Exabis Library

This course has been developed by physicians who had recently participated in the writing of the ECCO Crohn's disease consensus Guidelines. This course is intended for those who are interested in Inflammatory Bowel Disease(s) (IBD). One major aim of this e-learning activity is to increase competence and knowledge with regard to Luminal disease in order to improve patient outcomes.

Upon completion of this case you will:

• Know the evidence for induction of remission in mild-to-moderate Crohn’s disease;
• Know the evidence for maintaining remission in  Crohn’s disease;
• Know the evidence on how to react upon disease flares, immediately after induction therapy or during maintenance therapy; 
• Understand the benefits and risks of several medical therapies;
• Achieve familiarity how to use immunomodulatory agents in mono- or combination therapy;
• Achieve familiarity how to monitor Crohn’s disease patients who initiated medical therapy or who underwent surgery;
• Recognise indications for surgical management.

This course is designed for gastroenterologists, surgeons, and other interdisciplinary medical experts interested in IBD. The intended result of this activity is increased competence, knowledge, performance and improved patient outcome.

Upon completion of this activity learners will:

• Be aware of current treatment options for Crohn's disease
• Be able to understand treatment options are based on disease severity and prognostic factors at disease presentation
• Be able to understand the therapeutic choices for maintaining remission of disease
  
• Know how to prevent and treat the main adverse events related to drug therapy 
• Manage maintenance therapy in special situations

In this real-world-evidence (RWE) study we aimed to analyse the persistence of biologic therapy in biologic-naïve ulcerative colitis (UC) patients and to compare 1-year effectiveness of vedolizumab (VDZ) and anti-TNF.

Between 2017 and 2020, 1200 consecutively enrolled biologic-naïve and biologic- experienced patients with UC and Crohn´s disease (CD) were prospectively included in the VEDO_IBD-Registry from 45 IBD-experienced centres across Germany. After exclusion of bio-experienced patients, CD and missing outcomes, the final sample consisted of 274 biologic-naïve UC-patients with 1-year follow-up data. Switchers of a drug were considered as treatment failure (modified intention-to-treat analysis; mITT) while switchers were excluded from per protocol analysis (PP). Clinical response modified (reduction of partial Mayo score (pMayo) from baseline to 1-year by >3 points or a reduction of at least 30% compared to baseline or reaching remission at 1-year) and (steroid-free) remission rates (pMayo ≤1 plus a bleeding subscore=0 (and no systemic use of steroids or budesonide at 1-year)) were predefined as outcomes. To reduce the effect of confounders, PS adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI).

158 VDZ and 116 anti-TNF (ADA: 27.6%, IFX: 57.8%, GOL: 14.7%) biologic-naïve UC-patients were included in this prospective RWE comparing the effectiveness of VDZ vs anti-TNF. Until week 52 significantly more patients switched to another biologic-drug in the anti-TNF group than in the VDZ group (40.5% vs 16.5%; p<0.001) (Fig. 1). In mITT, clinical response at 1-year was significantly higher in VDZ than in anti-TNF treated patients (61.7% vs. 40.3%; OR 2.39 (95% CI 1.39-4.10)). VDZ also tended to be superior to anti-TNF for (steroid-free) remission (Tab. 1; p=0.058 (p=0.051)). In the PP-analysis, VDZ showed numerically higher 1-year effectiveness, but this did not reach statistical significance (Tab. 1). Analysing week-14 induction phase responders (Tab. 2), VDZ had numerically higher effectiveness rates compared to anti-TNF but without significant difference.

The 1-year maintenance findings suggested, in line with our previous induction phase data, only moderate long-term effectiveness in both groups. However, besides the significant response data, VDZ showed numerically higher remission rates compared to anti-TNF though only borderline significant. The higher treatment persistence of VDZ vs anti-TNF, along with the higher effectiveness, may suggest VDZ as a first-line biologic therapy option in UC patients.

Progress in medicine has been made in the past primarily through the clinical experience of physicians and uncontrolled observations. With the advent of medical journals, knowledge dissemination and much of medical progress had been made possible through clinical reports and meticulous observations on cases or series of cases. This was true for many medical breakthroughs, including the initial paper by Burrill Crohn, Leon Ginzburg and Gordon Oppenheimer, who described their observations of a mere 14 surgical patients with ‘regional ileitis’, which later became known as Crohn’s disease.1 However in recent decades, the controlled clinical trial gained primacy as the holy grail of evidence-based medicine, and observational studies similarly became subject to stricter and preferably comparative statistical methodology in the forms of population-based studies, prospective cohorts or retrospective case-control studies. This trend, towards comparative and preferably controlled research methodology as the prevailing dogma, has led to case reports falling out of favour with the medical scientific community touting its potential caveats of chance associations and susceptibility to many uncontrolled confounders. Coupled with the fact that case reports may create less citation potential, which is necessary for a journal impact factor and citation index standing, case reports and case series have also found it increasingly difficult to be published.2 Indeed most leading gastroenterology journals, JCC included, now generally refrain from publishing case reports or small case series.

These guidelines provide a guide to clinicians managing children with UC and IBD-unclassified management to provide modern management strategies while maintaining vigilance around appropriate outcomes and safety issues.

Background and aim: Acute severe colitis (ASC) is one of the few emergencies in pediatric gastroenterology. Tight monitoring and timely medical and surgical interventions may improve outcomes and minimize morbidity and mortality. We aimed to standardize daily treatment of ASC in children through detailed recommendations and practice points which are based on a systematic review of the literature and consensus of experts.

The aim of this new consensus is to establish standards for the diagnosis and management of Paediatric UC. It will include the use of immunosuppressors and biologics.