg/L, albumin ≤30 g/L, and increased endoscopic severity (severe on physician’s global assessment) (maximum score = 3) did not respond to IV steroids (positive predictive value [PPV] 78.1%, negative predictive value [NPV] 87.1%). Conclusions More than three quarters of patients scoring 3 (albumin ≤30 g/L, CRP ≥50 mg/L, and increased endoscopic severity) did not respond to IV steroids. This combination of parameters (ACE) identifies on admission a high-risk population who may benefit from earlier second-line medical treatment or surgical intervention.
IntroductionLiver cirrhosis is a growing global healthcare challenge. Cirrhosis is characterised by severe liver fibrosis, organ dysfunction and complications related to portal hypertension. There are no licensed antifibrotic or proregenerative medicines and liver transplantation is a scarce resource. Hepatic macrophages can promote both liver fibrogenesis and fibrosis regression. The safety and feasibility of peripheral infusion of ex vivo matured autologous monocyte-derived macrophages in patients with compensated cirrhosis has been demonstrated.Methods and analysisThe efficacy of autologous macrophage therapy, compared with standard medical care, will be investigated in a cohort of adult patients with compensated cirrhosis in a multicentre, open-label, parallel-group, phase 2, randomised controlled trial. The primary outcome is the change in Model for End-Stage Liver Disease score at 90 days. The trial will provide the first high-quality examination of the efficacy of autologous macrophage therapy in improving liver function, non-invasive fibrosis markers and other clinical outcomes in patients with compensated cirrhosis.Ethics and disseminationThe trial will be conducted according to the ethical principles of the Declaration of Helsinki 2013 and has been approved by Scotland A Research Ethics Committee (reference 15/SS/0121), National Health Service Lothian Research and Development department and the Medicine and Health Care Regulatory Agency-UK. Final results will be presented in peer-reviewed journals and at relevant conferences.Trial registration numbersISRCTN10368050 and EudraCT; reference 2015-000963-15
The European Association for the Study of the Liver has produced extensive guidelines for the investigation and management of drug-induced liver injury. Here, we provide a commentary and overview of some of the principle disease investigations and management that arise from these guideline recommendations.
Background and aimsSARS-CoV-2 and consequent pandemic has presented unique challenges. Beyond the direct COVID-related mortality in those with liver disease, we sought to determine the effect of lockdown on people with liver disease in Scotland. The effect of lockdown on those with alcohol-related disease is of interest; and whether there were associated implications for a change in alcohol intake and consequent presentations with decompensated disease.MethodsWe performed a retrospective analysis of patients admitted to seven Scottish hospitals with a history of liver disease between 1 April and 30 April 2020 and compared across the same time in 2017, 2018 and 2019. We also repeated an intermediate assessment based on a single centre to examine for delayed effects between 1 April and 31 July 2020.ResultsWe found that results and outcomes for patients admitted in 2020 were similar to those in previous years in terms of morbidity, mortality, and length of stay. In the Scotland-wide cohort: admission MELD (Model for End-stage Liver Disease) (16 (12–22) vs 15 (12–19); p=0.141), inpatient mortality ((10.9% vs 8.6%); p=0.499) and length of stay (8 days (4–15) vs 7 days (4–13); p=0.140). In the Edinburgh cohort: admission MELD (17 (12–23) vs 17 (13–21); p=0.805), inpatient mortality ((13.7% vs 10.1%; p=0.373) and length of stay (7 days (4–14) vs 7 days (3.5–14); p=0.525)).ConclusionThis assessment of immediate and medium-term lockdown impacts on those with chronic liver disease suggested a minimal effect on the presentation of decompensated liver disease to secondary care.
Results: Of the 55 included children, 33 (60%) had UC/IBDU, and 22 (40%) had Crohn's Disease (CD); [28 (51%) male, mean age at first VDZ dose 14.5±2.8 years, and median disease duration 3.5 years (IQR 1.8-5.1)]. All were previously treated with anti-TNF (27% primary failure, 49% secondary failure, 15% adverse reaction and 9% for other reasons) and 8 (15%) had prior surgical intervention. Success rates at week 14 were 21% in UC, and only 9% in CD (p=0.24). Median follow-up period was 22 weeks (IQR 14-22) from VDZ initiation (range 6-76). Success rates by last follow-up were 39% in UC and 27% in CD (p=0.36). By the last follow-up 8 (15%) new children required surgery, of whom 6 had colectomy for UC (18% of the entire UC cohort). There were three mild adverse events to VDZ, including pruritis, transient dyspnea and mild periorbital oedema; there were no serious drug-related adverse events. Median fecal calprotectin decreased from 1168mcg/gm (IQR 609-1409) prior to treatment to 412mcg/gm (IQR 54-745) following treatment when available (p=0.013). Conclusions: In this largest real-life cohort of VDZ use in pediatric refractory IBD to date, VDZ was safe and effective in 21% and 39% of UC at 14 weeks and last follow-up whereas in CD the rates were 9% and 27%. These data thus support previous findings of slow induction rate of VDZ, particularly in CD. Background: Prior to the availability of biologic therapies, corticosteroids and narcotics were frequently used in inflammatory bowel disease (IBD) patients due to a paucity of disease modifying therapies. The increased accessibility to effective biologics for IBD over the last decade should be leading to less use of corticosteroids and narcotic medications. Methods: Data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) were used to examine visits of patients with IBD. Trends in corticosteroid and narcotic prescriptions were explored, and predictors of use were assessed using survey-weighted chi-square tests. Here, we present the short and medium term outcomes from a single centre cohort of IBD patients treated with vedolizumab. Methods: A vedolizumab treatment pathway was agreed. The following were prospectively collected for all patients at each infusion: observations, routine haematology, biochemistry and inflammatory markers, clinical disease activity score, faecal calprotectin (FC) and adverse events. Clinical effectiveness was evaluated by assessing changes in HBI and SCCAI at 12-14 weeks and 26 weeks. Clinical remission was defined as a HBI <5 and SCCAI <3. Response was defined as a change in disease activity ≥3. Changes in CRP/ FC were also analysed. Results: By the end of November 2016, 94 patients had received vedolizumab treatment. 63/94 (27 CD, 33 UC, 3 IBDU) had completed 12-14 week follow-up and are included in the primary analysis of clinical efficacy. Median disease duration was 7.9 years (IQR 4-15) with 36/63 (57%) patients previously exposed to anti-TNF therapy. Median HBI and SCCAI a...
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