Distribution-Free Approach to the Design and Analysis of Randomized Stroke Trials With the Modified Rankin Scale.

Background: Many methods have been suggested for analyzing the modified Rankin Scale (mRS). However, there lacks a unified approach to analysis and sample size determination that properly uses the ordinal nature of the data. We propose a simple method for CI estimation and corresponding sample size determination.

Food Insecurity Negatively Impacts Gluten Avoidance and Nutritional Intake in Patients With Celiac Disease.

Background: Food insecurity is a major public health challenge. For patients with celiac disease (CeD), food insecurity may be particularly detrimental as it threatens the cornerstone of their treatment: adoption of a gluten-free diet (GFD). We aimed to characterize the prevalence of food insecurity in patients with CeD and evaluate its impact on GFD adoption and nutritional intake.

Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis.

Introduction: The optimal instrument for assessing histologic disease activity in patients with eosinophilic esophagitis (EoE) is unclear. We assessed the responsiveness of the EoE Histologic Scoring System (EoE-HSS) when compared with that of the peak eosinophil count (PEC).

Methods: Histopathology slides were obtained from patients with EoE at baseline and after 8 weeks of treatment with swallowed topical budesonide or elimination diet.

Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis.

Endoscopic ultrasound (EUS) may be a useful modality for disease assessment and risk stratification in ulcerative colitis. We assessed the reliability of a newly developed EUS index of inflammation called the EUS-Ulcerative Colitis (EUS-UC) score. The EUS-UC score components include total wall thickness, hyperemia, and depth of inflammation (DOI).

Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn's Disease After Elective Surgery: Meta-Analysis.

Background: Postoperative complication rates in patients with inflammatory bowel disease (IBD) receiving preoperative biologics have been analyzed without considering the surgical context. Emergency surgery may be associated with an increased risk of infectious complications, compared to elective operations.

Aims: To conduct a systematic review and meta-analysis investigating the relationship between preoperative biologic therapy and postoperative outcomes in Crohn's disease (CD) and ulcerative colitis (UC), focusing on elective surgery.

Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy.

Vedolizumab has become an integral part of the therapeutic armamentarium for patients with inflammatory bowel disease (IBD) who have failed conventional medical therapy. Vedolizumab is an α4β7 integrin antagonist that inhibits intestinal T-cell translocation by blocking integrin interactions with mucosal vascular addressin cellular adhesion molecule 1, reducing lymphocyte-mediated inflammation. Its gut selective mode of action and favorable safety profile have led to reports of off-label use for non-IBD-related inflammatory intestinal disorders, such as microscopic colitis, and small intestinal inflammatory conditions including autoimmune enteropathy and common variable immune deficiency-related enteritis.

Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study.

Background: The optimal ulcerative colitis biopsy protocol is unclear.

Aim: To evaluate the number of biopsies required to accurately assess microscopic disease activity in ulcerative colitis METHODS: Biopsies from patients with ≥4 rectosigmoid samples, and clinical and endoscopic data, were retrospectively obtained from a prospective biobank. Histology and endoscopic videos were read blindly.

Biomarkers of Crohn's Disease to Support the Development of New Therapeutic Interventions.

Background: Currently, 2 coprimary end points are used by health authorities to determine the effectiveness of therapeutic interventions in patients with Crohn's disease (CD): symptomatic remission (patient-reported outcome assessment) and endoscopic remission (ileocolonoscopy). However, there is lack of accepted biomarkers to facilitate regulatory decision-making in the development of novel therapeutics for the treatment of CD.

Methods: With support from the Helmsley Charitable Trust, Critical Path Institute formed the Crohn's Disease Biomarkers preconsortium (CDBpC) with members from the pharmaceutical industry, academia, and nonprofit organizations to evaluate the CD biomarker landscape.

KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy.

A reliable outcome measure is needed for bowel preparation quality during capsule endoscopy. Currently, no scales are adequately validated. Our objective was to update an existing small bowel preparation score, create a standardized training module, then determine its inter-rater and intra-rater reliability.

Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease.

Background: We assessed whether differential efficacy of early combined immunosuppression (ECI) in comparison with conventional management (CM) is present in patients with Crohn disease (CD) according to disease location.

