Background & Aims Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. Methods This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (Harvey–Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. Results Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26–52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. Conclusions Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.

ObjectivesThe understanding of changes in comorbidity might improve the management of upper gastrointestinal bleeding (UGIB); such changes might not be detectable in short-term studies. We aimed to study UGIB mortality as adjusted for comorbidity and the trends in risk scores over a 14-year period.MethodsPatients presenting with UGIB to a single institution, 1996–2010, were assessed. Those with multiple comorbidities were managed in a multi-disciplinary care unit since 2000. Trends with time were assessed using logistic regression, including those for Charlson comorbidity score, the complete Rockall score and 30-day mortality.Results2669 patients were included. The Charlson comorbidity score increased significantly with time: the odds of a high (3+) score increasing at a relative rate of 4.4% a year (OR 1.044; p<0.001). The overall 30-day mortality was 4.9% and inpatient mortality was 7.1%; these showed no relationship with time. When adjusted for the increasing comorbidity, the odds of death decreased significantly at a relative rate of 4.5% per year (p=0.038). After the introduction of multi-disciplinary care, the raw mortality OR was 0.680 (p=0.08), and adjusted for comorbidity it was 0.566 (p=0.013).Conclusions30-day mortality decreased when adjusted for the rising comorbidity in UGIB; whether this is related to the introduction of multi-disciplinary care needs to be considered.

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Summary Background Acute upper gastrointestinal bleeding (UGIB) remains a major cause of hospital admission worldwide. The recent UK National Confidential Enquiry into Patient Outcome and Death (NCEPOD) report on severe gastrointestinal bleeding used the Shock Index to assess bleeding severity and found an association between Shock Index and mortality. However, this has never been prospectively validated as a predictor of outcome in UGIB. Aims To compare the Shock Index with existing pre‐endoscopic UGIB risk scores in predicting outcomes after UGIB Methods In an international, prospective study of 3012 consecutive patients with UGIB, we compared the Shock Index with existing scores including the Glasgow Blatchford score (GBS), admission Rockall score, AIMS65, and the newly described “ABC” score. Pre‐determined endpoints were need for major (≥4 units red cells) transfusion, need for endoscopic therapy and 30‐day mortality. Results The Shock Index was inferior to the GBS in predicting need for major transfusion (area under the receiver operator characteristic curve [AUROC] 0.655 vs 0.836, P < 0.001) and need for endotherapy (AUROC 0.606 vs 0.747, P < 0.001). The Shock Index was inferior to all other scores for 30‐day mortality: for example, AUROC 0.611 vs 0.863 for ABC score (P < 0.001). Adding the Shock Index to the ABC score did not improve accuracy of the ABC score in predicting mortality (AUROC 0.864 vs 0.863, P = 0.95). Conclusion The Shock Index performed poorly with AUROCs <0.66 and was inferior to existing pre‐endoscopy scores at predicting major clinical endpoints after UGIB. We found no clear evidence that the Shock Index is clinically useful at predicting outcomes in UGIB. [Correction added on 20 December 2019, after first online publication: Summary section has been changed for clarification.]