Methods: In this posthoc analysis of the Randomized Evaluation of an Algorithm for Crohn's Treatment trial, the effect of ECI vs CM modified by disease location (isolated-colonic vs ileal-dominant) in terms of time to first complication (hospitalization, surgery, or disease-related complications-presence of a new abscess, fistula, or stricture; serious worsening of disease activity; extraintestinal manifestations) was analyzed using a marginal Cox proportional hazard model to account for cluster randomization. Factors adjusted included practice size, country, and other covariates selected in a backward logistic regression analysis with the first composition as outcome and P < 0.

Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis.

Background: Patient-reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies.

Aims: To develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research).

Methods: Concept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada.

Systematic Review: Patient Perceptions of Monitoring Tools in Inflammatory Bowel Disease.

Background And Aims: Inflammatory bowel disease (IBD) is a lifelong disease requiring frequent assessment to guide treatment and prevent flares or progression. Multiple tools are available for clinicians to monitor disease activity; however, there are a paucity of data to inform which monitoring tools are most acceptable to patients. The review aims to describe the available evidence for patient preference, satisfaction, tolerance and/or acceptability of the available monitoring tools in adults with IBD.

Cannabis for the Treatment of Crohn's Disease and Ulcerative Colitis: Evidence From Cochrane Reviews.

Background: We systematically reviewed the safety and effectiveness of cannabis and cannabinoids treatment for Crohn's disease (CD) and ulcerative colitis (UC).

Methods: MEDLINE, Embase, WHO ICTRP, AMED, PsychINFO, CENTRAL, ClinicalTrials.Gov, and the European Clinical Trials Register were searched for relevant studies.

Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease.

Background: We summarized the protocol-specified corticosteroid tapering regimens in clinical trials of moderate-severe ulcerative colitis (UC) and Crohn's disease (CD) and calculated differences in rates of clinical remission vs corticosteroid-free clinical remission (CSF-CR).

Methods: Through a systematic literature review through February 28, 2019, we identified 16 randomized controlled trials (RCTs) of biologics or small molecules in patients with moderate-severe UC or CD who reported CSF-CR as an outcome. We estimated the relative risk and 95% confidence interval of achieving CSF-CR vs overall clinical remission in patients treated with active intervention or placebo through random-effects meta-analysis.

Response to Placebo, Measured by Endoscopic Evaluation of Crohn's Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials.

Background & Aims: Endoscopy is used to measure activity of Crohn's disease (CD) and determine eligibility and outcomes of participants in randomized controlled trials of therapeutic agents. We aimed to estimate the rate of response to placebo in trials, based on endoscopic evaluation of CD activity, and identify factors that affect this response.

Methods: We collected patient-level data from randomized, double-blind, placebo-controlled trials of therapeutic agents for CD that included centrally-read endoscopic assessments with validated scoring indices.

Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review.

Eosinophilic esophagitis (EoE), a chronic allergic disorder of the esophagus, is characterized by symptoms of esophageal dysfunction and eosinophil-predominant inflammation. The incidence of EoE has increased substantially over the past two decades, coinciding with the so-called allergy epidemic. Current treatment options consist of dietary intervention, endoscopic dilatation, and pharmacotherapy.

Targeting anti-fibrotic pathways in Crohn's disease - The final frontier?

Intestinal fibrosis with stricture formation affects up to half of patients with Crohn's disease (CD), resulting in impaired quality of life, increased risk of surgical intervention, and associated patient morbidity. The underlying pathophysiologic mechansisms responsible for initiating and perpetuating intestinal fibrosis are complex, dynamic, and implicate both inflammation-dependent and independent pathways. Previously thought to be an irreversible complication of long-standing inflammation unresponsive to medical therapy, fibrostenotic CD has been traditionally managed with endoscopic or surgical approaches.

No increased risk of nephrotoxicity associated with 5-aminosalicylic acid in IBD: a population-based cohort and nested case-control study.

Background: There is conflicting evidence about nephrotoxicity risk associated with 5-aminosalicylates for treatment of IBD.

Aims: To determine population-based temporal trends for 5-aminosalicylates and estimated risk of nephrotoxicity associated with 5-aminosalicylate use for ulcerative colitis (UC) and Crohn's disease (CD).

Methods: Retrospective cohort and nested case-control study, using the Health Improvement Network primary care database linked to hospital discharge coding for patients in England, 1996-2017.